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Clinical Trial Details — Status: Suspended

Administrative data

NCT number NCT03150693
Other study ID # A041501
Secondary ID NCI-2016-01981U1
Status Suspended
Phase Phase 3
First received
Last updated
Start date June 1, 2017
Est. completion date August 2025

Study information

Verified date May 2024
Source Alliance for Clinical Trials in Oncology
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This partially randomized phase III trial studies the side effects of inotuzumab ozogamicin and how well it works when given with frontline chemotherapy in treating patients with newly diagnosed B acute lymphoblastic leukemia. Monoclonal antibodies, such as inotuzumab ozogamicin, may block cancer growth in different ways by targeting certain cells. Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving inotuzumab ozogamicin with chemotherapy may work better in treating young adults with B acute lymphoblastic leukemia.


Description:

PRIMARY OBJECTIVES: I. To confirm tolerability of the combination regimen with the addition of inotuzumab ozogamicin to the pediatric-inspired regimen of cancer and leukemia group B (CALGB) 10403. II. To determine whether the addition of inotuzumab ozogamicin significantly improves the event-free survival (EFS) in patients who achieve an induction response achieved with the pediatric-inspired regimen of CALGB 10403, without censoring for transplant. (Phase III) SECONDARY OBJECTIVES: I. To determine the impact of inotuzumab ozogamicin on disease-free (DFS) and overall survival (OS) in patients who achieve an induction response. II. To determine whether the addition of inotuzumab ozogamicin significantly improves the event-free survival (EFS) in patients who achieve an induction response achieved with the pediatric-inspired regimen of CALGB 10403, with censoring for transplant. III. To determine the impact of inotuzumab ozogamicin on minimal residual disease (MRD) and correlate this with the EFS, DFS and OS. IV. To determine the prognosis based on patients' low-density array (LDA) gene signature in terms of EFS, DFS, and OS after treatment with or without inotuzumab ozogamicin when added to the C10403 backbone regimen. V. To evaluate the toxicity and tolerability of the addition of inotuzumab ozogamicin to the pediatric-inspired regimen of CALGB 10403. TERTIARY OBJECTIVES: I. To assess both the correlation of MRD post-induction and at sequential timepoints with LDA signature. II. To evaluate the influence of MRD status (detectable vs. not and as a continuous measure) in relation to EFS both in the univariate setting as well as adjusting for other clinical features including initial white blood cell (WBC), ethnicity, gender and age at diagnosis. III. To evaluate the impact of inotuzumab ozogamicin (inotuzumab) on the kinetics of MRD during treatment with inotuzumab in patients randomized to the experimental treatment arm. IV. To perform genomic analyses to identify and evaluate the incidence and clinical significance of recurring novel fusion genes including those associated with the BCR-ABL1-like signature and to correlate with MRD status, CR rate, EFS and OS. V. To assess whether rs4958351 is correlated with L-asp allergic reaction in the adolescent and young adult (AYA) population. VI. To assess the incidence of inherited genetic variants in the GR1A1, CEP72, CPA2, TPMT, NUDT15, GRIN3A, GRIK1, and other genes (which can be found using a whole genome association study [GWAS]), are correlated with increased rates of target toxicities including peripheral neuropathy, hepatotoxicity, pancreatitis, myelosuppression, neurotoxicity, thrombosis, and osteonecrosis, and correlate with treatment discontinuation and other clinical response parameters including complete response (CR) rate, EFS, and OS. VII. To evaluate asparaginase pharmacokinetics in adolescents and young adults, and investigate its correlation with toxicities and treatment outcomes. VIII. To investigate the effect of anti-polyethylene glycol (PEG) and anti-agouti signaling protein (ASP) antibodies (PEG-ASP) on ASP enzyme activity. IX. To measure adherence to oral 6 mercaptopurine (MP) and methotrexate in AYAs with acute lymphoblastic leukemia (ALL) and to examine sociodemographic and behavioral determinants of adherence. X. To determine the impact of adherence on risk of relapse among AYAs with ALL. OUTLINE: COURSE I (REMISSION INDUCTION THERAPY): All patients receive allopurinol orally (PO) once daily until peripheral blasts and extramedullary disease are reduced and cytarabine intrathecally (IT) over 1 minute on day 1. Patients also receive daunorubicin hydrochloride intravenously (IV) and vincristine sulfate IV on days 1, 8, 15 and 22, dexamethasone PO or IV twice daily (BID) on days 1-7 and 15-21, pegylated L-aspiraginase IV on day 4, 5, or 6, and methotrexate IT over 1 minute on days 8 and 29. Patients with central nervous system (CNS) 3 disease receive methotrexate IT over 1 minute also on days 15 and 22. All patients then undergo bone marrow aspirate and biopsy on day 29. Patients with response to remission induction therapy are randomized to 1 of 2 arms. Patients with no response are omitted from the study. ARM I: COURSE II (REMISSION CONSOLIDATION CHEMOTHERAPY): Patients receive cyclophosphamide IV on days 1 and 29, cytarabine IV or SC on days 1-4, 8-11, 29-32, and 36-39, mercaptopurine PO on days 1-14 and 29-42, and vincristine sulfate IV on days 15, 22, 43, and 50. Patients also receive pegylated L-aspiraginase IV on days 15 and 43, and methotrexate IT on days 1, 8, 15, and 22. Patients with CNS3 receive methotrexate IT only on days 1 and 8. CD20 positive (+) patients receive rituximab IV on days 1, 8, 29, and 36. Patients then undergo bone marrow aspirate and biopsy on day 56. COURSE III (INTERIM MAINTENANCE CHEMOTHERAPY): Patients receive vincristine sulfate IV on days 1, 11, 21, 31, and 41, methotrexate IV and IT on days 1, 11, 21, 31, and 41, and pegylated L-aspiraginase IV on days 2 and 22. CD20+ patients receive rituximab IV on days 1 and 11. COURSE IV (DELAYED INTENSIFICATION): Patients receive vincristine sulfate IV on days 1, 8, 15, 43, and 50, dexamethasone PO or IV BID on days 1-7 and 15-21, doxorubicin IV on days 1, 8, and 15, and pegylated L-aspiraginase IV on day 4, 5, or 6 and day 43. Patients also receive cyclophosphamide IV on day 29, cytarabine IV or SC on days 29-32 and 36-39, thioguanine PO on days 29-42 and methotrexate IT on days 1, 29, and 36. CD20+ patients receive rituximab IV on days 1 and 8. Patients then undergo bone marrow aspirate and biopsy on day 50. COURSE V (MAINTENANCE THERAPY): Patients receive vincristine sulfate IV on days 1, 29, and 57, dexamethasone PO or IV BID on days 1-5, 29-33, and 57-61, and mercaptopurine PO on days 1-84. Patients also receive methotrexate IT or PO on days 8, 15, 22, 29, 36, 43, 50, 57, 64, 71, and 78. Treatment repeats every 12 weeks for up to 3 years in the absence of disease progression or unacceptable toxicity. ARM II: Patients receive inotuzumab ozogamicin IV on days 1, 8, and 15 and undergo bone marrow aspirate and biopsy on day 28. Treatment repeats every 28 days for up to 2 courses in the absence of disease progression or unacceptable toxicity. Patients also receive remission consolidated chemotherapy, interim maintenance chemotherapy, delayed intensification, and maintenance therapy as in Arm I. After completion of study treatment, patients are followed up every month for the first year, every 2 months for the second year, every 3 months for the third year, and every 6 months for the fourth through tenth year.


Recruitment information / eligibility

Status Suspended
Enrollment 310
Est. completion date August 2025
Est. primary completion date March 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years to 39 Years
Eligibility Inclusion Criteria: REGISTRATION ELIGIBILITY CRITERIA (STEP 1) - Newly diagnosed patients with CD-22 positive B-cell acute lymphoblastic leukemia (WHO criteria) are eligible. Patients with Burkitt type ALL are NOT eligible - Patients who have BCR-ABL fusion transcript determined by fluorescence in situ hybridization (FISH) or real time-polymerase chain reaction (RT-PCR) or t(9;22)(q34;q11) by cytogenetics are not eligible and should be considered for enrollment on studies that incorporate imatinib during induction; please note: flow cytometry is to be performed at the local reference lab and must include assessment of CD20 and CD22 positivity, as well as CD29 and CD22 anti-positivity - No prior therapy except for limited treatment (< 7 days) with corticosteroids or hydroxyurea and a single dose of intrathecal cytarabine - No prior therapy for acute leukemia except emergency therapy (corticosteroids or hydroxyurea) for blast cell crisis, superior vena cava syndrome, or renal failure due to leukemic infiltration of the kidneys; when indicated, leukapheresis or exchange transfusion is recommended to reduce the WBC - Single-dose intrathecal cytarabine is allowed prior to registration or prior to initiation of systematic therapy for patient convenience; systemic chemotherapy must begin within 72 hours of this intrathecal therapy - Patients receiving prior steroid therapy are eligible for study; the dose and duration of previous steroid therapy should be carefully documented on case report forms - Not pregnant and not nursing; for women of childbearing potential only, a negative urine or serum pregnancy test done =< 7 days prior to registration is required - Eastern Cooperative Oncology Group (ECOG) performance status 0-2 - Patients with down syndrome are excluded from this study - Aspartate aminotransferase (AST), alanine aminotransferase (ALT) =< 3 x upper limit of normal (ULN), unless suspected leukemic involvement of the liver - Direct bilirubin =< 3 x upper limit of normal (ULN), unless suspected leukemic involvement of the liver - Calculated (calc.) creatinine clearance >= 50 mL/min by Cockcroft-Gault RANDOMIZATION ELIGIBILITY CRITERIA (STEP 2) - Completion of remission induction therapy - Patients with M2 marrow or better are eligible; patients with M3 or M4 marrow (greater than 25% lymphoblasts) will not be eligible to be randomized - Rating: M0, M1; Blast Cells (%): 0-5.0 - Rating: M2; Blast Cells (%): 5.1-25.0 - Rating: M3; Blast Cells (%): > 25-50 - Rating: M4; Blast Cells (%): > 50.0 - The term "blast cell" includes any cell that cannot be classified as a more mature normal element, and includes "leukemic cells," pathologic lymphocytes, and stem cells - No ascites, effusions or significant edema - Absolute neutrophil count (ANC) >= 1,000/mm^3 - Platelet count >= 100,000/mm^3 - Total bilirubin =< 1.5 x upper limit of normal (ULN), except for patients with known Gilbert's syndrome - Aspartate aminotransferase (AST) =< 8 x upper limit of normal (ULN) - Completion of first 12 weeks (12+ weeks) of maintenance therapy (Course V) - Patient has at least 24 weeks (24+ weeks) remaining before end of maintenance therapy (Course V) - Patient is in complete continuous first remission at entry into A041501-HO1 - Patient is receiving oral anti-metabolite chemotherapy during the maintenance phase of therapy; treatment plan must call for the following doses of antimetabolites: 6MP 75 mg/m2/day orally; methotrexate (MTX) 20 mg/m2/week orally (modification of 6 MP or MTX dosing based on laboratory or clinical parameters is acceptable) - Patient is able and willing to use the Medication Event Monitoring System (MEMS) TrackCap (e.g. not using a pillbox)

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Allopurinol
Given PO
Cytarabine
Given IT, IV, SC
Daunorubicin Hydrochloride
Given IV
Vincristine Sulfate
Given IV
Dexamethasone
Given PO or IV
Pegylated L-Asparaginase
Given IV
Methotrexate
Given IT, IV, PO
Procedure:
Bone Marrow Aspiration and Biopsy
Undergo bone marrow aspiration and biopsy
Drug:
Cyclophosphamide
Given IV
Mercaptopurine
Given PO
Biological:
Rituximab
Given IV
Drug:
Doxorubicin
Given IV
Thioguanine
Given PO
Biological:
Inotuzumab Ozogamicin
Given IV
Other:
Laboratory Biomarker Analysis
Correlative studies

Locations

Country Name City State
Canada Tom Baker Cancer Centre Calgary Alberta
Canada QEII Health Sciences Centre/Nova Scotia Health Authority Halifax Nova Scotia
Canada Jewish General Hospital Montreal Quebec
Canada Ottawa Hospital and Cancer Center-General Campus Ottawa Ontario
Canada CancerCare Manitoba Winnipeg Manitoba
United States Hawaii Cancer Care - Westridge 'Aiea Hawaii
United States Pali Momi Medical Center 'Aiea Hawaii
United States Queen's Cancer Center - Pearlridge 'Aiea Hawaii
United States The Cancer Center of Hawaii-Pali Momi 'Aiea Hawaii
United States Providence Regional Cancer System-Aberdeen Aberdeen Washington
United States Riverwood Healthcare Center Aitkin Minnesota
United States University of New Mexico Cancer Center Albuquerque New Mexico
United States Lehigh Valley Hospital-Cedar Crest Allentown Pennsylvania
United States Saint Anthony's Health Alton Illinois
United States American Fork Hospital / Huntsman Intermountain Cancer Center American Fork Utah
United States Community Hospital of Anaconda Anaconda Montana
United States Alaska Breast Care and Surgery LLC Anchorage Alaska
United States Alaska Oncology and Hematology LLC Anchorage Alaska
United States Alaska Women's Cancer Care Anchorage Alaska
United States Anchorage Associates in Radiation Medicine Anchorage Alaska
United States Anchorage Oncology Centre Anchorage Alaska
United States Anchorage Radiation Therapy Center Anchorage Alaska
United States Katmai Oncology Group Anchorage Alaska
United States Providence Alaska Medical Center Anchorage Alaska
United States Trinity Health Saint Joseph Mercy Hospital Ann Arbor Ann Arbor Michigan
United States Kaiser Permanente-Deer Valley Medical Center Antioch California
United States PCR Oncology Arroyo Grande California
United States Duluth Clinic Ashland Ashland Wisconsin
United States Northwest Wisconsin Cancer Center Ashland Wisconsin
United States Emory University Hospital/Winship Cancer Institute Atlanta Georgia
United States Augusta University Medical Center Augusta Georgia
United States Rocky Mountain Cancer Centers-Aurora Aurora Colorado
United States The Medical Center of Aurora Aurora Colorado
United States Saint Alphonsus Medical Center-Baker City Baker City Oregon
United States Saint Louis Cancer and Breast Institute-Ballwin Ballwin Missouri
United States University of Maryland/Greenebaum Cancer Center Baltimore Maryland
United States Medical Center of Baton Rouge Baton Rouge Louisiana
United States Ochsner Health Center-Summa Baton Rouge Louisiana
United States Ochsner High Grove Baton Rouge Louisiana
United States Bronson Battle Creek Battle Creek Michigan
United States Overlake Medical Center Bellevue Washington
United States PeaceHealth Saint Joseph Medical Center Bellingham Washington
United States Saint Charles Health System Bend Oregon
United States Lehigh Valley Hospital - Muhlenberg Bethlehem Pennsylvania
United States Billings Clinic Cancer Center Billings Montana
United States Saint Vincent Frontier Cancer Center Billings Montana
United States Saint Vincent Healthcare Billings Montana
United States University of Alabama at Birmingham Cancer Center Birmingham Alabama
United States Prisma Health Cancer Institute - Spartanburg Boiling Springs South Carolina
United States Saint Alphonsus Cancer Care Center-Boise Boise Idaho
United States Saint Luke's Cancer Institute - Boise Boise Idaho
United States Central Care Cancer Center - Bolivar Bolivar Missouri
United States Beth Israel Deaconess Medical Center Boston Massachusetts
United States Dana-Farber Cancer Institute Boston Massachusetts
United States Massachusetts General Hospital Cancer Center Boston Massachusetts
United States Boulder Community Foothills Hospital Boulder Colorado
United States Boulder Community Hospital Boulder Colorado
United States Rocky Mountain Cancer Centers-Boulder Boulder Colorado
United States Bozeman Health Deaconess Hospital Bozeman Montana
United States Essentia Health Saint Joseph's Medical Center Brainerd Minnesota
United States Cox Cancer Center Branson Branson Missouri
United States Trinity Health IHA Medical Group Hematology Oncology - Brighton Brighton Michigan
United States Trinity Health Medical Center - Brighton Brighton Michigan
United States Roswell Park Cancer Institute Buffalo New York
United States Providence Saint Joseph Medical Center/Disney Family Cancer Center Burbank California
United States Fairview Ridges Hospital Burnsville Minnesota
United States Minnesota Oncology - Burnsville Burnsville Minnesota
United States Loyola Center for Health at Burr Ridge Burr Ridge Illinois
United States Saint James Community Hospital and Cancer Treatment Center Butte Montana
United States Saint Alphonsus Cancer Care Center-Caldwell Caldwell Idaho
United States Cambridge Medical Center Cambridge Minnesota
United States Trinity Health IHA Medical Group Hematology Oncology - Canton Canton Michigan
United States Trinity Health Medical Center - Canton Canton Michigan
United States Caro Cancer Center Caro Michigan
United States Saint Anthony Regional Hospital Carroll Iowa
United States Carson Tahoe Regional Medical Center Carson City Nevada
United States Sandra L Maxwell Cancer Center Cedar City Utah
United States Rocky Mountain Cancer Centers - Centennial Centennial Colorado
United States Providence Regional Cancer System-Centralia Centralia Washington
United States UNC Lineberger Comprehensive Cancer Center Chapel Hill North Carolina
United States Saint Joseph Mercy Chelsea Chelsea Michigan
United States Trinity Health IHA Medical Group Hematology Oncology - Chelsea Hospital Chelsea Michigan
United States Cheyenne Regional Medical Center-West Cheyenne Wyoming
United States Northwestern University Chicago Illinois
United States Rush University Medical Center Chicago Illinois
United States University of Chicago Comprehensive Cancer Center Chicago Illinois
United States University of Illinois Chicago Illinois
United States University of Cincinnati Cancer Center-UC Medical Center Cincinnati Ohio
United States Clackamas Radiation Oncology Center Clackamas Oregon
United States Providence Cancer Institute Clackamas Clinic Clackamas Oregon
United States Hematology Oncology Consultants-Clarkston Clarkston Michigan
United States Newland Medical Associates-Clarkston Clarkston Michigan
United States Case Western Reserve University Cleveland Ohio
United States Cleveland Clinic Foundation Cleveland Ohio
United States Prisma Health Cancer Institute - Laurens Clinton South Carolina
United States Community Cancer Institute Clovis California
United States University Oncology Associates Clovis California
United States Billings Clinic-Cody Cody Wyoming
United States Kootenai Health - Coeur d'Alene Coeur d'Alene Idaho
United States Prisma Health Richland Hospital Columbia South Carolina
United States Ohio State University Comprehensive Cancer Center Columbus Ohio
United States Mercy Hospital Coon Rapids Minnesota
United States Bay Area Hospital Coos Bay Oregon
United States UC Irvine Health Cancer Center-Newport Costa Mesa California
United States Siteman Cancer Center at West County Hospital Creve Coeur Missouri
United States Essentia Health - Deer River Clinic Deer River Minnesota
United States Cancer Center of Colorado at Sloan's Lake Denver Colorado
United States Colorado Blood Cancer Institute Denver Colorado
United States National Jewish Health-Main Campus Denver Colorado
United States Presbyterian - Saint Lukes Medical Center - Health One Denver Colorado
United States Rocky Mountain Cancer Centers-Midtown Denver Colorado
United States Rocky Mountain Cancer Centers-Rose Denver Colorado
United States Rose Medical Center Denver Colorado
United States SCL Health Saint Joseph Hospital Denver Colorado
United States The Women's Imaging Center Denver Colorado
United States Western Surgical Care Denver Colorado
United States Blank Children's Hospital Des Moines Iowa
United States Broadlawns Medical Center Des Moines Iowa
United States Iowa Lutheran Hospital Des Moines Iowa
United States Iowa Methodist Medical Center Des Moines Iowa
United States Mission Cancer and Blood - Des Moines Des Moines Iowa
United States Ascension Saint John Hospital Detroit Michigan
United States Wayne State University/Karmanos Cancer Institute Detroit Michigan
United States Essentia Health Saint Mary's - Detroit Lakes Clinic Detroit Lakes Minnesota
United States Kaiser Permanente Dublin Dublin California
United States Essentia Health Cancer Center Duluth Minnesota
United States Essentia Health Saint Mary's Medical Center Duluth Minnesota
United States Miller-Dwan Hospital Duluth Minnesota
United States Duke University Medical Center Durham North Carolina
United States Prisma Health Cancer Institute - Easley Easley South Carolina
United States Great Lakes Cancer Management Specialists-Doctors Park East China Township Michigan
United States Pocono Medical Center East Stroudsburg Pennsylvania
United States Fairview Southdale Hospital Edina Minnesota
United States Swedish Cancer Institute-Edmonds Edmonds Washington
United States Walter Knox Memorial Hospital Emmett Idaho
United States Mountain Blue Cancer Care Center - Swedish Englewood Colorado
United States Rocky Mountain Cancer Centers - Swedish Englewood Colorado
United States Swedish Medical Center Englewood Colorado
United States The Melanoma and Skin Cancer Institute Englewood Colorado
United States NorthShore University HealthSystem-Evanston Hospital Evanston Illinois
United States Providence Regional Cancer Partnership Everett Washington
United States Fairbanks Memorial Hospital Fairbanks Alaska
United States Inova Schar Cancer Institute Fairfax Virginia
United States Inova Fairfax Hospital Falls Church Virginia
United States Essentia Health Cancer Center-South University Clinic Fargo North Dakota
United States Weisberg Cancer Treatment Center Farmington Hills Michigan
United States Lake Region Healthcare Corporation-Cancer Care Fergus Falls Minnesota
United States Genesee Cancer and Blood Disease Treatment Center Flint Michigan
United States Genesee Hematology Oncology PC Flint Michigan
United States Genesys Hurley Cancer Institute Flint Michigan
United States Hurley Medical Center Flint Michigan
United States Trinity Regional Medical Center Fort Dodge Iowa
United States Holy Cross Hospital Fort Lauderdale Florida
United States Mercy Hospital Fort Smith Fort Smith Arkansas
United States Essentia Health - Fosston Fosston Minnesota
United States Kaiser Permanente-Fremont Fremont California
United States Fresno Cancer Center Fresno California
United States Kaiser Permanente-Fresno Fresno California
United States Unity Hospital Fridley Minnesota
United States Saint Luke's Cancer Institute - Fruitland Fruitland Idaho
United States Central Care Cancer Center - Garden City Garden City Kansas
United States NorthShore University HealthSystem-Glenbrook Hospital Glenview Illinois
United States National Jewish Health-Western Hematology Oncology Golden Colorado
United States Saint Mary's Hospital and Regional Medical Center Grand Junction Colorado
United States Corewell Health Grand Rapids Hospitals - Butterworth Hospital Grand Rapids Michigan
United States Corewell Health Grand Rapids Hospitals - Helen DeVos Children's Hospital Grand Rapids Michigan
United States Trinity Health Grand Rapids Hospital Grand Rapids Michigan
United States Central Care Cancer Center - Great Bend Great Bend Kansas
United States Benefis Sletten Cancer Institute Great Falls Montana
United States Great Falls Clinic Great Falls Montana
United States Banner North Colorado Medical Center Greeley Colorado
United States BI-LO Charities Children's Cancer Center Greenville South Carolina
United States East Carolina University Greenville North Carolina
United States Prisma Health Cancer Institute - Butternut Greenville South Carolina
United States Prisma Health Cancer Institute - Eastside Greenville South Carolina
United States Prisma Health Cancer Institute - Faris Greenville South Carolina
United States Prisma Health Greenville Memorial Hospital Greenville South Carolina
United States Saint Francis Cancer Center Greenville South Carolina
United States Saint Francis Hospital Greenville South Carolina
United States Prisma Health Cancer Institute - Greer Greer South Carolina
United States Academic Hematology Oncology Specialists Grosse Pointe Woods Michigan
United States Great Lakes Cancer Management Specialists-Van Elslander Cancer Center Grosse Pointe Woods Michigan
United States Michigan Breast Specialists-Grosse Pointe Woods Grosse Pointe Woods Michigan
United States Smilow Cancer Hospital Care Center at Saint Francis Hartford Connecticut
United States Essentia Health-Hayward Clinic Hayward Wisconsin
United States Lehigh Valley Hospital-Hazleton Hazleton Pennsylvania
United States Cancer and Blood Specialists-Henderson Henderson Nevada
United States Comprehensive Cancer Centers of Nevada - Henderson Henderson Nevada
United States Comprehensive Cancer Centers of Nevada-Horizon Ridge Henderson Nevada
United States Comprehensive Cancer Centers of Nevada-Southeast Henderson Henderson Nevada
United States GenesisCare USA - Henderson Henderson Nevada
United States Las Vegas Cancer Center-Henderson Henderson Nevada
United States Las Vegas Urology - Green Valley Henderson Nevada
United States Las Vegas Urology - Pebble Henderson Nevada
United States OptumCare Cancer Care at Seven Hills Henderson Nevada
United States Urology Specialists of Nevada - Green Valley Henderson Nevada
United States Essentia Health Hibbing Clinic Hibbing Minnesota
United States NorthShore University HealthSystem-Highland Park Hospital Highland Park Illinois
United States Island Urology-Hilo Hilo Hawaii
United States Memorial Regional Hospital/Joe DiMaggio Children's Hospital Hollywood Florida
United States Loyola Medicine Homer Glen Homer Glen Illinois
United States Hawaii Cancer Care Inc - Waterfront Plaza Honolulu Hawaii
United States Hawaii Cancer Care Inc-Liliha Honolulu Hawaii
United States Island Urology Honolulu Hawaii
United States Kaiser Permanente Moanalua Medical Center Honolulu Hawaii
United States Kapiolani Medical Center for Women and Children Honolulu Hawaii
United States Kuakini Medical Center Honolulu Hawaii
United States Queen's Cancer Cenrer - POB I Honolulu Hawaii
United States Queen's Cancer Center - Kuakini Honolulu Hawaii
United States Queen's Medical Center Honolulu Hawaii
United States Straub Clinic and Hospital Honolulu Hawaii
United States The Cancer Center of Hawaii-Liliha Honolulu Hawaii
United States University of Hawaii Cancer Center Honolulu Hawaii
United States Houston Methodist Hospital Houston Texas
United States University of Iowa/Holden Comprehensive Cancer Center Iowa City Iowa
United States Swedish Cancer Institute-Issaquah Issaquah Washington
United States Essentia Health - Jamestown Clinic Jamestown North Dakota
United States Freeman Health System Joplin Missouri
United States Mercy Hospital Joplin Joplin Missouri
United States Ascension Borgess Cancer Center Kalamazoo Michigan
United States Borgess Medical Center Kalamazoo Michigan
United States Bronson Methodist Hospital Kalamazoo Michigan
United States West Michigan Cancer Center Kalamazoo Michigan
United States Kalispell Regional Medical Center Kalispell Montana
United States University of Kansas Cancer Center Kansas City Kansas
United States Kadlec Clinic Hematology and Oncology Kennewick Washington
United States Kingman Regional Medical Center Kingman Arizona
United States Providence Regional Cancer System-Lacey Lacey Washington
United States Good Samaritan Medical Center Lafayette Colorado
United States Northwestern Medicine Lake Forest Hospital Lake Forest Illinois
United States Northwell Health/Center for Advanced Medicine Lake Success New York
United States Rocky Mountain Cancer Centers-Lakewood Lakewood Colorado
United States University of Michigan Health - Sparrow Lansing Lansing Michigan
United States Alliance for Childhood Diseases/Cure 4 the Kids Foundation Las Vegas Nevada
United States Ann M Wierman MD LTD Las Vegas Nevada
United States Comprehensive Cancer Centers of Nevada Las Vegas Nevada
United States Comprehensive Cancer Centers of Nevada - Central Valley Las Vegas Nevada
United States Comprehensive Cancer Centers of Nevada - Northwest Las Vegas Nevada
United States Comprehensive Cancer Centers of Nevada - Town Center Las Vegas Nevada
United States Comprehensive Cancer Centers of Nevada-Summerlin Las Vegas Nevada
United States Desert West Surgery Las Vegas Nevada
United States GenesisCare USA - Fort Apache Las Vegas Nevada
United States GenesisCare USA - Las Vegas Las Vegas Nevada
United States GenesisCare USA - Vegas Tenaya Las Vegas Nevada
United States Hope Cancer Care of Nevada Las Vegas Nevada
United States Las Vegas Cancer Center-Medical Center Las Vegas Nevada
United States Las Vegas Prostate Cancer Center Las Vegas Nevada
United States Las Vegas Urology - Cathedral Rock Las Vegas Nevada
United States Las Vegas Urology - Pecos Las Vegas Nevada
United States Las Vegas Urology - Smoke Ranch Las Vegas Nevada
United States Las Vegas Urology - Sunset Las Vegas Nevada
United States OptumCare Cancer Care at Charleston Las Vegas Nevada
United States OptumCare Cancer Care at Fort Apache Las Vegas Nevada
United States OptumCare Cancer Care at MountainView Las Vegas Nevada
United States Radiation Oncology Centers of Nevada Central Las Vegas Nevada
United States Radiation Oncology Centers of Nevada Southeast Las Vegas Nevada
United States Summerlin Hospital Medical Center Las Vegas Nevada
United States Sunrise Hospital and Medical Center Las Vegas Nevada
United States University Cancer Center Las Vegas Nevada
United States University Medical Center of Southern Nevada Las Vegas Nevada
United States Urology Specialists of Nevada - Central Las Vegas Nevada
United States Urology Specialists of Nevada - Northwest Las Vegas Nevada
United States Urology Specialists of Nevada - Southwest Las Vegas Nevada
United States Lawrence Memorial Hospital Lawrence Kansas
United States University of Kentucky/Markey Cancer Center Lexington Kentucky
United States Wilcox Memorial Hospital and Kauai Medical Clinic Lihue Hawaii
United States Rush Cancer Care in Lisle Lisle Illinois
United States Rocky Mountain Cancer Centers-Littleton Littleton Colorado
United States Hope Cancer Clinic Livonia Michigan
United States Trinity Health Saint Mary Mercy Livonia Hospital Livonia Michigan
United States Logan Regional Hospital Logan Utah
United States Rocky Mountain Cancer Centers-Sky Ridge Lone Tree Colorado
United States Sky Ridge Medical Center Lone Tree Colorado
United States PeaceHealth Saint John Medical Center Longview Washington
United States Banner McKee Medical Center Loveland Colorado
United States Covenant Medical Center-Lakeside Lubbock Texas
United States Great Lakes Cancer Management Specialists-Macomb Medical Campus Macomb Michigan
United States Michigan Breast Specialists-Macomb Township Macomb Michigan
United States University of Wisconsin Carbone Cancer Center - University Hospital Madison Wisconsin
United States North Shore University Hospital Manhasset New York
United States Fairview Clinics and Surgery Center Maple Grove Maple Grove Minnesota
United States Minnesota Oncology Hematology PA-Maplewood Maplewood Minnesota
United States Saint John's Hospital - Healtheast Maplewood Minnesota
United States Saint Mary's Oncology/Hematology Associates of Marlette Marlette Michigan
United States Marshfield Medical Center-Marshfield Marshfield Wisconsin
United States Loyola University Medical Center Maywood Illinois
United States Marjorie Weinberg Cancer Center at Loyola-Gottlieb Melrose Park Illinois
United States Idaho Urologic Institute-Meridian Meridian Idaho
United States Saint Luke's Cancer Institute - Meridian Meridian Idaho
United States Miami Cancer Institute Miami Florida
United States Medical College of Wisconsin Milwaukee Wisconsin
United States Abbott-Northwestern Hospital Minneapolis Minnesota
United States Health Partners Inc Minneapolis Minnesota
United States Hennepin County Medical Center Minneapolis Minnesota
United States Community Medical Center Missoula Montana
United States Saint Patrick Hospital - Community Hospital Missoula Montana
United States Kaiser Permanente-Modesto Modesto California
United States Monticello Cancer Center Monticello Minnesota
United States Good Samaritan Regional Health Center Mount Vernon Illinois
United States Intermountain Medical Center Murray Utah
United States Trinity Health Muskegon Hospital Muskegon Michigan
United States Saint Alphonsus Cancer Care Center-Nampa Nampa Idaho
United States Saint Luke's Cancer Institute - Nampa Nampa Idaho
United States Smilow Cancer Center/Yale-New Haven Hospital New Haven Connecticut
United States Yale University New Haven Connecticut
United States Long Island Jewish Medical Center New Hyde Park New York
United States UC Comprehensive Cancer Center at Silver Cross New Lenox Illinois
United States Ochsner Medical Center Jefferson New Orleans Louisiana
United States Cancer Center of Western Wisconsin New Richmond Wisconsin
United States New Ulm Medical Center New Ulm Minnesota
United States Mount Sinai Hospital New York New York
United States NYP/Weill Cornell Medical Center New York New York
United States Providence Newberg Medical Center Newberg Oregon
United States Corewell Health Lakeland Hospitals - Niles Hospital Niles Michigan
United States Cancer and Hematology Centers of Western Michigan - Norton Shores Norton Shores Michigan
United States Kaiser Permanente Oakland-Broadway Oakland California
United States Kaiser Permanente-Oakland Oakland California
United States McKay-Dee Hospital Center Ogden Utah
United States Mercy Hospital Oklahoma City Oklahoma City Oklahoma
United States University of Oklahoma Health Sciences Center Oklahoma City Oklahoma
United States Nebraska Medicine-Village Pointe Omaha Nebraska
United States University of Nebraska Medical Center Omaha Nebraska
United States Saint Alphonsus Medical Center-Ontario Ontario Oregon
United States UC Irvine Health/Chao Family Comprehensive Cancer Center Orange California
United States University of Chicago Medicine-Orland Park Orland Park Illinois
United States Orlando Health Cancer Institute Orlando Florida
United States Hope Cancer Care of Nevada-Pahrump Pahrump Nevada
United States Stanford Cancer Institute Palo Alto Palo Alto California
United States Essentia Health - Park Rapids Park Rapids Minnesota
United States Memorial Hospital West Pembroke Pines Florida
United States Thomas Jefferson University Hospital Philadelphia Pennsylvania
United States University of Pennsylvania/Abramson Cancer Center Philadelphia Pennsylvania
United States Mayo Clinic Hospital in Arizona Phoenix Arizona
United States University of Pittsburgh Cancer Institute (UPCI) Pittsburgh Pennsylvania
United States Hope Cancer Center Pontiac Michigan
United States Michigan Healthcare Professionals Pontiac Pontiac Michigan
United States Newland Medical Associates-Pontiac Pontiac Michigan
United States Trinity Health Saint Joseph Mercy Oakland Hospital Pontiac Michigan
United States Jefferson Healthcare Port Townsend Washington
United States Oregon Health and Science University Portland Oregon
United States Providence Portland Medical Center Portland Oregon
United States Providence Saint Vincent Medical Center Portland Oregon
United States Kootenai Clinic Cancer Services - Post Falls Post Falls Idaho
United States Fairview Northland Medical Center Princeton Minnesota
United States Miriam Hospital Providence Rhode Island
United States Rhode Island Hospital Providence Rhode Island
United States Utah Valley Regional Medical Center Provo Utah
United States Kaiser Permanente-Rancho Cordova Cancer Center Rancho Cordova California
United States Saint Charles Health System-Redmond Redmond Oregon
United States Kaiser Permanente- Marshall Medical Offices Redwood City California
United States Kaiser Permanente-Redwood City Redwood City California
United States Corewell Health Reed City Hospital Reed City Michigan
United States Radiation Oncology Associates Reno Nevada
United States Renown Regional Medical Center Reno Nevada
United States Saint Mary's Regional Medical Center Reno Nevada
United States Valley Medical Center Renton Washington
United States Kaiser Permanente-Richmond Richmond California
United States Virginia Commonwealth University/Massey Cancer Center Richmond Virginia
United States Riverton Hospital Riverton Utah
United States North Memorial Medical Health Center Robbinsdale Minnesota
United States Mayo Clinic in Rochester Rochester Minnesota
United States University of Rochester Rochester New York
United States Great Lakes Cancer Management Specialists-Rochester Hills Rochester Hills Michigan
United States Rohnert Park Cancer Center Rohnert Park California
United States Delbert Day Cancer Institute at PCRMC Rolla Missouri
United States Mercy Clinic-Rolla-Cancer and Hematology Rolla Missouri
United States Kaiser Permanente-Roseville Roseville California
United States The Permanente Medical Group-Roseville Radiation Oncology Roseville California
United States Kaiser Permanente - Sacramento Sacramento California
United States Kaiser Permanente Downtown Commons Sacramento California
United States Kaiser Permanente-South Sacramento Sacramento California
United States South Sacramento Cancer Center Sacramento California
United States University of California Davis Comprehensive Cancer Center Sacramento California
United States Ascension Saint Mary's Hospital Saginaw Michigan
United States Oncology Hematology Associates of Saginaw Valley PC Saginaw Michigan
United States Saint George Regional Medical Center Saint George Utah
United States Corewell Health Lakeland Hospitals - Marie Yeager Cancer Center Saint Joseph Michigan
United States Corewell Health Lakeland Hospitals - Saint Joseph Hospital Saint Joseph Michigan
United States Heartland Regional Medical Center Saint Joseph Missouri
United States Mercy Hospital Saint Louis Saint Louis Missouri
United States Mercy Hospital South Saint Louis Missouri
United States Saint Louis Cancer and Breast Institute-South City Saint Louis Missouri
United States Siteman Cancer Center-South County Saint Louis Missouri
United States Washington University School of Medicine Saint Louis Missouri
United States Park Nicollet Clinic - Saint Louis Park Saint Louis Park Minnesota
United States Regions Hospital Saint Paul Minnesota
United States United Hospital Saint Paul Minnesota
United States Siteman Cancer Center at Saint Peters Hospital Saint Peters Missouri
United States Huntsman Cancer Institute/University of Utah Salt Lake City Utah
United States LDS Hospital Salt Lake City Utah
United States Utah Cancer Specialists-Salt Lake City Salt Lake City Utah
United States Kaiser Permanente-San Francisco San Francisco California
United States Kaiser Permanente-Santa Teresa-San Jose San Jose California
United States Kaiser Permanente San Leandro San Leandro California
United States Kaiser Permanente-San Rafael San Rafael California
United States Kaiser San Rafael-Gallinas San Rafael California
United States Kootenai Cancer Clinic Sandpoint Idaho
United States Essentia Health Sandstone Sandstone Minnesota
United States Kaiser Permanente Medical Center - Santa Clara Santa Clara California
United States Kaiser Permanente-Santa Rosa Santa Rosa California
United States Mayo Clinic in Arizona Scottsdale Arizona
United States Kaiser Permanente Washington Seattle Washington
United States Pacific Gynecology Specialists Seattle Washington
United States Swedish Medical Center-Ballard Campus Seattle Washington
United States Swedish Medical Center-Cherry Hill Seattle Washington
United States Swedish Medical Center-First Hill Seattle Washington
United States PeaceHealth United General Medical Center Sedro-Woolley Washington
United States Prisma Health Cancer Institute - Seneca Seneca South Carolina
United States Saint Francis Regional Medical Center Shakopee Minnesota
United States Providence Regional Cancer System-Shelton Shelton Washington
United States Welch Cancer Center Sheridan Wyoming
United States Kaiser Permanente Cancer Treatment Center South San Francisco California
United States Kaiser Permanente-South San Francisco South San Francisco California
United States Essentia Health-Spooner Clinic Spooner Wisconsin
United States CoxHealth South Hospital Springfield Missouri
United States Mercy Hospital Springfield Springfield Missouri
United States Bhadresh Nayak MD PC-Sterling Heights Sterling Heights Michigan
United States Lakeview Hospital Stillwater Minnesota
United States Kaiser Permanente-Stockton Stockton California
United States Stony Brook University Medical Center Stony Brook New York
United States Essentia Health Saint Mary's Hospital - Superior Superior Wisconsin
United States State University of New York Upstate Medical University Syracuse New York
United States Ascension Saint Joseph Hospital Tawas City Michigan
United States National Jewish Health-Northern Hematology Oncology Thornton Colorado
United States Rocky Mountain Cancer Centers-Thornton Thornton Colorado
United States Munson Medical Center Traverse City Michigan
United States Saint Luke's Cancer Institute - Twin Falls Twin Falls Idaho
United States Kaiser Permanente Medical Center-Vacaville Vacaville California
United States Kaiser Permanente-Vallejo Vallejo California
United States PeaceHealth Southwest Medical Center Vancouver Washington
United States Upstate Cancer Center at Verona Verona New York
United States Essentia Health Virginia Clinic Virginia Minnesota
United States Ridgeview Medical Center Waconia Minnesota
United States Providence Saint Mary Regional Cancer Center Walla Walla Washington
United States Kaiser Permanente-Walnut Creek Walnut Creek California
United States Advanced Breast Care Center PLLC Warren Michigan
United States Great Lakes Cancer Management Specialists-Macomb Professional Building Warren Michigan
United States Macomb Hematology Oncology PC Warren Michigan
United States Michigan Breast Specialists-Warren Warren Michigan
United States Saint John Macomb-Oakland Hospital Warren Michigan
United States Mercy Hospital Washington Washington Missouri
United States Saint Mary's Oncology/Hematology Associates of West Branch West Branch Michigan
United States University of Cincinnati Cancer Center-West Chester West Chester Ohio
United States Methodist West Hospital West Des Moines Iowa
United States University of Kansas Hospital-Westwood Cancer Center Westwood Kansas
United States SCL Health Lutheran Medical Center Wheat Ridge Colorado
United States Ascension Via Christi Hospitals Wichita Wichita Kansas
United States Cancer Center of Kansas - Wichita Wichita Kansas
United States Cancer Center of Kansas-Wichita Medical Arts Tower Wichita Kansas
United States Wesley Medical Center Wichita Kansas
United States Rice Memorial Hospital Willmar Minnesota
United States Wake Forest University Health Sciences Winston-Salem North Carolina
United States Minnesota Oncology Hematology PA-Woodbury Woodbury Minnesota
United States Fairview Lakes Medical Center Wyoming Minnesota
United States University of Michigan Health - West Wyoming Michigan
United States North Star Lodge Cancer Center at Yakima Valley Memorial Hospital Yakima Washington
United States Providence Regional Cancer System-Yelm Yelm Washington
United States Huron Gastroenterology PC Ypsilanti Michigan
United States Trinity Health IHA Medical Group Hematology Oncology Ann Arbor Campus Ypsilanti Michigan

Sponsors (2)

Lead Sponsor Collaborator
Alliance for Clinical Trials in Oncology National Cancer Institute (NCI)

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type Measure Description Time frame Safety issue
Primary EFS Will be compared using log-rank tests. EFS curves will be constructed using the Kaplan-Meier product limit method, and additional analyses will be done using the Cox proportional hazards model. The corresponding hazard ratio, 2- and 3-year EFS estimates will be assessed, and EFS medians along with their 95% confidence intervals for the two treatment arms. Time from induction response to the time of progressive-disease, secondary malignancy, or death, assessed up to 3 years
Secondary DFS Time from achievement of CR to the time of relapse and/or death, assessed up to 10 years
Secondary OS Will be evaluated using Kaplan-Meier as well as Cox regression models. Time from randomization to the time of death due to any cause, assessed up to 10 years
Secondary Proportion of patients who achieve CR or any response to induction therapy Will be summarized as the proportion of patients who achieve any type of response to induction therapy divided by the number of all evaluable patients registered to this trial and who received at least one dose of induction therapy. Corresponding 95% binomial confidence intervals will also be calculated. Up to 10 years
Secondary Overall induction response rates Will be summarized as the proportion of patients who achieve any type of response to induction therapy divided by the number of all evaluable patients registered to this trial and who received at least one dose of induction therapy. Corresponding 95% binomial confidence intervals will also be calculated. Up to 10 years
Secondary Incidence of adverse events as assessed by Common Terminology Criteria for Adverse Events version 4.0 The maximum grade for each type of toxicity will be recorded for each patient, and frequency tables will be reviewed to determine toxicity patterns. In addition, all adverse event data that is graded as 3, 4, or 5 will be reviewed and classified as either "unrelated" or "unlikely to be related" to study treatment in the event of an actual relationship developing. The incidence of severe (grade 3+) adverse events or toxicities will be described for each treatment arm, but will also be compared between the arms. Fisher's exact tests will be used to quantitatively compare the incidence of severe as well as specific toxicities of interest between the treatment arms and we will graphically assess differences in maximum grades observed for toxicities between the arms. Tolerability of the treatment arms will be assessed through assessing the number of patients who required dose modifications and/or dose delays. Up to 10 years
Secondary Proportion of patients who go off treatment due to adverse reactions Will be assessed within each of the treatment arms and differences explores in these measures between the arms. Up to 10 years
Secondary Proportion of patients who refuse further treatment for lesser toxicities that inhibit their willingness to continue participation on the trial Will be assessed within each of the treatment arms and differences explores in these measures between the arms. Up to 10 years
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