Acute Lymphoblastic Leukemia Clinical Trial
Official title:
International Phase 3 Trial in Philadelphia Chromosome-Positive Acute Lymphoblastic Leukemia (Ph+ALL) Testing Imatinib in Combination With Two Different Cytotoxic Chemotherapy Backbones
Verified date | April 2024 |
Source | Children's Oncology Group |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This randomized phase III trial studies how well imatinib mesylate works in combination with two different chemotherapy regimens in treating patients with newly diagnosed Philadelphia chromosome positive acute lymphoblastic leukemia (ALL). Imatinib mesylate has been shown to improve outcomes in children and adolescents with Philadelphia chromosome positive (Ph+) ALL when given with strong chemotherapy, but the combination has many side effects. This trial is testing whether a different chemotherapy regimen may work as well as the stronger one but have fewer side effects when given with imatinib. The trial is also testing how well the combination of chemotherapy and imatinib works in another group of patients with a type of ALL that is similar to Ph+ ALL. This type of ALL is called "ABL-class fusion positive ALL", and because it is similar to Ph+ ALL, is thought it will respond well to the combination of agents used to treat Ph+ ALL.
Status | Recruiting |
Enrollment | 475 |
Est. completion date | September 30, 2027 |
Est. primary completion date | September 30, 2027 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 1 Year to 21 Years |
Eligibility | Inclusion Criteria: - For patients enrolled on APEC14B1 prior to enrollment on AALL1631, the required diagnostic bone marrow sample has been fulfilled - For patients who have not previously enrolled on APEC14B1 prior to enrollment on AALL1631, a baseline diagnostic sample (or peripheral blood sample with blasts if marrow sample unavailable) must be available to develop an MRD probe - In addition, laboratory reports detailing evidence of BCR-ABL1 fusion or ABL-class fusion must be submitted for rapid central review within 72 hours of study enrollment - >= 1 year (365 days) and =< 21 years at ALL diagnosis - Ph+ (BCR-ABL1 fusion): newly diagnosed de novo ALL (B-ALL or T-ALL) or mixed phenotypic acute leukemia (MPAL meeting 2016 World Health Organization [WHO] definition) with definitive evidence of BCR-ABL1 fusion by karyotype, fluorescence in situ hybridization (FISH) and/or molecular methodologies - ABL-class fusion: newly diagnosed B-ALL with definitive evidence of ABL-class fusions. ABL-class fusions are defined as those involving the following genes: ABL1, ABL2, CSF1R, PDGFRB, PDGFRA. Methods of detection include fluorescence in-situ hybridization (FISH, e.g. using break-apart or colocalization signals probes), multiplex or singleplex reverse-transcription polymerase chain reaction (RT-PCR), whole transcriptome or panel-based ribonucleic acid (RNA)-sequencing (e.g. TruSight RNA Pan-Cancer Panel; Illumina, San Diego, CA, USA or similar) - Ph+ patients must have previously started Induction therapy, which includes vincristine, a corticosteroid, pegaspargase, with or without anthracycline, and/or other standard cytotoxic chemotherapy - Ph+ patients have not received more than 14 days of multiagent Induction therapy beginning with the first dose of vinCRIStine - Ph+ patients may have started imatinib prior to study entry but have not received more than 14 days of imatinib - ABL-class fusion patients must have previously completed the 4 or 5 weeks of multiagent Induction chemotherapy (Induction IA phase) - ABL-class fusion patients may have started imatinib during Induction IA, at the same time of or after the first vinCRIStine dose - Patients must have a performance status corresponding to Eastern Cooperative Oncology Group (ECOG) scores of 0, 1, or 2 - Direct bilirubin =< 2.0 mg/dL - Shortening fraction of >= 27% by echocardiogram - Ejection fraction of >= 50% by radionuclide angiogram or echocardiogram - Corrected QT interval, QTc < 480 msec - Note: Repeat echocardiogram and electrocardiogram are not required if they were performed at or after initial ALL diagnosis, before study enrollment - Creatinine clearance or radioisotope glomerular filtration rate (GFR) >= 70 mL/min/1.73 m^2 or serum creatinine within normal limits based on age/gender, as follows: - 1 to < 2 years: maximum serum creatinine 0.6 mg/dL (both male and female) - 2 to < 6 years: maximum serum creatinine 0.8 mg/dL (both male and female) - 6 to < 10 years: maximum serum creatinine 1 mg/dL (both male and female) - 10 to < 13 years: maximum serum creatinine 1.2 mg/dL (both male and female) - 13 to < 16 years: maximum serum creatinine 1.5 mg/dL (male), 1.4 mg/dL (female) - >= 16 years: maximum serum creatinine 1.7 mg/dL (male), 1.4 mg/dL (female) Exclusion Criteria: - Known history of chronic myelogenous leukemia (CML) - ALL developing after a previous cancer treated with cytotoxic chemotherapy - Active, uncontrolled infection, or active systemic illness that requires ongoing vasopressor support or mechanical ventilation - Down syndrome - Pregnancy and breast feeding - Female patients who are pregnant since fetal toxicities and teratogenic effects have been noted for several of the study drugs; a pregnancy test is required for female patients of childbearing potential - Lactating females who plan to breastfeed their infants - Sexually active patients of reproductive potential who have not agreed to use an effective contraceptive method for the duration of treatment according to protocol - Patients with congenital long QT syndrome, history of ventricular arrhythmias or heart block - Prior treatment with dasatinib, or any TKI other than imatinib |
Country | Name | City | State |
---|---|---|---|
Australia | John Hunter Children's Hospital | Hunter Regional Mail Centre | New South Wales |
Australia | Perth Children's Hospital | Perth | Western Australia |
Australia | Princess Margaret Hospital for Children | Perth | Western Australia |
Australia | Sydney Children's Hospital | Randwick | New South Wales |
Australia | Queensland Children's Hospital | South Brisbane | Queensland |
Australia | The Children's Hospital at Westmead | Westmead | New South Wales |
Austria | St. Anna Children's Hospital | Vienna | |
Belgium | Hospitals Leuven | Leuven | Flemish Brabant |
Canada | Alberta Children's Hospital | Calgary | Alberta |
Canada | University of Alberta Hospital | Edmonton | Alberta |
Canada | IWK Health Centre | Halifax | Nova Scotia |
Canada | McMaster Children's Hospital at Hamilton Health Sciences | Hamilton | Ontario |
Canada | Kingston Health Sciences Centre | Kingston | Ontario |
Canada | Children's Hospital | London | Ontario |
Canada | Centre Hospitalier Universitaire Sainte-Justine | Montreal | Quebec |
Canada | The Montreal Children's Hospital of the MUHC | Montreal | Quebec |
Canada | Children's Hospital of Eastern Ontario | Ottawa | Ontario |
Canada | CHU de Quebec-Centre Hospitalier de l'Universite Laval (CHUL) | Quebec | |
Canada | Jim Pattison Children's Hospital | Saskatoon | Saskatchewan |
Canada | Saskatoon Cancer Centre | Saskatoon | Saskatchewan |
Canada | Centre Hospitalier Universitaire de Sherbrooke-Fleurimont | Sherbrooke | Quebec |
Canada | Hospital for Sick Children | Toronto | Ontario |
Canada | British Columbia Children's Hospital | Vancouver | British Columbia |
Canada | CancerCare Manitoba | Winnipeg | Manitoba |
Chile | Hospital Roberto del Rio-Universidad de Chile | Santiago | |
Czechia | University Hospital Motol | Praha | |
Finland | Tampere University Hospital | Tampere | |
France | CHU Hopital Sud | Rennes | |
Germany | Universitätsklinik Eppendorf | Hamburg | |
Germany | University Medical Center chleswig- Campus Kiel | Kiel | Schleswig-Holstein |
Hong Kong | Hong Kong Children's Hospital | Kowloon Bay | Kowloon |
Israel | Schneider Children's Medical Center of Israe | Petah-Tikva | Central District |
Italy | Clinica Pediatrica Università Milano-Bicocca Ospedale S. Gerardo/Fondazione MBBM | Monza | |
Netherlands | Princess Máxima Center for Pediatric Oncology | Utrecht | |
New Zealand | Christchurch Hospital | Christchurch | |
New Zealand | Starship Children's Hospital | Grafton | Auckland |
Puerto Rico | HIMA San Pablo Oncologic Hospital | Caguas | |
Puerto Rico | San Jorge Children's Hospital | San Juan | |
Puerto Rico | University Pediatric Hospital | San Juan | |
Saudi Arabia | King Faisal Specialist Hospital and Research Centre | Riyadh | |
Sweden | Skane University Hospital | Lund | Scania |
Switzerland | University Children's Hospital | Zurich | |
United States | Children's Hospital Medical Center of Akron | Akron | Ohio |
United States | Albany Medical Center | Albany | New York |
United States | Presbyterian Hospital | Albuquerque | New Mexico |
United States | University of New Mexico Cancer Center | Albuquerque | New Mexico |
United States | Lehigh Valley Hospital-Cedar Crest | Allentown | Pennsylvania |
United States | Texas Tech University Health Sciences Center-Amarillo | Amarillo | Texas |
United States | Providence Alaska Medical Center | Anchorage | Alaska |
United States | C S Mott Children's Hospital | Ann Arbor | Michigan |
United States | Mission Hospital | Asheville | North Carolina |
United States | Children's Healthcare of Atlanta - Egleston | Atlanta | Georgia |
United States | Augusta University Medical Center | Augusta | Georgia |
United States | Children's Hospital Colorado | Aurora | Colorado |
United States | Dell Children's Medical Center of Central Texas | Austin | Texas |
United States | Johns Hopkins University/Sidney Kimmel Cancer Center | Baltimore | Maryland |
United States | Sinai Hospital of Baltimore | Baltimore | Maryland |
United States | Eastern Maine Medical Center | Bangor | Maine |
United States | Walter Reed National Military Medical Center | Bethesda | Maryland |
United States | Children's Hospital of Alabama | Birmingham | Alabama |
United States | Saint Luke's Cancer Institute - Boise | Boise | Idaho |
United States | Dana-Farber Cancer Institute | Boston | Massachusetts |
United States | Massachusetts General Hospital Cancer Center | Boston | Massachusetts |
United States | Tufts Children's Hospital | Boston | Massachusetts |
United States | Montefiore Medical Center - Moses Campus | Bronx | New York |
United States | Maimonides Medical Center | Brooklyn | New York |
United States | Roswell Park Cancer Institute | Buffalo | New York |
United States | University of Vermont and State Agricultural College | Burlington | Vermont |
United States | UNC Lineberger Comprehensive Cancer Center | Chapel Hill | North Carolina |
United States | Medical University of South Carolina | Charleston | South Carolina |
United States | Carolinas Medical Center/Levine Cancer Institute | Charlotte | North Carolina |
United States | Novant Health Presbyterian Medical Center | Charlotte | North Carolina |
United States | University of Virginia Cancer Center | Charlottesville | Virginia |
United States | T C Thompson Children's Hospital | Chattanooga | Tennessee |
United States | Lurie Children's Hospital-Chicago | Chicago | Illinois |
United States | University of Chicago Comprehensive Cancer Center | Chicago | Illinois |
United States | University of Illinois | Chicago | Illinois |
United States | Cincinnati Children's Hospital Medical Center | Cincinnati | Ohio |
United States | Cleveland Clinic Foundation | Cleveland | Ohio |
United States | Rainbow Babies and Childrens Hospital | Cleveland | Ohio |
United States | Columbia Regional | Columbia | Missouri |
United States | Prisma Health Richland Hospital | Columbia | South Carolina |
United States | Nationwide Children's Hospital | Columbus | Ohio |
United States | Driscoll Children's Hospital | Corpus Christi | Texas |
United States | Medical City Dallas Hospital | Dallas | Texas |
United States | UT Southwestern/Simmons Cancer Center-Dallas | Dallas | Texas |
United States | Geisinger Medical Center | Danville | Pennsylvania |
United States | Dayton Children's Hospital | Dayton | Ohio |
United States | Rocky Mountain Hospital for Children-Presbyterian Saint Luke's Medical Center | Denver | Colorado |
United States | Blank Children's Hospital | Des Moines | Iowa |
United States | Ascension Saint John Hospital | Detroit | Michigan |
United States | Children's Hospital of Michigan | Detroit | Michigan |
United States | Kaiser Permanente Downey Medical Center | Downey | California |
United States | City of Hope Comprehensive Cancer Center | Duarte | California |
United States | Duke University Medical Center | Durham | North Carolina |
United States | Michigan State University Clinical Center | East Lansing | Michigan |
United States | El Paso Children's Hospital | El Paso | Texas |
United States | Inova Fairfax Hospital | Falls Church | Virginia |
United States | Sanford Broadway Medical Center | Fargo | North Dakota |
United States | Broward Health Medical Center | Fort Lauderdale | Florida |
United States | Golisano Children's Hospital of Southwest Florida | Fort Myers | Florida |
United States | Cook Children's Medical Center | Fort Worth | Texas |
United States | University of Florida Health Science Center - Gainesville | Gainesville | Florida |
United States | Helen DeVos Children's Hospital at Spectrum Health | Grand Rapids | Michigan |
United States | Saint Vincent Hospital Cancer Center Green Bay | Green Bay | Wisconsin |
United States | BI-LO Charities Children's Cancer Center | Greenville | South Carolina |
United States | East Carolina University | Greenville | North Carolina |
United States | Hackensack University Medical Center | Hackensack | New Jersey |
United States | Connecticut Children's Medical Center | Hartford | Connecticut |
United States | Penn State Children's Hospital | Hershey | Pennsylvania |
United States | Memorial Regional Hospital/Joe DiMaggio Children's Hospital | Hollywood | Florida |
United States | Kapiolani Medical Center for Women and Children | Honolulu | Hawaii |
United States | Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center | Houston | Texas |
United States | M D Anderson Cancer Center | Houston | Texas |
United States | Edwards Comprehensive Cancer Center | Huntington | West Virginia |
United States | Ascension Saint Vincent Indianapolis Hospital | Indianapolis | Indiana |
United States | Riley Hospital for Children | Indianapolis | Indiana |
United States | University of Iowa/Holden Comprehensive Cancer Center | Iowa City | Iowa |
United States | University of Mississippi Medical Center | Jackson | Mississippi |
United States | Nemours Children's Clinic-Jacksonville | Jacksonville | Florida |
United States | Bronson Methodist Hospital | Kalamazoo | Michigan |
United States | Children's Mercy Hospitals and Clinics | Kansas City | Missouri |
United States | East Tennessee Childrens Hospital | Knoxville | Tennessee |
United States | Alliance for Childhood Diseases/Cure 4 the Kids Foundation | 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 Medical Center of Southern Nevada | Las Vegas | Nevada |
United States | Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center | Lebanon | New Hampshire |
United States | University of Kentucky/Markey Cancer Center | Lexington | Kentucky |
United States | Arkansas Children's Hospital | Little Rock | Arkansas |
United States | Loma Linda University Medical Center | Loma Linda | California |
United States | Miller Children's and Women's Hospital Long Beach | Long Beach | California |
United States | Cedars Sinai Medical Center | Los Angeles | California |
United States | Children's Hospital Los Angeles | Los Angeles | California |
United States | Norton Children's Hospital | Louisville | Kentucky |
United States | Palms West Radiation Therapy | Loxahatchee Groves | Florida |
United States | Covenant Children's Hospital | Lubbock | Texas |
United States | UMC Cancer Center / UMC Health System | Lubbock | Texas |
United States | Medical Center of Central Georgia | Macon | Georgia |
United States | Valley Children's Hospital | Madera | California |
United States | University of Wisconsin Carbone Cancer Center | Madison | Wisconsin |
United States | Marshfield Medical Center-Marshfield | Marshfield | Wisconsin |
United States | Banner Children's at Desert | Mesa | Arizona |
United States | Miami Cancer Institute | Miami | Florida |
United States | Nicklaus Children's Hospital | Miami | Florida |
United States | University of Miami Miller School of Medicine-Sylvester Cancer Center | Miami | Florida |
United States | Children's Hospital of Wisconsin | Milwaukee | Wisconsin |
United States | NYU Winthrop Hospital | Mineola | New York |
United States | Children's Hospitals and Clinics of Minnesota - Minneapolis | Minneapolis | Minnesota |
United States | University of Minnesota/Masonic Cancer Center | Minneapolis | Minnesota |
United States | USA Health Strada Patient Care Center | Mobile | Alabama |
United States | West Virginia University Healthcare | Morgantown | West Virginia |
United States | Morristown Medical Center | Morristown | New Jersey |
United States | The Children's Hospital at TriStar Centennial | Nashville | Tennessee |
United States | Vanderbilt University/Ingram Cancer Center | Nashville | Tennessee |
United States | Rutgers Cancer Institute of New Jersey-Robert Wood Johnson University Hospital | New Brunswick | New Jersey |
United States | Saint Peter's University Hospital | New Brunswick | New Jersey |
United States | Yale University | New Haven | Connecticut |
United States | The Steven and Alexandra Cohen Children's Medical Center of New York | New Hyde Park | New York |
United States | Ochsner Medical Center Jefferson | New Orleans | Louisiana |
United States | Laura and Isaac Perlmutter Cancer Center at NYU Langone | New York | New York |
United States | Memorial Sloan Kettering Cancer Center | New York | New York |
United States | Mount Sinai Hospital | New York | New York |
United States | NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center | New York | New York |
United States | Newark Beth Israel Medical Center | Newark | New Jersey |
United States | Children's Hospital of The King's Daughters | Norfolk | Virginia |
United States | Advocate Children's Hospital-Oak Lawn | Oak Lawn | Illinois |
United States | Kaiser Permanente-Oakland | Oakland | California |
United States | UCSF Benioff Children's Hospital Oakland | Oakland | California |
United States | University of Oklahoma Health Sciences Center | Oklahoma City | Oklahoma |
United States | Children's Hospital and Medical Center of Omaha | Omaha | Nebraska |
United States | University of Nebraska Medical Center | Omaha | Nebraska |
United States | Children's Hospital of Orange County | Orange | California |
United States | AdventHealth Orlando | Orlando | Florida |
United States | Arnold Palmer Hospital for Children | Orlando | Florida |
United States | Nemours Children's Hospital | Orlando | Florida |
United States | Lucile Packard Children's Hospital Stanford University | Palo Alto | California |
United States | Advocate Children's Hospital-Park Ridge | Park Ridge | Illinois |
United States | Saint Joseph's Regional Medical Center | Paterson | New Jersey |
United States | Sacred Heart Hospital | Pensacola | Florida |
United States | Saint Jude Midwest Affiliate | Peoria | Illinois |
United States | Children's Hospital of Philadelphia | Philadelphia | Pennsylvania |
United States | Saint Christopher's Hospital for Children | Philadelphia | Pennsylvania |
United States | Phoenix Childrens Hospital | Phoenix | Arizona |
United States | Children's Hospital of Pittsburgh of UPMC | Pittsburgh | Pennsylvania |
United States | Legacy Emanuel Children's Hospital | Portland | Oregon |
United States | Oregon Health and Science University | Portland | Oregon |
United States | Naval Medical Center - Portsmouth | Portsmouth | Virginia |
United States | Rhode Island Hospital | Providence | Rhode Island |
United States | Renown Regional Medical Center | Reno | Nevada |
United States | Virginia Commonwealth University/Massey Cancer Center | Richmond | Virginia |
United States | Carilion Children's | Roanoke | Virginia |
United States | Mayo Clinic in Rochester | Rochester | Minnesota |
United States | University of Rochester | Rochester | New York |
United States | Beaumont Children's Hospital-Royal Oak | Royal Oak | Michigan |
United States | University of California Davis Comprehensive Cancer Center | Sacramento | California |
United States | Mercy Hospital Saint Louis | Saint Louis | Missouri |
United States | Washington University School of Medicine | Saint Louis | Missouri |
United States | Johns Hopkins All Children's Hospital | Saint Petersburg | Florida |
United States | Primary Children's Hospital | Salt Lake City | Utah |
United States | Children's Hospital of San Antonio | San Antonio | Texas |
United States | Methodist Children's Hospital of South Texas | San Antonio | Texas |
United States | University of Texas Health Science Center at San Antonio | San Antonio | Texas |
United States | Rady Children's Hospital - San Diego | San Diego | California |
United States | UCSF Medical Center-Mission Bay | San Francisco | California |
United States | Memorial Health University Medical Center | Savannah | Georgia |
United States | Maine Children's Cancer Program | Scarborough | Maine |
United States | Seattle Children's Hospital | Seattle | Washington |
United States | Sanford USD Medical Center - Sioux Falls | Sioux Falls | South Dakota |
United States | Providence Sacred Heart Medical Center and Children's Hospital | Spokane | Washington |
United States | Southern Illinois University School of Medicine | Springfield | Illinois |
United States | Stony Brook University Medical Center | Stony Brook | New York |
United States | State University of New York Upstate Medical University | Syracuse | New York |
United States | Madigan Army Medical Center | Tacoma | Washington |
United States | Mary Bridge Children's Hospital and Health Center | Tacoma | Washington |
United States | Saint Joseph's Hospital/Children's Hospital-Tampa | Tampa | Florida |
United States | Tampa General Hospital | Tampa | Florida |
United States | Scott and White Memorial Hospital | Temple | Texas |
United States | ProMedica Toledo Hospital/Russell J Ebeid Children's Hospital | Toledo | Ohio |
United States | Banner University Medical Center - Tucson | Tucson | Arizona |
United States | New York Medical College | Valhalla | New York |
United States | Children's National Medical Center | Washington | District of Columbia |
United States | MedStar Georgetown University Hospital | Washington | District of Columbia |
United States | Saint Mary's Hospital | West Palm Beach | Florida |
United States | Alfred I duPont Hospital for Children | Wilmington | Delaware |
United States | Wake Forest University Health Sciences | Winston-Salem | North Carolina |
United States | UMass Memorial Medical Center - University Campus | Worcester | Massachusetts |
Lead Sponsor | Collaborator |
---|---|
Children's Oncology Group | EsPhALL Network/ BFM Study Group, National Cancer Institute (NCI) |
United States, Australia, Austria, Belgium, Canada, Chile, Czechia, Finland, France, Germany, Hong Kong, Israel, Italy, Netherlands, New Zealand, Puerto Rico, Saudi Arabia, Sweden, Switzerland,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Incidence of toxicities associated with post-HSCT administration of imatinib mesylate | Evaluated according to NCI CTCAE version 5.0. Frequencies of target toxicities in high risk patients after the initiation of post-HSCT imatinib mesylate will be described. For the high risk patients, the specific targeted toxicities will include grade 4 neutropenia, grade 4 thrombocytopenia, grade 3 or higher bilirubin, grade 4 or higher transaminitis, and grade 3 or higher infection. | Up to 2 years | |
Other | Incidence of long-term toxicities in patients treated with chemotherapy plus imatinib mesylate (no transplant) in both arms | Evaluated according to NCI CTCAE version 5.0. Frequencies of long-term toxicities will be described and differences between randomized arms will be explored. Specific long-term toxicities to be explored include cardiac (echocardiographic abnormalities, including decreased left ventricular (LV) function and decreased LV wall thickness), growth (linear height, bone age), and second malignant neoplasm. | Up to 3 years | |
Other | MRD measured by IGH-T cell receptor (TCR) polymerase chain reaction (PCR) and next generation sequencing (NGS) assay | For all patients, frequencies and prognostic significance (DFS, EFS, OS) will be explored for MRD levels (i.e., MRD negative, detectable at < 5 x 10^-4, and dectectable at >= 5 x 10^-4) at end of Induction IB. | Up to 6 months | |
Other | MRD in high risk Ph+ patients measured by IGH-TCR PCR and NGS assay | The outcome of high risk Ph+ patients will be described, including proportion of patients who achieve MRD-negativity just prior to HSCT, and at regular intervals post-HSCT. Associations between these findings and long-term outcomes (e.g., OS, DFS) will be explored. | Up to 3 years | |
Other | MRD assessments made by IGH-TCR PCR assay and NGS assay | Concordance of MRD assessments made by IGH-TCR PCR assay and NGS assay will be described and evaluated. Scatter plots and diagrams will be used to examine agreements and patterns of agreement or any differences found. Concordance will be explored both for the overall cohort, as well as by risk group. The increased sensitivity of the NGS will be closely examined to find cases where the MRD levels are detectable by NGS but undetectable by PCR, as well as cases in which one test yields results and the other does not (test failure). Prognostic relationships on outcomes for these subjects will be inspected. | Up to 3 years | |
Other | IKZF1 gene aberrations and deletions | For both standard risk and high risk groups, frequencies and prognostic significance (OS, DFS) will be explored for IKZF1 gene aberrations and deletions. | Up to 3 years | |
Other | Frequency of p190 and p210 BCR-ABL1 fusion variants | For both standard risk and high risk groups, frequencies and prognostic significance (OS, DFS) will be explored for p190 and p210 BCR-ABL1 fusion variants in pediatric Ph+ ALL. | Up to 3 years | |
Other | Adherence to oral chemotherapeutic agents in standard risk Ph+ ALL patients | Adherence to imatinib mesylate, 6-mercaptopurine, and methotrexate will be evaluated in COG-enrolled participants using an electronic monitoring device. Adherence rate will be computed for each month of adherence monitoring. Longitudinal binomial regression will be conducted using generalized estimating equation methods by modeling monthly adherence rate as an unstructured mean model using five indicator variables of time for the study months. Time in months will also be treated as a continuous variable to explore temporal trends in adherence rate. Compound symmetry will be assumed as the working correlation matrix over time. Covariates that will be considered for adjustment include those hypothesized to be predictors of adherence, annual household income, parental education, time since start of maintenance, risk classification for ALL, and imatinib, 6-mercaptopurine (6MP), and methotrexate dose-intensity. | Up to 2 years | |
Other | Adherence to imatinib mesylate after allogeneic HSCT in high risk Ph+ ALL patients | Longitudinal binomial regression will be conducted using generalized estimating equation methods by modeling monthly adherence rate as an unstructured mean model using five indicator variables of time for the study months. Time in months will also be treated as a continuous variable to explore temporal trends in adherence rate. Compound symmetry will be assumed as the working correlation matrix over time. Covariates that will be considered for adjustment include those hypothesized to be predictors of adherence, annual household income, parental education, time since start of maintenance, risk classification for ALL, and imatinib, 6MP, and methotrexate dose-intensity. | Up to 2 years | |
Primary | Disease free survival (DFS) of Randomized Arms (standard risk [SR] Philadelphia chromosome [Ph+] acute lymphoblastic leukemia [ALL] patients) | Three-year DFS and 95% confidence intervals (CI) of SR Ph+ ALL patients treated continuous imatinib mesylate with high risk Children's Oncology Group (COG)-ALL chemotherapy backbone or more intensive European (Es)PhALL chemotherapy backbone. | Up to 3 years | |
Secondary | DFS on Randomized Arms (SR Ph+ ALL and ABL-class fusion positive patients) | Three-year DFS (time from randomization to relapse, second malignancy, or death in complete remission) and 95% CI of SR pediatric Ph+ and ABL-class fusion positive patients treated with continuous imatinib combined with either a high-risk COG-ALL chemotherapy backbone or the more intensive EsPhALL chemotherapy backbone. | Up to 3 years | |
Secondary | Feasibility of post hematopoietic stem cell transplantation (HSCT) imatinib mesylate administration after allogenic HSCT in high risk Ph+ ALL patients | The proportion of patients who receive at least 75% of intended doses. | Up to 2 years | |
Secondary | Event free survival (EFS) of high risk pediatric Ph+ ALL patients treated with EsPhALL chemotherapy, HSCT in first complete remission, and post-HSCT imatinib mesylate | Three-year EFS and 95% CI for high risk pediatric Ph+ ALL patients treated with EsPhALL chemotherapy, HSCT in first complete remission, and post-HSCT imatinib mesylate. EFS is defined as the time from the date of bone marrow for minimal residual disease (MRD) assessment at end-IB to first event (resistant disease [MRD >= 10-2 or morphologic residual disease at end of consolidation block 3], relapse, progressive disease [i.e., MRD >= 10-2 at two post-HSCT time points separated by at least 2 weeks], second malignancy, or death in complete remission), or time to last follow-up for patients without events. | Up to 3 years | |
Secondary | Incidence of grade 3 or higher infections in standard risk Ph+ ALL patients in the two randomized arms | Evaluated according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. The rate of infections during the post IB/pre-maintenance phases of treatment will be described for each randomization group. | Up to 3 years | |
Secondary | EFS of all Ph+ patients | Three-year EFS and 95% CI for Ph+ ALL patients. EFS here is defined as the time from enrollment until resistant disease, relapse, progressive disease post-HSCT, second malignant, or death, whichever occurs first. | Up to 3 years | |
Secondary | Overall survival (OS) of all Ph+ patients | Three-year OS and 95% CI for Ph+ ALL patients. OS is defined as the time from study enrollment to death from any cause. | Up to 3 years | |
Secondary | OS of SR Ph+ patients | Three-year OS (time from randomization to death from any cause) and 95% CI of SR pediatric Ph+ patients | Up to 3 years | |
Secondary | OS of SR Ph+ patients by randomization group | Three-year OS (time from randomization to death from any cause) and 95% CI of SR pediatric Ph+ patients by randomization group: treated with continuous imatinib combined with either a high-risk COG-ALL chemotherapy backbone or the more intensive EsPhALL chemotherapy backbone. | Up to 3 years | |
Secondary | OS of high risk Ph+ patients | Three-year OS (time from the date of MRD assessment at end-IB to death from any cause) and 95% CI of HR pediatric Ph+ patients. | Up to 3 years | |
Secondary | EFS of all eligibility ABL-class fusion positive ALL patients | Three-year EFS (time from enrollment until resistant disease, relapse, progressive disease post-HSCT, second malignancy, or death, whichever occurs first) and 95% CI of ABL-class fusion positive patients. | Up to 3 years | |
Secondary | OS of all eligibility ABL-class fusion positive ALL patients | Three-year OS (the time from study enrollment to death from any cause) and 95% CI of ABL-class fusion positive patients. | Up to 3 years |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
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