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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT00658814
Other study ID # NCI-2009-00790
Secondary ID NCI-2009-00790SW
Status Active, not recruiting
Phase Phase 2
First received
Last updated
Start date December 1, 2008
Est. completion date March 7, 2025

Study information

Verified date January 2024
Source National Cancer Institute (NCI)
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This phase II trial is studying the side effects of giving azacitidine together with gemtuzumab ozogamicin to see how well it works in treating older patients with previously untreated acute myeloid leukemia. Drugs used in chemotherapy, such as azacitidine, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Azacitidine may also stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Monoclonal antibodies, such as gemtuzumab ozogamicin, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them. Giving azacitidine together with gemtuzumab ozogamicin may kill more cancer cells.


Description:

PRIMARY OBJECTIVES: I. To test whether outcomes of patients of age 60 or older with previously untreated non-M3 acute myeloid leukemia treated with azacitidine plus gemtuzumab ozogamicin are sufficient to warrant phase III investigation. II. To estimate the frequency and severity of toxicities of this regimen in the good- and poor-risk groups of patients. III. To investigate in a preliminary manner the disease-free survival of patients who achieve complete remission and receive post-remission therapy on this study. IV. To investigate in a preliminary manner the cytogenetic response rates of patients treated with this regimen. V. To investigate in a preliminary manner the effects of cytogenetic abnormalities, promoter and global methylation changes, and multidrug resistance on overall survival and response to azacitidine plus gemtuzumab ozogamicin therapy. OUTLINE: Patients are stratified according to risk status (good [60-69 years of age OR Zubrod performance status [PS] 0-1] vs poor [>= 70 years of age AND Zubrod PS 2-3]). REMISSION INDUCTION THERAPY: Patients receive azacitidine intravenously (IV) over 10-40 minutes or subcutaneously (SC) once daily (QD) on days 1-7 and gemtuzumab ozogamicin IV over 2 hours on day 8. Patients with residual leukemia (blast count >= 5%) receive a second course of induction therapy beginning between days 15-29. Patients achieving complete remission (CR) or morphologic complete remission with incomplete blood count recovery (CRi) go on to receive consolidation therapy. CONSOLIDATION THERAPY: Patients receive one course of azacitidine and gemtuzumab ozogamicin as in induction therapy (with azacitidine given SC only). MAINTENANCE THERAPY: Patients receive azacitidine SC on days 1-7. Treatment repeats every 28 days for 4 courses in the absence of disease progression or unacceptable toxicity. Patients undergo bone marrow biopsies for cytogenetic studies at baseline, remission, and relapse or progression (and at completion of treatment if it does not correspond to one of these time points). Marrow and blood samples are submitted to correlatives studies and submitted to Southwest Oncology Group (SWOG) acute lymphoblastic leukemia (ALL)/chronic lymphocytic leukemia (CLL)/chronic myelogenous leukemia (CML) Repository in Seattle, WA. After completion of study therapy, patients are followed every 2 months for 2 years, every 3 months for 1 year, every 4 months for 1 year, and then every 6 months thereafter.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 133
Est. completion date March 7, 2025
Est. primary completion date June 1, 2013
Accepts healthy volunteers No
Gender All
Age group 60 Years and older
Eligibility Inclusion Criteria: - Morphologically confirmed diagnosis of acute myeloid leukemia (AML) with classification other than WHO acute promyelocytic leukemia (FAB M3), based on bone marrow examination performed within 14 days prior to registration; patients with World Health Organization (WHO) acute promyelocytic leukemia (FAB M3) or blastic transformation of chronic myelogenous leukemia are not eligible - Zubrod performance status 0-3 - No known hypersensitivity to azacitidine, mannitol, hydroxyurea, orgemtuzumab ozogamicin - No prior systemic chemotherapy for acute leukemia with the exception of hydroxyurea; administration of hydroxyurea to control high white blood cell (WBC) count prior to registration is permitted - Patients with a history of prior myelodysplastic syndrome (MDS) are eligible according to the following criteria: - No prior treatment of MDS with AML induction-type chemotherapy or high-dose chemotherapy with hematopoietic stem cell support - Prior cytarabine allowed if dose < 100 mg/m^2/day - Prior hematopoietic growth factors, thalidomide, lenalidomide, arsenic trioxide, and signal transduction inhibitors for treatment of MDS allowed - No prior treatment with azacitidine, decitabine, or gemtuzumab ozogamicin - At least 30 days since prior therapy for MDS and recovered - Bilirubin =< 2.0 x institutional upper limit of normal (IULN) within 14 days to registration, unless the elevation is believed to be due to hepatic infiltration by AML - Hyperbilirubinemia due primarily to elevated unconjugated hyperbilirubinemia secondary to Gilbert syndrome or hemolysis is allowed - Serum glutamic oxaloacetic transaminase (SGOT) aspartate aminotransferase (AST) =< 2 x IULN, or serum glutamic pyruvate transaminase (SGPT) alanine aminotransferase (ALT) =< 2.0 x IULN , unless the elevation is believed to be due to hepatic infiltration by AML - Serum creatinine =< 1.5 x IULN - Left ventricle ejection fraction (LVEF) >= 40% by multi-gated acquisition scan (MUGA) or echocardiogram (ECHO) AND no clinical evidence of congestive heart failure within the past 56 days - Pretreatment cytogenetics must be performed on all patients; collection of pretreatment specimens must be completed within 14 days prior to registration to S0703; specimens must be submitted to the site's preferred cytogenetics laboratory - Patients must consent to submit specimens to the Southwest Oncology Group (SWOG) acute lymphoblastic leukemia (ALL)/chronic lymphocytic leukemia (CLL)/chronic myelogenous leukemia (CML) repository for cellular and molecular studies; collection of pretreatment blood and/or marrow specimens must be completed within 14 days prior to registration; if a marrow specimen is available, either from the diagnostic marrow or a repeat pre-registration marrow, then it must be submitted along with a peripheral blood specimen; otherwise peripheral blood alone must be submitted; residual specimens will only be banked if the patient provides separate consent; sites are required to offer patients the opportunity to participate in banking - No central nervous system (CNS) involvement; if central nervous involvement is clinically suspected, it must be ruled out by a lumbar puncture - Women of reproductive potential must have a pregnancy test within 28 days prior to registration; patients must not be pregnant or nursing because of the teratogenic potential of the drugs used in this study; women/men of reproductive potential must have agreed to use an effective contraceptive method - Patients not known to be human immunodeficiency virus positive (HIV+) must be tested for HIV infection within 14 days prior to registration - HIV-positive patients must meet the following criteria: - No history of acquired immunodeficiency syndrome (AIDS)-defining events - CD4 cells >= 500/mm^3 - Viral load of < 50 copies HIV messenger ribonucleic acid (mRNA)/mm^3 if on cART or < 25,000 copies HIV mRNA if not on cART - No zidovudine or stavudine as part of cART Patients who are HIV+ and do not meet all of these criteria will not be eligible for this study - No other prior malignancy except for a) adequately treated basal cell or squamous cell skin cancer or b) any diagnosis of malignancy made within the past 2 years earlier, of which there is no clinically evident cancer, and for which the patient has completed all chemotherapy and radiotherapy at least 6 months prior to study registration; prior treatment with AML induction-type chemotherapy is not allowed; concurrent hormonal therapy is allowed - All patients must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelines - At the time of patient registration, the treating institution's name and identification (ID) number must be provided to the Data Operations Center in Seattle in order to ensure that the current (within 365 days) date of institutional review board approval for this study has been entered into the data base - Patients must have complete remission (CR) or CRi, documented by blood and marrow examinations performed within 42 days before this registration - Following completion of induction therapy, the blood counts must recover to absolute neutrophil count (ANC) >= 1,000/mcL and platelets >= 90,000/mcL (without transfusion), and must be maintained at these levels during the 7 days prior to registration - Patients must have serum creatinine =< 1.5 x IULN and SGOT or SGPT =< 1.5 x IULN within 28 days before registration - Patients must have recovered to =< Grade 2 from any induction cycle non-hematologic toxicities

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Azacitidine
Given IV or SC during induction; given SC during consolidation and maintenance
Gemtuzumab Ozogamicin
Given IV

Locations

Country Name City State
United States Cleveland Clinic Akron General Akron Ohio
United States University of New Mexico Cancer Center Albuquerque New Mexico
United States Saint Anthony's Health Alton Illinois
United States The Don and Sybil Harrington Cancer Center Amarillo Texas
United States Cancer Care Center at Island Hospital Anacortes Washington
United States AnMed Health Hospital Anderson South Carolina
United States Michigan Cancer Research Consortium NCORP Ann Arbor Michigan
United States Trinity Health Saint Joseph Mercy Hospital Ann Arbor Ann Arbor Michigan
United States University of Michigan Comprehensive Cancer Center Ann Arbor Michigan
United States Hospital District Sixth of Harper County Anthony Kansas
United States Hematology/Oncology Clinic PLLC Baton Rouge Louisiana
United States Bronson Battle Creek Battle Creek Michigan
United States Franciscan Saint Francis Health-Beech Grove Beech Grove Indiana
United States Mary Rutan Hospital Bellefontaine Ohio
United States PeaceHealth Saint Joseph Medical Center Bellingham Washington
United States Spectrum Health Big Rapids Hospital Big Rapids Michigan
United States Billings Clinic Cancer Center Billings Montana
United States Montana Cancer Consortium NCORP Billings Montana
United States Northern Rockies Radiation Oncology Center Billings Montana
United States Saint Vincent Frontier Cancer Center Billings Montana
United States Saint Vincent Healthcare Billings Montana
United States Saint Alphonsus Cancer Care Center-Boise Boise Idaho
United States Bozeman Health Deaconess Hospital Bozeman Montana
United States Harrison HealthPartners Hematology and Oncology-Bremerton Bremerton Washington
United States Providence Saint Joseph Medical Center/Disney Family Cancer Center Burbank California
United States Highline Medical Center-Main Campus Burien Washington
United States Saint James Community Hospital and Cancer Treatment Center Butte Montana
United States Saint Francis Medical Center Cape Girardeau Missouri
United States Southeast Missouri Hospital Cape Girardeau Missouri
United States Rocky Mountain Oncology Casper Wyoming
United States Cancer Center of Kansas - Chanute Chanute Kansas
United States Medical University of South Carolina Charleston South Carolina
United States Novant Health Presbyterian Medical Center Charlotte North Carolina
United States Adena Regional Medical Center Chillicothe Ohio
United States University of Cincinnati Cancer Center-UC Medical Center Cincinnati Ohio
United States Clackamas Radiation Oncology Center Clackamas Oregon
United States Columbus NCI Community Oncology Research Program Columbus Ohio
United States Doctors Hospital Columbus Ohio
United States Grant Medical Center Columbus Ohio
United States Mount Carmel Health Center West Columbus Ohio
United States Riverside Methodist Hospital Columbus Ohio
United States Dayton NCI Community Oncology Research Program Dayton Ohio
United States Good Samaritan Hospital - Dayton Dayton Ohio
United States Grandview Hospital Dayton Ohio
United States Miami Valley Hospital Dayton Ohio
United States Miami Valley Hospital North Dayton Ohio
United States Beaumont Hospital - Dearborn Dearborn Michigan
United States Decatur Memorial Hospital Decatur Illinois
United States Heartland Cancer Research NCORP Decatur Illinois
United States Grady Memorial Hospital Delaware Ohio
United States Ascension Saint John Hospital Detroit Michigan
United States Wayne State University/Karmanos Cancer Institute Detroit Michigan
United States Cancer Center of Kansas - Dodge City Dodge City Kansas
United States Cancer Center of Kansas - El Dorado El Dorado Kansas
United States Advocate Sherman Hospital Elgin Illinois
United States Blanchard Valley Hospital Findlay Ohio
United States Genesys Regional Medical Center-West Flint Campus Flint Michigan
United States Hurley Medical Center Flint Michigan
United States Cancer Center of Kansas - Fort Scott Fort Scott Kansas
United States Atrium Medical Center-Middletown Regional Hospital Franklin Ohio
United States Wayne Memorial Hospital Goldsboro North Carolina
United States Cancer Research Consortium of West Michigan NCORP Grand Rapids Michigan
United States Corewell Health Grand Rapids Hospitals - Butterworth Hospital Grand Rapids Michigan
United States Trinity Health Grand Rapids Hospital Grand Rapids Michigan
United States Benefis Sletten Cancer Institute Great Falls Montana
United States Berdeaux, Donald MD (UIA Investigator) Great Falls Montana
United States Great Falls Clinic Great Falls Montana
United States Wayne Hospital Greenville Ohio
United States Legacy Mount Hood Medical Center Gresham Oregon
United States Smilow Cancer Hospital Care Center at Saint Francis Hartford Connecticut
United States Northern Montana Hospital Havre Montana
United States Saint Peter's Community Hospital Helena Montana
United States Margaret R Pardee Memorial Hospital Hendersonville North Carolina
United States Cancer Center of Kansas-Independence Independence Kansas
United States Swedish Cancer Institute-Issaquah Issaquah Washington
United States Allegiance Health Jackson Michigan
United States University of Mississippi Medical Center Jackson Mississippi
United States Glacier Oncology PLLC Kalispell Montana
United States Kalispell Medical Oncology Kalispell Montana
United States Kalispell Regional Medical Center Kalispell Montana
United States Heartland Hematology and Oncology Associates Incorporated Kansas City Missouri
United States North Kansas City Hospital Kansas City Missouri
United States Research Medical Center Kansas City Missouri
United States Saint Joseph Health Center Kansas City Missouri
United States Saint Luke's Hospital of Kansas City Kansas City Missouri
United States University Health Truman Medical Center Kansas City Missouri
United States Kadlec Clinic Hematology and Oncology Kennewick Washington
United States Kettering Medical Center Kettering Ohio
United States Cancer Center of Kansas-Kingman Kingman Kansas
United States Fairfield Medical Center Lancaster Ohio
United States University of Michigan Health - Sparrow Lansing Lansing Michigan
United States Lawrence Memorial Hospital Lawrence Kansas
United States Saint Luke's East - Lee's Summit Lee's Summit Missouri
United States University of Kentucky/Markey Cancer Center Lexington Kentucky
United States Cancer Center of Kansas-Liberal Liberal Kansas
United States Southwest Medical Center Liberal Kansas
United States Liberty Radiation Oncology Center Liberty Missouri
United States Trinity Health Saint Mary Mercy Livonia Hospital Livonia Michigan
United States Marietta Memorial Hospital Marietta Ohio
United States Loyola University Medical Center Maywood Illinois
United States Providence Milwaukie Hospital Milwaukie Oregon
United States Community Medical Center Missoula Montana
United States Guardian Oncology and Center for Wellness Missoula Montana
United States Montana Cancer Specialists Missoula Montana
United States Saint Patrick Hospital - Community Hospital Missoula Montana
United States Good Samaritan Regional Health Center Mount Vernon Illinois
United States Knox Community Hospital Mount Vernon Ohio
United States Skagit Valley Hospital Mount Vernon Washington
United States Trinity Health Muskegon Hospital Muskegon Michigan
United States Tulane University School of Medicine New Orleans Louisiana
United States Licking Memorial Hospital Newark Ohio
United States Providence Newberg Medical Center Newberg Oregon
United States Cancer Center of Kansas - Newton Newton Kansas
United States Providence Willamette Falls Medical Center Oregon City Oregon
United States Menorah Medical Center Overland Park Kansas
United States Saint Luke's South Hospital Overland Park Kansas
United States Stanford Cancer Institute Palo Alto Palo Alto California
United States Cancer Center of Kansas - Parsons Parsons Kansas
United States Trinity Health Saint Joseph Mercy Oakland Hospital Pontiac Michigan
United States Lake Huron Medical Center Port Huron Michigan
United States Adventist Medical Center Portland Oregon
United States Legacy Emanuel Hospital and Health Center Portland Oregon
United States Legacy Good Samaritan Hospital and Medical Center Portland Oregon
United States Providence Portland Medical Center Portland Oregon
United States Providence Saint Vincent Medical Center Portland Oregon
United States Southern Ohio Medical Center Portsmouth Ohio
United States Harrison HealthPartners Hematology and Oncology-Poulsbo Poulsbo Washington
United States Kansas City NCI Community Oncology Research Program Prairie Village Kansas
United States Cancer Center of Kansas - Pratt Pratt Kansas
United States Reid Health Richmond Indiana
United States University of Rochester Rochester New York
United States Rutherford Hospital Rutherfordton North Carolina
United States University of California Davis Comprehensive Cancer Center Sacramento California
United States Ascension Saint Mary's Hospital Saginaw Michigan
United States Heartland Regional Medical Center Saint Joseph Missouri
United States Saint Joseph Oncology Inc Saint Joseph Missouri
United States Mercy Hospital Saint Louis Saint Louis Missouri
United States Saint Louis Cancer and Breast Institute-South City Saint Louis Missouri
United States Saint Louis-Cape Girardeau CCOP Saint Louis Missouri
United States Salem Hospital Salem Oregon
United States Cancer Center of Kansas - Salina Salina Kansas
United States Salina Regional Health Center Salina Kansas
United States Fred Hutchinson Cancer Center Seattle Washington
United States Harborview Medical Center Seattle Washington
United States Kaiser Permanente Washington Seattle Washington
United States Minor and James Medical PLLC Seattle Washington
United States Swedish Medical Center-First Hill Seattle Washington
United States University of Washington Medical Center - Montlake Seattle Washington
United States PeaceHealth United General Medical Center Sedro-Woolley Washington
United States Advent Health - Shawnee Mission Medical Center Shawnee Mission Kansas
United States Welch Cancer Center Sheridan Wyoming
United States Ascension Providence Hospitals - Southfield Southfield Michigan
United States Spartanburg Medical Center Spartanburg South Carolina
United States Cancer Care Northwest - Spokane South Spokane Washington
United States Evergreen Hematology and Oncology PS Spokane Washington
United States Memorial Medical Center Springfield Illinois
United States Springfield Regional Medical Center Springfield Ohio
United States Cotton O'Neil Cancer Center / Stormont Vail Health Topeka Kansas
United States Munson Medical Center Traverse City Michigan
United States Upper Valley Medical Center Troy Ohio
United States Legacy Meridian Park Hospital Tualatin Oregon
United States PeaceHealth Southwest Medical Center Vancouver Washington
United States Saint John Macomb-Oakland Hospital Warren Michigan
United States Cancer Center of Kansas - Wellington Wellington Kansas
United States Wenatchee Valley Hospital and Clinics Wenatchee Washington
United States Saint Ann's Hospital Westerville Ohio
United States Ascension Via Christi Hospitals Wichita Wichita Kansas
United States Associates In Womens Health 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 Wichita NCI Community Oncology Research Program Wichita Kansas
United States Clinton Memorial Hospital/Foster J Boyd Regional Cancer Center Wilmington Ohio
United States Cancer Center of Kansas - Winfield Winfield Kansas
United States Southeast Clinical Oncology Research Consortium NCORP Winston-Salem North Carolina
United States University of Michigan Health - West Wyoming Michigan
United States Greene Memorial Hospital Xenia Ohio
United States Genesis Healthcare System Cancer Care Center Zanesville Ohio

Sponsors (1)

Lead Sponsor Collaborator
National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Complete Response Morphologic complete remission (CR): ANC >=1,000/mcL, platelet count >=100,000/mcL, <5% bone marrow blasts, no Auer rods, no evidence of extramedullary disease. Morphologic complete remission with incomplete blood count recovery (CRi): Same as CR but ANC may be <1,000/mcL and/or platelet count <100,000/mcL. Up to 60 days
Primary 30-Day Survival Patients surviving more than 30 days after study registration 30 days
Secondary Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug Only adverse events that are possibly, probably or definitely related to study drug are reported. Up to 5 years
Secondary Relapse-free Survival Relapse-free survival (RFS) is defined for all patients who achieve CR or CRi. RFS is measured from the date CR or CRi is first achieved until relapse or death form any cause, with observation censored on the date of last contact for patients last known to be alive without report of relapse. Relapse from CR/CRi is defined as reappearance of leukemic blasts in the peripheral blood; or > 5% blasts in the bone marrow not attributable to another cause; or appearance or reappearance of extramedullary disease. Up to 5 years
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