Combination Chemotherapy With or Without Monoclonal Antibody Therapy in Treating Patients With AML Leukemia

Completed · Phase 3

Conditions studied: Leukemia

In brief

RATIONALE: Giving combination chemotherapy before a stem cell transplant helps stop the growth of cancer cells. It also helps stop the patient's immune system from rejecting the transplanted stem cells. When the healthy stem cells are infused into the patient they may help the patient's bone marrow make stem cells, red blood cells, white blood cells, and platelets. If the patient's stem cells are to be transplanted, the patient is also treated with a monoclonal antibody, such as gemtuzumab ozogamicin, to kill any remaining cancer cells or deliver cancer-killing substances to them without harming normal cells. It is not yet known whether combination chemotherapy is more effective with or without gemtuzumab ozogamicin followed by stem cell transplant in treating acute myeloid leukemia. PURPOSE: This randomized phase III trial is studying combination chemotherapy, gemtuzumab ozogamicin, and stem cell transplant to see how well they work compared to combination chemotherapy and peripheral stem cell transplant alone in treating patients with acute myeloid leukemia.

Key facts

Study ID

NCT00049517

Run by

Eastern Cooperative Oncology Group

People needed

657

Starts

2002-12-19

Expected to finish

2019-12-01

Last updated by the study team

2023-06-15

Who can join

Age: 16 and older, up to 60. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Morphologically confirmed acute myeloid leukemia (AML) (greater than 20% blasts in the peripheral blood or marrow) meeting any of the following criteria:
• Recurrent cytogenetic translocations
• t(8;21)(q22;q22)
• Bone marrow eosinophil abnormalities
• inv(16)(p13;q22)
• t(16;16)(p13;q22)
• 11q23 abnormalities
• Multilineage dysplasia without presence of myelodysplastic syndromes (MDS)
• Minimally differentiated AML
• AML without maturation
• AML with maturation
• AML not otherwise categorized
• Acute myelomonocytic leukemia
• Acute monocytic leukemia
• Acute erythroid leukemia
• Acute megakaryocytic leukemia
• Acute basophilic leukemia
• Patients undergoing allogeneic transplantation must have a sibling donor match defined as human leukocyte antigen (HLA) match or haplotype match with one locus mismatch on other haplotype
• Age 16 to 60
• Eastern Cooperative Oncology Group (ECOG) performance status 0-4
• Aspartate aminotransferase (AST) less than 4 times upper limit of normal (ULN)
• Alkaline phosphatase less than 4 times ULN
• Creatinine no greater than 2.0 mg/dL
• Creatinine clearance at least 50 mL/min
• Left ventricular ejection fraction (LVEF) at least 45% by post-induction multigated acquisition (MUGA) scan

You may not qualify if…

• Recurrent cytogenetic translocations
• Acute promyelocytic leukemia (PML) with t(15;17)(q22;q21)
• Variant acute PML with t(v;17)
• Multilineage dysplasia with prior MDS
• Acute panmyelosis with myelofibrosis
• Blastic transformation of chronic myelogenous leukemia
• Secondary AML (chemotherapy-induced or evolved from MDS)
• Pregnant or nursing
• Bilirubin greater than 2.0 mg/dL (unless related to Gilbert's syndrome or hemolysis)
• Significant cardiac disease requiring active therapy (e.g., digoxin, diuretics, antiarrhythmics, or antianginal medications)
• Prior biologic therapy
• Prior cytotoxic chemotherapy for any malignancy
• Prior radiotherapy for any malignancy

Where it is running

• Mayo Clinic Scottsdale — Scottsdale, Arizona, United States
• Aurora Presbyterian Hospital — Aurora, Colorado, United States
• Penrose Cancer Center at Penrose Hospital — Colorado Springs, Colorado, United States
• St. Anthony Central Hospital — Denver, Colorado, United States
• Porter Adventist Hospital — Denver, Colorado, United States
• Presbyterian - St. Luke's Medical Center — Denver, Colorado, United States
• St. Joseph Hospital — Denver, Colorado, United States
• Rose Medical Center — Denver, Colorado, United States
• CCOP - Colorado Cancer Research Program — Denver, Colorado, United States
• Swedish Medical Center — Englewood, Colorado, United States
• St. Mary's Regional Cancer Center at St. Mary's Hospital and Medical Center — Grand Junction, Colorado, United States
• North Colorado Medical Center — Greeley, Colorado, United States
• Sky Ridge Medical Center — Lone Tree, Colorado, United States
• Hope Cancer Care Center at Longmont United Hospital — Longmont, Colorado, United States
• McKee Medical Center — Loveland, Colorado, United States
• St. Mary - Corwin Regional Medical Center — Pueblo, Colorado, United States
• North Suburban Medical Center — Thornton, Colorado, United States
• Exempla Lutheran Medical Center — Wheat Ridge, Colorado, United States
• Eugene M. and Christine E. Lynn Cancer Institute at Boca Raton Community Hospital - West — Boca Raton, Florida, United States
• Eugene M. and Christine E. Lynn Cancer Institute at Boca Raton Community Hospital - Main Campus — Boca Raton, Florida, United States
• University of Florida Shands Cancer Center — Gainesville, Florida, United States
• University of Miami Sylvester Comprehensive Cancer Center - Miami — Miami, Florida, United States
• Winship Cancer Institute of Emory University — Atlanta, Georgia, United States
• Robert H. Lurie Comprehensive Cancer Center at Northwestern University — Chicago, Illinois, United States
• Lurleen Wallace Comprehensive Cancer at University of Alabama - Birmingham — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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