Phase 3
N=657
Combination Chemotherapy With or Without Monoclonal Antibody Therapy in Treating Patients With AML Leukemia
Leukemia
Bottom Line
View on ClinicalTrials.gov: NCT00049517 ↗Enrolled (actual)
657
Serious AEs
100.0%
Results posted
Feb 2013
Primary outcome: Primary: Overall Survival (Induction Phase) — 15.7; 23.7 months
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- sargramostim (Biological); busulfan (Drug); cyclophosphamide (Drug); cytarabine (Drug); gemtuzumab ozogamicin (GO) (Drug); Daunorubicin (Drug); Autologous HCT (Procedure); Allogeneic HCT (Procedure)
- Age
- Pediatric, Adult · 16+ yrs
- Sex
- All
- Sponsor
- Eastern Cooperative Oncology Group
- Primary completion
- Mar 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Overall Survival (Induction Phase) |
15.7; 23.7 | — |
| PRIMARY Disease-free Survival (Consolidation Phase) |
15.0; 13.6 | — |
| SECONDARY Overall Survival (Consolidation Phase) |
35.5; 27.9 | — |
Summary
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.
Eligibility Criteria
Inclusion Criteria
- 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
- Negative pregnancy test
- Fertile patients must use effective contraception
- HIV negative
- Prior hydroxyurea allowed
- Prior corticosteroids allowed
Exclusion Criteria
- 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
Data sourced from ClinicalTrials.gov (NCT00049517). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.