At a glance
ClinicalIndex Comparison Record- ✓Morphologically confirmed AML by bone marrow aspiration and biopsy within 14 days
- ✓Age 18-60 years
- ✓No prior systemic chemotherapy (hydroxyurea allowed)
- ✓Performance status Zubrod 0-3
- ✕M3 disease (acute promyelocytic leukemia)
- ✕Blastic transformation of chronic myelogenous leukemia
- ✕Pre-existing hematologic disorder evolving to AML (e.g., myelodysplasia or secondary leukemia)
- ✕Other malignancy within past 5 years (except adequately treated skin cancer or cervical carcinoma in situ)
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase III Study of the Addition of Gemtuzumab Ozogamicin (Mylotarg®) During Induction Therapy Versus Standard Induction With Daunomycin and Cytosine Arabinoside Followed by Consolidation and Subsequent Randomization to Post-Consolidation Therapy With Gemtuzumab Ozogamicin (Mylotarg®) or No Additional Therapy For Patients Under Age 61 With Previously Untreated De Novo Acute Myeloid Leukemia (AML)
In Brief
A Phase 3 clinical trial evaluating gemtuzumab ozogamicin, observation, and 2 other interventions for Leukemia. Completed, enrolled 637 participants across 279 sites in 3 countries.
Detailed Summary
RATIONALE: Drugs used in chemotherapy, such as cytarabine and daunorubicin, work in different ways to stop cancer cells from dividing so they stop growing and die. Monoclonal antibodies, such as gemtuzumab ozogamicin, can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells. Combining chemotherapy with gemtuzumab ozogamicin may kill more cancer cells. It is not yet known whether induction therapy using cytarabine and daunorubicin is more effective with or without gemtuzumab ozogamicin or whether postconsolidation therapy using gemtuzumab ozogamicin is more effective than no additional therapy in treating de novo (first occurrence) acute myeloid leukemia. PURPOSE: This randomized phase III trial is comparing two different regimens of chemotherapy and monoclonal antibody therapy to see how well they work in treating patients with previously untreated de novo acute myeloid leukemia.
Study Details
Timeline
Interventions
Given IV, induction Arm1 6mg/m2 D4; post-consolidation 5mg/m2 3 doses \>/= 28 days apart
No treatment given
IV; induction Arms1/2 and reinduction 100 mg/m2/d days 1-7; consolidation 3gm/m2 q3hrs D1, 3, 5
IV; induction Arm1 45mg/m2 D1-3; Arm2 and reinduction 60 mg/m2 D1-3;