At a glance
ClinicalIndex Comparison Record- ✓Acute myeloid leukemia (>30% myeloblasts in marrow or peripheral blood), excluding acute promyelocytic leukemia (FAB M3)
- ✓Refractory anemia with excess blasts in transformation (RAEB-T): 21-30% myeloblasts on bone marrow or peripheral blood
- ✓Refractory anemia with excess blasts (RAEB): 11-20% myeloblasts with other high-risk criteria
- ✓Age greater than 60 years
- ✕Blastic transformation of chronic myelogenous leukemia
- ✕CNS leukemia
- ✕Acute promyelocytic leukemia (FAB M3)
- ✕Currently receiving treatment for another malignancy
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Randomized, Placebo-Controlled, Double Blind, Trial of the Administration of the MDR Modulator, Zosuquidar Trihydrochloride (LY335979), During Conventional Induction and Post-Remission Therapy in Patients Greater Than 60 Years of Age With Newly Diagnosed Acute Myeloid Leukemia, Refractory Anemia With Excess Blasts in Transformation or High-Risk Refractory Anemia With Excess Blasts
In Brief
A Phase 3 clinical trial evaluating filgrastim, sargramostim, and 4 other interventions for Leukemia and Myelodysplastic Syndromes. Completed, enrolled 449 participants across 92 sites in 2 countries.
Detailed Summary
RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Zosuquidar trihydrochloride, a modulator of multidrug resistance (MDR), may help daunorubicin and cytarabine kill more cancer cells by making cancer cells more sensitive to the drugs. It is not yet known whether daunorubicin and cytarabine are more effective with or without zosuquidar trihydrochloride in treating acute myeloid leukemia or anemia. PURPOSE: This randomized phase III trial is studying how well giving zosuquidar trihydrochloride together with daunorubicin and cytarabine works compared to daunorubicin and cytarabine alone in treating older patients with newly diagnosed acute myeloid leukemia or anemia that has not responded to previous treatment.
Study Details
Timeline
Interventions
250 μg/m2/day by either intravenous or subcutaneous injection starting day 12, provided marrow aplasia is achieved, through recovery of absolute neutrophil count (ANC) to \> 500 cells/μl, sustained for 3 consecutive days. The dose may be rounded to the nearest vial size.
5 μg/kg/day by either intravenous or subcutaneous injection starting day 12, provided marrow aplasia is achieved, through recovery of absolute neutrophil count (ANC) to \> 500 cells/μl, sustained for 3 consecutive days. The dose may be rounded to the nearest vial size.
100 mg/m²/day by continuous intravenous infusion for 7 days (days 1-7).
45 mg/m²/day by 10 - 15 minute intravenous infusion for 3 days (days 1, 2, and 3).
Zosuquidar 550 mg/day by continuous intravenous infusion through a central venous catheter over approximately 6 hours on days 1, 2, and 3. The infusion will begin approximately one hour prior to daunorubicin on days 1, 2 and 3.
Placebo 550 mg/day by continuous intravenous infusion through a central venous catheter over approximately 6 hours on days 1, 2, and 3. The infusion will begin approximately one hour prior to daunorubicin on days 1, 2 and 3. Placebo consisted of a 1:1000 dilution of Infuvite, appropriately colored.