Leukemia Clinical Trial
Official title:
A Phase III Randomized of Cloretazine™ (VNP40101M) and Cytosine Arabinoside (AraC) in Patients With Acute Myeloid Leukemia in First Relapse
RATIONALE: Drugs used in chemotherapy, such as cytarabine and VNP40101M, work in different
ways to stop the growth of cancer cells, either by killing the cells or by stopping them
from dividing. Giving more than one drug (combination chemotherapy) may kill more cancer
cells.
PURPOSE: This randomized phase III trial is studying cytarabine and VNP40101M to see how
well they work compared to cytarabine alone in treating patients with relapsed acute myeloid
leukemia.
OBJECTIVES:
Primary
- Compare the complete response (CR) and CR (with platelet count < 100,000/mm^3 but ≥
20,000/mm^3 [transfusion independent for ≥ 7 consecutive days]) (CRp) rates in patients
with acute myeloid leukemia in first relapse treated with cytarabine with vs without
VNP40101M.
Secondary
- Compare time to progression in patients treated with these regimens.
- Compare duration of response in patients treated with these regimens.
- Compare the survival of patients treated with these regimens.
- Compare the toxicity of these regimens in these patients.
OUTLINE: This is a randomized, double-blind, placebo-controlled, parallel group, multicenter
study. Patients are stratified according to age (< 60 years vs ≥ 60 years) and duration of
first complete response (CR) or CR (with platelet count < 100,000/mm³ but ≥ 20,000/mm³
[transfusion independent for ≥ 7 consecutive days]) (CRp) (< 12 months vs ≥ 12 months).
- Induction therapy: Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients receive cytarabine IV continuously on days 1-3 and VNP40101M IV
over 30-60 minutes on day 2 (at least 12 hours after the start of cytarabine).
- Arm II: Patients receive cytarabine as in arm I and placebo IV over 30-60 minutes
on day 2 (at least 12 hours after the start of cytarabine).
In both arms, patients demonstrating at least 20% reduction of blasts in bone marrow (based
on total cellularity and percent blasts) after course 1 may receive 1 additional course of
induction therapy between days 35-60 in the absence of disease progression or unacceptable
toxicity. Patients achieving CR or CRp after 1 or 2 courses of induction therapy proceed to
consolidation therapy.
- Consolidation therapy: Beginning 6 weeks after initial documentation of CR or CRp,
patients receive 1 course of consolidation therapy, as per induction therapy, according
to their randomized treatment arm. These patients may then proceed to other
consolidation, maintenance, and/or intensification therapy (including stem cell
transplantation) off study at the discretion of the physician.
After completion of study treatment, patients are followed monthly for 6 months, every 2
months for 6 months, and then every 3 months for 2 years.
PROJECTED ACCRUAL: A total of 420 patients (280 in arm I and 140 in arm II) will be accrued
for this study within 24-30 months.
;
Allocation: Randomized, Masking: Double-Blind, Primary Purpose: Treatment
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