A Phase III Randomized of Cloretazine™ (VNP40101M) and Cytosine Arabinoside (AraC) in Patients With Acute Myeloid Leukemia in First Relapse
- 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
- 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: 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
Overall response rate
Bonny L. Johnson, RN, MSN
United States: Federal Government
|Roswell Park Cancer Institute||Buffalo, New York 14263|
|University of Chicago Cancer Research Center||Chicago, Illinois 60637|
|Duke Comprehensive Cancer Center||Durham, North Carolina 27710|
|Penn State Cancer Institute at Milton S. Hershey Medical Center||Hershey, Pennsylvania 17033-0850|
|Vanderbilt-Ingram Cancer Center||Nashville, Tennessee 37232-6838|
|New York Medical College||Valhalla, New York 10595|
|University of Miami Sylvester Comprehensive Cancer Center||Miami, Florida 33136|
|USC/Norris Comprehensive Cancer Center and Hospital||Los Angeles, California 90033-0804|
|Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute||Boston, Massachusetts 02115|
|UCSF Comprehensive Cancer Center||San Francisco, California 94115|
|Veterans Affairs Medical Center - Tampa (Haley)||Tampa, Florida 33612|
|M.D. Anderson Cancer Center at University of Texas||Houston, Texas 77030|
|Hollings Cancer Center at Medical University of South Carolina||Charleston, South Carolina 29425|
|Riverside Methodist Hospital Cancer Care||Columbus, Ohio 43214|
|Greenebaum Cancer Center at University of Maryland Medical Center||Baltimore, Maryland 21201|
|Jonsson Comprehensive Cancer Center at UCLA||Los Angeles, California 90095-1781|
|Chao Family Comprehensive Cancer Center at University of California Irvine Medical Center||Orange, California 92868|
|Robert H. Lurie Comprehensive Cancer Center at Northwestern University||Chicago, Illinois 60611|
|Saint Francis/Mount Sinai Regional Cancer Center at Saint Francis Hospital and Medical Center||Hartford, Connecticut 06105|
|Western Pennsylvania Cancer Institute at Western Pennsylvania Hospital||Pittsburgh, Pennsylvania 15224-1791|
|Nevada Cancer Institute||Las Vegas, Nevada 89135|
|Brody School of Medicine at East Carolina University||Greenville, North Carolina 27858|
|American Health Network - North Meridian||Indianapolis, Indiana 46260|
|New Mexico Cancer Care Alliance||Albuquerque, New Mexico 87106|