A Phase II Randomized Trial of Immunologic and Chemotherapeutic Agents for Treatment of Patients With Relapsed or Refractory Acute Myelogenous Leukemia
OBJECTIVES:
- Compare the rates of complete response (CR) and CR without full platelet recovery in
patients with relapsed or refractory acute myelogenous leukemia treated with gemtuzumab
ozogamicin and cytarabine vs daunorubicin liposomal and cytarabine vs cyclophosphamide,
cytarabine, and topotecan.
- Compare the toxicities of these 3 regimens in these patients.
OUTLINE: This is a randomized, multicenter study. Patients are stratified by disease status
(relapse less than 6 months after first complete response (CR) vs relapse 6-12 months after
first CR vs refractory to conventional initial induction chemotherapy (no more than 2
courses) or first reinduction (no more than 1 course) vs second or greater relapse).
- Induction: Patients are randomized to 1 of 3 treatment arms:
- Arm I: Patients receive cytarabine IV over 2 hours on days 1-4 and gemtuzumab
ozogamicin IV over 2 hours on day 5.
- Arm II: Patients receive daunorubicin liposomal IV over a minimum of 2 hours on
days 1-3 and cytarabine IV over 2 hours (beginning immediately after completion of
daunorubicin liposomal infusion) on days 1-4.
- Arm III: Patients receive cyclophosphamide IV over 1 hour every 12 hours on days
1-3, cytarabine IV over 2 hours (beginning immediately after completion of
cyclophosphamide infusion) on days 2-6, and topotecan IV continuously on days 2-6.
- Consolidation: Patients who achieve complete remission (CR) receive 1 additional course
of induction therapy on the same arm to which they were originally randomized beginning
within 4-6 weeks after initial documentation of CR. Patients on arm II receive no
additional daunorubicin liposomal if resting ejection fraction is less than 50%
preconsolidation. All patients receive sargramostim (GM-CSF) IV over 4 hours or SQ
daily beginning 24 hours after completion of consolidation therapy and continuing until
blood counts recover.
Patients are followed every 3 months through year 2, every 6 months through year 5, and then
annually thereafter until death.
PROJECTED ACCRUAL: A maximum of 150-165 patients (50-55 per arm) will be accrued for this
study within 2 years.
Interventional
Allocation: Randomized, Primary Purpose: Treatment
Mark R. Litzow, MD
Study Chair
Mayo Clinic
United States: Federal Government
CDR0000067944
NCT00005962
July 2000
Name | Location |
---|---|
Albert Einstein Comprehensive Cancer Center | Bronx, New York 10461 |
Mayo Clinic Cancer Center | Rochester, Minnesota 55905 |
Stanford University Medical Center | Stanford, California 94305-5408 |
H. Lee Moffitt Cancer Center and Research Institute | Tampa, Florida 33612 |
Indiana University Cancer Center | Indianapolis, Indiana 46202-5265 |
CCOP - Ann Arbor Regional | Ann Arbor, Michigan 48106 |
University of Minnesota Cancer Center | Minneapolis, Minnesota 55455 |
University of Rochester Cancer Center | Rochester, New York 14642 |
Ireland Cancer Center | Cleveland, Ohio 44106-5065 |
Kimmel Cancer Center of Thomas Jefferson University - Philadelphia | Philadelphia, Pennsylvania 19107 |
University of Pennsylvania Cancer Center | Philadelphia, Pennsylvania 19104 |
Fox Chase Cancer Center | Philadelphia, Pennsylvania 19111 |
Robert H. Lurie Comprehensive Cancer Center, Northwestern University | Chicago, Illinois 60611 |
CCOP - Missouri Valley Cancer Consortium | Omaha, Nebraska 68131 |
CCOP - Southern Nevada Cancer Research Foundation | Las Vegas, Nevada 89106 |
CCOP - Christiana Care Health Services | Wilmington, Delaware 19899 |
CCOP - Colorado Cancer Research Program, Inc. | Denver, Colorado 80209-5031 |
CCOP - Illinois Oncology Research Association | Peoria, Illinois 61602 |
CCOP - Carle Cancer Center | Urbana, Illinois 61801 |
Veterans Affairs Medical Center - Indianapolis (Roudebush) | Indianapolis, Indiana 46202 |
CCOP - Iowa Oncology Research Association | Des Moines, Iowa 50309-1016 |
Beth Israel Deaconess Medical Center | Boston, Massachusetts 02215 |
New England Medical Center Hospital | Boston, Massachusetts 02111 |
CCOP - Kalamazoo | Kalamazoo, Michigan 49007-3731 |
CCOP - Metro-Minnesota | Saint Louis Park, Minnesota 55416 |
Veterans Affairs Medical Center - East Orange | East Orange, New Jersey 07018-1095 |
CCOP - Northern New Jersey | Hackensack, New Jersey 07601 |
Hahnemann University Hospital | Philadelphia, Pennsylvania 19102-1192 |
University of Pittsburgh Cancer Institute | Pittsburgh, Pennsylvania 15213 |
CCOP - Duluth | Duluth, Minnesota 55805 |
CCOP - Scottsdale Oncology Program | Scottsdale, Arizona 85259-5404 |
CCOP - Cedar Rapids Oncology Project | Cedar Rapids, Iowa 52403-1206 |
CCOP - Ochsner | New Orleans, Louisiana 70121 |
CCOP - Merit Care Hospital | Fargo, North Dakota 58122 |
CCOP - Toledo Community Hospital Oncology Program | Toledo, Ohio 43623-3456 |
CCOP - Sioux Community Cancer Consortium | Sioux Falls, South Dakota 57105-1080 |
Holden Comprehensive Cancer Center at The University of Iowa | Iowa City, Iowa 52242-1009 |
NYU School of Medicine's Kaplan Comprehensive Cancer Center | New York, New York 10016 |
CCOP - Central Illinois | Springfield, Illinois 62526 |
CCOP - Columbus | Columbus, Ohio 43206 |
CCOP - MainLine Health | Wynnewood, Pennsylvania 19096 |
Veterans Affairs Medical Center - Madison | Madison, Wisconsin 53705 |
University of Wisconsin Comprehensive Cancer Center | Madison, Wisconsin 53792 |
CCOP - Evanston | Evanston, Illinois 60201 |
Veterans Affairs Medical Center - Lakeside Chicago | Chicago, Illinois 60611 |
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Baltimore, Maryland 21231-2410 |
Veterans Affairs Medical Center - New York | New York, New York 10010 |
CCOP - Marshfield Medical Research and Education Foundation | Marshfield, Wisconsin 54449 |
Cleveland Clinic Taussig Cancer Center | Cleveland, Ohio 44195 |
Cancer Center and Beckman Research Institute, City of Hope | Duarte, California 91010-3000 |
MBCCOP - LSU Health Sciences Center | New Orleans, Louisiana 70112 |
CCOP - Oklahoma | Tulsa, Oklahoma 74136 |
Veterans Affairs Medical Center - Pittsburgh | Pittsburgh, Pennsylvania 15240 |
Veterans Affairs Medical Center - Miami | Miami, Florida 33125 |
Cancer Institute of New Jersey | New Brunswick, New Jersey 08901 |
Veterans Affairs Medical Center - Minneapolis | Minneapolis, Minnesota 55417 |
Veterans Affairs Medical Center - Palo Alto | Palo Alto, California 94304 |
Veterans Affairs Medical Center - Brooklyn | Brooklyn, New York 11209 |
Veterans Affairs Medical Center - Tampa (Haley) | Tampa, Florida 33612 |
MBCCOP-Our Lady of Mercy Cancer Center | Bronx, New York 10466 |
Veterans Affairs Medical Center - Gainsville | Gainesville, Florida 32608-1197 |
Veterans Affairs Medical Center - Omaha | Omaha, Nebraska 68105 |