A Phase II Study Of Allogeneic Transplant For Older Patients With AML In First Morphologic Complete Remission Using A Non-Myeloablative Preparative Regimen
- Determine whether allogeneic stem cell transplantation from a matched sibling or
unrelated donor using a nonmyeloablative preparative regimen comprising fludarabine and
busulfan results in a 2-year disease-free survival that is better than historical
results using standard chemotherapy in older patients with acute myeloid leukemia in
first morphologic complete remission.
- Determine the 2-year actuarial risks of transplant-related mortality, acute and chronic
graft-versus-host disease, and relapse in patients treated with this regimen.
- Determine the recovery of T- and B-cell number and function and the time course of T,
B, and myeloid progenitor chimerism in patients treated with this regimen.
- Determine the pharmacokinetics of this regimen in these patients.
OUTLINE: This is a multicenter study.
- Preparative regimen: Patients receive fludarabine IV over 30 minutes on days -7 to -3
and busulfan IV over 2 hours 4 times per day (every 6 hours) on days -4 and -3.
- Graft-versus-host disease (GVHD) prophylaxis: Patients receive oral or IV tacrolimus
twice daily starting on days -2, with tapering between days 90-120, and stopping by
days 150-180. Patients also receive methotrexate IV on days 1, 3, 6,and 11 and rabbit
antithymocyte globulin (Thymoglobulin) IV over 4-6 hours on days -4 through -2.
- Allogeneic peripheral blood stem cell transplantation (PBSC): Patients undergo
allogeneic PBSC transplantation on day 0. Patients then receive filgrastim (G-CSF)
subcutaneously daily beginning on day 12 and continuing until blood counts recover.
Patients with progressive disease will be removed from the study and may receive
additional treatment at the discretion of the investigator.
Patients are followed monthly for 1 year, every 3 months for 1 year, and then every 6 months
for 3 years.
PROJECTED ACCRUAL: A total of 61 patients will be accrued for this study.
Masking: Open Label, Primary Purpose: Treatment
Progression-free survival at 2 years
Steven M. Devine, MD
Ohio State University Comprehensive Cancer Center
United States: Federal Government
|Roswell Park Cancer Institute||Buffalo, New York 14263|
|CCOP - Christiana Care Health Services||Wilmington, Delaware 19899|
|CCOP - North Shore University Hospital||Manhasset, New York 11030|
|Beth Israel Deaconess Medical Center||Boston, Massachusetts 02215|
|Long Island Jewish Medical Center||New Hyde Park, New York 11040|
|Mount Sinai Medical Center||New York, New York 10029|
|Wake Forest University Comprehensive Cancer Center||Winston-Salem, North Carolina 27157-1096|
|Greenebaum Cancer Center at University of Maryland Medical Center||Baltimore, Maryland 21201|
|New York Weill Cornell Cancer Center at Cornell University||New York, New York 10021|
|UCSF Helen Diller Family Comprehensive Cancer Center||San Francisco, California 94115|
|Dana-Farber/Harvard Cancer Center at Dana-Farber Cancer Institute||Boston, Massachusetts 02115|
|Masonic Cancer Center at University of Minnesota||Minneapolis, Minnesota 55455|
|Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis||St. Louis, Missouri 63110|
|Don Monti Comprehensive Cancer Center at North Shore University Hospital||Manhasset, New York 11030|
|Cancer Institute of New Jersey at Cooper - Voorhees||Voorhees, New Jersey 08043|
|Massachusetts General Hospital||Boston, Massachusetts 02114-2617|
|Tunnell Cancer Center at Beebe Medical Center||Lewes, Delaware 19958|
|Monter Cancer Center of the North Shore-LIJ Health System||Lake Success, New York 11042|
|Arthur G. James Cancer Hospital and Richard J. Solove Research Institute at Ohio State University Comprehensive Cancer Center||Columbus, Ohio 43210-1240|
|Union Hospital of Cecil County||Elkton MD, Maryland 21921|
|Dana-Farber/Brigham and Women's Cancer Center||Boston, Massachusetts 02115|