Clofarabine With Cytarabine for MRD Positive Leukemia
Recent studies have demonstrated that even low levels of minimum residual disease (MRD)
(>0.01% abnormal blasts) after aggressive re-induction therapy indicate a relatively poor
outcome in relapsed acute lymphoblastic leukemia (ALL) patients, including those who proceed
to allogeneic stem cell transplant (alloSCT). A similarly poor prognosis was seen in
pediatric acute myelogenous leukemia patients with sub-morphologic disease prior to alloSCT.
Studies to identify therapies that can eliminate persistent leukemia, have low toxicity
profiles and can serve as a bridge to transplant are needed.
This study will test the ability of clofarabine + cytarabine to eliminate minimal residual
disease (MRD) in acute myelogenous leukemia and acute lymphoblastic leukemia patients whose
bone marrows exhibit complete remission by morphology. The toxicity profile of this regimen
will be evaluated in addition to toxicity experienced by patients who proceed to stem cell
transplant. Overall length of remission will also be collected.
Interventional
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Ability of clofarabine and cytarabine to eliminate minimal residual disease (MRD) in acute myelogenous leukemia (AML) and acute lymphoblastic leukemia (ALL) patients whose bone marrows exhibit complete remission by morphology.
Patient's bone marrow will be evaluated for the amount of minimal residual disease (MRD) present after treatment on course 1 and 2.
Day 22-36 of course 1 and 2
No
Blythe Thomson, MD
Study Chair
Seattle Children's Hospital
United States: Institutional Review Board
T2009-002
NCT01158885
August 2010
October 2012
Name | Location |
---|---|
Johns Hopkins University | Baltimore, Maryland 21205 |
Stanford University Medical Center | Stanford, California 94305-5408 |
Phoenix Children's Hospital | Phoenix, Arizona 85016-7710 |
Childrens Hospital Los Angeles | Los Angeles, California 90027 |
Vanderbilt Children's Hospital | Nashville, Tennessee 37232-6310 |
City of Hope | Duarte, California 91010 |
New York University Medical Center | New York, New York 10016 |
Oregon Health and Science University | Portland, Oregon 97201 |
Seattle Children's Hospital | Seattle, Washington 98105 |
Dana Farber | Boston, Massachusetts 02115-6084 |
UCSF School of Medicine | San Francisco, California 94143-0106 |
University of Miami Cancer Center | Miami, Florida 33136 |
C.S. Mott Children's Hospital | Ann Arbor, Michigan 48109-0914 |
Childrens Hospital & Clinics of Minnesota | Minneapolis, Minnesota 55404-4597 |
Children's Hospital New York-Presbyterian | New York, New York 10032 |
Miller Children's Hospital | Long Beach, California 90806 |
Children's Memorial | Chicago, Illinois 60614 |
Oakland Children's Hospital | Oakland, California |
University of Minnesota Children's Hospital | Minneapolis, Minnesota |
Nationwide Childrens Hospital | Columbus, Ohio |
Children's Healthcare of Atlanta, Emory University | Atlanta, Georgia |
St. Jude | Memphis, Tennessee 38105-3678 |