A Phase II Study of CLAG Regimen in Combination With Imatinib Mesylate (Gleevec) in Refractory or Relapsed Acute Myeloid Leukemia
In relapsed or resistant acute myeloid leukemia (type of blood cancer where immature blood
cells are increased, blocking normal blood cells production) no standard therapy exits.
Response rates are similar for different chemotherapy treatments. Allogenic stem cell
transplant remains the only curative option
The purpose of this study is to evaluate the safety of combined chemotherapy treatment (CLAG
regimen) with Imatinib Mesylate (Gleevec). The CLAG regimen is a combination of the
chemotherapy drugs cladribine and cytarabine, as well as, neupogen which increases the white
blood counts.
Imatinib Mesylate is believed to work by interfering with the abnormal protein by blocking
it from telling the body to keep making more and more abnormal white blood cells. Imatinib
Mesylate is approved by the FDA for the treatment of chronic myeloid leukemia (CML) and
some types of acute lymphoblastic leukemia (ALL). Its use in combination with CLAG regimen
is considered experimental for the treatment of Acute Myeloid Leukemia / CML blast crisis
The goal of the study is to find out what effects (good and bad) Imatinib Mesylate
(Gleevec)combined with chemotherapy (CLAG regimen) on acute myeloid leukemia.
Interventional
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Establishing the overall response rate and the safety of combining imatinib mesylate with CLAG regimen
The amount of time it takes to enroll 20 pts. About 1 year
No
Rami S Komrokji, MD
Principal Investigator
The University of Cincinnati
United States: Institutional Review Board
CST1571AU235 / Komrokji
NCT00594555
November 2007
November 2008
Name | Location |
---|---|
University of Cincinnati | Cincinnati, Ohio 45267-0502 |