Clinical Trial: A Study Evaluating the Effects of CLAG With Gleevec in Refractory or Relapsed Acute Myeloid Leukemia
Study Status: Withdrawn
Recruit Status: Withdrawn
Study Type: Interventional
Official Title: A Phase II Study of CLAG Regimen in Combination With Imatinib Mesylate (Gleevec) in Refractory or Relapsed Acute Myeloid Leukemia
Brief Summary: The purpose of this study is to evaluate the safety of combined chemotherapy treatment (CLAG regimen) with Imatinib Mesylate (Gleevec) in patients with AML.
Detailed Summary:
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.
Sponsor: University of Cincinnati
Current Primary Outcome: Establishing the overall response rate and the safety of combining imatinib mesylate with CLAG regimen [ Time Frame: The amount of time it takes to enroll 20 pts. About 1 year ]
Original Primary Outcome: Establishing the overall response rate and the safety of combining Gleevec with CLAG regimen [ Time Frame: The amount of time it takes to enroll 20 pts. About 1 year ]
Current Secondary Outcome: The sample size is calculated based on two stage Phase II clinical design. Ten patients will be accrued during stage 1 and 10 during stage 2). [ Time Frame: 1 year ]
Original Secondary Outcome: Same as current
Information By: University of Cincinnati
Dates:
Date Received: January 3, 2008
Date Started: November 2007
Date Completion: November 2008
Last Updated: October 29, 2008
Last Verified: October 2008
