A Study Evaluating the Effects of CLAG With Gleevec in Refractory or Relapsed Acute Myeloid Leukemia

Phase 2

Withdrawn

• Conditions: Chronic Myeloid Leukemia, Blast Crisis; Acute Myeloid Leukemia
• Interventions: Drug: Imatinib Mesylate; Drug: CLAG

• Registration Number: NCT00594555
• Lead Sponsor: University of Cincinnati

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 Description

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.

Study Timeline

• Study Start: 2007-11
• Study First Submitted: 2008-01-03
• Study First Submitted QC: 2008-01-14
• Study First Posted: 2008-01-15
• Status Verified: 2008-10
• Last Update Submitted: 2008-10-29
• Last Update Posted: 2008-10-31
• Primary Completion: 2008-11
• Study Completion: 2008-11

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Single Arm - treatment period	Imatinib Mesylate	Drug Name/Days Administered Neupogen/Days 1-6 CLAG/Days 2-6 Gleevec/Days 2-15
Single Arm - treatment period	CLAG	Drug Name/Days Administered Neupogen/Days 1-6 CLAG/Days 2-6 Gleevec/Days 2-15

Primary Outcome Measures

Name	Time	Method
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

Secondary Outcome Measures

Name	Time	Method
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).	1 year

Trial Locations

Locations (1)

University of Cincinnati; 🇺🇸 Cincinnati, Ohio, United States