Safety and Efficacy of Imatinib in Chronic Myelogenous Patients in Relapse After Stem Cell Transplantation

Phase 2

Completed

• Conditions: Chronic Myeloid Leukemia

• Registration Number: NCT00219726
• Lead Sponsor: Poitiers University Hospital

Brief Summary

The aim of this phase II trial is asses the tolerability and the effectiveness of imatinib in patients with chronic myelogenous leukemia in chronic phase who are in relapse after stem cell transplantation.

Detailed Description

Patients will received Imatinib at a dose of 400mg daily. The tolerability of Imatinib given at a daily dose of 400mg will be assessed. The hematologic, cytogenetic and molecular responses will be evaluated at various check points.

Donor/recipient chimerism during Imatinib therapy will be assessed. Survival will be estimated.

Study Timeline

• Study Start: 2002-05
• Status Verified: 2005-09
• Study First Submitted: 2005-09-13
• Study First Submitted QC: 2005-09-13
• Study First Posted: 2005-09-22
• Study Completion: 2007-07
• Last Update Submitted: 2012-08-28
• Last Update Posted: 2012-08-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• CML Ph+ (assessed by cytogenetic or FISH)
• Age ≥ 18 year at inclusion
• PS grade 0 to 2 (ECOG)
• previous allogeneic stem cell transplantation
• molecular, cytogenetic or haematological relapse in chronic phase after transplantation
• Immune therapy for graft versus host disease stopped within 2 months from inclusion
• Adequate and organ function, defined as the following: total bilirubin <3x uln, sgpt <3x uln, creatinine <2x uln.
• informed consent sign up

Exclusion Criteria

• Age less than 18 y
• accelerated or blastic phase
• previous therapy with imatinib
• active malignancy other than CML or non-melanoma cancer of the skin
• current treatment with another investigational agent

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
- to assess the tolerability of Imatinib given at a daily dose of 400mg
- to evaluate the hematologic, cytogenetic and molecular responses at various check points.

Secondary Outcome Measures

Name	Time	Method
- to assess donor/recipient chimerism during Imatinib therapy
- to evaluate the survival

Trial Locations

Locations (1)

University Hospital; 🇫🇷 Poitiers, France