Phase II Trial to Study the Tolerability and the Effectiveness of Imatinib in Patients With Chronic Myelogenous Leukemia in Chronic Phase in Relapse After Allogeneic Stem Cell Transplantation

Poitiers University Hospital1 site in 1 country30 target enrollmentMay 2002

ConditionsChronic Myeloid Leukemia

DrugsImatinib mesylate

Overview

Phase: Phase 2
Intervention: Not specified
Conditions: Chronic Myeloid Leukemia
Sponsor: Poitiers University Hospital
Enrollment: 30
Locations: 1
Primary Endpoint: - to assess the tolerability of Imatinib given at a daily dose of 400mg
Status: Completed
Last Updated: 13 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

May 2002

End Date

July 2007

Last Updated

13 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Poitiers University Hospital

Eligibility Criteria

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.
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