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

Poitiers University Hospital

Status and phase: Completed; Phase 2

Conditions: Chronic Myeloid Leukemia

Treatments: Drug: Imatinib mesylate

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00219726

CSTI571AFR05

020947

Details and patient eligibility

About

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.

Full 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.

Enrollment: 30 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)