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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-05-31

Study Completion Date

2007-07-31

Brief Summary

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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

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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.

Conditions

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Chronic Myeloid Leukemia

Keywords

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CML Imatinib mesylate Stem cell transplantation

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Imatinib mesylate

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Principal Investigators

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François GUILHOT, MD

Role: STUDY_CHAIR

Department of Oncology Hematology and Cell therapy, University Hospital , 86021 Poitiers - FRANCE

Agnès DEVERGIE, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital "Saint-Louis" - Department of Hematology and Oncology - 75475 PARIS Cedex 10 (FRANCE)

Locations

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University Hospital

Poitiers, , France

Site Status

Countries

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France

Other Identifiers

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CSTI571AFR05

Identifier Type: -

Identifier Source: secondary_id

020947