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

Sponsor

Poitiers University Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT00219726

Collaborator

Novartis (Industry)

Enrollment

Location

Duration (Months)

0.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Chronic Myeloid Leukemia	Drug: Imatinib mesylate	Phase 2

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 Design

Study Type:

Interventional

Anticipated Enrollment :

30 participants

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

May 1, 2002

Study Completion Date :

Jul 1, 2007

Outcome Measures

Primary Outcome Measures

- 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

- to assess donor/recipient chimerism during Imatinib therapy []
- to evaluate the survival []

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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.
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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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University Hospital	Poitiers		France	86021

Sponsors and Collaborators

Poitiers University Hospital
Novartis

Investigators

Study Chair: François GUILHOT, MD, Department of Oncology Hematology and Cell therapy, University Hospital , 86021 Poitiers - FRANCE
Principal Investigator: Agnès DEVERGIE, MD, University Hospital "Saint-Louis" - Department of Hematology and Oncology - 75475 PARIS Cedex 10 (FRANCE)