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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00219726
Recruitment Status : Completed
First Posted : September 22, 2005
Last Update Posted : August 29, 2012
Information provided by:
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.

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 Type : Interventional  (Clinical Trial)
Estimated 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 2002
Study Completion Date : July 2007

Primary Outcome Measures :
  1. - to assess the tolerability of Imatinib given at a daily dose of 400mg
  2. - to evaluate the hematologic, cytogenetic and molecular responses at various check points.

Secondary Outcome Measures :
  1. - to assess donor/recipient chimerism during Imatinib therapy
  2. - to evaluate the survival

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00219726

University Hospital
Poitiers, France, 86021
Sponsors and Collaborators
Poitiers University Hospital
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)

Additional Information: Identifier: NCT00219726     History of Changes
Other Study ID Numbers: 020947
First Posted: September 22, 2005    Key Record Dates
Last Update Posted: August 29, 2012
Last Verified: September 2005

Keywords provided by Poitiers University Hospital:
Imatinib mesylate
Stem cell transplantation

Additional relevant MeSH terms:
Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Neoplasms by Histologic Type
Leukemia, Myeloid
Myeloproliferative Disorders
Bone Marrow Diseases
Hematologic Diseases
Imatinib Mesylate
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action