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

This study has been completed.
Sponsor:
Collaborator:
Novartis
Information provided by:
Poitiers University Hospital
ClinicalTrials.gov Identifier:
NCT00219726
First received: September 13, 2005
Last updated: August 28, 2012
Last verified: September 2005
  Purpose

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 Intervention Phase
Chronic Myeloid Leukemia
Drug: Imatinib mesylate
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Poitiers University Hospital:

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

Estimated Enrollment: 30
Study Start Date: May 2002
Estimated Study Completion Date: July 2007
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  • 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00219726

Locations
France
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)
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00219726     History of Changes
Other Study ID Numbers: 020947, CSTI571AFR05
Study First Received: September 13, 2005
Last Updated: August 28, 2012
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

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

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

ClinicalTrials.gov processed this record on April 16, 2014