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

This study is currently recruiting participants.

Verified by Poitiers University Hospital, September 2005

Sponsors and Collaborators:	Poitiers University Hospital Novartis
Information provided by:	Poitiers University Hospital
ClinicalTrials.gov Identifier:	NCT00219726

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 II

MedlinePlus related topics: Leukemia, Adult Acute Leukemia, Adult Chronic

Drug Information available for: Imatinib Imatinib mesylate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
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

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:	June 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

Contacts

Contact: François GUILHOT, MD

33 5 49 44 42 01

f.guilhot@chu-poitiers.fr

Locations

France
University Hospital	Recruiting
Poitiers, France, 86021
Contact: François GUILHOT, MD 33 5 49 44 42 01 f.guilhot@chu-poitiers.fr
Principal Investigator: François GUILHOT, MD

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

French CML Group (FI-LMC) web-site This link exits the ClinicalTrials.gov site

Study ID Numbers:	020947, CSTI571AFR05
Study First Received:	September 13, 2005
Last Updated:	September 13, 2005
ClinicalTrials.gov Identifier:	NCT00219726
Health Authority:	France: Afssaps - French Health Products Safety Agency

Keywords provided by Poitiers University Hospital:

CML
Imatinib mesylate
Stem cell transplantation

Study placed in the following topic categories:

Imatinib
Leukemia
Chronic myelogenous leukemia
Hematologic Diseases

Myeloproliferative Disorders
Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Leukemia, Myeloid
Bone Marrow Diseases

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Histologic Type
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents

Therapeutic Uses
Enzyme Inhibitors
Protein Kinase Inhibitors
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 15, 2009