Back to resultsSafety and Efficacy of Imatinib in Chronic Myelogenous Patients in Relapse After Stem Cell Transplantation
Primary Purpose
Chronic Myeloid Leukemia
Status
Completed
Phase
Phase 2
Locations
France
Study Type
Interventional
Intervention
Imatinib mesylate
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Myeloid Leukemia focused on measuring CML, Imatinib mesylate, Stem cell transplantation
Eligibility 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
Sites / Locations
- University Hospital
Outcomes
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
Full Information
NCT ID
NCT00219726
First Posted
September 13, 2005
Last Updated
August 28, 2012
Sponsor
Poitiers University Hospital
Collaborators
Novartis
1. Study Identification
Unique Protocol Identification Number
NCT00219726
Brief Title
Safety and Efficacy of Imatinib in Chronic Myelogenous Patients in Relapse After Stem Cell Transplantation
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 Type
Interventional
2. Study Status
Record Verification Date
September 2005
Overall Recruitment Status
Completed
Study Start Date
May 2002 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
July 2007 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Poitiers University Hospital
Collaborators
Novartis
4. Oversight
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Myeloid Leukemia
Keywords
CML, Imatinib mesylate, Stem cell transplantation
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Imatinib mesylate
Primary Outcome Measure Information:
Title
- to assess the tolerability of Imatinib given at a daily dose of 400mg
Title
- to evaluate the hematologic, cytogenetic and molecular responses at various check points.
Secondary Outcome Measure Information:
Title
- to assess donor/recipient chimerism during Imatinib therapy
Title
- to evaluate the survival
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
François GUILHOT, MD
Organizational Affiliation
Department of Oncology Hematology and Cell therapy, University Hospital , 86021 Poitiers - FRANCE
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Agnès DEVERGIE, MD
Organizational Affiliation
University Hospital "Saint-Louis" - Department of Hematology and Oncology - 75475 PARIS Cedex 10 (FRANCE)
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital
City
Poitiers
ZIP/Postal Code
86021
Country
France
12. IPD Sharing Statement
Learn more about this trial
Safety and Efficacy of Imatinib in Chronic Myelogenous Patients in Relapse After Stem Cell Transplantation
We'll reach out to this number within 24 hrs