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

Chronic Myeloid Leukemia Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00219726
• Other study ID #: 020947
• Secondary ID: CSTI571AFR05
• Status: Completed
• Phase: Phase 2
• First received: September 13, 2005
• Last updated: August 28, 2012
• Start date: May 2002
• Est. completion date: July 2007

Study information

• Verified date: September 2005
• Source: Poitiers University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: July 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Myeloid Leukemia
• Leukemia, Myelogenous, Chronic, BCR-ABL Positive

Intervention

Drug:
• Imatinib mesylate

Locations

Country	Name	City	State
France	University Hospital	Poitiers

Sponsors (2)

Lead Sponsor	Collaborator
Poitiers University Hospital	Novartis

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	- to assess the tolerability of Imatinib given at a daily dose of 400mg
Primary	- to evaluate the hematologic, cytogenetic and molecular responses at various check points.
Secondary	- to assess donor/recipient chimerism during Imatinib therapy
Secondary	- to evaluate the survival

External Links

•   French CML Group (FI-LMC) web-site