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

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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00219726

Enrollment

Registered

2005-09-22

Start date

2002-05-31

Completion date

2007-07-31

Last updated

2012-08-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Myeloid Leukemia

Keywords

CML, Imatinib mesylate, Stem cell transplantation

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.

Interventions

DRUGImatinib mesylate

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
- 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

Measure	Time frame
- to assess donor/recipient chimerism during Imatinib therapy	—
- to evaluate the survival	—

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026