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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


Phase 2
18 Years
N/A
Not Enrolling
Both
Chronic Myeloid Leukemia

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Trial Information

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


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.


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

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

- to assess the tolerability of Imatinib given at a daily dose of 400mg

Principal Investigator

François GUILHOT, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Department of Oncology Hematology and Cell therapy, University Hospital , 86021 Poitiers - FRANCE

Authority:

France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Study ID:

020947

NCT ID:

NCT00219726

Start Date:

May 2002

Completion Date:

July 2007

Related Keywords:

  • Chronic Myeloid Leukemia
  • CML
  • Imatinib mesylate
  • Stem cell transplantation
  • Leukemia
  • Leukemia, Myeloid
  • Leukemia, Myelogenous, Chronic, BCR-ABL Positive

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