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Completed

NCT Number: NCT00219726

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

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.

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Key information

Conditions

Chronic Myeloid Leukemia Bone Marrow Diseases Chronic Disease Disease Attributes Hematologic Diseases Hemic and Lymphatic Diseases Leukemia Leukemia, Myelogenous, Chronic, BCR-ABL Positive Leukemia, Myeloid Myeloproliferative Disorders Neoplasms Neoplasms by Histologic Type Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

University Hospital

Poitiers, 86021, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

imatinib mesylate

Drug

Primary outcomes

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

  2. - to evaluate the hematologic, cytogenetic and molecular responses at various check points.

Secondary outcomes

  1. - to assess donor/recipient chimerism during Imatinib therapy

  2. - to evaluate the survival

Sponsors and collaborators

Lead sponsor

Poitiers University Hospital

Other

Collaborators

  • Novartis

Registry information

Official study 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

Important dates

Study start
2002
Study completion
2007
First posted
Sep 22, 2005
Registry last updated
Aug 29, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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