NCT00219726

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started May 2002

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2002

Completed
3.4 years until next milestone

First Submitted

Initial submission to the registry

September 13, 2005

Completed
9 days until next milestone

First Posted

Study publicly available on registry

September 22, 2005

Completed
1.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2007

Completed
Last Updated

August 29, 2012

Status Verified

September 1, 2005

First QC Date

September 13, 2005

Last Update Submit

August 28, 2012

Conditions

Chronic Myeloid Leukemia

Keywords

CMLImatinib mesylateStem cell transplantation

Outcome Measures

Primary Outcomes (2)

  • - 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 Outcomes (2)

  • - to assess donor/recipient chimerism during Imatinib therapy

  • - to evaluate the survival

Interventions

Imatinib mesylateDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • CML Ph+ (assessed by cytogenetic or FISH)
  • PS grade 0 to 2 (ECOG)
  • previous allogeneic stem cell transplantation
  • molecular, cytogenetic or haematological relapse in chronic phase after transplantation
  • Adequate and organ function, defined as the following: total bilirubin \<3x uln, sgpt \<3x uln, creatinine \<2x uln.
  • informed consent sign up

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital

Poitiers, 86021, France

Location

MeSH Terms

Conditions

Leukemia, Myelogenous, Chronic, BCR-ABL Positive

Interventions

Imatinib Mesylate

Condition Hierarchy (Ancestors)

Leukemia, MyeloidLeukemiaNeoplasms by Histologic TypeNeoplasmsMyeloproliferative DisordersBone Marrow DiseasesHematologic DiseasesHemic and Lymphatic DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

BenzamidesAmidesOrganic ChemicalsBenzoatesAcids, CarbocyclicCarboxylic AcidsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsPiperazinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsPyrimidines

Study Officials

  • François GUILHOT, MD

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

    STUDY CHAIR

  • Agnès DEVERGIE, MD

    University Hospital "Saint-Louis" - Department of Hematology and Oncology - 75475 PARIS Cedex 10 (FRANCE)

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 13, 2005

First Posted

September 22, 2005

Study Start

May 1, 2002

Study Completion

July 1, 2007

Last Updated

August 29, 2012

Record last verified: 2005-09

Locations

FR(1)