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Treatment of Philadelphia-Positive Acute Lymphocytic Leukemia (Ph+ ALL) in the Elderly With Imatinib Mesylate (STI571) and Chemotherapy.

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified April 2007 by Hospices Civils de Lyon.
Recruitment status was:  Active, not recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00149136
First Posted: September 8, 2005
Last Update Posted: April 27, 2007
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Hospices Civils de Lyon
  Purpose

ALL patients aged 55 years or older were treated with steroids during one week and Ph+ve cases were then offered a specific therapy including an induction treatment with steroids, cyclophosphamide, daunorubicin and vincristine, followed, irrespective of response to induction chemotherapy, by imatinib, 600 mg daily, combined with intermittent steroids during 2 months. Patients in complete response (CR) were then given 10 blocks of alternating chemotherapy, including 2 additional two-month blocks of imatinib, for a total treatment duration of 2 years. Therapy of occult central nervous system leukemia included 5 intrathecal injections of methotrexate and cranial irradiation.

Duration of therapy : 2 years.


Condition Intervention Phase
Acute Lymphocytic Leukemia Drug: imatinib Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Official Title: Evaluation of Imatinib (GLIVEC) After Induction Therapy in Patients Aged More Than 55 Years With Philadelphia Positive Acute Lymphoblastic Leukaemia (Ph+ ALL) : a Non Randomised, Controlled, Open, Multicentric, International Phase II Clinical Study (CSTI 571 AFR09 Trial)

Resource links provided by NLM:


Further study details as provided by Hospices Civils de Lyon:

Primary Outcome Measures:
  • Impact of Imatinib on survival in elderly patients with Ph+ALL

Secondary Outcome Measures:
  • Tolerance of Imatinib
  • Complete remission rate
  • Minimal Residual Disease after Imatinib treatment
  • Leukemia free survival
  • Impact of steroids given before starting chemotherapy
  • Study of potential resistance mechanisums to Imatinib

Estimated Enrollment: 30
Study Start Date: August 2002
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   55 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Ph+ ALL patients
  • 55 years or older
  • Signed written informed consent

Exclusion Criteria:

  • CML in transformation
  • Concomitant malignancy
  • Previous treatment by Imatinib
  • Severe organ condition
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00149136


Locations
France
Xavier THOMAS
Lyon, France, 69437
Sponsors and Collaborators
Hospices Civils de Lyon
Investigators
Principal Investigator: Xavier THOMAS, MD Hospices Civils de Lyon
  More Information

ClinicalTrials.gov Identifier: NCT00149136     History of Changes
Other Study ID Numbers: 2002.280
First Submitted: September 6, 2005
First Posted: September 8, 2005
Last Update Posted: April 27, 2007
Last Verified: April 2007

Keywords provided by Hospices Civils de Lyon:
Acute Lymphocytic Leukemia,
Ph+,
elderly patients,
Imatinib

Additional relevant MeSH terms:
Leukemia
Leukemia, Lymphoid
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Imatinib Mesylate
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action