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

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. Identifier: NCT00149136
Recruitment Status : Unknown
Verified April 2007 by Hospices Civils de Lyon.
Recruitment status was:  Active, not recruiting
First Posted : September 8, 2005
Last Update Posted : April 27, 2007
Information provided by:
Hospices Civils de Lyon

September 6, 2005
September 8, 2005
April 27, 2007
August 2002
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Impact of Imatinib on survival in elderly patients with Ph+ALL
Same as current
Complete list of historical versions of study NCT00149136 on Archive Site
  • 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
Same as current
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Treatment of Philadelphia-Positive Acute Lymphocytic Leukemia (Ph+ ALL) in the Elderly With Imatinib Mesylate (STI571) and Chemotherapy.
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)

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.

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Phase 2
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Acute Lymphocytic Leukemia
Drug: imatinib
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*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Unknown status
Same as current
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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
Sexes Eligible for Study: All
55 Years to 90 Years   (Adult, Older Adult)
Contact information is only displayed when the study is recruiting subjects
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Hospices Civils de Lyon
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Principal Investigator: Xavier THOMAS, MD Hospices Civils de Lyon
Hospices Civils de Lyon
April 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP