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 because the information has not been verified recently.
Verified April 2007 by Hospices Civils de Lyon.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
Hospices Civils de Lyon
ClinicalTrials.gov Identifier:
NCT00149136
First received: September 6, 2005
Last updated: April 26, 2007
Last verified: April 2007

September 6, 2005
April 26, 2007
August 2002
Not Provided
Impact of Imatinib on survival in elderly patients with Ph+ALL
Same as current
Complete list of historical versions of study NCT00149136 on ClinicalTrials.gov 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
Not Provided
Not Provided
 
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.

Not Provided
Interventional
Phase 2
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Acute Lymphocytic Leukemia
Drug: imatinib
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
30
Not Provided
Not Provided

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
Both
55 Years to 90 Years
No
Contact information is only displayed when the study is recruiting subjects
France
 
NCT00149136
2002.280
Not Provided
Not Provided
Hospices Civils de Lyon
Not Provided
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