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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)

Status
UNKNOWN
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00149136
Enrollment
30
Registered
2005-09-08
Start date
2002-08-31
Completion date
Unknown
Last updated
2007-04-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Lymphocytic Leukemia

Keywords

Acute Lymphocytic Leukemia,, Ph+,, elderly patients,, Imatinib

Brief summary

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.

Interventions

DRUGimatinib

Sponsors

Hospices Civils de Lyon
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
55 Years to 90 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Impact of Imatinib on survival in elderly patients with Ph+ALL

Secondary

MeasureTime frame
Complete remission rate
Minimal Residual Disease after Imatinib treatment
Tolerance of Imatinib
Impact of steroids given before starting chemotherapy
Study of potential resistance mechanisums to Imatinib
Leukemia free survival

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026