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

• Sponsor: Hospices Civils de Lyon (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT00149136
• Collaborator: (none)
• Enrollment: 30
• Location: 1

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Acute Lymphocytic Leukemia	Drug: imatinib	Phase 2

Study Design

• Study Type: Interventional
• 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)
• Study Start Date: Aug 1, 2002

Outcome Measures

Primary Outcome Measures

1. Impact of Imatinib on survival in elderly patients with Ph+ALL []

Secondary Outcome Measures

1. Tolerance of Imatinib []

2. Complete remission rate []

3. Minimal Residual Disease after Imatinib treatment []

4. Leukemia free survival []

5. Impact of steroids given before starting chemotherapy []

6. Study of potential resistance mechanisums to Imatinib []

Eligibility Criteria

Criteria

• Ages Eligible for Study: 55 Years to 90 Years
• Sexes Eligible for Study: All
• Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Xavier THOMAS	Lyon		France	69437

Sponsors and Collaborators

• Hospices Civils de Lyon

Investigators

• Principal Investigator: Xavier THOMAS, MD, Hospices Civils de Lyon

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00149136
• Other Study ID Numbers: 2002.280
• First Posted: Sep 8, 2005
• Last Update Posted: Apr 27, 2007
• Last Verified: Apr 1, 2007

• Keywords provided by , ,: Acute Lymphocytic Leukemia,; Ph+,; elderly patients,; Imatinib
• Additional relevant MeSH terms: Leukemia; Leukemia, Lymphoid; Precursor Cell Lymphoblastic Leukemia-Lymphoma; Imatinib Mesylate

Study Results

No Results Posted as of Apr 27, 2007