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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-08-31

Brief Summary

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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.

Detailed Description

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Conditions

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Acute Lymphocytic Leukemia

Keywords

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Acute Lymphocytic Leukemia, Ph+, elderly patients, Imatinib

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Blinding Strategy

NONE

Interventions

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imatinib

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

55 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Principal Investigators

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Xavier THOMAS, MD

Role: PRINCIPAL_INVESTIGATOR

Hospices Civils de Lyon

Locations

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Xavier THOMAS

Lyon, , France

Site Status

Countries

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France

Other Identifiers

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2002.280

Identifier Type: -

Identifier Source: org_study_id