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

Sponsored by:	Hospices Civils de Lyon
Information provided by:	Hospices Civils de Lyon
ClinicalTrials.gov Identifier:	NCT00149136

Purpose

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	Intervention	Phase
Acute Lymphocytic Leukemia	Drug: imatinib	Phase II

MedlinePlus related topics: Leukemia, Adult Acute Leukemia, Adult Chronic

Drug Information available for: Imatinib Imatinib mesylate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Non-Randomized, Open Label, Uncontrolled, Single Group Assignment
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)

Further study details as provided by Hospices Civils de Lyon:

Primary Outcome Measures:

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

Secondary Outcome Measures:

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

Estimated Enrollment:	30
Study Start Date:	August 2002

Eligibility

Ages Eligible for Study:	55 Years to 90 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00149136

Locations

France
Xavier THOMAS
Lyon, France, 69437

Sponsors and Collaborators

Hospices Civils de Lyon

Investigators

Principal Investigator:

Xavier THOMAS, MD

Hospices Civils de Lyon

More Information

Study ID Numbers:	2002.280
Study First Received:	September 6, 2005
Last Updated:	April 26, 2007
ClinicalTrials.gov Identifier:	NCT00149136
Health Authority:	France: Afssaps - French Health Products Safety Agency

Keywords provided by Hospices Civils de Lyon:

Acute Lymphocytic Leukemia,
Ph+,
elderly patients,
Imatinib

Study placed in the following topic categories:

Imatinib
Lymphatic Diseases
Leukemia
Leukemia, Lymphoid

Immunoproliferative Disorders
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Lymphoproliferative Disorders
Lymphoma

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Histologic Type
Molecular Mechanisms of Pharmacological Action
Immune System Diseases
Antineoplastic Agents

Therapeutic Uses
Enzyme Inhibitors
Protein Kinase Inhibitors
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009