STI571 in Treating Patients With Chronic Myelogenous Leukemia in Blast Crisis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00006475
Recruitment Status : Completed
First Posted : April 26, 2004
Last Update Posted : February 21, 2013
Information provided by (Responsible Party):

Brief Summary:

RATIONALE: STI571 may interfere with the growth of cancer cells and may be an effective treatment for leukemia.

PURPOSE: Phase II trial to study the effectiveness of STI571 in treating patients who have chronic myelogenous leukemia in blast crisis.

Condition or disease Intervention/treatment Phase
Leukemia Drug: imatinib mesylate Phase 2

Detailed Description:

OBJECTIVES: I. Determine the safety profile of STI571 in patients with chronic myelogenous leukemia in blast crisis. II. Provide expanded access of this treatment to these patients. III. Determine the rate of hematological response and duration of response in patients treated with this regimen. IV. Determine the improvements in symptomatic parameters in patients treated with this regimen. V. Determine the cytogenetic response in patients treated with this regimen. VI. Determine the overall survival in patients treated with this regimen.

OUTLINE: This is an expanded-access, multicenter study. Patients receive oral STI571 daily. Treatment continues for 1 year in the absence of disease progression or unacceptable toxicity. Patients who are considered to have benefited may continue treatment beyond 1 year.


Study Type : Interventional  (Clinical Trial)
Primary Purpose: Treatment
Official Title: An Open-Label Study to Determine the Efficacy and Safety of STI571 in Patients With Chronic Myeloid Leukemia in Blast Crisis
Study Start Date : September 2000
Actual Primary Completion Date : December 2002
Actual Study Completion Date : December 2002

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

DISEASE CHARACTERISTICS: Diagnosis of chronic myelogenous leukemia (CML) in blast crisis, defined by at least one of the following: 30% blasts in peripheral blood and/or bone marrow Flow cytometry criteria Extramedullary disease other than spleen, lymph node, and/or liver involvement Newly diagnosed CML in blast crisis OR CML in blast crisis with prior therapy for accelerated or blastic phases Philadelphia (Ph) chromosome positive OR Ph chromosome negative and Bcr/Abl positive

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Life expectancy: Not specified Hematopoietic: See Disease Characteristics Hepatic: SGOT and SGPT no greater than 3 times upper limit of normal (ULN) (no greater than 5 times ULN if liver involvement) Bilirubin no greater than 3 times ULN Renal: Creatinine no greater than 2 times ULN Cardiovascular: No grade 3 or 4 cardiac disease Other: Not pregnant or nursing Negative pregnancy test Fertile patients must use effective barrier contraception during and for at least 2 weeks after study for women and for at least 3 months after study for men No history of noncompliance with medical regimens No serious concurrent medical condition

PRIOR CONCURRENT THERAPY: Biologic therapy: At least 48 hours since prior interferon alfa At least 6 weeks since prior hematopoietic stem cell transplantation No concurrent anticancer biologic therapy Chemotherapy: At least 6 weeks since prior busulfan At least 24 hours since prior hydroxyurea At least 2 weeks since prior homoharringtonine At least 1 week since prior low-dose cytarabine (less than 30 mg/m2 every 12-24 hours daily) At least 2 weeks since prior moderate-dose cytarabine (100-200 mg/m2 for 5-7 days) At least 4 weeks since prior high-dose cytarabine (1-3 g/m2 every 12-24 hours for 6-12 doses) At least 3 weeks since prior anthracyclines, mitoxantrone, or etoposide No concurrent anticancer chemotherapy Endocrine therapy: Not specified Radiotherapy: Not specified Surgery: Not specified Other: At least 4 weeks since other prior investigational agents No other concurrent anticancer investigational agents

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00006475

United States, New Jersey
Novartis Pharmaceuticals Corporation
East Hanover, New Jersey, United States, 07936
Sponsors and Collaborators
Study Chair: Ilana Monteleone Novartis Pharmaceuticals

Publications of Results:
Hensley ML, van Hoomissen IC, Krahnke T, et al.: Imatinib in chronic myeloid leukemia (CML): outcomes in >7000 patients treated on expanded access program (EAP). [Abstract] Proceedings of the American Society of Clinical Oncology 22: A-2328, 2003.
van Hoomissen IC, Hensley ML, Krahnke T, et al.: Imatinib expanded access program (EAP): results of treatment in >7000 patients with chronic myeloid leukemia (CML). [Abstract] Blood 102 (11): A-3370, 2003.

Responsible Party: Novartis Identifier: NCT00006475     History of Changes
Other Study ID Numbers: CDR0000068302
First Posted: April 26, 2004    Key Record Dates
Last Update Posted: February 21, 2013
Last Verified: February 2013

Keywords provided by Novartis:
relapsing chronic myelogenous leukemia
blastic phase chronic myelogenous leukemia
chronic myelogenous leukemia, BCR-ABL1 positive
Philadelphia chromosome negative chronic myelogenous leukemia

Additional relevant MeSH terms:
Leukemia, Myeloid
Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Blast Crisis
Neoplasms by Histologic Type
Myeloproliferative Disorders
Bone Marrow Diseases
Hematologic Diseases
Cell Transformation, Neoplastic
Neoplastic Processes
Pathologic Processes
Imatinib Mesylate
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action