STI571 in Treating Patients With Chronic Myelogenous Leukemia in Blast Crisis

February 20, 2013 updated by: Novartis

An Open-Label Study to Determine the Efficacy and Safety of STI571 in Patients With Chronic Myeloid Leukemia in Blast Crisis

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

PROJECTED ACCRUAL: Not determined

Study Type

Interventional

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New Jersey
      • East Hanover, New Jersey, United States, 07936
        • Novartis Pharmaceuticals Corporation

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novartis

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

  • 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.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2000

Primary Completion (ACTUAL)

December 1, 2002

Study Completion (ACTUAL)

December 1, 2002

Study Registration Dates

First Submitted

November 6, 2000

First Submitted That Met QC Criteria

April 23, 2004

First Posted (ESTIMATE)

April 26, 2004

Study Record Updates

Last Update Posted (ESTIMATE)

February 21, 2013

Last Update Submitted That Met QC Criteria

February 20, 2013

Last Verified

February 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CDR0000068302
  • NOVARTIS-CSTI5710115

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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