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STI571 in Treating Patients With Chronic Myelogenous Leukemia in Blast Crisis

Primary Purpose

Leukemia

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
imatinib mesylate
Sponsored by
Novartis
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Leukemia focused on measuring relapsing chronic myelogenous leukemia, blastic phase chronic myelogenous leukemia, chronic myelogenous leukemia, BCR-ABL1 positive, Philadelphia chromosome negative chronic myelogenous leukemia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Novartis Pharmaceuticals Corporation

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
November 6, 2000
Last Updated
February 20, 2013
Sponsor
Novartis
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1. Study Identification

Unique Protocol Identification Number
NCT00006475
Brief Title
STI571 in Treating Patients With Chronic Myelogenous Leukemia in Blast Crisis
Official Title
An Open-Label Study to Determine the Efficacy and Safety of STI571 in Patients With Chronic Myeloid Leukemia in Blast Crisis
Study Type
Interventional

2. Study Status

Record Verification Date
February 2013
Overall Recruitment Status
Completed
Study Start Date
September 2000 (undefined)
Primary Completion Date
December 2002 (Actual)
Study Completion Date
December 2002 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novartis

4. Oversight

5. Study Description

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.
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Leukemia
Keywords
relapsing chronic myelogenous leukemia, blastic phase chronic myelogenous leukemia, chronic myelogenous leukemia, BCR-ABL1 positive, Philadelphia chromosome negative chronic myelogenous leukemia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
imatinib mesylate

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ilana Monteleone
Organizational Affiliation
Novartis Pharmaceuticals
Official's Role
Study Chair
Facility Information:
Facility Name
Novartis Pharmaceuticals Corporation
City
East Hanover
State/Province
New Jersey
ZIP/Postal Code
07936
Country
United States

12. IPD Sharing Statement

Citations:
Citation
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.
Results Reference
result
Citation
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.
Results Reference
result

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STI571 in Treating Patients With Chronic Myelogenous Leukemia in Blast Crisis

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