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STI571 in Treating Patients With Accelerated Phase Chronic Myelogenous Leukemia

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 accelerated 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: Confirmed diagnosis of chronic myelogenous leukemia in accelerated phase At least 15% but less than 30% blasts in blood or bone marrow At least 30% blasts plus promyelocytes in the peripheral blood or bone marrow At least 20% peripheral basophils Thrombocyte count less than 100,000/mm3 (unrelated to therapy) Patients must have never been in blastic phase Ph chromosome positive OR Ph chromosome negative and Bcr/Abl positive PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-3 Life expectancy: Not specified Hematopoietic: See Disease Characteristics Blood counts recovered from any prior antileukemic agents Hepatic: Bilirubin no greater than 1.5 times upper limit of normal (ULN) (no greater than 3 times ULN if liver involvement suspected) AST and ALT no greater than 3 times ULN (no greater than 5 times ULN if liver involvement suspected) Renal: Creatinine no greater than 2 times ULN Cardiovascular: No grade 3 or 4 cardiac disease Other: No serious other concurrent medical condition 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 at least 3 months after study for men No history of noncompliance with medical regimens PRIOR CONCURRENT THERAPY: Biologic therapy: At least 48 hours since prior interferon alfa Prior hematopoietic stem cell transplantation allowed if blood counts have recovered No concurrent biologic therapy Chemotherapy: At least 14 days since prior homoharringtonine At least 24 hours since prior hydroxyurea At least 7 days since prior low dose cytarabine (less than 30 mg/m2 every 12-24 hours daily) At least 14 days since prior moderate dose cytarabine (100-200 mg/m2 for 5-7 days) At least 28 days since prior high dose cytarabine (1-3 g/m2 every 12-24 hours for 6-12 doses) At least 21 days since prior anthracyclines, mitoxantrone, etoposide, methotrexate, or cyclophosphamide At least 6 weeks since prior busulfan No concurrent chemotherapy Endocrine therapy: Not specified Radiotherapy: Not specified Surgery: Not specified Other: At least 28 days since prior other investigational agents No concurrent other investigational agents

Sites / Locations

  • Novartis Pharmaceuticals Corporation

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
July 5, 2000
Last Updated
January 30, 2014
Sponsor
Novartis
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1. Study Identification

Unique Protocol Identification Number
NCT00006052
Brief Title
STI571 in Treating Patients With Accelerated Phase Chronic Myelogenous Leukemia
Official Title
A Study to Determine the Efficacy and Safety of STI571 in Patients With Chronic Myeloid Leukemia in Accelerated Phase
Study Type
Interventional

2. Study Status

Record Verification Date
January 2014
Overall Recruitment Status
Completed
Study Start Date
June 2000 (undefined)
Primary Completion Date
June 2003 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

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

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
RATIONALE: STI571 may interfere with the growth of cancer cells and may be effective treatment for chronic myelogenous leukemia. PURPOSE: Phase II trial to study the effectiveness of STI571 in treating patients who have accelerated phase chronic myelogenous leukemia.
Detailed Description
OBJECTIVES: I. Determine the safety of STI571 in patients with accelerated phase Philadelphia chromosome positive (or chromosome negative and Bcr/Abl positive) chronic myelogenous leukemia. II. Determine the rate of hematological response to this treatment in these patients. III. Determine the improvements in symptomatic parameters with this treatment in these patients. IV. Determine the cytogenetic response to this treatment in these patients. V. Determine the time to treatment failure in these patients after receiving this treatment. OUTLINE: Patients receive oral STI571 daily. Treatment continues for at least 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
accelerated 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: Confirmed diagnosis of chronic myelogenous leukemia in accelerated phase At least 15% but less than 30% blasts in blood or bone marrow At least 30% blasts plus promyelocytes in the peripheral blood or bone marrow At least 20% peripheral basophils Thrombocyte count less than 100,000/mm3 (unrelated to therapy) Patients must have never been in blastic phase Ph chromosome positive OR Ph chromosome negative and Bcr/Abl positive PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-3 Life expectancy: Not specified Hematopoietic: See Disease Characteristics Blood counts recovered from any prior antileukemic agents Hepatic: Bilirubin no greater than 1.5 times upper limit of normal (ULN) (no greater than 3 times ULN if liver involvement suspected) AST and ALT no greater than 3 times ULN (no greater than 5 times ULN if liver involvement suspected) Renal: Creatinine no greater than 2 times ULN Cardiovascular: No grade 3 or 4 cardiac disease Other: No serious other concurrent medical condition 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 at least 3 months after study for men No history of noncompliance with medical regimens PRIOR CONCURRENT THERAPY: Biologic therapy: At least 48 hours since prior interferon alfa Prior hematopoietic stem cell transplantation allowed if blood counts have recovered No concurrent biologic therapy Chemotherapy: At least 14 days since prior homoharringtonine At least 24 hours since prior hydroxyurea At least 7 days since prior low dose cytarabine (less than 30 mg/m2 every 12-24 hours daily) At least 14 days since prior moderate dose cytarabine (100-200 mg/m2 for 5-7 days) At least 28 days since prior high dose cytarabine (1-3 g/m2 every 12-24 hours for 6-12 doses) At least 21 days since prior anthracyclines, mitoxantrone, etoposide, methotrexate, or cyclophosphamide At least 6 weeks since prior busulfan No concurrent chemotherapy Endocrine therapy: Not specified Radiotherapy: Not specified Surgery: Not specified Other: At least 28 days since prior other investigational agents No concurrent other 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

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STI571 in Treating Patients With Accelerated Phase Chronic Myelogenous Leukemia

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