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Imatinib Mesylate Plus Cytarabine in Treating Patients With Chronic Myelogenous Leukemia

Primary Purpose

Leukemia

Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
cytarabine
imatinib mesylate
Sponsored by
OHSU Knight Cancer Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Leukemia focused on measuring chronic phase chronic myelogenous leukemia, Philadelphia chromosome positive chronic myelogenous leukemia

Eligibility Criteria

18 Years - 120 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

DISEASE CHARACTERISTICS: Cytogenetically confirmed chronic phase chronic myelogenous leukemia (CML) Less than 15% blasts in peripheral blood or bone marrow Less than 30% blasts and promyelocytes in peripheral blood or bone marrow Less than 20% basophils in blood or bone marrow Platelet count at least 100,000/mm^3 Philadelphia chromosome positive No more than 6 months since initial diagnosis No presence of leukemia beyond the bone marrow, blood, liver, or spleen (i.e., chloroma) Refused allogeneic stem cell transplantation as first-line therapy PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Eastern Cooperative Oncology Group (ECOG) 0-2 Life expectancy: Not specified Hematopoietic: See Disease Characteristics Hepatic: Bilirubin no greater than 1.5 times upper limit of normal (ULN) AST or ALT no greater than 2 times ULN Renal: Creatinine no greater than 1.5 times ULN Cardiovascular: No New York Heart Association class III or IV heart disease Other: Not pregnant or nursing Negative pregnancy test Fertile patients must use effective barrier contraception during and for at least 3 months after study participation No other serious uncontrolled medical condition No history of noncompliance to medical regimens or potential unreliability PRIOR CONCURRENT THERAPY: Biologic therapy: See Disease Characteristics No prior biologic therapy for CML Chemotherapy: No prior chemotherapy for CML except hydroxyurea Concurrent hydroxyurea to control blood counts during first 3 months of treatment allowed No other concurrent chemotherapy Endocrine therapy: No prior endocrine therapy for CML Radiotherapy: No prior radiotherapy for CML Surgery: Not specified Other: More than 28 days since prior investigational anticancer agents Prior anagrelide hydrochloride for CML allowed Concurrent anagrelide hydrochloride to control blood counts during first 3 months of treatment allowed No concurrent grapefruit juice or grapefruit

Sites / Locations

  • Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute
  • OHSU Knight Cancer Institute

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Cytarabine/ Imatinib Mesylate

Arm Description

Outcomes

Primary Outcome Measures

The Rate of Major Cytogenetic Response at 6 Months
Cytogenetic response is defined in terms of the percentage of Philadelphia (Ph) chromosome. Major cytogenetic response is defined as 0-34% Ph-positive cells.

Secondary Outcome Measures

The Rate of Complete Cytogenetic Response at 6 Months
The Rate of Complete and Major Cytogenetic Responses at 12 Months
The Rate of Minor Cytogenetic Responses at 6 and 12 Months
The Rate of Complete Hematologic Responses at 6 and 12 Months

Full Information

First Posted
August 10, 2001
Last Updated
December 8, 2015
Sponsor
OHSU Knight Cancer Institute
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00022490
Brief Title
Imatinib Mesylate Plus Cytarabine in Treating Patients With Chronic Myelogenous Leukemia
Official Title
A Phase II Study To Determine The Anti-Leukemic Effects Of STI571 In Combination With Ara-C In Patients With Chronic Myelogenous Leukemia In Chronic Phase
Study Type
Interventional

2. Study Status

Record Verification Date
December 2015
Overall Recruitment Status
Terminated
Study Start Date
June 2001 (undefined)
Primary Completion Date
May 2011 (Actual)
Study Completion Date
July 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
OHSU Knight Cancer Institute
Collaborators
National Cancer Institute (NCI)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Imatinib mesylate may stop the growth of cancer cells by blocking the enzymes necessary for cancer cell growth. PURPOSE: This phase II trial is studying giving imatinib mesylate together with cytarabine to see how well it works in treating patients with chronic phase chronic myelogenous leukemia.
Detailed Description
OBJECTIVES: Determine the rate and duration of complete or major and minor cytogenetic responses after 6 and 12 months of treatment in patients with chronic phase chronic myelogenous leukemia treated with imatinib mesylate and cytarabine. Determine the rate and duration of complete hematologic responses after 6 and 12 months of treatment in patients treated with this regimen. Determine the rate of molecular response in patients with a complete cytogenetic response after 6 and 12 months of treatment with this regimen. Determine the pharmacokinetics of this regimen in these patients. Determine the safety of this regimen in these patients. OUTLINE: This is a nonrandomized, open-label, multicenter study. Patients receive oral imatinib mesylate on days 1-28 and cytarabine subcutaneously on days 15-28. Courses repeat every 28 days for 12 months in the absence of disease progression or unacceptable toxicity. Patients are followed for 30-60 days. PROJECTED ACCRUAL: A total of 15 patients will be accrued for this study.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Leukemia
Keywords
chronic phase chronic myelogenous leukemia, Philadelphia chromosome positive chronic myelogenous leukemia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
24 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Cytarabine/ Imatinib Mesylate
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
cytarabine
Intervention Description
Once daily subcutaneous injection of Ara-C (Cytarabine) at a dose of 20 mg (10 mg or 5 mg if they have been dose reduced) per square meter of calculated body surface area, on days 15-28 of each sequential 28 day cycle
Intervention Type
Drug
Intervention Name(s)
imatinib mesylate
Intervention Description
Once daily oral administration of STI571 (Imatinib Mesylate) at a dose of 400 mg for 12 months.
Primary Outcome Measure Information:
Title
The Rate of Major Cytogenetic Response at 6 Months
Description
Cytogenetic response is defined in terms of the percentage of Philadelphia (Ph) chromosome. Major cytogenetic response is defined as 0-34% Ph-positive cells.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
The Rate of Complete Cytogenetic Response at 6 Months
Time Frame
6 months
Title
The Rate of Complete and Major Cytogenetic Responses at 12 Months
Time Frame
12 months
Title
The Rate of Minor Cytogenetic Responses at 6 and 12 Months
Time Frame
6 and 12 months
Title
The Rate of Complete Hematologic Responses at 6 and 12 Months
Time Frame
6 and 12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
120 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
DISEASE CHARACTERISTICS: Cytogenetically confirmed chronic phase chronic myelogenous leukemia (CML) Less than 15% blasts in peripheral blood or bone marrow Less than 30% blasts and promyelocytes in peripheral blood or bone marrow Less than 20% basophils in blood or bone marrow Platelet count at least 100,000/mm^3 Philadelphia chromosome positive No more than 6 months since initial diagnosis No presence of leukemia beyond the bone marrow, blood, liver, or spleen (i.e., chloroma) Refused allogeneic stem cell transplantation as first-line therapy PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Eastern Cooperative Oncology Group (ECOG) 0-2 Life expectancy: Not specified Hematopoietic: See Disease Characteristics Hepatic: Bilirubin no greater than 1.5 times upper limit of normal (ULN) AST or ALT no greater than 2 times ULN Renal: Creatinine no greater than 1.5 times ULN Cardiovascular: No New York Heart Association class III or IV heart disease Other: Not pregnant or nursing Negative pregnancy test Fertile patients must use effective barrier contraception during and for at least 3 months after study participation No other serious uncontrolled medical condition No history of noncompliance to medical regimens or potential unreliability PRIOR CONCURRENT THERAPY: Biologic therapy: See Disease Characteristics No prior biologic therapy for CML Chemotherapy: No prior chemotherapy for CML except hydroxyurea Concurrent hydroxyurea to control blood counts during first 3 months of treatment allowed No other concurrent chemotherapy Endocrine therapy: No prior endocrine therapy for CML Radiotherapy: No prior radiotherapy for CML Surgery: Not specified Other: More than 28 days since prior investigational anticancer agents Prior anagrelide hydrochloride for CML allowed Concurrent anagrelide hydrochloride to control blood counts during first 3 months of treatment allowed No concurrent grapefruit juice or grapefruit
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Brian J. Druker, MD
Organizational Affiliation
OHSU Knight Cancer Institute
Official's Role
Study Chair
Facility Information:
Facility Name
Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Facility Name
OHSU Knight Cancer Institute
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States

12. IPD Sharing Statement

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Imatinib Mesylate Plus Cytarabine in Treating Patients With Chronic Myelogenous Leukemia

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