Imatinib Mesylate Plus Cytarabine in Treating Patients With Chronic Myelogenous Leukemia

Leukemia Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00022490
• Other study ID #: CDR0000068822
• Secondary ID: OHSU-NCI-4653OHS
• Status: Terminated
• Phase: Phase 2
• First received: August 10, 2001
• Last updated: December 8, 2015
• Start date: June 2001
• Est. completion date: July 2011

Study information

• Verified date: December 2015
• Source: OHSU Knight Cancer Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal GovernmentUnited States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 24
• Est. completion date: July 2011
• Est. primary completion date: May 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 120 Years

Eligibility

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

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Leukemia
• Leukemia, Myelogenous, Chronic, BCR-ABL Positive
• Leukemia, Myeloid

Intervention

Drug:
• cytarabine
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
• imatinib mesylate
Once daily oral administration of STI571 (Imatinib Mesylate) at a dose of 400 mg for 12 months.

Locations

Country	Name	City	State
United States	Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute	Boston	Massachusetts
United States	OHSU Knight Cancer Institute	Portland	Oregon

Sponsors (2)

Lead Sponsor	Collaborator
OHSU Knight Cancer Institute	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	6 months	No
Secondary	The Rate of Complete Cytogenetic Response at 6 Months		6 months	No
Secondary	The Rate of Complete and Major Cytogenetic Responses at 12 Months		12 months	No
Secondary	The Rate of Minor Cytogenetic Responses at 6 and 12 Months		6 and 12 months	No
Secondary	The Rate of Complete Hematologic Responses at 6 and 12 Months		6 and 12 months	No