Chemotherapy and Biological Therapy in Treating Patients With Chronic Phase Chronic Myelogenous Leukemia

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

1998-03-31

Study Completion Date

2001-10-31

Brief Summary

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RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining biological therapy with chemotherapy may kill more cancer cells.

PURPOSE: Phase II trial to study the effectiveness of chemotherapy with cytarabine and homoharringtonine and biological therapy with interferon alfa in treating patients with chronic phase chronic myelogenous leukemia.

Detailed Description

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OBJECTIVES: I. Determine the effectiveness of low dose cytarabine, homoharringtonine, and interferon alfa in stimulating a complete cytogenic response in patients with Philadelphia chromosome positive early chronic phase chronic myelogenous leukemia. II. Evaluate the duration of the cytogenic response in these patients after this treatment. III. Determine differential success rates and analyze results by prognostic subsets (e.g., risk group, splenomegaly, thrombocytosis, age, etc.) in this patient population.

OUTLINE: Patients receive debulking therapy consisting of hydroxyurea until blood count is at proper level. Patients then receive interferon alfa and cytarabine daily by subcutaneous injection. Homoharringtonine is administered by continuous infusion on days 1-5. Treatment continues for 5-7 years in the absence of unacceptable toxicity or disease progression (accelerated or blastic phase CML). If complete remission is achieved, peripheral blood stem cells are collected. Patients are followed every 3 months for the first year and every 6 months thereafter.

PROJECTED ACCRUAL: A total of 100 patients will be accrued for this study within 3 years.

Conditions

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Leukemia

Keywords

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chronic phase chronic myelogenous leukemia Philadelphia chromosome positive chronic myelogenous leukemia Homoharringtonine HHT cephalotaxus alkaloid cytarabine Interferon Alpha 2-A Roferon-A Ara-C DepotCyt Cytosine Arabinosine Hydrochloride

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Chemotherapy with Cytarabine + Homoharringtonine

Interferon alfa and cytarabine daily by subcutaneous injection. Homoharringtonine is administered by continuous infusion on days 1-5.

Group Type EXPERIMENTAL

Recombinant Interferon Alfa

Intervention Type BIOLOGICAL

Daily by subcutaneous injection.

Cytarabine

Intervention Type DRUG

Daily by subcutaneous injection.

Omacetaxine Mepesuccinate

Intervention Type DRUG

Homoharringtonine is administered by continuous infusion on days 1-5.

Interventions

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Recombinant Interferon Alfa

Daily by subcutaneous injection.

Intervention Type BIOLOGICAL

Cytarabine

Daily by subcutaneous injection.

Intervention Type DRUG

Omacetaxine Mepesuccinate

Homoharringtonine is administered by continuous infusion on days 1-5.

Intervention Type DRUG

Other Intervention Names

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Interferon Alpha 2-A Roferon-A Ara-C DepotCyt Cytosine Arabinosine Hydrochloride CGX-635-CML-202 HHT Homoharringtonine

Eligibility Criteria

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Inclusion Criteria

DISEASE CHARACTERISTICS: Cytologically confirmed early chronic phase chronic myelogenous leukemia (CML) Diagnosed within 12 months Philadelphia chromosome positive OR bcr positive No late chronic phase, accelerated phase, or blastic phase CML

PATIENT CHARACTERISTICS: Age: 12 and over Performance status: Zubrod 0-2 Life expectancy: Not specified Hematopoietic: Not specified Hepatic: Bilirubin less than 2 mg/dL Renal: Creatinine less than 2 mg/dL Cardiovascular: No severe heart disease Other: No psychoses Not pregnant or nursing Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY: Biologic therapy: Less than 1 month of prior interferon alfa Chemotherapy: Less than 1 month of prior cytarabine Prior hydroxyurea allowed Endocrine therapy: Not specified Radiotherapy: Not specified Surgery: Not specified

Minimum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Hagop M. Kantarjian, MD

Role: STUDY_CHAIR

M.D. Anderson Cancer Center

Locations

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University of Texas - MD Anderson Cancer Center

Houston, Texas, United States

Site Status

Countries

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United States