Chemotherapy and Biological Therapy in Treating Patients With Chronic Phase Chronic Myelogenous Leukemia
|ClinicalTrials.gov Identifier: NCT00003239|
Recruitment Status : Completed
First Posted : April 30, 2004
Last Update Posted : July 30, 2012
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.
|Condition or disease||Intervention/treatment||Phase|
|Leukemia||Biological: Recombinant Interferon Alfa Drug: Cytarabine Drug: Omacetaxine Mepesuccinate||Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||90 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Therapy of Early Chronic Phase Chronic Myelogenous Leukemia (CML) With Alpha Interferon (IFN-A), Low-Dose Cytosine Arabinoside (ARA-C), and Homoharringtonine (HHT)|
|Study Start Date :||March 1998|
|Primary Completion Date :||October 2001|
|Study Completion Date :||October 2001|
Experimental: Chemotherapy with Cytarabine + Homoharringtonine
Interferon alfa and cytarabine daily by subcutaneous injection. Homoharringtonine is administered by continuous infusion on days 1-5.
Biological: Recombinant Interferon Alfa
Daily by subcutaneous injection.
Other Names:Drug: Cytarabine
Daily by subcutaneous injection.
Other Names:Drug: Omacetaxine Mepesuccinate
Homoharringtonine is administered by continuous infusion on days 1-5.
- Number of Patients with Complete Cytogenic Response [ Time Frame: Every 3 months ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00003239
|United States, Texas|
|University of Texas - MD Anderson Cancer Center|
|Houston, Texas, United States, 77030-4009|
|Study Chair:||Hagop M. Kantarjian, MD||M.D. Anderson Cancer Center|