Homoharringtonine Compared With Hydroxyurea for Chronic Myelogenous Leukemia That Has Not Responded to Interferon Alfa
Leukemia
About this trial
This is an interventional treatment trial for Leukemia focused on measuring relapsing chronic myelogenous leukemia, chronic phase chronic myelogenous leukemia, Philadelphia chromosome positive chronic myelogenous leukemia
Eligibility Criteria
Documentation of Disease: 1.1 Diagnosis of Chronic Myelogenous Leukemia (CML) in chronic phase. Patients in either accelerated or blastic phases are not eligible. Clonal cytogenetic evolution alone does not exclude patients. See Appendix I for definitions of accelerated and blastic phases of CML. 1.2 Patients in whom a Philadelphia chromosome [t(9;22)] is not detectable by cytogenetic studies are eligible if they meet one of the following criteria: BCR/ABL protein detectable by immunoblotting BCR/ABL rearrangement detectable by Southern blot analysis Polymerase chain reaction (PCR) positive fusion transcripts for BCR/ABL BCR/ABL translocation present by fluorescence in situ hybridization (FISH). Prior Treatment: 2.1 No previous therapy with homoharringtonine (HHT) 2.2 No more than six months cumulative (<180 days) of prior hydroxyurea (HU) therapy. However, patients may not have received more than 60 days of HU treatment after failing interferon. Patients with previous intolerance or failure to respond to HU are not eligible. 2.3 Patients must have failed an adequate trial (5M units/m2/day) of alpha-Interferon (IFN) or IFN/ara-C to be eligible, as defined below (any ONE of the following): Failure to achieve a complete hematologic response after 6 months of IFN therapy. Failure to achieve any cytogenetic response (i.e., still 100% Ph+) after 12 months of IFN therapy. Intolerable adverse effects of IFN therapy after at least one month of IFN treatment. Significant documented toxicity of ≥ grade 3 (using NCI Common Toxicity Criteria guidelines) due to IFN is required. Loss of a prior hematologic remission or cytogenetic response to IFN. A two-fold increase in WBC count when compared to WBC count when IFN therapy was initiated. Age ≥ 16 years Patients with uncontrolled tachyarrhythmias (such as, atrial fibrillation, paroxysmal supraventricular tachycardia, and ventricular tachycardias not adequately controlled) are not eligible. Non-pregnant and non-nursing. Treatment under this protocol would expose an unborn child to significant risks. Women and men of reproductive potential should agree to use an effective means of birth control.
Sites / Locations
- Veterans Affairs Medical Center - Birmingham
- MBCCOP - University of South Alabama
- CCOP - Greater Phoenix
- Veterans Affairs Medical Center - Phoenix (Hayden)
- Veterans Affairs Medical Center - Tucson
- Arizona Cancer Center
- University of Arkansas for Medical Sciences
- Veterans Affairs Medical Center - Little Rock (McClellan)
- University of California San Diego Cancer Center
- Veterans Affairs Medical Center - Long Beach
- USC/Norris Comprehensive Cancer Center
- Jonsson Comprehensive Cancer Center, UCLA
- Beckman Research Institute, City of Hope
- Veterans Affairs Outpatient Clinic - Martinez
- CCOP - Bay Area Tumor Institute
- Chao Family Comprehensive Cancer Center
- University of California Davis Medical Center
- UCSF Cancer Center and Cancer Research Institute
- Veterans Affairs Medical Center - San Francisco
- CCOP - Santa Rosa Memorial Hospital
- David Grant Medical Center
- Veterans Affairs Medical Center - Denver
- University of Colorado Cancer Center
- CCOP - Christiana Care Health Services
- Lombardi Cancer Center, Georgetown University
- Walter Reed Army Medical Center
- CCOP - Mount Sinai Medical Center
- CCOP - Atlanta Regional
- Dwight David Eisenhower Army Medical Center
- Cancer Research Center of Hawaii
- University of Illinois at Chicago Health Sciences Center
- Veterans Affairs Medical Center - Chicago (Westside Hospital)
- University of Chicago Cancer Research Center
- CCOP - Central Illinois
- Veterans Affairs Medical Center - Hines (Hines Junior VA Hospital)
- Loyola University Medical Center
- University of Iowa Hospitals and Clinics
- University of Kansas Medical Center
- CCOP - Wichita
- Veterans Affairs Medical Center - Wichita
- Veterans Affairs Medical Center - Lexington
- Albert B. Chandler Medical Center, University of Kentucky
- MBCCOP - LSU Medical Center
- Tulane University School of Medicine
- Veterans Affairs Medical Center - New Orleans
- Louisiana State University Health Sciences Center - Shreveport
- Veterans Affairs Medical Center - Shreveport
- Veterans Affairs Medical Center - Togus
- Marlene & Stewart Greenebaum Cancer Center, University of Maryland
- Dana-Farber Cancer Institute
- Boston Medical Center
- Veterans Affairs Medical Center - Boston (Jamaica Plain)
- University of Massachusetts Memorial Medical Center
- Veterans Affairs Medical Center - Ann Arbor
- University of Michigan Comprehensive Cancer Center
- Veterans Affairs Medical Center - Detroit
- Barbara Ann Karmanos Cancer Institute
- Henry Ford Hospital
- CCOP - Grand Rapids Clinical Oncology Program
- Providence Hospital - Southfield
- Veterans Affairs Medical Center - Minneapolis
- University of Minnesota Cancer Center
- Veterans Affairs Medical Center - Biloxi
- University of Mississippi Medical Center
- Veterans Affairs Medical Center - Jackson
- Keesler Medical Center - Keesler AFB
- Veterans Affairs Medical Center - Columbia (Truman Memorial)
- Ellis Fischel Cancer Center - Columbia
- Veterans Affairs Medical Center - Kansas City
- CCOP - Kansas City
- St. Louis University Health Sciences Center
- Barnes-Jewish Hospital
- CCOP - St. Louis-Cape Girardeau
- CCOP - Cancer Research for the Ozarks
- CCOP - Montana Cancer Consortium
- University of Nebraska Medical Center
- CCOP - Southern Nevada Cancer Research Foundation
- Norris Cotton Cancer Center
- Veterans Affairs Medical Center - Albuquerque
- MBCCOP - University of New Mexico HSC
- Veterans Affairs Medical Center - Buffalo
- Roswell Park Cancer Institute
- CCOP - North Shore University Hospital
- North Shore University Hospital
- Memorial Sloan-Kettering Cancer Center
- New York Presbyterian Hospital - Cornell Campus
- Mount Sinai Medical Center, NY
- Herbert Irving Comprehensive Cancer Center
- State University of New York - Upstate Medical University
- Veterans Affairs Medical Center - Syracuse
- CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C.
- Lineberger Comprehensive Cancer Center, UNC
- Veterans Affairs Medical Center - Durham
- Duke Comprehensive Cancer Center
- CCOP - Southeast Cancer Control Consortium
- Comprehensive Cancer Center of Wake Forest University Baptist Medical Center
- Barrett Cancer Center, The University Hospital
- Veterans Affairs Medical Center - Cincinnati
- Cleveland Clinic Taussig Cancer Center
- CCOP - Columbus
- Arthur G. James Cancer Hospital - Ohio State University
- Veterans Affairs Medical Center - Dayton
- CCOP - Dayton
- Oklahoma Medical Research Foundation
- Veterans Affairs Medical Center - Oklahoma City
- Oregon Cancer Center at Oregon Health Sciences University
- Veterans Affairs Medical Center - Portland
- CCOP - Columbia River Program
- Rhode Island Hospital
- Medical University of South Carolina
- CCOP - Greenville
- CCOP - Upstate Carolina
- University of Tennessee, Memphis Cancer Center
- Veterans Affairs Medical Center - Memphis
- Simmons Cancer Center - Dallas
- Brooke Army Medical Center
- University of Texas Medical Branch
- Texas Tech University Health Science Center
- University of Texas Health Science Center at San Antonio
- Veterans Affairs Medical Center - San Antonio (Murphy)
- Veterans Affairs Medical Center - Temple
- CCOP - Scott and White Hospital
- Huntsman Cancer Institute
- Veterans Affairs Medical Center - Salt Lake City
- CCOP - Southwestern Vermont Regional Cancer Center
- Vermont Cancer Center
- Veterans Affairs Medical Center - White River Junction
- Veterans Affairs Medical Center - Richmond
- MBCCOP - Massey Cancer Center
- CCOP - Virginia Mason Research Center
- Swedish Cancer Institute
- Veterans Affairs Medical Center - Seattle
- CCOP - Northwest
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
Homoharringtonine
Hydroxyurea