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Homoharringtonine Plus Low-Dose Cytarabine in Treating Patients With Newly Diagnosed Chronic Myelogenous Leukemia in Chronic Phase Clinical Trials Information presented on Clinical Trials Search isn't intended to be a substitute for proven healthcare advice, trips or treatment using a real physician. We are not docs. Always confer with your mD on Homoharringtonine Plus Low-Dose Cytarabine in Treating Patients With Newly Diagnosed Chronic Myelogenous Leukemia in Chronic Phase conditions. Clinical Trials Search.org is a site dedicated to listing clinical research studies in human subjects. Homoharringtonine Plus Low-Dose Cytarabine in Treating Patients With Newly Diagnosed Chronic Myelogenous Leukemia in Chronic Phase Clinical research trials and Homoharringtonine Plus Low-Dose Cytarabine in Treating Patients With Newly Diagnosed Chronic Myelogenous Leukemia in Chronic Phase medical trials take place in hundreds of localities across the U.S.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials usually measure the effectiveness of new drugs. The intention of the studies / projects is to resolve certain human health questions. Clinical trials are a popular means for physicians, government agencies, and private sector corporations to detect remedies for all forms of circumstances, like Homoharringtonine Plus Low-Dose Cytarabine in Treating Patients With Newly Diagnosed Chronic Myelogenous Leukemia in Chronic Phase. Homoharringtonine Plus Low-Dose Cytarabine in Treating Patients With Newly Diagnosed Chronic Myelogenous Leukemia in Chronic Phase Clinical Trials and other clinical trials allow for volunteers to undergo healthcare treatment options before they are available to the masses. Most times the participants receive treatment for free, and every now and again they are paid for their time. Occasionally there is a cost for a Homoharringtonine Plus Low-Dose Cytarabine in Treating Patients With Newly Diagnosed Chronic Myelogenous Leukemia in Chronic Phase clinical trial. Subjects typically recieve the finest healthcare available for their Homoharringtonine Plus Low-Dose Cytarabine in Treating Patients With Newly Diagnosed Chronic Myelogenous Leukemia in Chronic Phase condition. Hazards are a reality, nonetheless, and might include more or frequent mD trips, health risks (potentially life-endangering), and/or the treatment being ineffective. Trials are federally regulated with stern guidelines to protect clinical trials subjects.
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Home > "H" Clinical Trials Conditions > Homoharringtonine Plus Low-Dose Cytarabine in Treating Patients With Newly Diagnosed Chronic Myelogenous Leukemia in Chronic Phase Homoharringtonine Plus Low-Dose Cytarabine in Treating Patients With Newly Diagnosed Chronic Myelogenous Leukemia in Chronic Phase
Homoharringtonine Plus Low-Dose Cytarabine in Treating Patients With Newly Diagnosed Chronic Myelogenous Leukemia in Chronic Phase
For Condition: chronic phase chronic myelogenous leukemia,Philadelphia chromosome positive chronic myelogenous leukemia
Status: No longer recruiting
Sponsor(s): National Cancer Institute (NCI) , Cancer and Leukemia Group B
Synopsis: RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining more than one drug may kill more cancer cells. PURPOSE: Phase II trial to study the effectiveness of homoharringtonine plus low-dose cytarabine in treating patients who have newly diagnosed chronic phase chronic myelogenous leukemia.
Details: OBJECTIVES: I. Assess the hematologic and cytogenetic response rate of newly diagnosed patients with chronic myelogenous leukemia treated with homoharringtonine and low dose cytarabine. II. Assess the toxicity of this combination regimen in these patients. PROTOCOL OUTLINE: Patients receive cytarabine and homoharringtonine concurrently by continuous intravenous infusion for 7 days. Courses repeat every 28 days. Patients receive a minimum of 9 courses of therapy in the absence of disease progression and unacceptable toxicity. Patients who are major cytogenetic responders at 9 months may continue therapy or switch to interferon. Minor cytogenetic responders are switched to interferon, and nonresponders are removed from therapy and given the option to switch to interferon. Patients are followed every 6 months for 10 years. PROJECTED ACCRUAL: This study will accrue up to 60 patients in 1.5 years.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 16 Years/
Genders:
Protocol Entry Criteria: PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- - Histologically proven, newly diagnosed chronic myelogenous leukemia in chronic phase - Must meet one or more of the following criteria: Cytogenetically determined; Philadelphia chromosome (Ph+) BCR/ABL protein detectable by immunoblotting; Polymerase chain reaction positive fusion transcripts for BCR/ABL; BCR/ABL translocation present by fluorescence in situ hybridization - Must be ineligible for early allogeneic bone marrow transplant - Must be registered on companion protocols CALGB-9665 and CALGB-29801 --Prior/Concurrent Therapy-- - Biologic therapy: No prior interferon therapy - Chemotherapy: No more than 8 weeks of prior hydroxyurea therapy; No prior homoharringtonine; No prior busulfan or cytarabine for disease; No other concurrent chemotherapy Endocrine therapy: No concurrent hormone therapy except for nondisease related conditions; No concurrent dexamethasone or other steroidal antiemetics - Radiotherapy: No concurrent palliative radiotherapy for splenomegaly - Surgery: No concurrent surgical splenectomy except in emergency situation --Patient Characteristics-- - Age: 16 and over - Performance status: ECOG 0-2 - Life expectancy: Not specified - Hematopoietic: Not specified - Hepatic: Bilirubin no greater than 1.5 times upper limit of normal (ULN) - Renal: Creatinine no greater than 1.5 times ULN - Other: Not pregnant or nursing; Fertile patients must use effective contraception
Total Enrollment:
Location and Contact Information:
Overall Study Official:
RichardStone, Study Chair, Cancer and Leukemia Group B
Veterans Affairs Medical Center - Birmingham
Birmingham, Alabama, 35233-1996
United States
Roswell Park Cancer Institute
Buffalo, New York, 14263-0001
United States
Veterans Affairs Medical Center - Columbia (Truman Memorial)
Columbia, Missouri, 65201
United States
Ellis Fischel Cancer Center - Columbia
Columbia, Missouri, 65203
United States
Veterans Affairs Medical Center - White River Junction
White River Junction, Vermont, 05009
United States
University of Nebraska Medical Center
Omaha, Nebraska, 68198-3330
United States
Veterans Affairs Medical Center - Chicago (Westside Hospital)
Chicago, Illinois, 60612
United States
Veterans Affairs Medical Center - Richmond
Richmond, Virginia, 23249
United States
UCSF Cancer Center and Cancer Research Institute
San Francisco, California, 94143-0128
United States
Veterans Affairs Medical Center - Minneapolis
Minneapolis, Minnesota, 55417
United States
Norris Cotton Cancer Center
Lebanon, New Hampshire, 03756-0002
United States
MBCCOP - Massey Cancer Center
Richmond, Virginia, 23298-0037
United States
Lineberger Comprehensive Cancer Center, UNC
Chapel Hill, North Carolina, 27599-7295
United States
University of California San Diego Cancer Center
La Jolla, California, 92093-0658
United States
Veterans Affairs Medical Center - Durham
Durham, North Carolina, 27705
United States
Veterans Affairs Medical Center - Togus
Togus, Maine, 04330
United States
Boston Medical Center
Boston, Massachusetts, 02118
United States
North Shore University Hospital
Manhasset, New York, 11030
United States
University of Chicago Cancer Research Center
Chicago, Illinois, 60637-1470
United States
Barnes-Jewish Hospital
St. Louis, Missouri, 63110
United States
CCOP - Southern Nevada Cancer Research Foundation
Las Vegas, Nevada, 89106
United States
University of Tennessee, Memphis Cancer Center
Memphis, Tennessee, 38103
United States
Vermont Cancer Center
Burlington, Vermont, 05401-3498
United States
University of Massachusetts Memorial Medical Center
Worcester, Massachusetts, 01655
United States
CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C.
Syracuse, New York, 13217
United States
State University of New York - Upstate Medical University
Syracuse, New York, 13210
United States
Duke Comprehensive Cancer Center
Durham, North Carolina, 27710
United States
Jersey City Medical Center
Jersey City, New Jersey, 07304
United States
Mount Sinai Medical Center, NY
New York City, New York, 10029
United States
Lombardi Cancer Center
Washington D.C., District of Columbia, 20007
United States
Rhode Island Hospital
Providence, Rhode Island, 02903
United States
Veterans Affairs Medical Center - San Francisco
San Francisco, California, 94121
United States
CCOP - Mount Sinai Medical Center
Miami, Florida, 33140
United States
Veterans Affairs Medical Center - Memphis
Memphis, Tennessee, 38104
United States
Dana-Farber Cancer Institute
Boston, Massachusetts, 02115
United States
CCOP - North Shore University Hospital
Manhasset, New York, 11030
United States
New York Presbyterian Hospital - Cornell Campus
New York City, New York, 10021
United States
St. Joseph's Hospital and Medical Center
Paterson, New Jersey, 07503
United States
Holden Comprehensive Cancer Center at The University of Iowa
Iowa City, Iowa, 52242-1009
United States
Memorial Sloan-Kettering Cancer Center
New York City, New York, 10021
United States
Medical University of South Carolina
Charleston, South Carolina, 29425-0721
United States
Comprehensive Cancer Center at Wake Forest University
Winston Salem, North Carolina, 27157-1082
United States
Marlene & Stewart Greenebaum Cancer Center, University of Maryland
Baltimore, Maryland, 21201
United States
Walter Reed Army Medical Center
Washington D.C., District of Columbia, 20307-5000
United States
Arthur G. James Cancer Hospital - Ohio State University
Columbus, Ohio, 43210-1240
United States
Veterans Affairs Medical Center - Buffalo
Buffalo, New York, 14215
United States
CCOP - Southeast Cancer Control Consortium
Winston Salem, North Carolina, 27104-4241
United States
CCOP - Christiana Care Health Services
Wilmington, Delaware, 19899
United States
University of Illinois at Chicago Health Sciences Center
Chicago, Illinois, 60612
United States
Veterans Affairs Medical Center - Syracuse
Syracuse, New York, 13210
United States
Additional Information:
Study ID Numbers: CDR0000066797; CLB-19804
Study Start Date: December 1998
Record last reviewed: December 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00003694
Other Chronic Phase Chronic Myelogenous Leukemia Studies:
1. Imatinib Mesylate in Treating Patients With Chronic Myelogenous Leukemia
2. Cyclophosphamide and Filgrastim Followed By Peripheral Stem Cell Transplantation in Treating Patients With Chronic or Accelerated Phase Myelogenous Leukemia
3. Chemotherapy, Biological Therapy, and/or Bone Marrow or Peripheral Stem Cell Transplantation in Treating Patients With Chronic Myelogenous Leukemia
4. Arsenic Trioxide and Imatinib Mesylate in Treating Patients With Chronic Myelogenous Leukemia
5. Arsenic Trioxide in Treating Patients With Relapsed or Refractory Chronic Myelogenous Leukemia
Related Studies:
Other chronic phase chronic myelogenous leukemia Clinical Trials
Other Ohio Clinical Trials
Other Columbus Clinical Trials
Homoharringtonine Plus Low-Dose Cytarabine in Treating Patients With Newly Diagnosed Chronic Myelogenous Leukemia in Chronic Phase
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