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Bone Marrow or Peripheral Stem Cell Transplantation in Treating Patients With Chronic Myeloid Leukemia Clinical Trials Information presented on Clinical Trials Search isn't designed to be a substitute for certified healthcare advice, travels to or professional assistance using a genuine medical doctor. We are not physicians. Always confer with your dr. about Bone Marrow or Peripheral Stem Cell Transplantation in Treating Patients With Chronic Myeloid Leukemia conditions. Clinical Trials Search.org is a site devoted to listing clinical research studies in human subjects. Bone Marrow or Peripheral Stem Cell Transplantation in Treating Patients With Chronic Myeloid Leukemia Clinical research trials and Bone Marrow or Peripheral Stem Cell Transplantation in Treating Patients With Chronic Myeloid Leukemia medical trials happen in hundreds of places across the United States. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials usually measure the effectualness of new drugs. The intention of the studies / undertakings is to solve certain human healthcare questions. Clinical trials are a popular manner for mDs, government agencies, and private sector companies to locate treatments for all forms of circumstances, such as Bone Marrow or Peripheral Stem Cell Transplantation in Treating Patients With Chronic Myeloid Leukemia. Bone Marrow or Peripheral Stem Cell Transplantation in Treating Patients With Chronic Myeloid Leukemia Clinical Trials and other clinical trials allow for volunteers to undergo medical treatment choices before they are available to the general public. Some times the human subjects get treatment for free of charge, and sometimes they are paid for their time. Occasionally there is a cost for a Bone Marrow or Peripheral Stem Cell Transplantation in Treating Patients With Chronic Myeloid Leukemia clinical trial. Participants frequently get the best healthcare available for their Bone Marrow or Peripheral Stem Cell Transplantation in Treating Patients With Chronic Myeloid Leukemia condition. Risks are a reality, nonetheless, and can include extra or frequent physician trips, medical risks (possibly life-jeopardising), and/or the treatment being ineffective. Trials are federally governed with exacting guidelines to protect clinical trials subjects.
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Home > "B" Clinical Trials Conditions > Bone Marrow or Peripheral Stem Cell Transplantation in Treating Patients With Chronic Myeloid Leukemia  Bone Marrow or Peripheral Stem Cell Transplantation in Treating Patients With Chronic Myeloid Leukemia
Bone Marrow or Peripheral Stem Cell Transplantation in Treating Patients With Chronic Myeloid Leukemia
For Condition: chronic phase chronic myelogenous leukemia,accelerated phase chronic myelogenous leukemia,Philadelphia chromosome positive chronic myelogenous leukemia
Status: No longer recruiting
Sponsor(s): National Cancer Institute (NCI) , Fred Hutchinson Cancer Research Center
Synopsis: RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining chemotherapy with bone marrow or peripheral stem cell transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more cancer cells. It is not yet known which treatment is more effective for chronic myeloid leukemia. PURPOSE: Randomized phase III trial to compare the effectiveness of donor peripheral stem cell transplantation with donor bone marrow transplantation in treating patients with chronic myeloid leukemia.
Details: OBJECTIVES: I. Compare the incidence of persistent cytogenetic relapse. II. Evaluate survival and nonrelapse mortality. III. Compare hospitalization and treatment associated expense. IV. Compare incidence and severity of graft versus host disease (GVHD). PROTOCOL OUTLINE: This is a randomized study. Patients are stratified by age, interval from diagnosis to transplant, and patient and donor gender. Patients receive busulfan (BU) orally qid for 4 days, followed by CY for 2 days beginning on the day after the last dose of BU. Patients rest for 1 day prior to marrow or PBSC infusion. Donors randomized to the PBSC arm receive 5 daily doses of filgrastim (G-CSF) by subcutaneous injection commencing on day -5. PBSCs are collected and stored at 4 C overnight and infused on day 0. Donors randomized to the marrow arm have marrow collected on day 0. Methotrexate (MTX) is administered 24 hours after the last stem cell infusion. Cyclosporine is administered according to protocol FHCRC-267.00. PROJECTED ACCRUAL: 30 patients per year will be entered for a total of 3 years.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 15 Years/65 Years
Genders:
Protocol Entry Criteria: PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- - Diagnostically proven CML with the presence of the Ph chromosome in marrow metaphases, or BCR/ABL positivity by PCR or Southern blot - Must meet criteria for either; Chronic Phase or Accelerated Phase: Chronic Phase: -no chromosomal abnormalities other than a single Ph chromosome and less than 10% blasts in marrow and peripheral blood Accelerated Phase, any one of the following: -more than 10% and less than 30% myeloblasts plus promyelocytes in marrow or peripheral blood -major perturbations of white count, platelet count or hematocrit uncontrolled by chemotherapy with busulfan (BU) or hydroxyurea (Hydrea) -progressive splenomegaly -extramedullary tumor -presence of any nonconstitutional cytogenetic abnormality additional to a single Ph chromosome -persistent unexplained fever or bone pain --Prior/Concurrent Therapy-- - Not specified --Patient Characteristics-- - Age: 15 to 65 - Performance status: Not specified - Life expectancy: Not limited by any disease other than CML - Hematopoietic: Not specified - Hepatic: SGOT no greater than 2 times normal - Renal: Not specified - Cardiovascular: Prior cardiac problems must undergo evaluation with cardiac ejection fraction studies; Must be able to tolerate full dosage of cyclophosphamide (CY) - Other: No serologic evidence of exposure to HIV; Must have HLA identical family member; Concurrent registration on protocol FHCRC-267.00 - Donor Entry Criteria: HLA identical family member; Must have adequate veins for leukapheresis or agree to placement of central venous catheter; Must be able to psychologically, physiologically, and medically tolerate PBSC or marrow harvest; Negative for HIV and hepatitis A, B, and C antigens; Females must be postmenopausal or have a negative pregnancy test; Must be at least 12 years of age
Total Enrollment:
Location and Contact Information:
Overall Study Official:
JerryRadich, Study Chair, Fred Hutchinson Cancer Research Center
Fred Hutchinson Cancer Research Center
Seattle, Washington, 98109-1024
United States
Additional Information:
Study ID Numbers: CDR0000064853; FHCRC-1092.00,NCI-H96-0926
Study Start Date: May 1996
Record last reviewed: March 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00002789
Other Chronic Phase Chronic Myelogenous Leukemia Studies:
1. Chemotherapy, Low-Dose Total-Body Irradiation, and Peripheral Stem Cell Transplantation Followed By Chemotherapy and Donor Lymphocyte Infusion in Treating Older Patients With Chronic Myeloid Leukemia
2. Donor Bone Marrow Transplantation in Treating Patients With Hematologic Cancer
3. Vaccine Therapy in Treating Patients With Chronic Myelogenous Leukemia
4. Chemotherapy and Biological Therapy in Treating Patients With Chronic Phase Chronic Myelogenous Leukemia
5. BMS-354825 in Treating Patients With Chronic Phase Chronic Myelogenous Leukemia That Is Resistant to Imatinib Mesylate
Related Studies:
Other chronic phase chronic myelogenous leukemia Clinical Trials
Other Washington Clinical Trials
Other Seattle Clinical Trials
Bone Marrow or Peripheral Stem Cell Transplantation in Treating Patients With Chronic Myeloid Leukemia
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