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Filgrastim-Mobilized Peripheral Stem Cell Transplantation Compared With Bone Marrow Transplantation From Unrelated Donors in Treating Patients With Hematologic Malignancies Clinical Trials Information presented on Clinical Trials Search is not designed to be a substitute for certified medical advice, trips or professional assistance with a real medical doctor. We aren't docs. Always confer with your doctor about Filgrastim-Mobilized Peripheral Stem Cell Transplantation Compared With Bone Marrow Transplantation From Unrelated Donors in Treating Patients With Hematologic Malignancies conditions. Clinical Trials Search.org is a website committed to listing clinical research studies in human subjects. Filgrastim-Mobilized Peripheral Stem Cell Transplantation Compared With Bone Marrow Transplantation From Unrelated Donors in Treating Patients With Hematologic Malignancies Clinical research trials and Filgrastim-Mobilized Peripheral Stem Cell Transplantation Compared With Bone Marrow Transplantation From Unrelated Donors in Treating Patients With Hematologic Malignancies health trials happen in many of cities across the US. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally measure the effectualness of new does drugs. The intention of the studies / projects is to figure out particular human healthcare questions. Clinical trials are a popular manner for doctors, government agencies, and private sector corporations to detect cures for all forms of circumstances, like Filgrastim-Mobilized Peripheral Stem Cell Transplantation Compared With Bone Marrow Transplantation From Unrelated Donors in Treating Patients With Hematologic Malignancies. Filgrastim-Mobilized Peripheral Stem Cell Transplantation Compared With Bone Marrow Transplantation From Unrelated Donors in Treating Patients With Hematologic Malignancies Clinical Trials and other clinical trials allow for volunteers to undergo medical treatment options before they are available to the general public. Most times the subjects get treatment for free of charge, and occasionally they are paid for their time. Occasionally there is a cost for a Filgrastim-Mobilized Peripheral Stem Cell Transplantation Compared With Bone Marrow Transplantation From Unrelated Donors in Treating Patients With Hematologic Malignancies clinical trial. Subjects frequently get the best healthcare possible for their Filgrastim-Mobilized Peripheral Stem Cell Transplantation Compared With Bone Marrow Transplantation From Unrelated Donors in Treating Patients With Hematologic Malignancies condition. Hazards are a reality, however, and could include more or frequent mD visits, health risks (possibly life-jeopardizing), and/or the treatment being ineffectual. Trials are federally regulated with exacting guidelines to protect clinical trials patients.
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Home > "F" Clinical Trials Conditions > Filgrastim-Mobilized Peripheral Stem Cell Transplantation Compared With Bone Marrow Transplantation From Unrelated Donors in Treating Patients With Hematologic Malignancies  Filgrastim-Mobilized Peripheral Stem Cell Transplantation Compared With Bone Marrow Transplantation From Unrelated Donors in Treating Patients With Hematologic Malignancies
Filgrastim-Mobilized Peripheral Stem Cell Transplantation Compared With Bone Marrow Transplantation From Unrelated Donors in Treating Patients With Hematologic Malignancies
For Condition: myelodysplastic and myeloproliferative disease,chronic leukemia,chronic myeloproliferative disorders,acute leukemia
Status: Recruiting
Sponsor(s): Blood and Marrow Transplant Clinical Trials Network , National Heart, Lung, and Blood Institute (NHLBI),National Cancer Institute (NCI)
Synopsis: RATIONALE: Colony-stimulating factors, such as filgrastim, stimulate the production of blood cells. Peripheral stem cell transplantation or bone marrow transplantation may be able to replace immune cells that were destroyed by chemotherapy used to kill cancer cells. Giving filgrastim to mobilize (stimulate) peripheral stem cells that can be collected for peripheral stem cell transplantation may result in fewer side effects after the transplant. Sometimes the transplanted cells can make an immune response against the body's normal tissues. Methotrexate and cyclosporine or tacrolimus may prevent this from happening. It is not yet known whether filgrastim-mobilized donor peripheral stem cell transplantation is more effective than donor bone marrow transplantation in treating hematologic malignancies. PURPOSE: Randomizedphase III trial to compare the effectiveness of filgrastim-mobilized donor peripheral stem cell transplantation with that of donor bone marrow transplantation in treating patients who have hematologic cancer.
Details: OBJECTIVES: Primary - Compare the 2-year survival rate in patients with hematologic malignancies treated with filgrastim (G-CSF)-mobilized peripheral blood stem cell (PBSC) transplantation vs bone marrow transplantation from HLA-compatible unrelated donors. Secondary - Compare the survival rate after transplantation in patients treated with these regimens. - Compare the incidence of graft failure, acute graft-versus-host disease (GVHD), and chronic GVHD in patients treated with these regimens. - Compare the time off all immunosuppressive therapy and immune reconstitution in patients treated with these regimens. - Compare the incidence of neutrophil and platelet engraftment in patients treated with these regimens. - Compare the incidence of relapse and infection in patients treated with these regimens. - Compare the adverse events in patients treated with these regimens. - Compare the quality of life of patients treated with these regimens. - Correlate cell subsets in bone marrow or PBSC grafts with transplantation outcome in patients treated with these regimens. - Compare the time to return to baseline functional score, toxicity score, and complete blood count and WBC differential values in donors contributing G-CSF-mobilized PBSCs vs bone marrow for these patients. - Compare the quality of life of these donors. OUTLINE: This is a partially randomized, open-label, multicenter study. Patients are stratified according to participating center and disease risk (good vs poor). - All patients receive 1 of the following conditioning regimens, at the discretion of the participating center: - Conditioning regimen A: Patients receive cyclophosphamide IV and total body irradiation. - Conditioning regimen B: Patients receive busulfan orally or IV and cyclophosphamide IV. - Conditioning regimen C: Patients receive fludarabine IV and melphalan IV. - Patients are randomized to 1 of 2 treatment arms. - Arm I: Patients receive filgrastim (G-CSF)-mobilized allogeneic peripheral blood stem cell transplantation on day 0. - Arm II: Patients receive allogeneic bone marrow transplantation on day 0. - Patients receive 1 of the following GVHD prophylaxis regimens, at the discretion of the participating center: - GVHD regimen A: Beginning no later than day -1, patients receive cyclosporine IV and then orally daily followed by a taper beginning on approximately day 50 and continuing until approximately day 190. Patients also receive methotrexate IV on days 1, 3, 6, and 11. - GVHD regimen B: Beginning no later than day -1, patients receive tacrolimus IV and then orally daily followed by a taper beginning on approximately day 50 and continuing until approximately day 190. Patients also receive methotrexate as in GVHD regimen A. Patients who fail to achieve engraftment may receive an additional infusion of stem cells from the original donor or may undergo another transplantation from a different donor, at the discretion of the participating center. Patients receive additional therapies (e.g., testicular irradiation, CNS prophylaxis, and/or donor lymphocyte infusions) as appropriate and at the discretion of the participating center. Quality of life (QOL) is assessed in patients at baseline and at 6 months, 1 year, and 2 years post-transplantation. QOL is assessed in donors at baseline, on day 4 of G-CSF administration (for arm I donors), within 2 days after donation, weekly for 3 weeks, and then at 6 and 12 months. Patients are followed weekly until day 100, at 6 months, 1 year, and then annually for 2 years post-transplantation. PROJECTED ACCRUAL: A total of 550-630 patients (275-315 per treatment arm) will be accrued for this study within 3 years.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: /66 Years
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Diagnosis of any of the following: - Acute myeloid leukemia - Not in remission OR in any remission - Acute lymphoblastic leukemia - Not in remission OR in any remission - Chronic myelogenous leukemia - Chronic phase meeting any of the following criteria: - In hematologic remission - In partial or complete cytogenetic remission - Stable disease, but not in hematologic remission - Accelerated phase - Blastic phase - Myelodysplastic syndromes (MDS) of any of the following subtypes: - Refractory anemia (RA) - RA with ringed sideroblasts - Refractory cytopenia with multilineage dysplasia - Refractory cytopenia with multilineage dysplasia and ringed sideroblasts - RA with excess blasts-1 (5-10% blasts) - RA with excess blasts-2 (10-20% blasts) - MDS, unclassifiable - MDS associated with isolated del(5q) - Myeloproliferative disorder of any of the following subtypes: - Chronic myelomonocytic leukemia - Agnogenic myeloid metaplasia with myelofibrosis (idiopathic myelofibrosis) - Juvenile myelomonocytic leukemia - No lymphoma or other malignant or nonmalignant disorders - HLA-matched unrelated donor meeting the following criteria: - Matched for HLA-A, B, and DRB1 antigens - One antigen mismatch at HLA-A, B, or DRB1 with or without mismatch at HLA-C is allowed PATIENT CHARACTERISTICS: Age - 66 and under Performance status - Not specified Life expectancy - Not specified Hematopoietic - Not specified Hepatic - Bilirubin 2 times upper limit of normal* (ULN) - ALT or AST 2 times ULN NOTE: *Except for isolated hyperbilirubinemia secondary to Gilbert's syndrome Renal - Creatinine 2 times ULN Cardiovascular - No cardiac insufficiency - No coronary artery disease requiring treatment Pulmonary - FVC 50% of predicted* - FEV_1 50% of predicted* - DLCO 50% of predicted* NOTE: *Corrected for hemoglobin Other - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception - HIV negative - No active infection requiring systemic therapy with antibacterial, antifungal, or antiviral agents PRIOR CONCURRENT THERAPY: Biologic therapy - No prior allogeneic or autologous hematopoietic stem cell transplantation - No concurrent alemtuzumab Chemotherapy - Not specified Endocrine therapy - No concurrent glucocorticosteroids during graft-versus-host disease prophylaxis Radiotherapy - Not specified Surgery - Not specified Other - No concurrent enrollment in a phase I study
Total Enrollment:
Location and Contact Information:
Overall Study Official:
ClaudioAnasetti, Principal Investigator, Fred Hutchinson Cancer Research Center
Kansas City Cancer Centers - Central *Recruiting*
Kansas City, Missouri, 64111
United States
Recruiting Joseph McGuirk 816-531-2740
Ireland Cancer Center *Recruiting*
Cleveland, Ohio, 44106-5065
United States
Recruiting Hillard Lazarus 216-844-3629
Rebecca and John Moores UCSD Cancer Center *Recruiting*
La Jolla, California, 92037-0960
United States
Recruiting Edward Ball 858-657-7058
Lombardi Cancer Center at Georgetown University Medical Center *Recruiting*
Washington D.C., District of Columbia, 20007
United States
Recruiting Saul Yanovich 202-444-7759
Cancer Institute at Oregon Health and Science University *Recruiting*
Portland, Oregon, 97239-3098
United States
Recruiting Kamar Godder 503-494-0829
Mayo Clinic Cancer Center *Recruiting*
Rochester, Minnesota, 55905
United States
Recruiting Shakila Khan 507-284-2652
Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute *Recruiting*
Boston, Massachusetts, 02115
United States
Recruiting Corey Cutler 617-632-3779
University of Minnesota Cancer Center *Recruiting*
Minneapolis, Minnesota, 55455
United States
Recruiting Daniel Weisdorf 612-624-3101
Comprehensive Cancer Center at Wake Forest University *Recruiting*
Winston Salem, North Carolina, 27157-1082
United States
Recruiting David Hurd 336-716-7972
St. Louis Children's Hospital *Recruiting*
St. Louis, Missouri, 63110
United States
Recruiting Shalini Shenoy 314-454-6018
Massey Cancer Center at Virginia Commonwealth University *Recruiting*
Richmond, Virginia, 23298-0037
United States
Recruiting John McCarty 804-828-4360
Siteman Cancer Center *Recruiting*
St. Louis, Missouri, 63110
United States
Recruiting Steven Devine 314-935-5000
Vanderbilt-Ingram Cancer Center at Vanderbilt Medical Center *Recruiting*
Nashville, Tennessee, 37232-6310
United States
Recruiting Haydar Frangoul 615-936-1762
University of Texas - MD Anderson Cancer Center *Recruiting*
Houston, Texas, 77030-4009
United States
Recruiting Paolo Anderlini 713-794-5743
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins *Recruiting*
Baltimore, Maryland, 21231
United States
Recruiting Richard Jones 443-287-7104
Duke Comprehensive Cancer Center *Recruiting*
Durham, North Carolina, 27710
United States
Recruiting Joanne Kurtzberg 919-668-1119
City of Hope Comprehensive Cancer Center *Recruiting*
Duarte, California, 91010-3000
United States
Recruiting Stephen Forman 626-359-8111
Barbara Ann Karmanos Cancer Institute *Recruiting*
Detroit, Michigan, 48201-1379
United States
Recruiting Jared Klein 313-745-8861
Oklahoma University Medical Center at University of Oklahoma Health Sciences Center *Recruiting*
Oklahoma City, Oklahoma, 73190
United States
Recruiting George Selby 405-271-4022
Fred Hutchinson Cancer Research Center *Recruiting*
Seattle, Washington, 98109
United States
Recruiting Claudio Anasetti 206-667-7115
Holden Comprehensive Cancer Center at University of Iowa *Recruiting*
Iowa City, Iowa, 52242-1009
United States
Recruiting Margarida Magalhaes-Silverman 319-384-9156
Shands Cancer Center at the University of Florida Health Science Center *Recruiting*
Gainesville, Florida, 32610-100277
United States
Recruiting John Wingard 352-846-1846
Abramson Cancer Center at University of Pennsylvania Medical Center *Recruiting*
Philadelphia, Pennsylvania, 19104-4283
United States
Recruiting Edward Stadtmauer 215-662-7910
Stanford Cancer Center at Stanford University Medical Center *Recruiting*
Stanford, California, 94305
United States
Recruiting Laura Johnston 650-723-0822
UNMC Eppley Cancer Center at the University of Nebraska Medical Center *Recruiting*
Omaha, Nebraska, 68198-3330
United States
Recruiting Marcel Devetten 402-559-5166
North Shore University Hospital *Recruiting*
Manhasset, New York, 11030
United States
Recruiting Indira Sahdev 718-470-3611
Children's Memorial Hospital - Chicago *Recruiting*
Chicago, Illinois, 60614
United States
Recruiting Reggie Duerst 773-975-8512
Arthur G. James Cancer Hospital - Ohio State University *Recruiting*
Columbus, Ohio, 43210-1240
United States
Recruiting Edward Copelan 614-293-4519
Mount Sinai Medical Center, NY *Recruiting*
New York City, New York, 10029
United States
Recruiting Luis Isola 212-241-6021
Huntsman Cancer Institute *Recruiting*
Salt Lake City, Utah, 84112
United States
Recruiting Michael Pulsipher 801-588-3498
Memorial Sloan-Kettering Cancer Center *Recruiting*
New York City, New York, 10021
United States
Recruiting Richard O'Reilly 212-639-5957
Charles A. Sammons Cancer Center *Recruiting*
Dallas, Texas, 75246
United States
Recruiting Edward Agura 214-820-1800
Indiana Blood and Marrow Transplantation *Recruiting*
Indianapolis, Indiana, 46237
United States
Recruiting Jan Jansen 317-865-5500
Winship Cancer Institute of Emory University *Recruiting*
Atlanta, Georgia, 30322
United States
Recruiting Ned Waller 404-727-4995
Cancer Center at Hackensack University Medical Center *Recruiting*
Hackensack, New Jersey, 07601
United States
Recruiting Joel Brochstein 201-996-5600
Additional Information:
Study ID Numbers: CDR0000349376; MAYO-215803,BMTCTN-0201,FHCRC-1860.00
Study Start Date:
Record last reviewed: December 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00075816
Other Myelodysplastic And Myeloproliferative Disease Studies:
1. 3-AP and Cytarabine in Treating Patients With Hematologic Cancer
2. Donor Peripheral Stem Cell Transplantation in Treating Patients With Myelodysplastic Syndrome, Acute Myeloid Leukemia, or Myeloproliferative Disorder
3. Donor Stem Cell Transplantation in Treating Patients With Myelodysplastic Syndrome and Myeloproliferative Disorders
4. 3-AP Followed By Fludarabine In Treating Patients With Relapsed or Refractory Acute or Chronic Leukemia or High-Risk Myelodysplastic Syndrome
5. Monoclonal Antibody Therapy in Treating Patients With Ovarian Epithelial Cancer, Melanoma, Acute Myeloid Leukemia, Myelodysplastic Syndrome, or Non-Small Cell Lung Cancer
Related Studies:
Other myelodysplastic and myeloproliferative disease Clinical Trials
Other Minnesota Clinical Trials
Other Minneapolis Clinical Trials
Filgrastim-Mobilized Peripheral Stem Cell Transplantation Compared With Bone Marrow Transplantation From Unrelated Donors in Treating Patients With Hematologic Malignancies
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