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Total-Body Irradiation With Or Without Fludarabine Followed By Allogeneic Hematopoietic Stem Cell Transplantation in Treating Patients With Hematologic Malignancies Clinical Trials References presented on Clinical Trials Search isn't meant to be a substitute for proven healthcare advice, trips or professional assistance using a genuine physician. We are not docs. Always confer with your physician about Total-Body Irradiation With Or Without Fludarabine Followed By Allogeneic Hematopoietic Stem Cell Transplantation in Treating Patients With Hematologic Malignancies conditions. Clinical Trials Search.org is a site devoted to listing clinical research studies in human subjects. Total-Body Irradiation With Or Without Fludarabine Followed By Allogeneic Hematopoietic Stem Cell Transplantation in Treating Patients With Hematologic Malignancies Clinical research trials and Total-Body Irradiation With Or Without Fludarabine Followed By Allogeneic Hematopoietic Stem Cell Transplantation in Treating Patients With Hematologic Malignancies healthcare trials happen in hundreds of localities throughout the United States of America. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials usually evaluate the potency of new drugs. The propose of the studies / projects is to answer particular human health questions. Clinical trials are a popular way for mDs, government agencies, and private sector companies to detect cures for all sorts of conditions, such as Total-Body Irradiation With Or Without Fludarabine Followed By Allogeneic Hematopoietic Stem Cell Transplantation in Treating Patients With Hematologic Malignancies. Total-Body Irradiation With Or Without Fludarabine Followed By Allogeneic Hematopoietic Stem Cell Transplantation in Treating Patients With Hematologic Malignancies Clinical Trials and other clinical trials allow volunteers to acquire healthcare treatment choices before they are available to the general public. Some times the subjects recieve professional assistance for free, and every now and again they are compensated for their time. Sometimes there is a cost for a Total-Body Irradiation With Or Without Fludarabine Followed By Allogeneic Hematopoietic Stem Cell Transplantation in Treating Patients With Hematologic Malignancies clinical trial. Subjects frequently obtain the most expert healthcare possible for their Total-Body Irradiation With Or Without Fludarabine Followed By Allogeneic Hematopoietic Stem Cell Transplantation in Treating Patients With Hematologic Malignancies condition. Risks are a reality, nevertheless, and can include more or frequent doctor trips, medical risks (possibly life-threatening), and/or the treatment being uneffective. Trials are federally governed with stern guidelines to protect clinical trials patients.
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Home > "T" Clinical Trials Conditions > Total-Body Irradiation With Or Without Fludarabine Followed By Allogeneic Hematopoietic Stem Cell Transplantation in Treating Patients With Hematologic Malignancies  Total-Body Irradiation With Or Without Fludarabine Followed By Allogeneic Hematopoietic Stem Cell Transplantation in Treating Patients With Hematologic Malignancies
Total-Body Irradiation With Or Without Fludarabine Followed By Allogeneic Hematopoietic Stem Cell Transplantation in Treating Patients With Hematologic Malignancies
For Condition: Lymphoma,childhood non-Hodgkin's lymphoma,plasma cell neoplasm,childhood Hodgkin's lymphoma,Leukemia
Status: Recruiting
Sponsor(s): Fred Hutchinson Cancer Research Center , National Cancer Institute (NCI)
Synopsis: RATIONALE: Drugs used in chemotherapy, such as fludarabine, work in different ways to stop cancer cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage cancer cells. Donor peripheral stem cell transplantation may be able to replace immune cells that were destroyed by chemotherapy and radiation therapy. Sometimes the transplanted cells can reject the body's normal tissues. Mycophenolate mofetil and cyclosporine may prevent this from happening. It is not yet known whether total-body irradiation followed by donor stem cell transplantation is more effective with or without fludarabine in treating hematologic malignancies (cancer). PURPOSE: Randomizedphase III trial to study the effectiveness of total-body irradiation with or without fludarabine followed by allogeneichematopoietic stem cell transplantation in treating patients who have hematologic cancer.
Details: OBJECTIVES: Primary - Compare the nonrelapse mortality 1 year after nonmyeloablative conditioning comprising low-dose total body irradiation (TBI) with vs without fludarabine followed by HLA-matched related allogeneic hematopoietic stem cell transplantation in patients with hematologic malignancies at low or moderate risk for graft rejection. Secondary - Compare the 1-year overall survival of patients after treatment with these regimens. - Compare the incidence of graft rejection in patients treated with these regimens. - Compare the incidence of grades II-IV acute graft-versus-host disease (GVHD) and chronic extensive GVHD in patients treated with these regimens. - Compare the rates of disease progression and/or relapse-related mortality in patients treated with these regimens. - Compare the immune reconstitution and risk of infection in patients treated with these regimens. OUTLINE: This is a randomized, multicenter study. Patients are stratified according to participating center, disease risk (indolent vs aggressive), and prior conventional hematopoietic stem cell transplantation (yes vs no). - Patients are randomized to 1 of 2 treatment arms. - Arm I: Patients receive fludarabine IV on days -4 to -2. Patients then undergo low-dose total body irradiation (TBI) on day 0. - Arm II: Patients undergo low-dose TBI on day 0. - Allogeneic peripheral blood stem cell transplantation (PBSCT): After TBI, patients undergo PBSCT on day 0. - Immunosuppression: Patients receive oral cyclosporine twice daily on days -3 to 56 in the absence of graft-versus-host disease (GVHD). Patients with no evidence of GVHD at day 56 begin a cyclosporine taper and continue the taper until day 180. Patients with evidence of disease progression and no evidence of GVHD prior to day 56 receive tapered doses of cyclosporine for 2 weeks. Patients also receive oral mycophenolate mofetil (MMF) twice daily on days 0-27 in the absence of GVHD. If treatment for GVHD is required before day 28, MMF is continued until a steroid taper begins. Patients are followed on days 28, 56, and 84, at 6, 12, 18, and 24 months, and then annually for 5 years post-transplantation. PROJECTED ACCRUAL: A total of 200 patients (100 per treatment arm) will be accrued for this study within 3 years.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: /74 Years
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Diagnosis of a hematologic malignancy treatable with hematopoietic stem cell transplantation (HSCT) OR a B-cell malignancy, including any of the following: - Diffuse large B-cell non-Hodgkin's lymphoma (NHL) - Not eligible for conventional myeloablative HSCT OR failed autologous HSCT - Low-grade NHL with less than 6 months duration of complete response (CR) between courses of conventional therapy - Chronic lymphocytic leukemia - Failed 2 lines of conventional therapy and refractory to fludarabine - Hodgkin's lymphoma - Received and failed front-line therapy - Failed or were not eligible for autologous transplantation - Multiple myeloma - Chemosensitive disease after failed autografting - Acute myeloid leukemia - Less then 5% marrow blasts at the time of transplantation and beyond first CR - Acute lymphoblastic leukemia - Less than 5% marrow blasts at the time of transplantation and beyond first CR - Chronic myelogenous leukemia - Chronic phase allowed provided the patient is beyond the first chronic phase and was previously treated with myelosuppressive chemotherapy or HSCT and has less than 5% marrow blasts at time of transplantation - Myelodysplastic syndromes - Received prior myelosuppressive chemotherapy or HSCT and less than 5% marrow blasts at time of transplantation - Not eligible for conventional allogeneic HSCT AND must have disease that is expected to be stable for at least 100 days without chemotherapy - Not curable with an autologous transplantation - Patients who refused to be treated on a conventional HSCT study are eligible - No rapidly progressive aggressive NHL, unless in minimal disease state - No chronic myelomonocytic leukemia or myeloproliferative disorder - No concurrent CNS involvement with disease refractory to intrathecal chemotherapy - Available HLA-matched related donor - Genotypically identical in at least 1 haplotype - Phenotypically or genotypically identical donor at the allele level at HLA-A, -B, -C, -DRB1, and -DQB1 allowed - No identical twin NOTE: A new classification scheme for adult non-Hodgkin's lymphoma has been adopted by PDQ. The terminology of "indolent" or "aggressive" lymphoma will replace the former terminology of "low", "intermediate", or "high" grade lymphoma. However, this protocol uses the former terminology. PATIENT CHARACTERISTICS: Age - Under 75 Performance status - Karnofsky 50-100% (adult patients) - Lansky 50-100% (pediatric patients) Life expectancy - Not severely limited by disease other than malignancy Hematopoietic - Not specified Hepatic - No fulminant liver failure - No cirrhosis of the liver with evidence of portal hypertension - No alcoholic hepatitis - No esophageal varices - No history of bleeding esophageal varices - No hepatic encephalopathy - No uncorrectable hepatic synthetic dysfunction evidenced by prolongation of the PT - No ascites related to portal hypertension - No bacterial or fungal liver abscess - No biliary obstruction - No chronic viral hepatitis with bilirubin greater than 3 mg/dL - No symptomatic biliary disease Renal - Not specified Cardiovascular - Ejection fraction at least 35% - No poorly controlled hypertension - No symptomatic coronary artery disease - No other cardiac failure requiring therapy Pulmonary - DLCO at least 30% - Total lung capacity at least 30% - FEV_1 at least 30% - No concurrent supplementary continuous oxygen - No fungal pneumonia with radiological progression after receiving amphotericin formulation or mold-active azoles for more than 1 month Other - Not pregnant or nursing - Fertile patients must use effective contraception during and for up to 12 months after study participation - HIV negative - No active non-hematological malignancy except localized nonmelanoma skin cancer PRIOR CONCURRENT THERAPY: Biologic therapy - See Disease Characteristics - No prior autograft immediately before nonmyeloablative HSCT (tandem approach) - No concurrent growth factors (e.g., filgrastim [G-CSF]) during mycophenolate mofetil administration Chemotherapy - See Disease Characteristics - More than 3 weeks since prior myelosuppressive chemotherapy Endocrine therapy - Not specified Radiotherapy - Prior radiotherapy for high risk sites of bulky disease or skeletal lesions allowed Surgery - Not specified Other - Prior cytoreduction for advanced disease allowed
Total Enrollment:
Location and Contact Information:
Overall Study Official:
BrendaSandmaier, Principal Investigator, Fred Hutchinson Cancer Research Center
Medical College of Wisconsin Cancer Center *Recruiting*
Milwaukee, Wisconsin, 53226
United States
Recruiting James Wade 414-805-4609
Cancer Institute at Oregon Health and Science University *Recruiting*
Portland, Oregon, 97239-3098
United States
Recruiting Richard Maziarz 503-494-6345
Huntsman Cancer Institute *Recruiting*
Salt Lake City, Utah, 84112
United States
Recruiting Michael Pulsipher 801-585-0303
Universitaet Leipzig *Recruiting*
Leipzig, , D-04103
Germany
Recruiting Dietger Niederwieser 49-341-971-3050
Stanford Cancer Center at Stanford University Medical Center *Recruiting*
Stanford, California, 94305-5623
United States
Recruiting Karl Blume 650-723-0822
Fred Hutchinson Cancer Research Center *Recruiting*
Seattle, Washington, 98109-1024
United States
Recruiting Brenda Sandmaier 206-667-4961
University of Torino *Recruiting*
Torino, , 10126
Italy
Recruiting Benedetto Bruno 39-11-633-4418
Additional Information:
Study ID Numbers: CDR0000346618; FHCRC-1813.00
Study Start Date:
Record last reviewed: February 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00075478
Other Lymphoma Studies:
1. Bone Marrow Transplantation in Treating Patients With Hematologic Cancer
2. Denileukin Diftitox in Treating Patients With Non-Hodgkin's Lymphoma
3. Radiation Therapy and Chemotherapy Plus Peripheral Stem Cell Transplantation in Treating Patients With High-Grade Lymphoma or Acute Lymphoblastic Leukemia
4. Epoetin alfa in Treating Anemia in Patients Who Are Receiving Chemotherapy
5. Nonmyeloablative preparative regimen using Mylotarg for patients with high risk AML, ALL, CML and MDS
Related Studies:
Other Lymphoma Clinical Trials
Other Wisconsin Clinical Trials
Other Milwaukee Clinical Trials
Total-Body Irradiation With Or Without Fludarabine Followed By Allogeneic Hematopoietic Stem Cell Transplantation in Treating Patients With Hematologic Malignancies
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