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Comparison of Fludarabine Plus Total-body Irradiation With Combination Chemotherapy Followed by Donor Peripheral Stem Cell Transplantation in Treating Patients With Relapsed Non-Hodgkin's Lymphoma or Chronic Lymphocytic Leukemia Clinical Trials Data presented on Clinical Trials Search is not meant to be a substitute for qualified health advice, visits or treatment with a real mD. We are not doctors. Always consult your doctor about Comparison of Fludarabine Plus Total-body Irradiation With Combination Chemotherapy Followed by Donor Peripheral Stem Cell Transplantation in Treating Patients With Relapsed Non-Hodgkin's Lymphoma or Chronic Lymphocytic Leukemia conditions. Clinical Trials Search.org is a site devoted to listing clinical research studies in human subjects. Comparison of Fludarabine Plus Total-body Irradiation With Combination Chemotherapy Followed by Donor Peripheral Stem Cell Transplantation in Treating Patients With Relapsed Non-Hodgkin's Lymphoma or Chronic Lymphocytic Leukemia Clinical research trials and Comparison of Fludarabine Plus Total-body Irradiation With Combination Chemotherapy Followed by Donor Peripheral Stem Cell Transplantation in Treating Patients With Relapsed Non-Hodgkin's Lymphoma or Chronic Lymphocytic Leukemia healthcare trials happen in many 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 generally assess the effectivity of new drugs. The purpose of the studies / projects is to solve particular human medical questions. Clinical trials are a popular way for doctors, government agencies, and private sector companies to discover cures for all varieties of conditions, such as Comparison of Fludarabine Plus Total-body Irradiation With Combination Chemotherapy Followed by Donor Peripheral Stem Cell Transplantation in Treating Patients With Relapsed Non-Hodgkin's Lymphoma or Chronic Lymphocytic Leukemia. Comparison of Fludarabine Plus Total-body Irradiation With Combination Chemotherapy Followed by Donor Peripheral Stem Cell Transplantation in Treating Patients With Relapsed Non-Hodgkin's Lymphoma or Chronic Lymphocytic Leukemia Clinical Trials and other clinical trials allow volunteers to have health treatment alternatives before they are available to the masses. Some times the human subjects obtain treatment for without cost, and sometimes they are compensated for their time. Occasionally there is a cost for a Comparison of Fludarabine Plus Total-body Irradiation With Combination Chemotherapy Followed by Donor Peripheral Stem Cell Transplantation in Treating Patients With Relapsed Non-Hodgkin's Lymphoma or Chronic Lymphocytic Leukemia clinical trial. Test subjects oftentimes receive the most effective healthcare possible for their Comparison of Fludarabine Plus Total-body Irradiation With Combination Chemotherapy Followed by Donor Peripheral Stem Cell Transplantation in Treating Patients With Relapsed Non-Hodgkin's Lymphoma or Chronic Lymphocytic Leukemia condition. Dangers are a reality, however, and may include extra or frequent physician visits, healthcare dangers (possibly life-jeopardising), and/or the treatment being uneffective. Trials are federally governed with rigorous guidelines to protect clinical trials patients.
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Home > "C" Clinical Trials Conditions > Comparison of Fludarabine Plus Total-body Irradiation With Combination Chemotherapy Followed by Donor Peripheral Stem Cell Transplantation in Treating Patients With Relapsed Non-Hodgkin's Lymphoma or Chronic Lymphocytic Leukemia  Comparison of Fludarabine Plus Total-body Irradiation With Combination Chemotherapy Followed by Donor Peripheral Stem Cell Transplantation in Treating Patients With Relapsed Non-Hodgkin's Lymphoma or Chronic Lymphocytic Leukemia
Comparison of Fludarabine Plus Total-body Irradiation With Combination Chemotherapy Followed by Donor Peripheral Stem Cell Transplantation in Treating Patients With Relapsed Non-Hodgkin's Lymphoma or Chronic Lymphocytic Leukemia
For Condition: refractory chronic lymphocytic leukemia,recurrent diffuse small lymphocytic/marginal zone lymphoma,recurrent grade I follicular small cleaved cell lymphoma,Waldenstrom's Macroglobulinemia,recurrent grade II follicular mixed cell lymphoma,recurrent adult diffuse small cleaved cell lymphoma
Status: No longer recruiting
Sponsor(s): Simmons Cancer Center ,
Synopsis: RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Peripheral stem cell transplantation may be able to replace immune cells that were destroyed by chemotherapy or radiation therapy. Sometimes the transplanted cells are rejected by the body's normal tissues. Cyclosporine, mycophenolate mofetil, methotrexate, and tacrolimus may prevent this from happening. PURPOSE: Randomized phase II trial to compare the effectiveness of fludarabine plus total-body irradiation with that of combination chemotherapy followed by donor peripheral stem cell transplantation in treating patients who have relapsed non-Hodgkin's lymphoma or chronic lymphocytic leukemia.
Details: OBJECTIVES: - Compare the 1-year overall survival rate of patients with relapsed low-grade non-Hodgkin's lymphoma or chronic lymphocytic leukemia treated with fludarabine and total body irradiation vs cyclophosphamide and fludarabine followed by allogeneic peripheral blood stem cell transplantation and donor lymphocyte infusions. - Compare the toxic effects of these regimens in these patients. - Compare the incidence and severity of acute and chronic graft-versus-host disease in patients treated with these regimens. - Compare the 1-year treatment-related mortality and infectious complications in patients treated with these regimens. - Compare the efficacy of these treatment regimens, in terms of 1-year disease-free survival, of these patients. - Compare the quality of life of patients treated with these regimens. OUTLINE: This is a randomized, multicenter study. Patients are stratified according to disease, age (less than 55 vs over 55), and participating transplantation center. Patients are randomized to 1 of 2 treatment arms. - Arm I: Patients receive fludarabine IV on days -4 to -2. Patients undergo total body irradiation followed by allogeneic peripheral blood stem cell transplantation (PBSCT) on day 0. Patients receive graft-versus-host disease (GVHD) prophylaxis comprising oral cyclosporine twice daily on days -2 to 90 followed by a taper on days 90-150 and oral mycophenolate mofetil twice daily on days 0-28. - Arm II: Patients receive fludarabine IV on days -6 to -2 and cyclophosphamide IV on days -3 to -2. Patients undergo PBSCT on day 0. Patients receive GVHD prophylaxis comprising methotrexate IV on days 1, 3, 6, and 11 and tacrolimus IV continuously and then orally on days -2 to 90 followed by a taper on days 90-150. At approximately day 180, patients with persistent disease, evidence of T-cell chimerism, and no GVHD may receive up to 3 donor lymphocyte infusions administered every 1-2 months. Quality of life is assessed at baseline, 1 month, every 3 months for 1 year, and then every 6 months for 1 year. Patients are followed at 1 month, every 3 months for 1 year, and then annually for 2 years. PROJECTED ACCRUAL: A total of 100 patients (50 per treatment arm) will be accrued for this study.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/75 Years
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Diagnosis of chronic lymphocytic leukemia OR - Diagnosis of non-Hodgkin's lymphoma - Lymphoplasmacytic lymphoma - Grade I follicular small cleaved cell lymphoma - Grade II follicular mixed cell lymphoma - Diffuse small cleaved cell lymphoma - Small lymphocytic lymphoma - Relapsed after at least 1 course of prior therapy - Availability of a 6/6 HLA A, B, and DR identical sibling donor - Nonmyeloablative transplantation candidate - No clinically significant effusions or ascites that would preclude administration of methotrexate PATIENT CHARACTERISTICS: Age: - 18 to 75 Performance status: - ECOG 0-2 OR - Zubrod 0-2 Life expectancy: - At least 6 months Hematopoietic: - Not specified Hepatic: - Bilirubin no greater than 3 mg/dL Renal: - Creatinine no greater than 2 mg/dL Cardiovascular: - LVEF at least 40% on MUGA scan or echocardiogram Pulmonary: - DLCO at least 50% of predicted Other: - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception - No uncontrolled bacterial, viral, fungal, or parasitic infection - HIV1 and HIV2 negative - No other active malignancy except basal cell skin cancer - No recent history of drug or alcohol abuse - No other primary disease or comorbid illness that would severely limit life expectancy PRIOR CONCURRENT THERAPY: Biologic therapy: - See Disease Characteristics - Prior autologous bone marrow transplantation allowed if disease has progressed after transplantation - No entry on study as part of a tandem autologous transplantation followed by nonmyeloablative allograft protocol Chemotherapy: - Not specified Endocrine therapy: - Not specified Radiotherapy: - Not specified Surgery: - Not specified
Total Enrollment:
Location and Contact Information:
Overall Study Official:
RobertCollins, Study Chair, Simmons Cancer Center
James P. Wilmot Cancer Center
Rochester, New York, 14642
United States
Simmons Cancer Center - Dallas
Dallas, Texas, 75235-8590
United States
University of Toronto
Toronto, Ontario, M5S 1A8
Canada
Princess Margaret Hospital
Toronto, Ontario, M4S 1KN
Canada
Florida Hospital Cancer Institute
Orlando, Florida, 32804
United States
Ottawa Regional Cancer Centre
Ottawa, Ontario, K1H 1C4
Canada
Hopital du Saint-Sacrament, Quebec
Quebec City, Quebec, G1S 4L8
Canada
Holden Comprehensive Cancer Center
Iowa City, Iowa, 52242-1009
United States
Delaware Clinical & Laboratory Physicians
Newark, Delaware, 19713
United States
University of Missouri Kansas City School of Medicine
Kansas City, Missouri, 64111
United States
Kimmel Cancer Center of Thomas Jefferson University - Philadelphia
Philadelphia, Pennsylvania, 19107-5541
United States
Blood and Marrow Transplant Group of Georgia
Atlanta, Georgia, 30342-1601
United States
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, 37212
United States
Texas Transplant Institute
San Antonio, Texas, 78229
United States
Oregon Cancer Institute
Portland, Oregon, 97239
United States
H. Lee Moffitt Cancer Center and Research Institute
Tampa, Florida, 33612-9497
United States
Hackensack University Medical Center
Hackensack, New Jersey, 07601
United States
University of Wisconsin Comprehensive Cancer Center
Madison, Wisconsin, 53792
United States
Rocky Mountain Cancer Centers
Denver, Colorado, 80218
United States
St. Joseph's Hospital and Medical Center
Paterson, New Jersey, 07503
United States
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
United States
Massey Cancer Center
Richmond, Virginia, 23298-0037
United States
University of Pennsylvania Cancer Center
Philadelphia, Pennsylvania, 19104-4283
United States
Additional Information:
Study ID Numbers: CDR0000069462; SPRI-UTSMC-0501228,UTSMC-0501228,NCI-V02-1706,AMGEN-UTSMC-0501228,ROCHE-UTSMC-0501228,IBMTR-SC-00-02.1
Study Start Date:
Record last reviewed: April 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00041288
Other Recurrent Grade Ii Follicular Mixed Cell Lymphoma Studies:
1. 506U78 in Treating Patients With Recurrent or Refractory Non-Hodgkin's Lymphoma or T-cell Lymphoma
2. Chemotherapy Plus Bone Marrow Transplantation in Treating Patients With Refractory Non-Hodgkin's Lymphoma, Hodgkin's Disease, or Multiple Myeloma
3. Radiolabeled Monoclonal Antibody Therapy Plus Peripheral Stem Cell Transplantation in Treating Patients With Lymphoma or Waldenstrom's Macroglobulinemia
4. Epratuzumab in Treating Patients With Non-Hodgkin's Lymphoma
5. Rituximab and Combination Chemotherapy Followed by Bone Marrow or Peripheral Stem Cell Transplantation in Treating Patients With Relapsed or Refractory Non-Hodgkin's Lymphoma
Related Studies:
Other recurrent grade II follicular mixed cell lymphoma Clinical Trials
Other Ontario Clinical Trials
Other Ottawa Clinical Trials
Comparison of Fludarabine Plus Total-body Irradiation With Combination Chemotherapy Followed by Donor Peripheral Stem Cell Transplantation in Treating Patients With Relapsed Non-Hodgkin's Lymphoma or Chronic Lymphocytic Leukemia
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