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Home > "P" Clinical Trials Conditions > Peripheral Stem Transplantation in Treating Patients With Refractory or Relapsed Non-Hodgkin's Lymphoma  Peripheral Stem Transplantation in Treating Patients With Refractory or Relapsed Non-Hodgkin's Lymphoma
Peripheral Stem Transplantation in Treating Patients With Refractory or Relapsed Non-Hodgkin's Lymphoma
For Condition: childhood lymphoblastic lymphoma,Graft Versus Host Disease,childhood large cell lymphoma,adult non-Hodgkin's lymphoma,childhood small noncleaved cell lymphoma
Status: Recruiting
Sponsor(s): Fred Hutchinson Cancer Research Center , National Cancer Institute (NCI)
Synopsis: RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining chemotherapy with autologous and allogeneic peripheral stem cell transplantation may allow the doctor to give higher doses of chemotherapy drugs to kill more tumor cells. PURPOSE: Phase I/II trial to study the effectiveness of autologous peripheral stem cell transplantation followed by allogeneic peripheral stem cell transplantation in treating patients who have refractory or relapsednon-Hodgkin's lymphoma.
Details: OBJECTIVES: - Assess engraftment of HLA-identical peripheral blood stem cell (PBSC) allografts given after conditioning with total body irradiation and postgrafting immunosuppression with cyclosporine and mycophenolate mofetil in patients with refractory or relapsed non-Hodgkin's lymphoma treated with initial autologous PBSC transplantation. - Determine nonrelapse mortality at day 100 in patients treated with this regimen. - Determine disease-free and overall survival of patients treated with this regimen. OUTLINE: This is a multicenter study. Patients are stratified according to response to prior chemotherapy (sensitive vs resistant). Patients who do not have autologous peripheral blood stem cells (PBSC) stored receive mobilization on another protocol, then have PBSC collected and stored. Patients then proceed to conditioning and transplantation. Patients may receive one of two conditioning regimens. - Regimen 1: Patients receive cyclophosphamide IV on days -6 and -5 followed by total body irradiation (TBI) twice a day on days -3 to -1. Autologous PBSC are reinfused on day 0. - Regimen 2: Patients receive carmustine IV over 3 hours on day -7, etoposide IV over 2 hours and cytarabine IV over 3 hours twice a day on days -6 to -3, and melphalan IV over 30 minutes on day -2. Autologous PBSC are reinfused on day 0. Some patients may receive involved field irradiation to bulky disease after autologous PBSC reinfusion and before nonmyeloablative allograft. Within 40-120 days after autologous PBSC transplantation, patients proceed to nonmyeloablative allograft. Cyclosporine administered orally twice daily on days -3 to 56, then tapered based on disease risk. TBI is administered on day 0 followed by allogeneic PBSC infusion. Patients also receive oral mycophenolate mofetil twice a day beginning on day 0 and continuing until day 27. Based on day 56 disease status, patients may receive donor lymphocyte infusion (DLI) if there is evidence of disease progression and no evidence of graft-vs-host disease. DLI may be repeated every 65 days for up to 4 doses. Patients are followed weekly for 3 months, at 4 and 6 months, every 6 months for 2 years, and then annually until 5 years after transplantation. PROJECTED ACCRUAL: A total of 40 patients will be accrued for this study within 4 years.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: /65 Years
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Primary non-Hodgkin's lymphoma - Refractory or relapsed disease after standard chemotherapy - Tumor detectable by radiograph or bone marrow biopsy - HLA-identical sibling donor available - Not identical twin - Age 12 and over PATIENT CHARACTERISTICS: Age: - 65 and under Performance status: - Karnofsky 60-100% Life expectancy: - At least 3 months Hematopoietic: - Not specified Hepatic: - Not at high risk for veno-occlusive disease of the liver - Bilirubin no greater than 2.0 mg/dL - SGOT or SGPT no greater than 2 times normal Renal: - Creatinine no greater than 2.0 mg/dL - Creatinine clearance at least 50 mL/min Cardiovascular: - Cardiac ejection fraction at least 45% by MUGA or cardiac echo - No poorly controlled hypertension Pulmonary: - DLCO at least 50% of predicted Other: - HIV negative - Not pregnant - Fertile patients must use effective contraception during and for 1 year after study participation PRIOR CONCURRENT THERAPY: Biologic therapy: - No prior autologous peripheral blood stem cell transplantation - No concurrent growth factors during mycophenolate mofetil administration Chemotherapy: - See Disease Characteristics Endocrine therapy: - Not specified Radiotherapy: - At least 3 months since prior radiotherapy to the mediastinum Surgery: - Not specified
Total Enrollment:
Location and Contact Information:
Overall Study Official:
DavidMaloney, Study Chair, Fred Hutchinson Cancer Research Center
Huntsman Cancer Institute *Recruiting*
Salt Lake City, Utah, 84112
United States
Recruiting Michael Pulsipher 801-224-0421
Universitaet Leipzig *Recruiting*
Leipzig, , D-04103
Germany
Recruiting Dietger Niederwieser 49-341-971-3050
Fred Hutchinson Cancer Research Center *Recruiting*
Seattle, Washington, 98109-1024
United States
Recruiting David Maloney 206-667-5616
Additional Information:
Study ID Numbers: CDR0000067779; NCI-G00-1776,FHCRC-1409.00
Study Start Date:
Record last reviewed: October 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00005803
Other Childhood Small Noncleaved Cell Lymphoma Studies:
1. Monoclonal Antibody Therapy and Peripheral Stem Cell Transplantation in Treating Patients With Non-Hodgkin's Lymphoma
2. BMS-247550 in Treating Patients With Relapsed or Refractory Low-Grade Lymphoproliferative Disorders
3. Monoclonal Antibody in Treating Patients With Relapsed or Refractory Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma
4. Radiolabeled Monoclonal Antibody in Treating Patients With Non-Hodgkin's Lymphoma
5. Biological Therapy Plus Monoclonal Antibody Therapy in Treating Patients With Relapsed or Refractory Non-Hodgkin's Lymphoma
Related Studies:
Other childhood small noncleaved cell lymphoma Clinical Trials
Other Utah Clinical Trials
Other Salt Lake City Clinical Trials
Peripheral Stem Transplantation in Treating Patients With Refractory or Relapsed Non-Hodgkin's Lymphoma
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