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Low-Dose Chemotherapy and Radiation Therapy Before Allogeneic Stem Cell Transplantation in Treating Patients With Refractory Chronic Lymphocytic Leukemia Clinical Trials Data presented on Clinical Trials Search is not meant to be a substitute for qualified medical advice, visits or professional assistance with a genuine dr.. We are not doctors. Always consult your mD about Low-Dose Chemotherapy and Radiation Therapy Before Allogeneic Stem Cell Transplantation in Treating Patients With Refractory Chronic Lymphocytic Leukemia conditions. Clinical Trials Search.org is a site devoted to listing clinical research studies in human subjects. Low-Dose Chemotherapy and Radiation Therapy Before Allogeneic Stem Cell Transplantation in Treating Patients With Refractory Chronic Lymphocytic Leukemia Clinical research trials and Low-Dose Chemotherapy and Radiation Therapy Before Allogeneic Stem Cell Transplantation in Treating Patients With Refractory Chronic Lymphocytic Leukemia medical trials take place in many of places throughout the U.S.A.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials usually evaluate the effectiveness of new does drugs. The purpose of the studies / projects is to solve specific human healthcare questions. Clinical trials are a popular way for mDs, government agencies, and private sector companies to find cures for all varieties of conditions, like Low-Dose Chemotherapy and Radiation Therapy Before Allogeneic Stem Cell Transplantation in Treating Patients With Refractory Chronic Lymphocytic Leukemia. Low-Dose Chemotherapy and Radiation Therapy Before Allogeneic Stem Cell Transplantation in Treating Patients With Refractory Chronic Lymphocytic Leukemia Clinical Trials and other clinical trials allow for volunteers to have health treatment options before they are available to the masses. Many times the human subjects acquire professional assistance for free of charge, and sometimes they are compensated for their time. Occasionally there is a cost for a Low-Dose Chemotherapy and Radiation Therapy Before Allogeneic Stem Cell Transplantation in Treating Patients With Refractory Chronic Lymphocytic Leukemia clinical trial. Test subjects typically obtain the finest healthcare available for their Low-Dose Chemotherapy and Radiation Therapy Before Allogeneic Stem Cell Transplantation in Treating Patients With Refractory Chronic Lymphocytic Leukemia condition. Dangers are a reality, nevertheless, and might include additional or frequent doctor trips, medical dangers (possibly life-jeopardising), and/or the treatment being ineffectual. Trials are federally regulated with strict guidelines to protect clinical trials patients.
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Home > "L" Clinical Trials Conditions > Low-Dose Chemotherapy and Radiation Therapy Before Allogeneic Stem Cell Transplantation in Treating Patients With Refractory Chronic Lymphocytic Leukemia  Low-Dose Chemotherapy and Radiation Therapy Before Allogeneic Stem Cell Transplantation in Treating Patients With Refractory Chronic Lymphocytic Leukemia
Low-Dose Chemotherapy and Radiation Therapy Before Allogeneic Stem Cell Transplantation in Treating Patients With Refractory Chronic Lymphocytic Leukemia
For Condition: refractory chronic lymphocytic leukemia
Status: Recruiting
Sponsor(s): Fred Hutchinson Cancer Research Center , National Cancer Institute (NCI)
Synopsis: RATIONALE: Fludarabine may suppress the immune system and reduce the chance of developing graft-versus-host disease following allogeneic stem cell transplantation. Combining fludarabine with total-body irradiation may be effective in killing cancer cells before stem cell transplantation. PURPOSE: Phase II trial to study the effectiveness of low-dose fludarabine and total-body irradiation before allogeneic stem cell transplantation in treating patients who have refractorychronic lymphocytic leukemia.
Details: OBJECTIVES: - Compare the 18-month survival rate of patients with fludarabine-refractory chronic lymphocytic leukemia treated with nonmyeloablative allogeneic hematopoietic stem cell transplantation (HSCT) from matched-related donors with that observed in historical controls. - Determine the incidence of grade 2-4 acute and chronic graft-versus-host disease in patients treated with low-dose total body irradiation, fludarabine, peripheral blood stem cell infusion, and immunosuppression with cyclosporine and mycophenolate mofetil. - Determine the rate and types of infections in patients treated with this regimen. - Determine the rate of transplant-related mortality in the first 200 days in patients treated with this regimen. - Compare the rate of relapse of patients treated with this regimen with historical data on autologous HSCT. OUTLINE: This is a multicenter study. - Conditioning regimen: Patients receive fludarabine IV on days -4 to -2. Patients then undergo total body irradiation (TBI) on day 0. - Allogeneic stem cell transplantation: After TBI, patients undergo hematopoietic stem cell infusion on day 0. - Immunosuppression: Patients receive oral cyclosporine twice daily on days -3 to 180 (with tapering beginning on day 56 in the absence of graft-versus-host disease [GVHD]). Patients also receive oral mycophenolate mofetil daily on days 0-27 (may continue if GVHD occurs). - Donor lymphocyte infusion (DLI): If no GVHD occurs before day 180, patients with stable or progressive disease receive donor lymphocyte infusion (DLI) over 30 minutes beginning at least 2 weeks after completion of immunosuppression. DLI may be repeated every 28-65 days for a total of 3 infusions. Patients are followed monthly for 3 months and then every 3-6 months for approximately 2 years. PROJECTED ACCRUAL: A total of 40 patients will be accrued for this study within 1 year.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 21 Years/
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Diagnosis of chronic lymphocytic leukemia (CLL) defined by the following criteria: - Absolute peripheral lymphocytosis greater than 5,000/mm^3 that persisted for at least 4 weeks - Mature lymphocytes with less than 55% cells comprising atypical lymphocytes, prolymphocytes, or lymphoblasts in peripheral blood - Normal cellular or hypercellular bone marrow aspirate and biopsy with greater than 30% of the nucleated cells of lymphoid origin - Flow cytometric evidence of more than one B-cell marker (CD19, CD20, or CD23) plus CD5 in peripheral blood or bone marrow - CLL that progresses to prolymphocytic leukemia and CLL/small lymphocytic lymphoma is allowed - Refractory disease by one of the following criteria: - Failure to meet NCI Working Group criteria for complete or partial response after therapy with a regimen containing fludarabine (or another nucleoside analog [e.g., cladribine or pentostatin]) - Disease relapse within 12 months after completing therapy with a regimen containing fludarabine (or another nucleoside analog) - Availability of a suitable HLA-matched related donor - Related donor who is HLA genotypically identical at 1 haplotype (at least) and may be phenotypically or genotypically identical at the allele level at HLA-A, -B, -C, -DRB1, and -DQB1 - No identical twins - No active CNS involvement PATIENT CHARACTERISTICS: Age - 21 and over Performance status - Karnofsky 70-100% Life expectancy - Not specified Hematopoietic - See Disease Characteristics Hepatic - AST or ALT no greater than 4 times upper limit of normal - No bridging periportal fibrosis demonstrated on liver biopsy - No cirrhosis demonstrated on liver biopsy with clinical evidence of synthetic liver dysfunction demonstrated on prolonged coagulation studies and not explained by other conditions Renal - Not specified Cardiovascular - Cardiac ejection fraction at least 40% - No NCI grade 3 or 4 cardiac disease - No poorly controlled hypertension Pulmonary - DLCO at least 40% - No requirement for continuous supplementary oxygen - No severe deficits in pulmonary function Other - Not pregnant - Fertile patients must use effective contraception during and for 12 months after study treatment - HIV negative - HTLV-1 and HTLV-2 negative - No other concurrent malignancy except nonmelanoma skin cancer PRIOR CONCURRENT THERAPY: Biologic therapy - No concurrent growth factors during mycophenolate mofetil administration Chemotherapy - See Disease Characteristics Endocrine therapy - Not specified Radiotherapy - Not specified Surgery - Not specified
Total Enrollment:
Location and Contact Information:
Overall Study Official:
ChristopherFlowers, Study Chair, Fred Hutchinson Cancer Research Center
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 Christopher Flowers 206-667-5701
University of Torino *Recruiting*
Torino, , 10126
Italy
Recruiting Benedetto Bruno 39-11-633-4418
Cancer Institute at Oregon Health and Science University *Recruiting*
Portland, Oregon, 97239
United States
Recruiting Elliot Epner 503-494-1551
Additional Information:
Study ID Numbers: CDR0000301894; FHCRC-1711.00
Study Start Date:
Record last reviewed: April 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00060424
Other Refractory Chronic Lymphocytic Leukemia Studies:
1. LMB-2 Immunotoxin in Treating Patients With Chronic Lymphocytic Leukemia
2. Combination Chemotherapy in Treating Patients With Chronic Lymphocytic Leukemia, Non-Hodgkin's Lymphoma, or Multiple Myeloma
3. FR901228 in Treating Children with Refractory or Recurrent Solid Tumors or Leukemia
4. Monoclonal Antibody Therapy in Treating Patients With Chronic Lymphocytic Leukemia, Lymphocytic Lymphoma, Acute Lymphoblastic Leukemia, or Acute Myeloid Leukemia
5. Thalidomide in Treating Patients With Relapsed Chronic Lymphocytic Leukemia
Related Studies:
Other refractory chronic lymphocytic leukemia Clinical Trials
Other Washington Clinical Trials
Other Seattle Clinical Trials
Low-Dose Chemotherapy and Radiation Therapy Before Allogeneic Stem Cell Transplantation in Treating Patients With Refractory Chronic Lymphocytic Leukemia
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