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Sirolimus in Preventing Graft-Versus-Host Disease in Patients With Hematologic Malignancies Who Are Undergoing Allogeneic Hematopoietic Stem Cell Transplantation Clinical Trials Info presented on Clinical Trials Search isn't intended to be a substitute for certified health advice, travels to or treatment by using a genuine physician. We are not physicians. Always consult your dr. on Sirolimus in Preventing Graft-Versus-Host Disease in Patients With Hematologic Malignancies Who Are Undergoing Allogeneic Hematopoietic Stem Cell Transplantation conditions. Clinical Trials Search.org is a site committed to listing clinical research studies in human subjects. Sirolimus in Preventing Graft-Versus-Host Disease in Patients With Hematologic Malignancies Who Are Undergoing Allogeneic Hematopoietic Stem Cell Transplantation Clinical research trials and Sirolimus in Preventing Graft-Versus-Host Disease in Patients With Hematologic Malignancies Who Are Undergoing Allogeneic Hematopoietic Stem Cell Transplantation health trials occur in hundreds of cities 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 typically assess the effectivity of new drugs. The propose of the studies / undertakings is to resolve certain human health questions. Clinical trials are a popular means for physicians, government agencies, and private sector companies to locate treatments for all sorts of conditions, including Sirolimus in Preventing Graft-Versus-Host Disease in Patients With Hematologic Malignancies Who Are Undergoing Allogeneic Hematopoietic Stem Cell Transplantation. Sirolimus in Preventing Graft-Versus-Host Disease in Patients With Hematologic Malignancies Who Are Undergoing Allogeneic Hematopoietic Stem Cell Transplantation Clinical Trials and other clinical trials permit volunteers to acquire medical treatment choices before they are available to the masses. Some times the test subjects obtain professional assistance for free, and every now and again they are compensated for their time. Sometimes there is a cost for a Sirolimus in Preventing Graft-Versus-Host Disease in Patients With Hematologic Malignancies Who Are Undergoing Allogeneic Hematopoietic Stem Cell Transplantation clinical trial. Participants oftentimes recieve the most expert healthcare available for their Sirolimus in Preventing Graft-Versus-Host Disease in Patients With Hematologic Malignancies Who Are Undergoing Allogeneic Hematopoietic Stem Cell Transplantation condition. Hazards are a reality, however, and can include extra or frequent physician visits, health risks (potentially life-endangering), and/or the treatment being uneffective. Trials are federally governed with rigorous guidelines to protect clinical trials subjects.
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Home > "S" Clinical Trials Conditions > Sirolimus in Preventing Graft-Versus-Host Disease in Patients With Hematologic Malignancies Who Are Undergoing Allogeneic Hematopoietic Stem Cell Transplantation  Sirolimus in Preventing Graft-Versus-Host Disease in Patients With Hematologic Malignancies Who Are Undergoing Allogeneic Hematopoietic Stem Cell Transplantation
Sirolimus in Preventing Graft-Versus-Host Disease in Patients With Hematologic Malignancies Who Are Undergoing Allogeneic Hematopoietic Stem Cell Transplantation
For Condition: myelodysplastic and myeloproliferative diseases,Leukemia,Lymphoma,plasma cell neoplasm,chronic myeloproliferative disorders,Graft Versus Host Disease
Status: Recruiting
Sponsor(s): National Cancer Institute (NCI) ,
Synopsis: RATIONALE: Sirolimus may be effective in preventing graft-versus-host disease in patients who are undergoing allogeneic stem cell transplantation. PURPOSE: Randomizedphase II trial to compare the effectiveness of three different regimens of sirolimus-treated T cells and/or sirolimus by mouth in preventing graft-versus-host disease in patients who are undergoing allogeneic hematopoietic stem cell transplantation for hematologic malignancies .
Details: OBJECTIVES: Primary - Determine the safety and feasibility of sirolimus-generated Th2 cells with vs without in vivo sirolimus vs in vivo sirolimus alone for graft-versus-host disease (GVHD) prevention after allogeneic hematopoietic stem cell transplantation in patients with hematologic malignancies. - Determine the GVHD rate in patients treated with these regimens. Secondary - Determine the pattern of post-transplantation CD4+ and CD8+ T-cell production of Th1- and Th2-type cytokines in patients treated with these regimens. - Determine the kinetics of alloengraftment, incidence of opportunistic infection, and incidence of malignant disease in complete remission in patients treated with these regimens. - Determine, preliminarily, whether T cells collected after transplantation have increased reactivity to patient tumor cells relative to donor T cells collected before transplantation. - Determine the pattern of post-transplantation CD14+ monocyte production of inflammatory cytokines interleukin-1-alpha and tumor necrosis factor alpha in patients treated with these regimens. OUTLINE: This is a randomized, pilot study. Patients are stratified according to age (18 to 45 vs 46 to 75). - Induction chemotherapy: Patients with CD20+ B-cell malignancies receive rituximab IV on day 1. All patients receive fludarabine IV over 30 minutes and etoposide, doxorubicin, and vincristine IV continuously on days 1-4; cyclophosphamide IV over 30 minutes on day 5; oral prednisone on days 1-5; and filgrastim (G-CSF) subcutaneously (SC) beginning on day 6 and continuing until blood counts recover. Treatment repeats every 21 days for 1-3 courses depending on the quantity of host immune T cells remaining after each course. All patients, including those who develop progressive disease during induction chemotherapy, then proceed to transplantation chemotherapy. - Transplantation chemotherapy: Patients receive fludarabine IV over 30 minutes and cyclophosphamide IV over 2 hours on days -6 to -3. - Patients undergo allogeneic peripheral blood stem cell transplantation on day 0. Patients receive G-CSF SC beginning on day 0 and continuing until blood counts recover. Patients also receive cyclosporine orally or IV over 2 hours twice daily beginning on day -1 and continuing until approximately day 100 followed by a taper until day 180. Patients are also randomized to 1 of 3 treatment arms. - Arm I: Patients receive donor Th2 cells IV on day 1. - Arm II: Patients receive donor Th2 cells as in arm I. Patients also receive an initial loading dose of oral sirolimus once on day -2 and then oral sirolimus once daily on days -1 to 1. - Arm III: Patients receive oral sirolimus as in arm II. - Donor lymphocyte infusion (DLI): Patients with persistent or progressive malignant disease after transplantation may receive DLI. DLI may be administered alone or in combination with chemotherapy. Treatment continues in the absence of disease progression or unacceptable toxicity. Patients are followed weekly for 6 weeks post-transplantation, at 3 months, every 3 months for 1 year, every 6 months for 1 year, and then annually thereafter. PROJECTED ACCRUAL: A total of 30-76 patients (approximately 10-25 per treatment arm) will be accrued for this study within 2.5-3.5 years.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/75 Years
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Diagnosis of 1 of the following hematologic malignancies, myelodysplasia, or myeloproliferative disorders: - Chronic lymphocytic leukemia - Relapsed after fludarabine - Non-complete remission (CR) after salvage regimen - Hodgkin's or non-Hodgkin's lymphoma (all types, including mantle cell lymphoma) - Primary treatment failure - Relapsed after autologous stem cell transplantation (SCT) - Non-CR after salvage regimen - Multiple myeloma - Primary treatment failure - Relapsed after autologous SCT - Non-CR after salvage regimen - Acute myeloid leukemia - In first CR (CR1) and at high risk [excludes t(8;21), t(15;17), or inv(16)] - In second CR (CR2) or greater - Acute lymphoblastic leukemia - In CR1 and at high risk [t(9;22) or bcr-abl+; t(4;11), 1(1;19), t(8;14)] - In CR2 or greater - Myelodysplastic syndromes - Refractory anemia with excess blasts (RAEB) - RAEB in transformation (requires bone marrow and blood blasts of less than 10% after induction chemotherapy) - Myeloproliferative disorders* - Idiopathic myelofibrosis - Polycythemia vera - Essential thrombocythemia - Chronic myelomonocytic leukemia NOTE: *Patients must be end-stage, primarily defined as disease severity refractory to splenectomy - Chronic myelogenous leukemia refractory to imatinib mesylate - Chronic phase - Accelerated phase - Acute leukemia must be in hematologic remission (less than 5% of blood or marrow blasts) - Must have a first-degree relative donor matched at 6/6 HLA antigens (A, B, and DR) - No active CNS involvement by malignancy PATIENT CHARACTERISTICS: Age - 18 to 75 Performance status - ECOG 0-1 Life expectancy - At least 3 months Hematopoietic - Not specified Hepatic - ALT and AST no greater than 2.5 times upper limit of normal* - Bilirubin less than 2.5 mg/dL* - No chronic active hepatitis B - Hepatitis B core antibody-positive allowed, provided patient is surface antigen-negative and without evidence of active infection - No hepatitis C infection NOTE: *Values above these levels may be accepted, at the discretion of the principal investigator or study chairman, if the elevations are due to liver involvement Renal - Creatinine no greater than 1.5 mg/dL - Creatinine clearance at least 50 mL/min Cardiovascular - LVEF greater than 45% by 2-dimensional ECHO or MUGA Pulmonary - DLCO greater than 50% of expected Other - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception during and for at least 1 year after study participation - HIV negative - No active infection that is not responding to antimicrobial therapy - No psychiatric illness that would preclude study compliance or informed consent PRIOR CONCURRENT THERAPY: Biologic therapy - See Disease Characteristics Chemotherapy - See Disease Characteristics Endocrine therapy - No concurrent steroids as antiemetics during chemotherapy - No concurrent steroids during transplantation Radiotherapy - Not specified Surgery - See Disease Characteristics Other - At least 2 weeks since prior therapy and recovered
Total Enrollment:
Location and Contact Information:
Overall Study Official:
MichaelBishop, Study Chair, National Cancer Institute (NCI)
Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support *Recruiting*
Bethesda, Maryland, 20892-1182
United States
Recruiting Patient Recruitment 888-NCI-1937
Additional Information:
Study ID Numbers: CDR0000350350; NCI-04-C-0055
Study Start Date:
Record last reviewed: January 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00077480
Other Myelodysplastic And Myeloproliferative Diseases Studies:
1. High-Dose Chemotherapy Plus Peripheral Stem Cell Transplantation in Treating Patients With Hematologic Cancer
2. T-Cell-Depleted Allogeneic Stem Cell Transplantation Followed By Treated Donor T Cells After Immunoablative Induction Chemotherapy and Reduced-Intensity Transplantation Conditioning in Treating Patients With Hematologic Malignancies
3. Umbilical Cord Blood Transplantation in Treating Patients With High-Risk Hematologic Cancer
4. Sirolimus in Preventing Graft-Versus-Host Disease in Patients With Hematologic Malignancies Who Are Undergoing Allogeneic Hematopoietic Stem Cell Transplantation
5. Peripheral Stem Cell Transplantation in Treating Patients With Hematologic Cancer or Aplastic Anemia
Related Studies:
Other myelodysplastic and myeloproliferative diseases Clinical Trials
Other Maryland Clinical Trials
Other Bethesda Clinical Trials
Sirolimus in Preventing Graft-Versus-Host Disease in Patients With Hematologic Malignancies Who Are Undergoing Allogeneic Hematopoietic Stem Cell Transplantation
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