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Sponsored by: |
Massachusetts General Hospital |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00513474 |
RATIONALE: Rasburicase may be an effective treatment for graft-versus-host disease caused by a donor stem cell transplant.
PURPOSE: This clinical trial is studying how well rasburicase works in preventing graft-versus-host disease in patients with hematologic cancer or other disease undergoing donor stem cell transplant.
Condition | Intervention |
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Chronic Myeloproliferative Disorders Graft Versus Host Disease Leukemia Lymphoma Multiple Myeloma and Plasma Cell Neoplasm Myelodysplastic Syndromes Myelodysplastic/Myeloproliferative Diseases |
Drug: busulfan Drug: cyclophosphamide Drug: cyclosporine Drug: etoposide Drug: methotrexate Drug: rasburicase Drug: sirolimus Drug: tacrolimus Procedure: allogeneic hematopoietic stem cell transplantation Procedure: flow cytometry Procedure: immunologic technique Procedure: laboratory biomarker analysis Procedure: peripheral blood stem cell transplantation Procedure: total-body irradiation |
Study Type: | Interventional |
Study Design: | Supportive Care, Open Label |
Official Title: | Rasburicase to Prevent Graft -Versus-Host Disease |
Estimated Enrollment: | 25 |
Study Start Date: | January 2008 |
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a multicenter study.
Patients receive a conventional myeloablative conditioning regimen consisting of high doses of cyclophosphamide, busulfan, and etoposide, with or without total-body irradiation. Depending on the preparative regimen selected, the conditioning of recipients will take a total of 6 to 7 days. On day 0, patients will receive filgrastim (G-CSF)-mobilized HLA-matched, related, or unrelated donor allogeneic peripheral blood stem cells (unmanipulated). Patients will receive standard graft-vs-host disease prophylaxis consisting of cyclosporine or tacrolimus and methotrexate or sirolimus. Patients will receive rasburicase IV over 30 minutes, beginning on the first day of conditioning therapy, for 5 consecutive days. If after 5 days of rasburicase the patient's uric acid plasma level remains above 5 mg/dL, rasburicase may be continued for up to 7 days in total.
Blood is obtained on day 0 and then at 14, 28, and 42 days post-transplant for immunologic studies, including quantitative analysis to follow the recovery of T cells, B cells, natural killer cells, dendritic cells (DC), and monocytes using flow cytometry (FCM); phenotypic analysis of T cells, DC and monocytes by FCM; lymphocyte activation analysis: CD3, CD4, CD8, CD25 2. CD3, CD8, CD71, CD69; DC analysis: CD45, CD14, DR, CD86, CD80 2. CD45, CD14, CD40, CD11c; and in vitro functional studies such as mixed lymphocyte reaction (MLR) and cell-mediated lysis (CML) to assess for the graft-versus-host and host-versus-graft responses. Peripheral blood is collected for chimerism studies on days 28 and 100 post-transplant.
After completion of study treatment, patients are followed periodically.
Ages Eligible for Study: | 18 Years to 65 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Patients with hematologic malignancies for whom conventional myeloablative allogeneic stem cell transplantation is deemed clinically appropriate and who are eligible for conventional myeloablative allogeneic stem cell transplantation on treatment plans/protocols, including any of the following:
Must be receiving filgrastim (G-CSF)-mobilized related or unrelated donor allogeneic peripheral blood stem cells
PATIENT CHARACTERISTICS:
Inclusion criteria:
Patients with symptomatic visceral, blood stream or nervous system opportunistic infection are eligible if the infection has been appropriately treated and controlled
Exclusion criteria:
Active congestive heart failure from any cause
PRIOR CONCURRENT THERAPY:
United States, Massachusetts | |
Massachusetts General Hospital | Recruiting |
Boston, Massachusetts, United States, 02114-2617 | |
Contact: Bimalangshu R. Dey, MD, PhD 617-724-5255 BDEY@partners.org |
Principal Investigator: | Bimalangshu R. Dey, MD, PhD | Massachusetts General Hospital |
Study ID Numbers: | CDR0000558480, MGH-07-071, DFCI-07-071 |
Study First Received: | August 6, 2007 |
Last Updated: | November 13, 2008 |
ClinicalTrials.gov Identifier: | NCT00513474 |
Health Authority: | Unspecified |
graft versus host disease anaplastic large cell lymphoma angioimmunoblastic T-cell lymphoma extranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissue nodal marginal zone B-cell lymphoma recurrent adult Burkitt lymphoma recurrent adult diffuse large cell lymphoma recurrent adult diffuse mixed cell lymphoma recurrent adult diffuse small cleaved cell lymphoma recurrent adult Hodgkin lymphoma recurrent adult immunoblastic large cell lymphoma recurrent adult lymphoblastic lymphoma recurrent adult T-cell leukemia/lymphoma recurrent cutaneous T-cell non-Hodgkin lymphoma recurrent grade 1 follicular lymphoma |
recurrent grade 2 follicular lymphoma recurrent grade 3 follicular lymphoma recurrent mantle cell lymphoma recurrent marginal zone lymphoma recurrent mycosis fungoides/Sezary syndrome recurrent small lymphocytic lymphoma splenic marginal zone lymphoma Waldenstrom macroglobulinemia recurrent adult acute lymphoblastic leukemia refractory chronic lymphocytic leukemia recurrent adult acute myeloid leukemia adult acute myeloid leukemia with 11q23 (MLL) abnormalities adult acute myeloid leukemia with inv(16)(p13;q22) adult acute myeloid leukemia with t(15;17)(q22;q12) adult acute myeloid leukemia with t(16;16)(p13;q22) |
Blast Crisis Sezary syndrome Cyclosporine Chronic myelogenous leukemia Hodgkin lymphoma, adult Lymphoma, small cleaved-cell, diffuse Tacrolimus Cyclosporins Lymphoma, large-cell, immunoblastic Preleukemia Hemorrhagic Disorders Lymphoma, Large-Cell, Anaplastic Neoplasm Metastasis Methotrexate Etoposide |
Myelodysplastic syndromes Precursor Cell Lymphoblastic Leukemia-Lymphoma Hematologic Diseases Leukemia, Myeloid, Chronic, Atypical, BCR-ABL Negative Leukemia, Myelomonocytic, Chronic Blood Coagulation Disorders Acute myelogenous leukemia Leukemia, Myeloid Folic Acid Myelodysplastic myeloproliferative disease Waldenstrom Macroglobulinemia Leukemia, Myeloid, Accelerated Phase B-cell lymphomas Anaplastic large cell lymphoma Lymphoma, Non-Hodgkin |
Antimetabolites Anti-Infective Agents Antimetabolites, Antineoplastic Immunologic Factors Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Physiological Effects of Drugs Reproductive Control Agents Gout Suppressants Pathologic Processes Therapeutic Uses Syndrome Antifungal Agents Abortifacient Agents Cardiovascular Diseases |
Alkylating Agents Dermatologic Agents Nucleic Acid Synthesis Inhibitors Disease Neoplasms by Histologic Type Immune System Diseases Enzyme Inhibitors Folic Acid Antagonists Abortifacient Agents, Nonsteroidal Immunosuppressive Agents Pharmacologic Actions Neoplasms Myeloablative Agonists Antineoplastic Agents, Alkylating Antirheumatic Agents |