drugset / Trial / NCT00112593

Fludarabine and Total-Body Irradiation Followed By Donor Stem Cell Transplant and Cyclosporine and Mycophenolate Mofetil in Treating HIV-Positive Patients With or Without Cancer

NCT00112593

NaSingle-groupOpen-labelTreatment

Summary

This clinical trial studies the side effects and best dose of giving fludarabine and total-body irradiation (TBI) together followed by a donor stem cell transplant and cyclosporine and mycophenolate mofetil in treating human immunodeficiency virus (HIV)-positive patients with or without cancer. Giving low doses of chemotherapy, such as fludarabine, and TBI before a donor bone marrow or peripheral blood stem cell transplant helps stop the growth of cancer or abnormal cells and helps stop the patient's immune system from rejecting the donor's stem cells. The donated stem cells may replace the patient's immune cells and help destroy any remaining cancer cells (graft-versus-tumor effect). Sometimes the transplanted cells from a donor can also make an immune response against the body's normal cells. Giving cyclosporine (CSP) and mycophenolate mofetil (MMF) after the transplant may stop this from happening.

Timeline

Start
1999-11
Primary completion
2014-11
Completion

Drugs

EvaluationDrugModalityDoseRoute
Subject Fludarabine Small molecule Intravenous
Background Cyclosporine Peptide Intravenous
Background Mycophenolate Mofetil Small molecule Intravenous

Indications

AIDS-related primary central nervous system lymphoma Burkitt lymphoma HIV infectious disease Hodgkins lymphoma MALT lymphoma T-cell large granular lymphocyte leukemia Waldenstrom macroglobulinemia acquired polycythemia vera acute myeloid leukemia with 11q23 abnormalities acute myeloid leukemia with t(8;21)(q22;q22) translocation acute myeloid leukemia, del(5q31-q32) acute myeloid leukemia, inv(16)(p13.1;q22) acute myeloid leukemia, t(16;16)(p13.1;q22) acute promyelocytic leukemia acute undifferentiated leukemia adult T-cell leukemia/lymphoma adult acute lymphoblastic leukemia aggressive NK-cell leukemia anaplastic large cell lymphoma angioimmunoblastic T-cell lymphoma blast phase chronic myelogenous leukemia, BCR-ABL1 positive cancer of unknown primary site childhood acute lymphoblastic leukemia childhood acute myeloid leukemia childhood myelodysplastic syndrome chronic eosinophilic leukemia chronic lymphocytic leukemia/small lymphocytic lymphoma chronic neutrophilic leukemia essential thrombocythemia extramedullary plasmacytoma extranodal nasal NK/T cell lymphoma grade III lymphomatoid granulomatosis hairy cell leukemia hepatosplenic T-cell lymphoma intraocular lymphoma juvenile myelomonocytic leukemia large-cell immunoblastic lymphoma leukemia, myeloid, accelerated-phase mantle cell lymphoma mast cell leukemia mycosis fungoides and variants myeloproliferative neoplasm, unclassifiable nodal marginal zone B-cell lymphoma peripheral T-cell lymphoma, not otherwise specified plasma cell myeloma post-transplant lymphoproliferative disease primary central nervous system lymphoma primary cutaneous B-cell lymphoma primary myelofibrosis primary plasmacytoma of the bone primary systemic amyloidosis prolymphocytic leukemia small intestine lymphoma splenic marginal zone lymphoma testicular lymphoma