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
Allogeneic Hematopoietic Stem Cell Transplantation for Induction of Mixed Hematopoietic Chimerism in Patients Infected With Human Immunodeficiency Virus-1 Using a Non-Marrow Ablative Conditioning Regimen Containing Total Body Irradiation in Combination With Post-Transplant Immunosuppression With Cyclosporine and Mycophenolate Mofetil
Sponsor: Fred Hutchinson Cancer Center
This NA trial investigates AIDS-related Diffuse Large Cell Lymphoma and AIDS-related Diffuse Mixed Cell Lymphoma and is currently completed. Fred Hutchinson Cancer Center leads this study, which shows 11 recorded versions since 1999 — indicating substantial longitudinal coverage. As an oncology study, it adds to the longitudinal record of treatment development for this indication.
Study Description(click to expand)PRIMARY OBJECTIVES: I. To determine the safety of treating high-risk HIV1-infected patients with 200 centigray (cGy) TBI plus post-transplant MMF/CSP. II. To determine whether 200 cGy TBI plus post-transplant MMF/CSP results in stable mixed donor lymphocyte chimerism (5-95% donor cluster of differentiation \[CD\]3) in high-risk human immunodeficiency virus (HIV)-1 infected patients. SECONDARY OBJECTIVES: I. To define the kinetics of immune reconstitution following a non-lethal conditioning regimen in HIV1-infected patients. II. To determine the effect of a non-lethal conditioning regimen on viral load. OUTLINE: CONDITIONING REGIMEN: Patients receive fludarabine intravenously (IV) over 2 hours on days -4, -3, and -2. Patients undergo TBI on day 0. TRANSPLANTATION: After completion of TBI, patients undergo allogeneic bone marrow or peripheral blood stem cell transplantation on day 0. IMMUNOSUPPRESSION: Patients receive cyclosporine IV or orally (PO) 2 to 3 times daily on days -3 to 99 with taper beginning on day 100 and continuing until day 177 in the absence of graft-vs-host disease (GVHD). Beginning within 6 hours after transplantation, patients also receive mycophenolate mofetil IV or PO 3 times daily on days 0 to 40 followed by a taper in the absence of GVHD. After completion of study treatment, patients are followed up...
PRIMARY OBJECTIVES:
I. To determine the safety of treating high-risk HIV1-infected patients with 200 centigray (cGy) TBI plus post-transplant MMF/CSP.
II. To determine whether 200 cGy TBI plus post-transplant MMF/CSP results in stable mixed donor lymphocyte chimerism (5-95% donor cluster of differentiation \[CD\]3) in high-risk human immunodeficiency virus (HIV)-1 infected patients.
SECONDARY OBJECTIVES:
I. To define the kinetics of immune reconstitution following a non-lethal conditioning regimen in HIV1-infected patients.
II. To determine the effect of a non-lethal conditioning regimen on viral load.
OUTLINE:
CONDITIONING REGIMEN: Patients receive fludarabine intravenously (IV) over 2 hours on days -4, -3, and -2. Patients undergo TBI on day 0.
TRANSPLANTATION: After completion of TBI, patients undergo allogeneic bone marrow or peripheral blood stem cell transplantation on day 0.
IMMUNOSUPPRESSION: Patients receive cyclosporine IV or orally (PO) 2 to 3 times daily on days -3 to 99 with taper beginning on day 100 and continuing until day 177 in the absence of graft-vs-host disease (GVHD). Beginning within 6 hours after transplantation, patients also receive mycophenolate mofetil IV or PO 3 times daily on days 0 to 40 followed by a taper in the absence of GVHD.
After completion of study treatment, patients are followed up for at least 1 year.
Status Flow
Change History
11 versions recorded-
Jan 2026 — Present [monthly]
Completed NA
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Sep 2024 — Present [monthly]
Completed NA
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Jul 2024 — Sep 2024 [monthly]
Completed NA
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Jan 2023 — Jul 2024 [monthly]
Completed NA
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Dec 2022 — Jan 2023 [monthly]
Completed NA
▶ Show 6 earlier versions
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May 2022 — Dec 2022 [monthly]
Completed NA
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Jan 2021 — May 2022 [monthly]
Completed NA
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Jun 2018 — Jan 2021 [monthly]
Completed NA
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Jul 2017 — Jun 2018 [monthly]
Completed NA
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Feb 2017 — Jul 2017 [monthly]
Completed NA
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Jan 2017 — Feb 2017 [monthly]
Completed NA
First recorded
Nov 1999
Trial started
Per CT.gov start date — pre-dates our first snapshot
Eligibility Summary
No eligibility information available.
Contact Information
- Fred Hutchinson Cancer Center
- National Cancer Institute (NCI)
For direct contact, visit the study record on ClinicalTrials.gov .