N/A
Completed N=5
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
leukemia · Non-Hodgkin's Lymphoma · Diffuse Large B-Cell Lymphoma · Angioimmunoblastic T-cell lymphoma
Source: ClinicalTrials.gov NCT00112593 ↗
Enrolled (actual)
5
Serious AEs
0.0%
Results posted
May 2017
Primary outcomePrimary: Death From Regimen Toxicity or Opportunistic Infection — 0 Participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Death From Regimen Toxicity or Opportunistic Infection |
— | — |
| PRIMARY Death From GVHD |
— | — |
| PRIMARY Successful Induction of Mixed Hematopoietic Chimerism as Assessed by the Percentage of Peripheral Blood T Cells That Are of Donor Origin |
5 | — |
| SECONDARY Overall Survival |
0.40 | — |
| SECONDARY Progression of HIV |
— | — |
| SECONDARY Reconstitution of HIV-specific Immunity |
2 | — |
Eligibility Criteria
Inclusion Criteria
- Patients with hematologic malignancy, lymphoma or other HIV-associated malignancy are eligible provided these criteria are met:
- The malignancy is in complete remission or very good partial remission, defined as a significant reduction of disease with therapy and no evidence for continued tumor growth in the case of lymphoma or solid tumors
- Highly active antiretroviral therapy (HAART) is initiated within one month of hematopoietic cell transplant
- Viral load has decreased by >= 1.5 logs or viral load 100 cells/ul
- HIV infected patients without malignancy who have failed HAART are eligible provided that these criteria are met:
- They have been treated with more than one regimen of HAART for a total of at least 6 months duration
- The viral load is 75 years
Data sourced from ClinicalTrials.gov (NCT00112593). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.