At a glance

ClinicalIndex Comparison Record

N/ACompleted· 5 enrolled

Drug / intervention

fludarabine phosphate +5 moredrug

Likely dose

Not stated in record

Key inclusion· 5

✓Hematologic malignancy, lymphoma, or HIV-associated malignancy in complete remission or very good partial remission
✓HAART initiated within one month of transplant with viral load decreased by ≥1.5 logs or <5000 copies/ml plasma (for malignancy patients)
✓CD4 count >100 cells/ul (for malignancy patients)
✓HIV-infected patients without malignancy must have failed HAART, treated with >1 regimen for ≥6 months total duration, with viral load <50 copies/ml and CD4 <100 cells/ul

Key exclusion· 6

✕Positive serology for Toxoplasma gondii with treatment or active infection
✕Other disease or organ dysfunction that would limit survival to less than 30 days
✕Medical history of noncompliance with HAART or medical therapy
✕Donor is HIV-positive

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00112593

NCT00112593N/ACompleted

Compare CT.gov

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

Fred Hutchinson Cancer Center·interventional·Posted Jun 3, 2005·Updated May 24, 2017

In Brief

A clinical study evaluating fludarabine phosphate, total-body irradiation, and 4 other interventions for Accelerated Phase Chronic Myelogenous Leukemia and 178 related conditions. Completed, enrolled 5 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional

Allocation--

Masking--

Primary Purpose--

CountriesUnited States

CollaboratorsNational Cancer Institute (NCI)

Timeline

N/ACompletedFinished

2000200120022003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027

Enrollment StartNov 1999

First PostedJun 2005

Primary CompletionNov 2014

TodayJul 2026

First PostedJun 3, 2005

Enrollment StartNov 1, 1999

Primary CompletionNov 1, 2014

TodayJul 2, 2026

Enrollment to primary: 15 yearsPosted 21.1 years ago

Interventions

fludarabine phosphatedrug

Given IV

total-body irradiationradiation

Undergo TBI

peripheral blood stem cell transplantationprocedure

Undergo allogeneic bone marrow or peripheral blood stem cell transplantation

cyclosporinedrug

Given IV or PO

mycophenolate mofetildrug

Given IV or PO

laboratory biomarker analysisother

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