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NCT00005785 · ClinicalTrials.gov registry record · Phase 1
Stem Cell (Modified Bone Marrow) Transplantation in HIV-Infected Patients With Blood Cancer
A Phase 1 study, sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK).
- Completed
- Registry status
- Phase 1
- Development phase
- 30
- Enrollment target
NCT00005785 is a Phase 1 study that has completed, run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK). The registered enrollment target is 30 participants.
The verdict
NCT00005785, a Phase 1 study, has completed, sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK).
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 30 participants
- Enrollment target
Study Summary
This study will investigate the safety and effectiveness of a new stem cell transplant procedure to treat acute or chronic leukemia, multiple myeloma, myelodysplastic syndrome, Hodgkin's and non-Hodgkin's lymphoma in HIV-infected patients. HIV-infected patients usually are not offered bone marrow transplant treatments because they are at increased risk of dying from the intense chemotherapy and radiation therapy used for the procedure. This study uses a modified procedure, transplanting stem cells instead of bone marrow, designed to be less dangerous for such patients. Patients will also undergo a procedure called gene transfer to try to halt progression of their HIV infection. The procedure in this study differs from standard bone marrow transplantation in three ways: Stem cells will be transplanted instead of bone marrow. (Stem cells, which are produced by the bone marrow, mature into the different blood components-white and red cells and platelets.) The stem cell donor will be given a drug that releases these cells from their bone marrow into the blood stream. The cells will then be collected from the donor by apheresis, a procedure in which whole blood is drawn, the stem cells separated and removed, and the rest of the blood returned to the donor.); The procedure will use lower doses of chemotherapy than the conventional method, and will not use radiation therapy; or A laboratory-manufactured gene designed to obstruct HIV reproduction will be inserted into the stem cells, rendering future cells that develop from resistance to the virus. Prospective patients will be tested for matching with an HIV-negative donor (family member) and will undergo a medical history, physical examination and several tests (e.g., breathing tests, X-rays, etc.) to determine eligibility for the study. Study participants will then undergo apheresis to collect white blood cells called lymphocytes. Stem cells will be collected from the donor. Half the donated cells will have the HIV-r
Interventions
- DRUG GCSF Mobilized Allogeneic PBSC Cultured w/Cytokines; Transduced w/RV
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 1999-09 |
| Est. Completion | 2001-11 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00005785
The ClinicalTrials.gov registry entry for NCT00005785 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 30 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), which has 490 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which GCSF Mobilized Allogeneic PBSC Cultured w/Cytokines; Transduced w/RV is the first listed.
NCT00005785 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00005785 about?
NCT00005785 is a clinical study titled "Stem Cell (Modified Bone Marrow) Transplantation in HIV-Infected Patients With Blood Cancer". This study will investigate the safety and effectiveness of a new stem cell transplant procedure to treat acute or chronic leukemia, multiple myeloma, myelodysplastic syndrome, Hodgkin's and non-Hodgkin's lymphoma in HIV-infected patients. HIV-infected patients usually are not offered bone marrow t...
What is the current status of trial NCT00005785?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 30 participants. The study started on 1999-09. Estimated completion is 2001-11.
What interventions are being tested in trial NCT00005785?
The interventions under investigation include: GCSF Mobilized Allogeneic PBSC Cultured w/Cytokines; Transduced w/RV (DRUG).
Who is sponsoring clinical trial NCT00005785?
This trial is sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), which has 490 total clinical trials registered on ClinicalTrials.gov.
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