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NCT00569985 · ClinicalTrials.gov registry record · Phase 1
Gene Therapy-Treated Stem Cells in Treating Patients Undergoing Stem Cell Transplant for Intermediate-Grade or High-Grade AIDS-Related Lymphoma
A Phase 1 study, sponsored by City of Hope Medical Center.
- Completed
- Registry status
- Phase 1
- Development phase
- 5
- Enrollment target
NCT00569985: Completed Phase 1 study, sponsored by City of Hope Medical Center.
NCT00569985 is a Phase 1 study that has completed, run by City of Hope Medical Center. The registered enrollment target is 5 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (92% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00569985, a Phase 1 study, has completed, sponsored by City of Hope Medical Center.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 5 participants
- Enrollment target
Study Summary
This pilot clinical trial studies biological therapy in treating patients with acquired immune deficiency syndrome (AIDS)-related lymphoma undergoing stem cell transplant. Giving chemotherapy before a stem cell transplant stops the growth of cancer cells by stopping them from dividing or killing them. After treatment, stem cells are collected from the patient's blood and stored. The stem cells are then returned to the patient to replace the blood-forming cells that were destroyed by the chemotherapy. Giving biological therapy as part of the stem cell transplant may be more effective in treating patients with AIDS-related lymphoma
Primary Outcome
The toxicities observed after each stem cell infusion will be summarized in terms of type (organ affected or laboratory determination such as ANC), severity (by NCI CTCAE version 3 and nadir or maximum values for the laboratory measures), time of onset (i.e., course number), duration, and reversibility of outcome. Tables will be created to summarize these toxicities and side effects by dose and by course.
Interventions
- DRUG cyclophosphamide
- DRUG etoposide
- PROCEDURE autologous hematopoietic stem cell transplantation
- DRUG carmustine
- BIOLOGICAL lentivirus vector rHIV7-shI-TAR-CCR5RZ-transduced hematopoietic progenitor cells
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 5 participants |
| Start Date | 2007-06 |
| Est. Completion | 2019-11-12 |
| Phase | Phase 1 |
What the finished NCT00569985 record still lists
NCT00569985 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 5 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (92% lower).
The record links to 0 conditions, and to 5 interventions - of which cyclophosphamide is the first listed.
NCT00569985 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00569985 about?
NCT00569985 is a clinical study titled "Gene Therapy-Treated Stem Cells in Treating Patients Undergoing Stem Cell Transplant for Intermediate-Grade or High-Grade AIDS-Related Lymphoma". This pilot clinical trial studies biological therapy in treating patients with acquired immune deficiency syndrome (AIDS)-related lymphoma undergoing stem cell transplant. Giving chemotherapy before a stem cell transplant stops the growth of cancer cells by stopping them from dividing or killing the...
What is the current status of trial NCT00569985?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 5 participants. The study started on 2007-06. Estimated completion is 2019-11-12.
What interventions are being tested in trial NCT00569985?
The interventions under investigation include: cyclophosphamide (DRUG), etoposide (DRUG), autologous hematopoietic stem cell transplantation (PROCEDURE), carmustine (DRUG), lentivirus vector rHIV7-shI-TAR-CCR5RZ-transduced hematopoietic progenitor cells (BIOLOGICAL).
Who is sponsoring clinical trial NCT00569985?
This trial is sponsored by City of Hope Medical Center, which has 582 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00569985's enrollment target sits among peer trials
5 1989th of 2000 higher than 6 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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