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NCT00301834 · ClinicalTrials.gov registry record · Phase 2
Alemtuzumab, Fludarabine, and Busulfan Followed By Donor Stem Cell Transplant in Treating Young Patients With Hematologic Disorders
A Phase 2 study, sponsored by University of California, San Francisco.
- Completed
- Registry status
- Phase 2
- Development phase
- 35
- Enrollment target
NCT00301834: Completed Phase 2 study, sponsored by University of California, San Francisco.
NCT00301834 is a Phase 2 study that has completed, run by University of California, San Francisco. The registered enrollment target is 35 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (74% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00301834, a Phase 2 study, has completed, sponsored by University of California, San Francisco.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 35 participants
- Enrollment target
Study Summary
RATIONALE: Monoclonal antibodies, such as alemtuzumab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them. Drugs used in chemotherapy, such as fludarabine and busulfan, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. A peripheral stem cell, bone marrow , or umbilical cord blood transplant may be able to replace blood-forming cells that were destroyed by chemotherapy. Sometimes the transplanted cells from a donor can make an immune response against the body's normal cells. Giving cyclosporine together with methotrexate and methylprednisolone may stop this from happening. PURPOSE: This phase II trial is studying how well giving alemtuzumab together with fludarabine and busulfan works when given before donor stem cell transplant in treating young patients with hematologic disorders.
Primary Outcome
Peripheral blood chimerism studies were performed by quantitative real time polymerase chain reaction (qPCR) evaluation of differential short tandem repeat DNA sequences
Interventions
- DRUG fludarabine phosphate
- BIOLOGICAL alemtuzumab
- DRUG methotrexate
- DRUG busulfan
- DRUG cyclosporine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 35 participants |
| Start Date | 2005-01 |
| Est. Completion | 2011-09 |
| Phase | Phase 2 |
What the finished NCT00301834 record still lists
NCT00301834 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 35 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (74% lower).
The record links to 0 conditions, and to 5 interventions - of which fludarabine phosphate is the first listed.
NCT00301834 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00301834 about?
NCT00301834 is a clinical study titled "Alemtuzumab, Fludarabine, and Busulfan Followed By Donor Stem Cell Transplant in Treating Young Patients With Hematologic Disorders". RATIONALE: Monoclonal antibodies, such as alemtuzumab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them. Drugs used in chemotherapy, such as fludarabine and bus...
What is the current status of trial NCT00301834?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 35 participants. The study started on 2005-01. Estimated completion is 2011-09.
What interventions are being tested in trial NCT00301834?
The interventions under investigation include: fludarabine phosphate (DRUG), alemtuzumab (BIOLOGICAL), methotrexate (DRUG), busulfan (DRUG), cyclosporine (DRUG).
Who is sponsoring clinical trial NCT00301834?
This trial is sponsored by University of California, San Francisco, which has 1,713 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00301834's enrollment target sits among peer trials
35 1524th of 2000 higher than 462 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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