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NCT00301951 · ClinicalTrials.gov registry record · Phase 1
Low-Dose Fludarabine, Busulfan, and Anti-Thymocyte Globulin Followed By Donor Umbilical Cord Blood Transplant in Treating Patients With Advanced Hematologic Cancer
A Phase 1 study of Lymphoma and Leukemia, sponsored by University of California, San Francisco.
- Completed
- Registry status
- Phase 1
- Development phase
- 7
- Enrollment target
- 1
- Study location
NCT00301951: Completed Phase 1 study of Lymphoma and Leukemia, sponsored by University of California, San Francisco.
NCT00301951 is a Phase 1 study of Lymphoma and Leukemia that has completed, run by University of California, San Francisco. The registered enrollment target is 7 participants, below the 484-participant average among 299 other Lymphoma trials with a reported enrollment target (99% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00301951, a Phase 1 study of Lymphoma and Leukemia, has completed, sponsored by University of California, San Francisco.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 7 participants
- Enrollment target
- 1
- Study location
Study Summary
RATIONALE: Giving chemotherapy before a donor umbilical cord blood transplant helps stop both the growth of cancer cells and the patient's immune system from rejecting the donor's stem cells. When the healthy stem cells from a donor are infused into the patient, they may help the patient's bone marrow make stem cells, red blood cells, white blood cells, and platelets. Sometimes the transplanted cells from a donor can make an immune response against the body's normal cells. Giving chemotherapy, such as fludarabine and busulfan, and antithymocyte globulin before transplant and tacrolimus and mycophenolate mofetil after transplant may stop this from happening. PURPOSE: This clinical trial is studying how well giving low-dose fludarabine and busulfan together with anti-thymocyte globulin, followed by donor umbilical cord blood transplant works in treating patients with advanced hematologic cancer.
Primary Outcome
as determined by \> 80% engraftment rate at day 180 and a \< 50% transplant-related mortality rate at day 100
Conditions Studied
Interventions
- DRUG fludarabine phosphate
- DRUG busulfan
- BIOLOGICAL anti-thymocyte globulin
- DRUG mycophenolate mofetil
- BIOLOGICAL sargramostim
Study Locations (1)
California
- UCSF Comprehensive Cancer Center - San Francisco
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 7 participants |
| Start Date | 2004-09 |
| Est. Completion | 2009-07 |
| Phase | Phase 1 |
What the finished NCT00301951 record still lists
NCT00301951 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 7 participants, a relatively small participant target, below the 484-participant average among 299 other Lymphoma trials with a reported enrollment target (99% lower).
The record links to 4 conditions, with Lymphoma appearing as the primary indexed condition, and to 5 interventions - of which fludarabine phosphate is the first listed.
NCT00301951 reports a single indexed study location in California.
Frequently Asked Questions
What is clinical trial NCT00301951 about?
NCT00301951 is a clinical study titled "Low-Dose Fludarabine, Busulfan, and Anti-Thymocyte Globulin Followed By Donor Umbilical Cord Blood Transplant in Treating Patients With Advanced Hematologic Cancer". RATIONALE: Giving chemotherapy before a donor umbilical cord blood transplant helps stop both the growth of cancer cells and the patient's immune system from rejecting the donor's stem cells. When the healthy stem cells from a donor are infused into the patient, they may help the patient's bone marr...
What is the current status of trial NCT00301951?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 7 participants. The study started on 2004-09. Estimated completion is 2009-07.
What conditions does trial NCT00301951 study?
This clinical trial studies the following conditions: Lymphoma, Leukemia, Myelodysplastic Syndromes, Multiple Myeloma and Plasma Cell Neoplasm.
What interventions are being tested in trial NCT00301951?
The interventions under investigation include: fludarabine phosphate (DRUG), busulfan (DRUG), anti-thymocyte globulin (BIOLOGICAL), mycophenolate mofetil (DRUG), sargramostim (BIOLOGICAL).
Who is sponsoring clinical trial NCT00301951?
This trial is sponsored by University of California, San Francisco, which has 1,713 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00301951 being conducted?
This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT00301951's enrollment target sits among peer trials
7 286th of 299 higher than 12 of 299 other Lymphoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Lymphoma 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.
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