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NCT01596699 · ClinicalTrials.gov registry record · Phase 2
Pilot Trial of Clofarabine Added to Standard Busulfan and Fludarabine for Conditioning Prior to Allogeneic Hematopoietic Cell Transplantation
A Phase 2 study, sponsored by University of California, San Francisco.
- Terminated
- Registry status
- Phase 2
- Development phase
- 16
- Enrollment target
NCT01596699: Clinical Trial Phase 2 study, sponsored by University of California, San Francisco.
NCT01596699 is a Phase 2 study that was terminated before completion, run by University of California, San Francisco. The registered enrollment target is 16 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (88% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01596699, a Phase 2 study, was terminated before completion, sponsored by University of California, San Francisco.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 16 participants
- Enrollment target
Study Summary
The purpose of this study is to find out what effects, good and/or bad, the addition of clofarabine, a new chemotherapy agent, to a standard busulfan and fludarabine conditioning treatment has. The study will also look at what causes some people to have high drug levels of these medications in their body compared to other people that may have low drug levels even if they all receive the same dose of medication.
Primary Outcome
Severe Toxicity will be defined as death or Grade IV by NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 pulmonary or hepatic failure (including moderate veno-occlusive disease(VOD) related to the transplant conditioning regimen within 100 days post-HCT. VOD will be defined by standard criteria. Patients must have Bilirubin \>2.0 plus Hepatomegaly and/or Right upper quadrant (RUQ) pain plus Weight gain \>5%.
Interventions
- DRUG Fludarabine
- DRUG Busulfan
- DRUG Alemtuzumab
- DRUG Clofarabine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 16 participants |
| Start Date | 2012-05-24 |
| Est. Completion | 2019-06 |
| Phase | Phase 2 |
Why NCT01596699 stopped before completion
NCT01596699 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 16 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (88% lower).
The record links to 0 conditions, and to 4 interventions - of which Fludarabine is the first listed.
NCT01596699 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01596699 about?
NCT01596699 is a clinical study titled "Pilot Trial of Clofarabine Added to Standard Busulfan and Fludarabine for Conditioning Prior to Allogeneic Hematopoietic Cell Transplantation". The purpose of this study is to find out what effects, good and/or bad, the addition of clofarabine, a new chemotherapy agent, to a standard busulfan and fludarabine conditioning treatment has. The study will also look at what causes some people to have high drug levels of these medications in their...
What is the current status of trial NCT01596699?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 16 participants. The study started on 2012-05-24. Estimated completion is 2019-06.
What interventions are being tested in trial NCT01596699?
The interventions under investigation include: Fludarabine (DRUG), Busulfan (DRUG), Alemtuzumab (DRUG), Clofarabine (DRUG).
Who is sponsoring clinical trial NCT01596699?
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 NCT01596699's enrollment target sits among peer trials
16 1908th of 2000 higher than 82 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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