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NCT00521859 · ClinicalTrials.gov registry record · Phase 1
Cloretazine (VNP40101M) With Hematopoietic Cell Transplantation for Hematologic Malignancies
A Phase 1 study, sponsored by M.D. Anderson Cancer Center.
- Completed
- Registry status
- Phase 1
- Development phase
- 5
- Enrollment target
NCT00521859: Completed Phase 1 study, sponsored by M.D. Anderson Cancer Center.
NCT00521859 is a Phase 1 study that has completed, run by M.D. Anderson Cancer 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
NCT00521859, a Phase 1 study, has completed, sponsored by M.D. Anderson Cancer Center.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 5 participants
- Enrollment target
Study Summary
Primary: Define the maximal tolerated dose (MTD) of VNP40401M when given with hematopoietic cell transplantation (HCT) Secondary: * Describe the change in pharmacokinetic (PK) parameters with increasing doses of drug. * Describe and estimate the frequency of \> Grade 3 non-hematologic/non-infectious toxicities at the MTD. * Report the efficacy of the regimen. * Evaluate the rate of engraftment for the regimen.
Interventions
- DRUG Fludarabine
- DRUG Cloretazine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 5 participants |
| Start Date | 2007-08 |
| Est. Completion | 2010-12 |
| Phase | Phase 1 |
What the finished NCT00521859 record still lists
NCT00521859 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 2 interventions - of which Fludarabine is the first listed.
NCT00521859 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00521859 about?
NCT00521859 is a clinical study titled "Cloretazine (VNP40101M) With Hematopoietic Cell Transplantation for Hematologic Malignancies". Primary: Define the maximal tolerated dose (MTD) of VNP40401M when given with hematopoietic cell transplantation (HCT) Secondary: * Describe the change in pharmacokinetic (PK) parameters with increasing doses of drug. * Describe and estimate the frequency of \> Grade 3 non-hematologic/non-infecti...
What is the current status of trial NCT00521859?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 5 participants. The study started on 2007-08. Estimated completion is 2010-12.
What interventions are being tested in trial NCT00521859?
The interventions under investigation include: Fludarabine (DRUG), Cloretazine (DRUG).
Who is sponsoring clinical trial NCT00521859?
This trial is sponsored by M.D. Anderson Cancer Center, which has 2,692 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00521859'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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