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NCT01900509 · ClinicalTrials.gov registry record · Phase 1
Bendamustine Hydrochloride, Clofarabine, and Etoposide in Treating Younger Patients With Relapsed or Refractory Hematologic Malignancies
A Phase 1 study, sponsored by St. Jude Children's Research Hospital.
- Completed
- Registry status
- Phase 1
- Development phase
- 16
- Enrollment target
NCT01900509: Completed Phase 1 study, sponsored by St. Jude Children's Research Hospital.
NCT01900509 is a Phase 1 study that has completed, run by St. Jude Children's Research Hospital. The registered enrollment target is 16 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (73% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01900509, a Phase 1 study, has completed, sponsored by St. Jude Children's Research Hospital.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 16 participants
- Enrollment target
Study Summary
Participants with relapsed or refractory leukemia or lymphoma will be recruited for this study to find whether or not the addition of a new drug called bendamustine will be safe and possible to give with other chemotherapy drugs. This drug is approved by the Food and Drug Administration (FDA) for the treatment of other cancers in adults that are similar to those being studied in the research trial. PRIMARY OBJECTIVES * To establish the maximum tolerated dose (MTD) of bendamustine in combination with clofarabine and etoposide in pediatric participants with hematologic malignancies. * To characterize the safety profile and dose-limiting toxicities (DLTs) of bendamustine in combination with clofarabine and etoposide. SECONDARY OBJECTIVES * To estimate event-free survival at 4 months. * To estimate minimal residual disease (MRD) levels present at end of each cycle of therapy in participants with leukemia. * To characterize the pharmacokinetic profile of bendamustine in the proposed regimen.
Primary Outcome
Establish MTD of bendamustine in combination with clofarabine and etoposide.
Interventions
- DRUG Etoposide
- DRUG Dexamethasone
- DRUG Bendamustine
- DRUG Clofarabine
- DRUG Etoposide phosphate
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 16 participants |
| Start Date | 2013-08 |
| Est. Completion | 2016-05 |
| Phase | Phase 1 |
What the finished NCT01900509 record still lists
NCT01900509 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 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (73% lower).
The record links to 0 conditions, and to 5 interventions - of which Etoposide is the first listed.
NCT01900509 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01900509 about?
NCT01900509 is a clinical study titled "Bendamustine Hydrochloride, Clofarabine, and Etoposide in Treating Younger Patients With Relapsed or Refractory Hematologic Malignancies". Participants with relapsed or refractory leukemia or lymphoma will be recruited for this study to find whether or not the addition of a new drug called bendamustine will be safe and possible to give with other chemotherapy drugs. This drug is approved by the Food and Drug Administration (FDA) for th...
What is the current status of trial NCT01900509?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 16 participants. The study started on 2013-08. Estimated completion is 2016-05.
What interventions are being tested in trial NCT01900509?
The interventions under investigation include: Etoposide (DRUG), Dexamethasone (DRUG), Bendamustine (DRUG), Clofarabine (DRUG), Etoposide phosphate (DRUG).
Who is sponsoring clinical trial NCT01900509?
This trial is sponsored by St. Jude Children's Research Hospital, which has 410 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01900509's enrollment target sits among peer trials
16 1786th of 2000 higher than 203 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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