Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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 is a Phase 1 study that has completed, run by St. Jude Children's Research Hospital. The registered enrollment target is 16 participants.
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.
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01900509
The ClinicalTrials.gov registry entry for NCT01900509 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 16 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is St. Jude Children's Research Hospital, which has 410 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 5 interventions - of which Etoposide is the first listed.
NCT01900509 reports 0 study locations.
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
Explore more on PlainTrial
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.