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NCT02046291 · ClinicalTrials.gov registry record · Phase 1
Safety of Romiplostim (Nplate®) Following UCBT
A Phase 1 study, sponsored by Masonic Cancer Center, University of Minnesota.
- Completed
- Registry status
- Phase 1
- Development phase
- 21
- Enrollment target
NCT02046291 is a Phase 1 study that has completed, run by Masonic Cancer Center, University of Minnesota. The registered enrollment target is 21 participants.
The verdict
NCT02046291, a Phase 1 study, has completed, sponsored by Masonic Cancer Center, University of Minnesota.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 21 participants
- Enrollment target
Study Summary
This is a single institution, phase I dose escalation study of weekly romiplostim post umbilical cord blood transplantation in patients who fail to achieve platelet engraftment by day +30. Engraftment is defined as a platelet count ≥ 20 x 109/L on 3 consecutive measurements without transfusion for 7 days. Romiplostim is administered at the assigned dose as 6 weekly injections beginning by day +42 post transplant. Up to 4 dose levels (4, 6, 8, and 10 mcg/kg/dose) will be evaluated with the maximum tolerated dose (MTD) of romiplostim determined by using the Continual Reassessment Method (CRM). The goal of this CRM will be to identify 1 of the 4 dose levels which corresponds to the desired maximum toxicity rate of 20% or less.
Interventions
- DRUG Romiplostim
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 21 participants |
| Start Date | 2015-04-10 |
| Est. Completion | 2021-06-01 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02046291
The ClinicalTrials.gov registry entry for NCT02046291 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 21 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Masonic Cancer Center, University of Minnesota, which has 249 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Romiplostim is the first listed.
NCT02046291 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02046291 about?
NCT02046291 is a clinical study titled "Safety of Romiplostim (Nplate®) Following UCBT". This is a single institution, phase I dose escalation study of weekly romiplostim post umbilical cord blood transplantation in patients who fail to achieve platelet engraftment by day +30. Engraftment is defined as a platelet count ≥ 20 x 109/L on 3 consecutive measurements without transfusion for 7...
What is the current status of trial NCT02046291?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 21 participants. The study started on 2015-04-10. Estimated completion is 2021-06-01.
What interventions are being tested in trial NCT02046291?
The interventions under investigation include: Romiplostim (DRUG).
Who is sponsoring clinical trial NCT02046291?
This trial is sponsored by Masonic Cancer Center, University of Minnesota, which has 249 total clinical trials registered on ClinicalTrials.gov.
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