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NCT02145403 · ClinicalTrials.gov registry record · Phase 1
Phase 1/2 Study of Carfilzomib for the Prevention of Relapse and GVHD in Allo-HCT for Hematologic Malignancies
A Phase 1 study of Hematologic Malignancies and Graft-Versus-Host Disease, sponsored by University of Michigan Rogel Cancer Center.
- Completed
- Registry status
- Phase 1
- Development phase
- 53
- Enrollment target
- 1
- Study location
NCT02145403: Completed Phase 1 study of Hematologic Malignancies and Graft-Versus-Host Disease, sponsored by University of Michigan Rogel Cancer Center.
NCT02145403 is a Phase 1 study of Hematologic Malignancies and Graft-Versus-Host Disease that has completed, run by University of Michigan Rogel Cancer Center. The registered enrollment target is 53 participants, below the 2,711-participant average among 45 other Hematologic Malignancies trials with a reported enrollment target (98% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02145403, a Phase 1 study of Hematologic Malignancies and Graft-Versus-Host Disease, has completed, sponsored by University of Michigan Rogel Cancer Center.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 53 participants
- Enrollment target
- 1
- Study location
Study Summary
The investigators hypothesize that adding carfilzomib to standard conditioning regimen for allo-HCT for advanced or high-risk hematologic malignancies will decrease post-transplant relapse and treatment-related mortality by decreasing severe GVHD, leading to overall improvement in transplant outcomes.
Primary Outcome
Subjects were enrolled on the first dose level (20 mg/m\^2), following a standard 3+3 dose escalation. For any given dose level, if none of the 3 subjects developed a treatment-related dose limiting toxicity (DLT), defined per protocol, dose escalation would follow. If a DLT occurred in any given dose level, the cohort would be expanded to 6. Further dose escalation would be made only if DLTs occurred in \<2 out of 6 subjects. If \>=2 of 6 develop DLTs, dose de-escalation would be made to the pr
Conditions Studied
Interventions
- DRUG Carfilzomib
- DRUG Tacrolimus
Study Locations (1)
Michigan
- University of Michigan Hospital - Ann Arbor
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 53 participants |
| Start Date | 2014-10 |
| Est. Completion | 2020-10-16 |
| Phase | Phase 1 |
What the finished NCT02145403 record still lists
NCT02145403 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 53 participants, a relatively small participant target, below the 2,711-participant average among 45 other Hematologic Malignancies trials with a reported enrollment target (98% lower).
The record links to 3 conditions, with Hematologic Malignancies appearing as the primary indexed condition, and to 2 interventions - of which Carfilzomib is the first listed.
NCT02145403 reports a single indexed study location in Michigan.
Frequently Asked Questions
What is clinical trial NCT02145403 about?
NCT02145403 is a clinical study titled "Phase 1/2 Study of Carfilzomib for the Prevention of Relapse and GVHD in Allo-HCT for Hematologic Malignancies". The investigators hypothesize that adding carfilzomib to standard conditioning regimen for allo-HCT for advanced or high-risk hematologic malignancies will decrease post-transplant relapse and treatment-related mortality by decreasing severe GVHD, leading to overall improvement in transplant outcome...
What is the current status of trial NCT02145403?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 53 participants. The study started on 2014-10. Estimated completion is 2020-10-16.
What conditions does trial NCT02145403 study?
This clinical trial studies the following conditions: Hematologic Malignancies, Graft-Versus-Host Disease, Relapse.
What interventions are being tested in trial NCT02145403?
The interventions under investigation include: Carfilzomib (DRUG), Tacrolimus (DRUG).
Who is sponsoring clinical trial NCT02145403?
This trial is sponsored by University of Michigan Rogel Cancer Center, which has 292 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02145403 being conducted?
This trial has 1 study location across Michigan. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Where NCT02145403's enrollment target sits among peer trials
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participants (enrollment target), bucketed by value
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