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NCT02250300 · ClinicalTrials.gov registry record · Phase 1
MLN9708 for the Prophylaxis of Chronic Graft-versus-host Disease in Patient Undergoing Allogeneic Transplantation
A Phase 1 study of Allogeneic Hematopoietic Stem Cell Transplantation, sponsored by Mehdi Hamadani.
- Completed
- Registry status
- Phase 1
- Development phase
- 68
- Enrollment target
- 1
- Study location
NCT02250300: Completed Phase 1 study of Allogeneic Hematopoietic Stem Cell Transplantation, sponsored by Mehdi Hamadani.
NCT02250300 is a Phase 1 study of Allogeneic Hematopoietic Stem Cell Transplantation that has completed, run by Mehdi Hamadani. The registered enrollment target is 68 participants, below the 97-participant average among 3 other Allogeneic Hematopoietic Stem Cell Transplantation trials with a reported enrollment target (30% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02250300, a Phase 1 study of Allogeneic Hematopoietic Stem Cell Transplantation, has completed, sponsored by Mehdi Hamadani.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 68 participants
- Enrollment target
- 1
- Study location
Study Summary
This is a phase I/II study of MLN9708 for the prophylaxis of chronic graft-versus-host-disease (GVHD) in patients undergoing allogeneic hematopoietic stem cell transplantation (HSCT). During the phase I portion, patients undergoing both sibling and unrelated donor transplantation will be enrolled on the same arm to determine the dose-limiting toxicity (DLT) and maximum-tolerated dose (MTD). During the phase II portion of the trial, patients will be enrolled into two separate and independent cohorts: a) Matched sibling transplants and b) Unrelated donors transplants. Both cohorts will be enrolled and analyzed separately.
Primary Outcome
Maximum-tolerated dose of ixazomib (MLN9708) will be determined from the incidence of dose limiting toxicities at each dosage. Results for both escalation phase cohorts (3.0 mg and 4.0 mg) were used to determine the maximum tolerated dose.
Conditions Studied
Interventions
- DRUG MLN9708 (2.3 mg)
- DRUG MLN9708 (4.0 mg)
- DRUG MLN9708 (3.0 mg)
Study Locations (1)
Wisconsin
- Froedtert Hospital and the Medical College of Wisconsin - Milwaukee
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 68 participants |
| Start Date | 2014-11-19 |
| Est. Completion | 2020-10-06 |
| Phase | Phase 1 |
What the finished NCT02250300 record still lists
NCT02250300 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 68 participants, a relatively small participant target, below the 97-participant average among 3 other Allogeneic Hematopoietic Stem Cell Transplantation trials with a reported enrollment target (30% lower).
The record links to 1 condition, with Allogeneic Hematopoietic Stem Cell Transplantation appearing as the primary indexed condition, and to 3 interventions - of which MLN9708 (2.3 mg) is the first listed.
NCT02250300 reports a single indexed study location in Wisconsin.
Frequently Asked Questions
What is clinical trial NCT02250300 about?
NCT02250300 is a clinical study titled "MLN9708 for the Prophylaxis of Chronic Graft-versus-host Disease in Patient Undergoing Allogeneic Transplantation". This is a phase I/II study of MLN9708 for the prophylaxis of chronic graft-versus-host-disease (GVHD) in patients undergoing allogeneic hematopoietic stem cell transplantation (HSCT). During the phase I portion, patients undergoing both sibling and unrelated donor transplantation will be enrolled o...
What is the current status of trial NCT02250300?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 68 participants. The study started on 2014-11-19. Estimated completion is 2020-10-06.
What conditions does trial NCT02250300 study?
This clinical trial studies the following conditions: Allogeneic Hematopoietic Stem Cell Transplantation.
What interventions are being tested in trial NCT02250300?
The interventions under investigation include: MLN9708 (2.3 mg) (DRUG), MLN9708 (4.0 mg) (DRUG), MLN9708 (3.0 mg) (DRUG).
Who is sponsoring clinical trial NCT02250300?
This trial is sponsored by Mehdi Hamadani, which has 2 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02250300 being conducted?
This trial has 1 study location across Wisconsin. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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