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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 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.
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.
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02250300
The ClinicalTrials.gov registry entry for NCT02250300 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 68 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 97-participant average among 3 other Allogeneic Hematopoietic Stem Cell Transplantation trials with a reported enrollment target (30% lower). The listed sponsor is Mehdi Hamadani, which has 2 total studies on file at ClinicalTrials.gov.
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 1 study location spanning 1 distinct geographic area - top geographies include 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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Related
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