CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 68 enrolled
Drug / intervention
MLN9708 (2.3 mg) +2 moredrug
Likely dose
MLN9708 (2.3 mg)from record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02250300
NCT02250300Phase 2Completed
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MLN9708 for the Prophylaxis of Chronic Graft-versus-host Disease in Patient Undergoing Allogeneic Transplantation

Mehdi Hamadani·interventional·Posted Sep 26, 2014·Updated Mar 8, 2023

In Brief

A Phase 2 clinical trial evaluating MLN9708 (2.3 mg), MLN9708 (4.0 mg), and 1 other intervention for Allogeneic Hematopoietic Stem Cell Transplantation. Completed, enrolled 68 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAllogeneic Hematopoietic Stem Cell Transplantation
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
201520162017201820192020202120222023202420252026
First PostedSep 26, 2014
Enrollment StartNov 19, 2014
Primary CompletionOct 6, 2020
TodayJul 2, 2026
Enrollment to primary: 5.9 yearsPosted 11.8 years ago

Interventions

MLN9708 (2.3 mg)drug

2.3 mg

MLN9708 (4.0 mg)drug

4.0 mg

MLN9708 (3.0 mg)drug

3.0 mg