At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 186 enrolled
Drug / intervention
Abatacept +1 moredrug
Likely dose
Not stated in 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.
Abatacept Combined With a Calcineurin Inhibitor and Methotrexate for Graft Versus Host Disease Prophylaxis: A Randomized Controlled Trial
In Brief
A Phase 2 clinical trial evaluating Abatacept and placebo for Graft vs Host Disease and Malignancy. Completed, enrolled 186 participants across 14 sites in 2 countries.
Detailed Summary
This is a phase II multi-center, randomized, double blind, placebo-controlled trial. The investigators are doing this study to see if a new drug, abatacept, can be used together with a calcineurin inhibitor (cyclosporine or tacrolimus) and methotrexate to provide better protection against Acute Graft versus Host Disease (aGvHD) without causing more infections.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsGraft vs Host Disease, Malignancy
CountriesCanada, United States
CollaboratorsFDA Office of Orphan Products Development
Timeline
Phase 2CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedDec 2012
Enrollment StartFeb 2013
Primary CompletionJun 2018
Study CompletionMar 2024
TodayJul 2026
First PostedDec 6, 2012
Enrollment StartFeb 1, 2013
Primary CompletionJun 30, 2018
Study CompletionMar 30, 2024
TodayJul 2, 2026
Enrollment to primary: 5.4 yearsPosted 13.6 years ago
Interventions
Abataceptdrug
Arm B-investigational prophylaxis with abatacept, a calcineurin inhibitor and methotrexate
placebodrug