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Abatacept as GVHD Prophylaxis Phase 2

NCT01743131 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 186

Last updated 2025-12-11

Study results available
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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.

Conditions

  • Graft vs Host Disease
  • Malignancy

Interventions

DRUG

Abatacept

Arm B-investigational prophylaxis with abatacept, a calcineurin inhibitor and methotrexate

DRUG

placebo

Sponsors & Collaborators

Principal Investigators

  • Leslie Kean, MD, PhD · Boston Children's Hospital

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
6 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-02-01
Primary Completion
2018-06-30
Completion
2024-03-30

Countries

  • United States
  • Canada

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01743131 on ClinicalTrials.gov