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NCT02806947 · ClinicalTrials.gov registry record · Phase 2

A Study to Evaluate Steroid-free Treatment for Standard-Risk aGVHD (BMT CTN 1501)

A Phase 2 study, sponsored by Medical College of Wisconsin.

Completed
Registry status
Phase 2
Development phase
127
Enrollment target

NCT02806947: Completed Phase 2 study, sponsored by Medical College of Wisconsin.

NCT02806947 is a Phase 2 study that has completed, run by Medical College of Wisconsin. The registered enrollment target is 127 participants, roughly in line with the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT02806947, a Phase 2 study, has completed, sponsored by Medical College of Wisconsin.

COMPLETED
Registry status
Phase 2
Development phase
127 participants
Enrollment target

Study Summary

The study is a Phase II randomized, open label, multicenter trial designed to identify whether sirolimus is a potential alternative to prednisone as an up-front treatment for patients with standard-risk acute GVHD defined according to clinical and biomarker-based risk stratification. This trial incorporates both a novel up front GVHD therapy (sirolimus) as well as a novel BMT CTN developed acute GVHD biomarker test.

Primary Outcome

Scoring of CR/PR is in comparison to the participant's acute GVHD status at randomization. Complete response (CR) is defined as staging of 0 for in all target organs for GVHD - skin, GI tract, and liver. Partial response (PR) is defined as improvement in some target organ(s) without worsening in others. Death and initiation of systemic acute GVHD treatment beyond randomized treatment are considered failures for this endpoint. Organ staging is defined below: Skin stage: 0: No rash 1. Rash \<25

Interventions

  • DRUG Sirolimus
  • DRUG Prednisone

Trial Details

FieldValue
Enrollment Target 127 participants
Start Date 2016-10
Est. Completion 2019-02-19
Phase Phase 2
Medical College of Wisconsin

447 total trials

What the finished NCT02806947 record still lists

NCT02806947 is an interventional study that assigns participants to a tested intervention. The registered 127 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target.

The record links to 0 conditions, and to 2 interventions - of which Sirolimus is the first listed.

NCT02806947 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT02806947 about?

NCT02806947 is a clinical study titled "A Study to Evaluate Steroid-free Treatment for Standard-Risk aGVHD (BMT CTN 1501)". The study is a Phase II randomized, open label, multicenter trial designed to identify whether sirolimus is a potential alternative to prednisone as an up-front treatment for patients with standard-risk acute GVHD defined according to clinical and biomarker-based risk stratification. This trial inco...

What is the current status of trial NCT02806947?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 127 participants. The study started on 2016-10. Estimated completion is 2019-02-19.

What interventions are being tested in trial NCT02806947?

The interventions under investigation include: Sirolimus (DRUG), Prednisone (DRUG).

Who is sponsoring clinical trial NCT02806947?

This trial is sponsored by Medical College of Wisconsin, which has 447 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT02806947's enrollment target sits among peer trials

127 555th of 2000 higher than 1,445 of 2,000 other Phase 2 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT02806947, the US trial registry maintained by the National Library of Medicine. NCT02806947 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.