Trial · NCT04934670
A Study to Compare T-Guard vs Ruxolitinib for Treatment of Steroid-Refractory Acute Graft-vs-Host Disease (BMT CTN 2002)
NCT04934670, Phase 3, Terminated, Xenikos; results first posted 2024-08-27
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Study to Compare T-Guard vs Ruxolitinib for Treatment of Steroid-Refractory Acute Graft-vs-Host Disease (BMT CTN 2002). Trials, record NCT04934670. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04934670
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study to Compare T-Guard vs Ruxolitinib for Treatment of Steroid-Refractory Acute Graft-vs-Host Disease (BMT CTN 2002)
- NCT number
- NCT04934670
- Status
- Terminated
- Phases
- Phase 3
- Enrollment
- 12 participants, actual
- Lead sponsor
- Xenikos
- Conditions
- Steroid-Refractory Acute Graft Versus Host Disease
- Interventions
- T-Guard, Ruxolitinib
- First posted
- 2021-06-22
- Last updated
- 2024-08-27
- Other registries' IDs
- eudract:2021-000343-53
- Results first posted
- 2024-08-27
- Limitations and caveats
Early termination leading to small numbers of subjects analyzed, which resulted in the preparation and submission to the FDA and European authorities of an abbreviated clinical study report that did not contain all the outcome measures as specified in the clinical protocol.
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Complete Response (CR) | Day 28 | The primary objective of this trial is to assess the rate of CR on Day 28 post-randomization in Grades III and IV SR-aGVHD patients treated with T-Guard treatment in comparison to ruxolitinib. Participants were classified as Day 28 CR if these three conditions were satisfied: 1\. Stage 0 aGVHD (no remaining symptoms) in the three target organs skin, bowel and liver, 2 . The participant is still alive at Day 28, 3 . No additional systemic treatment for aGVHD has been administered through Day 28. |
| Secondary | Overall Survival (OS) | Day 180 | OS is defined as survival of death from any cause. The time from randomization until death from any cause will be described for each arm. |
| Secondary | Duration of Complete Response (DoCR) | Day 28 | DoCR will be evaluated only in the set of participants who are in CR at Day 28 post-randomization. The primary definition of DoCR is the time from Day 28 until an aGVHD target organ worsens by at least 1 stage and requires a significant escalation in treatment, or death. |
Source ClinicalTrials.gov
Outcomes3
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Complete Response (CR) | Day 28 | Intention to treat (ITT) | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Overall Survival (OS) | Day 180 | Participants randomized to the treatment arms were analyzed. For both treatment arms, the number of participants who died are reported. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Duration of Complete Response (DoCR) | Day 28 | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group6
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Complete Response (CR) | T-Guard | 2 | Participants | ||
| Complete Response (CR) | Ruxolitinib | 0 | Participants | ||
| Overall Survival (OS) | T-Guard | 4 | Participants | ||
| Overall Survival (OS) | Ruxolitinib | 1 | Participants | ||
| Duration of Complete Response (DoCR) | T-Guard | 2 | Participants | ||
| Duration of Complete Response (DoCR) | Ruxolitinib | 0 | Participants |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | T-Guard | 7 | |
| Overall Study | STARTED | Ruxolitinib | 5 | |
| Overall Study | COMPLETED | T-Guard | 2 | |
| Overall Study | COMPLETED | Ruxolitinib | 1 | |
| Overall Study | NOT COMPLETED | T-Guard | 5 | |
| Overall Study | NOT COMPLETED | Ruxolitinib | 4 |
Source ClinicalTrials.gov
Adverse events120
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Anaemia | Blood and lymphatic system disorders | T-Guard | 3 | 7 | 4 |
| other | Anaemia | Blood and lymphatic system disorders | Ruxolitinib | 0 | 5 | 0 |
| other | Febrile neutropenia | Blood and lymphatic system disorders | T-Guard | 0 | 7 | 0 |
| other | Febrile neutropenia | Blood and lymphatic system disorders | Ruxolitinib | 1 | 5 | 1 |
| other | Thrombocytopenia | Blood and lymphatic system disorders | T-Guard | 1 | 7 | 1 |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Ruxolitinib | 0 | 5 | 0 |
| other | Thrombotic microangiopathy | Blood and lymphatic system disorders | T-Guard | 2 | 7 | 2 |
| other | Thrombotic microangiopathy | Blood and lymphatic system disorders | Ruxolitinib | 0 | 5 | 0 |
| other | Factor XIII deficiency | Congenital, familial and genetic disorders | T-Guard | 0 | 7 | 0 |
| other | Factor XIII deficiency | Congenital, familial and genetic disorders | Ruxolitinib | 1 | 5 | 1 |
1 to 10 of 120Source ClinicalTrials.gov
See all 120 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | T-Guard | 4 | 7 |
| Total, all-cause mortality | Ruxolitinib | 1 | 5 |
| Total, other adverse events | T-Guard | 7 | 7 |
| Total, other adverse events | Ruxolitinib | 5 | 5 |
| Total, serious adverse events | T-Guard | 5 | 7 |
| Total, serious adverse events | Ruxolitinib | 2 | 5 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 37749187 | RESULT |
Source PubMed
Grants2
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|---|---|---|---|---|---|
| U24HL138660 | Blood and Marrow Transplant Clinical Trials Network DCC- The Medical College of Wisconsin, Inc. | HAMADANI, MEHDI HUSSAIN; DEVINE, STEVEN M.; LOGAN, BRENT R; MENDIZABAL, ADAM M. | MEDICAL COLLEGE OF WISCONSIN | NATIONAL HEART, LUNG, AND BLOOD INSTITUTE | 2017 to 2025 | NIH RePORTER |
| U10HL069294 | Blood & Marrow Transplant Clinical Trials Network Data Coordinating Center | HOROWITZ, MARY MARESCA | MEDICAL COLLEGE OF WISCONSIN | NATIONAL HEART, LUNG, AND BLOOD INSTITUTE | 2011 to 2016 | NIH RePORTER |
Trial comparisons5
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| T-Guard vs Ruxolitinib: Complete Response (CR) | Trial comparisons |
| T-Guard vs Ruxolitinib: Duration of Complete Response (DoCR) | Trial comparisons |
| T-Guard vs Ruxolitinib: Overall Survival (OS) | Trial comparisons |
| T-Guard vs Ruxolitinib: deaths from any cause | Trial comparisons |
| T-Guard vs Ruxolitinib: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT04934670
GET https://conductscience.org/api/trials/v1/NCT04934670/events?page=2