Trial · NCT02953678
A Study of Ruxolitinib in Combination With Corticosteroids for the Treatment of Steroid-Refractory Acute Graft-Versus-Host Disease (REACH-1)
NCT02953678, Phase 2, Completed, Incyte Corporation; results first posted 2019-08-20
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Study of Ruxolitinib in Combination With Corticosteroids for the Treatment of Steroid-Refractory Acute Graft-Versus-Host Disease (REACH-1). Trials, record NCT02953678. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02953678
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study of Ruxolitinib in Combination With Corticosteroids for the Treatment of Steroid-Refractory Acute Graft-Versus-Host Disease (REACH-1)
- NCT number
- NCT02953678
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 71 participants, actual
- Lead sponsor
- Incyte Corporation
- Conditions
- Graft-versus-host Disease (GVHD)
- Interventions
- Ruxolitinib, Prednisone or methylprednisolone
- First posted
- 2016-11-03
- Last updated
- 2021-11-24
- Results first posted
- 2019-08-20
Source ClinicalTrials.gov
Registered outcomes10
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Overall Response Rate (ORR) at Day 28 | From baseline to Day 28 | Defined as the percentage of participants demonstrating a complete response (CR), very good partial response (VGPR), or partial response (PR). |
| Secondary | Overall Response Rate (ORR) | From baseline to days 14, 56, and 100 | Defined as the percentage of participants demonstrating a CR, VGPR, or PR. |
| Secondary | Nonrelapse Mortality (NRM) | From baseline to Months 6, 9, 12, and 24 | Defined as the proportion of subjects who died due to causes other than malignancy relapse. |
| Secondary | Percentage of Participants With Six-month Duration of Response (DOR) | From Baseline up to 6 months | Defined as the time from first response until graft-versus-host disease (GVHD) progression or death. DOR was assessed when all participants who were on the study completed the Day 180 visit. |
| Secondary | Percentage of Participants With Three-month DOR | From Baseline up to 3 months | Defined as the time from first response until GVHD progression or death. DOR was assessed when all participants who were on the study completed the Day 84 visit. |
| Secondary | Relapse Rate | From Baseline until death, withdrawal of consent, or the end of the study, whichever occurs first (up to approximately 24 months) | Defined as the percentage of participants whose underlying malignancy relapsed. |
| Secondary | Relapse-related Mortality Rate | From Baseline until death, withdrawal of consent, or the end of the study, whichever occurs first (up to approximately 24 months) | Defined as the percentage of participants whose malignancy relapsed and had a fatal outcome. |
| Secondary | Failure-free Survival (FFS) | From Baseline until death, withdrawal of consent, or the end of the study, whichever occurs first (up to approximately 24 months) | Defined as the time from first dose of ruxolitinib to the earliest date that a participant died, had a relapse/progression of the underlying malignancy, required additional therapy for aGVHD, or demonstrated signs or symptoms of chronic graft-versus-host disease (cGVHD). |
| Secondary | Overall Survival (OS) | From Baseline until death, withdrawal of consent, or the end of the study, whichever occurs first (up to approximately 24 months) | Defined as the time from study enrollment (first day of ruxolitinib treatment) to death due to any cause. |
| Secondary | Number of Participants With Treatment-emergent Adverse Events (TEAES), Serious TEAEs, And Grade 3 or Higher TEAEs | From signing the informed consent form up to 30-35 days after the last dose of study treatment (up to 24 months) | AE was any unfavorable and unintended sign, symptom, or disease temporally associated with use of medical treatment or procedure that may or may not be considered related to the medical treatment or procedure. Serious AE was any untoward medical occurrence that results in death; is life-threatening; requires inpatient hospitalization or prolongation of present hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect or is a medically important event that may not be immediately life-threatening or result in death or hospitalization. TEAE was an AE that was reported for the first time, or worsening of a pre-existing event after the first dose of study drug (until 30 days after the last dose of study drug). Severity of AEs was described and graded using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE version 4.03). Grade 3 and above would constitute a severe, life-threatening, or death event. |
Source ClinicalTrials.gov
Outcomes10
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Overall Response Rate (ORR) at Day 28 | From baseline to Day 28 | Efficacy Evaluable Participants who had a CR, VGPR, or PR at Day 28 response assessment or other response assessments within ± 2 days of Day 28, on or before the start of new anti-GVHD therapy | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Overall Response Rate (ORR) | From baseline to days 14, 56, and 100 | Efficacy Evaluable Population included all participants enrolled in this study. | percentage of participants | NUMBER |
| SECONDARY | Nonrelapse Mortality (NRM) | From baseline to Months 6, 9, 12, and 24 | Efficacy Evaluable Participants including all responders as of the data cutoff (02 JUL 2018). | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Six-month Duration of Response (DOR) | From Baseline up to 6 months | Efficacy Evaluable Population included all participants enrolled in this study. Participants who achieved ORR were analyzed for this outcome measure. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Three-month DOR | From Baseline up to 3 months | Efficacy Evaluable Population included all participants enrolled in this study. Participants who achieved ORR were analyzed for this outcome measure. | percentage of participants | NUMBER |
| SECONDARY | Relapse Rate | From Baseline until death, withdrawal of consent, or the end of the study, whichever occurs first (up to approximately 24 months) | Efficacy Evaluable Population included all participants enrolled in this study. | percentage of participants | NUMBER |
| SECONDARY | Relapse-related Mortality Rate | From Baseline until death, withdrawal of consent, or the end of the study, whichever occurs first (up to approximately 24 months) | Efficacy Evaluable Population included all participants enrolled in this study. | percentage of participants | NUMBER |
| SECONDARY | Failure-free Survival (FFS) | From Baseline until death, withdrawal of consent, or the end of the study, whichever occurs first (up to approximately 24 months) | Efficacy Evaluable Participants | days | MEDIAN |
| SECONDARY | Overall Survival (OS) | From Baseline until death, withdrawal of consent, or the end of the study, whichever occurs first (up to approximately 24 months) | Efficacy Evaluable Participants: Participants who had CR, VGPR, or PR on or before the start of new anti-GVHD therapy. | days | MEDIAN |
| SECONDARY | Number of Participants With Treatment-emergent Adverse Events (TEAES), Serious TEAEs, And Grade 3 or Higher TEAEs | From signing the informed consent form up to 30-35 days after the last dose of study treatment (up to 24 months) | Safety Evaluable Population included all participants enrolled in the study who received at least 1 dose of study drug. | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group19
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Overall Response Rate (ORR) at Day 28 | Ruxolitinib in Combination With Corticosteroids | Responders - CR | 19 | Participants | |
| Overall Response Rate (ORR) at Day 28 | Ruxolitinib in Combination With Corticosteroids | Responders - VGPR | 7 | Participants | |
| Overall Response Rate (ORR) at Day 28 | Ruxolitinib in Combination With Corticosteroids | Responders - PR | 13 | Participants | |
| Overall Response Rate (ORR) | Ruxolitinib in Combination With Corticosteroids | Day 14 | 62.0 | 95% Confidence Interval 49.7 to 73.2 | percentage of participants |
| Overall Response Rate (ORR) | Ruxolitinib in Combination With Corticosteroids | Day 56 | 36.6 | 95% Confidence Interval 25.5 to 48.9 | percentage of participants |
| Overall Response Rate (ORR) | Ruxolitinib in Combination With Corticosteroids | Day 100 | 32.4 | 95% Confidence Interval 21.8 to 44.5 | percentage of participants |
| Nonrelapse Mortality (NRM) | Ruxolitinib in Combination With Corticosteroids | 6 months | 44.4 | 95% Confidence Interval 32.5 to 55.7 | percentage of participants |
| Nonrelapse Mortality (NRM) | Ruxolitinib in Combination With Corticosteroids | 9 months | 48.2 | 95% Confidence Interval 35.8 to 59.5 | percentage of participants |
| Nonrelapse Mortality (NRM) | Ruxolitinib in Combination With Corticosteroids | 12 months | 52.9 | 95% Confidence Interval 39.6 to 64.5 | percentage of participants |
| Nonrelapse Mortality (NRM) | Ruxolitinib in Combination With Corticosteroids | 24 months | 64.8 | 95% Confidence Interval 46.0 to 78.5 | percentage of participants |
1 to 10 of 19Source ClinicalTrials.gov
See all 19 results by groupParticipant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Ruxolitinib in Combination With Corticosteroids | 71 | |
| Overall Study | COMPLETED | Ruxolitinib in Combination With Corticosteroids | 0 | |
| Overall Study | NOT COMPLETED | Ruxolitinib in Combination With Corticosteroids | 71 |
Source ClinicalTrials.gov
Adverse events210
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 | Ruxolitinib in Combination With Corticosteroids | 45 | 71 | |
| other | Neutropenia | Blood and lymphatic system disorders | Ruxolitinib in Combination With Corticosteroids | 6 | 71 | |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Ruxolitinib in Combination With Corticosteroids | 13 | 71 | |
| other | Pericardial effusion | Cardiac disorders | Ruxolitinib in Combination With Corticosteroids | 7 | 71 | |
| other | Sinus tachycardia | Cardiac disorders | Ruxolitinib in Combination With Corticosteroids | 14 | 71 | |
| other | Dry eye | Eye disorders | Ruxolitinib in Combination With Corticosteroids | 11 | 71 | |
| other | Vision blurred | Eye disorders | Ruxolitinib in Combination With Corticosteroids | 8 | 71 | |
| other | Abdominal distension | Gastrointestinal disorders | Ruxolitinib in Combination With Corticosteroids | 11 | 71 | |
| other | Abdominal pain | Gastrointestinal disorders | Ruxolitinib in Combination With Corticosteroids | 15 | 71 | |
| other | Ascites | Gastrointestinal disorders | Ruxolitinib in Combination With Corticosteroids | 6 | 71 |
1 to 10 of 210Source ClinicalTrials.gov
See all 210 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Ruxolitinib in Combination With Corticosteroids | 46 | 71 |
| Total, other adverse events | Ruxolitinib in Combination With Corticosteroids | 69 | 71 |
| Total, serious adverse events | Ruxolitinib in Combination With Corticosteroids | 59 | 71 |
Source ClinicalTrials.gov
Papers2
The papers the trial lists on ClinicalTrials.gov.
Grants0
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.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
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/NCT02953678
GET https://conductscience.org/api/trials/v1/NCT02953678/events?page=2