Trial · NCT03112603
A Study of Ruxolitinib vs Best Available Therapy (BAT) in Patients With Steroid-refractory Chronic Graft vs. Host Disease (GvHD) After Bone Marrow Transplantation (REACH3)
NCT03112603, Phase 3, Completed, Incyte Corporation; results first posted 2022-04-15
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Study of Ruxolitinib vs Best Available Therapy (BAT) in Patients With Steroid-refractory Chronic Graft vs. Host Disease (GvHD) After Bone Marrow Transplantation (REACH3). Trials, record NCT03112603. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03112603
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study of Ruxolitinib vs Best Available Therapy (BAT) in Patients With Steroid-refractory Chronic Graft vs. Host Disease (GvHD) After Bone Marrow Transplantation (REACH3)
- NCT number
- NCT03112603
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 330 participants, actual
- Lead sponsor
- Incyte Corporation
- Conditions
- Graft-versus-host Disease (GVHD)
- Interventions
Ruxolitinib, Extracorporeal photopheresis (ECP), Low-dose methotrexate (MTX), Mycophenolate mofetil (MMF), mechanistic Target of Rapamycin (mTOR) inhibitors (everolimus or sirolimus), Infliximab, Rituximab, Pentostatin, Imatinib, Ibrutinib
- First posted
- 2017-04-13
- Last updated
- 2025-08-12
- Other registries' IDs
- eudract:2016-004432-38
- Results first posted
- 2022-04-15
Source ClinicalTrials.gov
Registered outcomes24
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Efficacy of Ruxolitinib Versus Investigator's Choice Best Available Therapy (BAT) in Participants With Moderate or Severe Steroid Refractory Chronic Graft Versus Host Disease (SR-cGvHD) Assessed by Overall Response Rate (ORR) at the Cycle 7 Day 1 Visit | Cycle 7 Day 1 (each cycle was comprised of 4 weeks) | ORR was defined as the percentage of participants in each arm demonstrating a complete response (CR) or partial response (PR) based on chronic GvHD (cGvHD) disease assessments (National Institutes of Health Consensus Criteria) without the requirement of additional systemic therapies for an earlier progression, mixed response, or non-response. Scoring of response was relative to the organ score at the time of randomization. CR: complete resolution of all signs and symptoms of cGVHD in all evaluable organs without the initiation or addition of new systemic therapy. PR: improvement in at least one organ (e.g., improvement of 1 or more points on a 4- to 7-point scale, or an improvement of 2 or more points on a 10- to 12-point scale) without progression in other organs or sites, initiation, or addition of new systemic therapies. |
| Secondary | Rate of Participants With Clinically Relevant Improvement of the Modified Lee cGvHD Symptom Scale Score | Baseline; Cycle 7 Day 1 (each cycle was comprised of 4 weeks) | To assess improvement of symptoms based on the total symptom score (TSS); a responder was defined as having achieved a clinically relevant reduction from Baseline of the TSS. The scale consists of 30 items in 7 subscales (skin, eye, mouth, lung, nutrition, energy, and psychological). Participants reported their level of symptom "bother" over the previous month on a 5-point likert scale: not at all, slightly, moderately, quite a bit, or extremely. Subscale scores and the summary score range from 0 to 100, with a higher score indicating worse symptoms. |
| Secondary | Rate of Failure-free Survival (FFS) | Baseline to when the last participant reached Cycle 7 Day 1 (each cycle was comprised of 4 weeks) | Composite time to event endpoint incorporating the following FFS events: (i) relapse or recurrence of underlying disease or death due to underlying disease, (ii) nonrelapse mortality, or (iii) addition or initiation of another systemic therapy for cGvHD. |
| Secondary | Rate of FFS at Study Completion | From Baseline to Last Participant Last Visit (LPLV) (approximately 5 years) | Composite time to event endpoint incorporating the following FFS events: (i) relapse or recurrence of underlying disease or death due to underlying disease, (ii) nonrelapse mortality, or (iii) addition or initiation of another systemic therapy for cGvHD. |
| Secondary | Best Overall Response (BOR) at Cycle 7 Day 1 | up to Cycle 7 Day 1 (each cycle was comprised of 4 weeks) | BOR was defined as the percentage of participants who achieved an overall response (CR+PR) based on cGvHD disease assessments (National Institutes of Health Consensus Criteria) without the requirement of additional systemic therapies for an earlier progression, mixed response, or non-response at any time point (up to Cycle 7 Day 1 or the start of additional systemic therapy for cGvHD). Scoring of response was relative to the organ score at the time of randomization. CR: complete resolution of all signs and symptoms of cGVHD in all evaluable organs without the initiation or addition of new systemic therapy. PR: improvement in at least one organ (e.g., improvement of 1 or more points on a 4- to 7-point scale, or an improvement of 2 or more points on a 10- to 12-point scale) without progression in other organs or sites, initiation, or addition of new systemic therapies. This analysis was based on the primary cutoff date (May 2020). |
| Secondary | BOR During Cross-over Treatment With Ruxolitinib | from Crossover Cycle 1 Day 1 to any time point up to and including Crossover Cycle 7 Day 1 (each cycle was comprised of 4 weeks) | BOR was defined as the percentage of participants who achieved an overall response (CR+PR) based on cGvHD disease assessments (National Institutes of Health Consensus Criteria) without the requirement of additional systemic therapies for an earlier progression, mixed response, or non-response at any time point (up to Cycle 7 Day 1 or the start of additional systemic therapy for cGvHD). Scoring of response was relative to the organ score at the time of randomization. CR: complete resolution of all signs and symptoms of cGVHD in all evaluable organs without the initiation or addition of new systemic therapy. PR: improvement in at least one organ (e.g., improvement of 1 or more points on a 4- to 7-point scale, or an improvement of 2 or more points on a 10- to 12-point scale) without progression in other organs or sites, initiation, or addition of new systemic therapies. |
| Secondary | ORR at the End of Cycle 3 | Cycle 4 Day 1 (each cycle was comprised of 4 weeks) | ORR was defined as the percentage of participants in each arm demonstrating a CR or PR based on cGvHD disease assessments (National Institutes of Health Consensus Criteria) without the requirement of additional systemic therapies for an earlier progression, mixed response, or non-response. Scoring of response was relative to the organ score at the time of randomization. CR: complete resolution of all signs and symptoms of cGVHD in all evaluable organs without the initiation or addition of new systemic therapy. PR: improvement in at least one organ (e.g., improvement of 1 or more points on a 4- to 7-point scale, or an improvement of 2 or more points on a 10- to 12-point scale) without progression in other organs or sites, initiation, or addition of new systemic therapies. |
| Secondary | Duration of Response Through Study Completion | from first response to LPLV (approximately 5 years) | DOR was defined as the time from first response until cGvHD progression, death, or the date of change/addition of systemic therapies for cGvHD and as assessed for responders only. Response was based on cGvHD disease assessments (National Institutes of Health consensus criteria). Duration of response was evaluated in participants who achieved a CR or PR at or before Cycle 7 Day 1. The analysis included a larger number of participants than the number of participants who achieved CR or PR at Cycle 7 Day 1 (82 ruxolitinib and 42 BAT) because the analysis took into account not only those participants who achieved CR or PR at Cycle 7 Day 1, but also participants who achieved CR or PR before Cycle 7 Day 1 but who may have lost their response at Cycle 7 Day 1. For this reason, the number of participants in this analysis does not align with the best overall response (BOR) at Cycle 7 Day 1. This analysis was based on the cutoff date upon study completion (December 2022). |
| Secondary | Overall Survival (OS) | from the date of randomization to the date of death due to any cause up to LPLV (approximately 5 years) | Overall survival was defined as the time from the date of randomization to the date of death due to any cause. |
| Secondary | Cumulative Incidence of Non-relapse Mortality (NRM) | Months 3, 6, 12, 18, 24, 30, and 36 | Defined as the cumulative incidence rate from competing risk analysis for NRM from the date of randomization to the date of death not preceded by underlying disease relapse/recurrence. |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 registered outcomesOutcomes24
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Efficacy of Ruxolitinib Versus Investigator's Choice Best Available Therapy (BAT) in Participants With Moderate or Severe Steroid Refractory Chronic Graft Versus Host Disease (SR-cGvHD) Assessed by Overall Response Rate (ORR) at the Cycle 7 Day 1 Visit | Cycle 7 Day 1 (each cycle was comprised of 4 weeks) | Full Analysis Set (FAS): all participants to whom study treatment was assigned by randomization. Data reported are from the start of the study to Cycle 7 Day 1 (data cutoff of 08 May 2020). | percentage of participants | NUMBER |
| SECONDARY | Rate of Participants With Clinically Relevant Improvement of the Modified Lee cGvHD Symptom Scale Score | Baseline; Cycle 7 Day 1 (each cycle was comprised of 4 weeks) | FAS. Data reported are from the start of the study to Cycle 7 Day 1 (data cutoff of 08 May 2020). | percentage of participants | NUMBER |
| SECONDARY | Rate of Failure-free Survival (FFS) | Baseline to when the last participant reached Cycle 7 Day 1 (each cycle was comprised of 4 weeks) | FAS. Data reported are from the start of the study to Cycle 7 Day 1 (data cutoff of 08 May 2020). | months | MEDIAN |
| SECONDARY | Rate of FFS at Study Completion | From Baseline to Last Participant Last Visit (LPLV) (approximately 5 years) | FAS | months | MEDIAN |
| SECONDARY | Best Overall Response (BOR) at Cycle 7 Day 1 | up to Cycle 7 Day 1 (each cycle was comprised of 4 weeks) | FAS. Data reported are from the start of the study to Cycle 7 Day 1 (data cutoff of 08 May 2020). | percentage of participants | NUMBER |
| SECONDARY | BOR During Cross-over Treatment With Ruxolitinib | from Crossover Cycle 1 Day 1 to any time point up to and including Crossover Cycle 7 Day 1 (each cycle was comprised of 4 weeks) | Cross-over Analysis Set | percentage of participants | NUMBER |
| SECONDARY | ORR at the End of Cycle 3 | Cycle 4 Day 1 (each cycle was comprised of 4 weeks) | FAS | percentage of participants | NUMBER |
| SECONDARY | Duration of Response Through Study Completion | from first response to LPLV (approximately 5 years) | FAS. Duration of response was evaluated in participants who achieved a CR or PR at or before Cycle 7 Day 1. | Months | MEDIAN |
| SECONDARY | Overall Survival (OS) | from the date of randomization to the date of death due to any cause up to LPLV (approximately 5 years) | FAS | months | MEDIAN |
| SECONDARY | Cumulative Incidence of Non-relapse Mortality (NRM) | Months 3, 6, 12, 18, 24, 30, and 36 | FAS. Only participants with available data were analyzed. | percentage of participants | NUMBER |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 outcomesResults by group169
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
Efficacy of Ruxolitinib Versus Investigator's Choice Best Available Therapy (BAT) in Participants With Moderate or Severe Steroid Refractory Chronic Graft Versus Host Disease (SR-cGvHD) Assessed by Overall Response Rate (ORR) at the Cycle 7 Day 1 Visit | Ruxolitinib | 49.7 | 95% Confidence Interval 41.8 to 57.6 | percentage of participants | |
Efficacy of Ruxolitinib Versus Investigator's Choice Best Available Therapy (BAT) in Participants With Moderate or Severe Steroid Refractory Chronic Graft Versus Host Disease (SR-cGvHD) Assessed by Overall Response Rate (ORR) at the Cycle 7 Day 1 Visit | Best Available Therapy | 25.6 | 95% Confidence Interval 19.1 to 33.0 | percentage of participants | |
| Rate of Participants With Clinically Relevant Improvement of the Modified Lee cGvHD Symptom Scale Score | Ruxolitinib | 24.2 | 95% Confidence Interval 17.9 to 31.5 | percentage of participants | |
| Rate of Participants With Clinically Relevant Improvement of the Modified Lee cGvHD Symptom Scale Score | Best Available Therapy | 11.0 | 95% Confidence Interval 6.6 to 16.8 | percentage of participants | |
| Rate of Failure-free Survival (FFS) | Ruxolitinib | NA | 95% Confidence Interval 18.6 to NA | months | |
| Rate of Failure-free Survival (FFS) | Best Available Therapy | 5.7 | 95% Confidence Interval 5.6 to 6.5 | months | |
| Rate of FFS at Study Completion | Ruxolitinib | 38.4 | 95% Confidence Interval 22.1 to NA | months | |
| Rate of FFS at Study Completion | Best Available Therapy | 5.7 | 95% Confidence Interval 5.6 to 6.5 | months | |
| Best Overall Response (BOR) at Cycle 7 Day 1 | Ruxolitinib | 76.4 | 95% Confidence Interval 69.1 to 82.6 | percentage of participants | |
| Best Overall Response (BOR) at Cycle 7 Day 1 | Best Available Therapy | 60.4 | 95% Confidence Interval 52.4 to 67.9 | percentage of participants |
1 to 10 of 169Source ClinicalTrials.gov
See all 169 results by groupParticipant flow18
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| End of Randomization Period | STARTED | Ruxolitinib | 165 | |
| End of Randomization Period | STARTED | Best Available Therapy | 164 | |
| End of Randomization Period | STARTED | Ruxolitinib Cross-Over Period | 0 | |
| End of Randomization Period | COMPLETED | Ruxolitinib | 29 | |
| End of Randomization Period | COMPLETED | Best Available Therapy | 24 | |
| End of Randomization Period | COMPLETED | Ruxolitinib Cross-Over Period | 0 | |
| End of Randomization Period | NOT COMPLETED | Ruxolitinib | 136 | |
| End of Randomization Period | NOT COMPLETED | Best Available Therapy | 140 | |
| End of Randomization Period | NOT COMPLETED | Ruxolitinib Cross-Over Period | 0 | |
| End of Cross Over Period | STARTED | Ruxolitinib | 0 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 participant flowAdverse events831
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 | 56 | 165 | |
| other | Anaemia | Blood and lymphatic system disorders | Best Available Therapy | 25 | 158 | |
| other | Anaemia | Blood and lymphatic system disorders | Ruxolitinib Cross-Over Period | 15 | 70 | |
| other | Leukopenia | Blood and lymphatic system disorders | Ruxolitinib | 10 | 165 | |
| other | Leukopenia | Blood and lymphatic system disorders | Best Available Therapy | 2 | 158 | |
| other | Leukopenia | Blood and lymphatic system disorders | Ruxolitinib Cross-Over Period | 1 | 70 | |
| other | Neutropenia | Blood and lymphatic system disorders | Ruxolitinib | 25 | 165 | |
| other | Neutropenia | Blood and lymphatic system disorders | Best Available Therapy | 8 | 158 | |
| other | Neutropenia | Blood and lymphatic system disorders | Ruxolitinib Cross-Over Period | 8 | 70 | |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Ruxolitinib | 21 | 165 |
1 to 10 of 831Source ClinicalTrials.gov
See all 831 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Ruxolitinib | 37 | 165 |
| Total, all-cause mortality | Best Available Therapy | 40 | 158 |
| Total, all-cause mortality | Ruxolitinib Cross-Over Period | 10 | 70 |
| Total, other adverse events | Ruxolitinib | 158 | 165 |
| Total, other adverse events | Best Available Therapy | 132 | 158 |
| Total, other adverse events | Ruxolitinib Cross-Over Period | 62 | 70 |
| Total, serious adverse events | Ruxolitinib | 86 | 165 |
| Total, serious adverse events | Best Available Therapy | 71 | 158 |
| Total, serious adverse events | Ruxolitinib Cross-Over Period | 27 | 70 |
Source ClinicalTrials.gov
Papers6
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.
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GET https://conductscience.org/api/trials/v1/NCT03112603
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