Trial · NCT02400463
A Pilot Study of Ruxolitinib in Secondary Hemophagocytic Syndrome
NCT02400463, Phase 2, Completed, University of Michigan Rogel Cancer Center; results first posted 2020-11-18
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Pilot Study of Ruxolitinib in Secondary Hemophagocytic Syndrome. Trials, record NCT02400463. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02400463
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Pilot Study of Ruxolitinib in Secondary Hemophagocytic Syndrome
- NCT number
- NCT02400463
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 6 participants, actual
- Lead sponsor
- University of Michigan Rogel Cancer Center
- Conditions
- Hemophagocytic Syndrome (HPS)
- Interventions
- Ruxolitinib
- First posted
- 2015-03-27
- Last updated
- 2021-01-25
- Results first posted
- 2020-11-18
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Overall Survival at 2 Months | 2 Months | Number of Patients Alive at 2 Months after the first administration of ruxolitinib. |
| Secondary | Percentage of Patients With a Response to Treatment With Ruxolitinib | 2 Months | Complete response is defined as complete normalization of all quantifiable symptoms and laboratory abnormalities. A partial response is defined as at least a 25% improvement in two or more quantifiable symptoms/laboratory markers. |
| Secondary | Duration of Response | Up to 3 years (Due to funding and other constraints, participant follow-up was discontinued in 2020. Thus, not all participants were followed for a full three years.) | Duration will be calculated from the date of the determination of partial response or better until the date of progression, death, or additional non-protocol therapy. |
| Secondary | Progression Free Survival Time | Up to 3 years (Due to funding and other constraints, participant follow-up was discontinued in 2020. Thus, not all participants were followed for a full three years.) | Progressive Disease is defined as at least a 50% worsening in two or more quantifiable laboratory markers. Calculated from the first administration of ruxolitinib until the date of progression or death. |
| Secondary | Regimen Related Toxicities | Up to 30 days after last treatment administration | Incidence and grade of adverse events (AEs) unlikely, possibly or probably related to treatment (tx) with ruxolitinib. Graded per Common Terminology Criteria for Adverse Events (CTCAE) v.4. Grade refers to the severity of the AE, from mild (grade 1) to life-threatening (grade 4). |
Source ClinicalTrials.gov
Outcomes5
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Overall Survival at 2 Months | 2 Months | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Percentage of Patients With a Response to Treatment With Ruxolitinib | 2 Months | percentage of participants | NUMBER | |
| SECONDARY | Duration of Response | Up to 3 years (Due to funding and other constraints, participant follow-up was discontinued in 2020. Thus, not all participants were followed for a full three years.) | months | MEDIAN | |
| SECONDARY | Progression Free Survival Time | Up to 3 years (Due to funding and other constraints, participant follow-up was discontinued in 2020. Thus, not all participants were followed for a full three years.) | months | MEDIAN | |
| SECONDARY | Regimen Related Toxicities | Up to 30 days after last treatment administration | Adverse Events | NUMBER |
Source ClinicalTrials.gov
Results by group8
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Overall Survival at 2 Months | Ruxolitinib | 6 | Participants | ||
| Percentage of Patients With a Response to Treatment With Ruxolitinib | Ruxolitinib | 100 | percentage of participants | ||
| Duration of Response | Ruxolitinib | 17.25 | Full Range 3.5 to 35.5 | months | |
| Progression Free Survival Time | Ruxolitinib | 17.25 | Full Range 3.5 to 35.5 | months | |
| Regimen Related Toxicities | Ruxolitinib | Grade 1 | 5 | Adverse Events | |
| Regimen Related Toxicities | Ruxolitinib | Grade 2 | 3 | Adverse Events | |
| Regimen Related Toxicities | Ruxolitinib | Grade 3 | 1 | Adverse Events | |
| Regimen Related Toxicities | Ruxolitinib | Grade 4 | 1 | Adverse Events |
Source ClinicalTrials.gov
Participant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Ruxolitinib | 6 | |
| Overall Study | COMPLETED | Ruxolitinib | 6 | |
| Overall Study | NOT COMPLETED | Ruxolitinib | 0 |
Source ClinicalTrials.gov
Adverse events46
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 | Blood and lymphatic system disorders - Other, specify | Blood and lymphatic system disorders | Ruxolitinib | 2 | 6 | 2 |
| other | Ear and labyrinth disorders - Other, specify | Ear and labyrinth disorders | Ruxolitinib | 1 | 6 | 1 |
| other | Cushingoid | Endocrine disorders | Ruxolitinib | 1 | 6 | 1 |
| other | Abdominal pain | Gastrointestinal disorders | Ruxolitinib | 2 | 6 | 2 |
| other | Constipation | Gastrointestinal disorders | Ruxolitinib | 2 | 6 | 2 |
| other | Dysphagia | Gastrointestinal disorders | Ruxolitinib | 1 | 6 | 1 |
| other | Gastrointestinal disorders - Other, specify | Gastrointestinal disorders | Ruxolitinib | 1 | 6 | 1 |
| other | Nausea | Gastrointestinal disorders | Ruxolitinib | 2 | 6 | 3 |
| other | Fatigue | General disorders | Ruxolitinib | 3 | 6 | 4 |
| other | Fever | General disorders | Ruxolitinib | 1 | 6 | 2 |
1 to 10 of 46Source ClinicalTrials.gov
See all 46 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Ruxolitinib | 0 | 6 |
| Total, other adverse events | Ruxolitinib | 6 | 6 |
| Total, serious adverse events | Ruxolitinib | 2 | 6 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 31537486 | DERIVED |
Source PubMed
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/NCT02400463
GET https://conductscience.org/api/trials/v1/NCT02400463/events?page=2