Trial · NCT02759731
Study of Baricitinib, a JAK1/2 Inhibitor, in Chronic Graft-Versus-Host Disease After Allogeneic Hematopoietic Stem Cell Transplantation
NCT02759731, Phase 1, Phase 2, Completed, National Cancer Institute (NCI); results first posted 2023-10-25
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Study of Baricitinib, a JAK1/2 Inhibitor, in Chronic Graft-Versus-Host Disease After Allogeneic Hematopoietic Stem Cell Transplantation. Trials, record NCT02759731. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02759731
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study of Baricitinib, a JAK1/2 Inhibitor, in Chronic Graft-Versus-Host Disease After Allogeneic Hematopoietic Stem Cell Transplantation
- NCT number
- NCT02759731
- Status
- Completed
- Phases
- Phase 1, Phase 2
- Enrollment
- 24 participants, actual
- Lead sponsor
- National Cancer Institute (NCI)
- Conditions
- Chronic Graft vs Host Disease, Chronic Graft-Versus-Host Disease
- Interventions
- Baricitinib
- First posted
- 2016-05-03
- Last updated
- 2024-10-08
- Results first posted
- 2023-10-25
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Phase 1: Number of Participants With Dose-Limiting Toxicities (DLT) | Starting at each dose level initiation, every 2 weeks up to the first 4 weeks of each dose | DLT is defined as any grade ≥3 non-hematologic or grade ≥4 hematologic adverse event, or hemoglobin \<6.5 g/dL, within 4 weeks of starting any dose level (1mg, 2mg, or 4 mg) except those that are clearly and incontrovertibly due to extraneous causes. Adverse events were assessed by the Common Terminology Criteria for Adverse Events (CTCAE v4.0). Grade 3 is severe. Grade 4 is life-threatening. |
| Primary | Phase 2: Number of Participants With Any Serious and/or Non-Serious Grades 3, 4, and/or 5 Adverse Events Due to Drug | every 4 weeks through study completion (up to 48 weeks) | Adverse events were assessed by the Common Terminology Criteria for Adverse Events (CTCAE v4.0). Grade 3 is severe. Grade 4 is life-threatening. And Grade 5 is death related to adverse event. |
| Primary | Phase 2: Overall Response at 24 Weeks | 24 weeks | Response was assessed by the National Institutes of Health (NIH) chronic graft-versus-host disease (cGVHD) response criteria. Complete Response (CR) is defined as resolution of all manifestations in each organ or site. Partial Response (PR) is defined as improvement at least 1 organ or site without progression in any other organ or site. Lack of Response including unchanged, mixed response, and disease progression. Mixed response is a CR or PR in at least 1 organ accompanied by progression in another organ. Unchanged is outcomes that do not meet the criteria for CR, PR, disease progression, or mixed response. Disease Progression is a change in the manifestations in each organ or site that does not meet the criteria for CR, PR, mixed response, unchanged or lack of response. |
| Other | Phase 1 and 2: Number of Participants With Serious and/or Non-serious Adverse Events Assessed by the Common Terminology Criteria for Adverse Events (CTCAE v4.0) | Date treatment consent signed to 30 days off study drug, approximately 73 months and 28 days. | Here is the number of participants with serious and/or non-serious adverse events assessed by the Common Terminology Criteria for Adverse Events (CTCAE v4.0). A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life-threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned. |
Source ClinicalTrials.gov
Outcomes4
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Phase 1: Number of Participants With Dose-Limiting Toxicities (DLT) | Starting at each dose level initiation, every 2 weeks up to the first 4 weeks of each dose | Single arm study (intra-patient(pt) dose escalation). All pts exposed to both dose levels(DL) unless prematurely developed toxicity that led to study discontinuation/dose modification. We report as 1 arm\&then report dose modifications/discontinuation separately. Modification/discontinuation does not define those pts as a separate group. 20/24pts analyzed DL2 because they never made it to 3month mark when dose escalation occurred/never underwent dose escalation to 4mg due to toxicity/progression. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Phase 2: Number of Participants With Any Serious and/or Non-Serious Grades 3, 4, and/or 5 Adverse Events Due to Drug | every 4 weeks through study completion (up to 48 weeks) | This is a single arm study (with intra-patient dose escalation) - so all participants are exposed to both dose levels unless they prematurely developed toxicity that led to study discontinuation or dose modification. We report as one arm and then report the dose modifications/discontinuation separately - but the modification/discontinuation does not define those participants as a separate group. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Phase 2: Overall Response at 24 Weeks | 24 weeks | This is a single arm study (with intra-patient dose escalation) - so all participants are exposed to both dose levels unless they prematurely developed toxicity that led to study discontinuation or dose modification. We report as one arm and then report the dose modifications/discontinuation separately - but the modification/discontinuation does not define those participants as a separate group. | Participants | COUNT_OF_PARTICIPANTS |
| OTHER_PRE_SPECIFIED | Phase 1 and 2: Number of Participants With Serious and/or Non-serious Adverse Events Assessed by the Common Terminology Criteria for Adverse Events (CTCAE v4.0) | Date treatment consent signed to 30 days off study drug, approximately 73 months and 28 days. | This is a single arm study (with intra-patient dose escalation) - so all participants are exposed to both dose levels unless they prematurely developed toxicity that led to study discontinuation or dose modification. We report as one arm and then report the dose modifications/discontinuation separately - but the modification/discontinuation does not define those participants as a separate group. | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group12
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Phase 1: Number of Participants With Dose-Limiting Toxicities (DLT) | Dose Level 1, 2 mg of Baricitinib | 0 | Participants | ||
| Phase 1: Number of Participants With Dose-Limiting Toxicities (DLT) | Dose Level 2, 4 mg of Baricitinib | 0 | Participants | ||
| Phase 2: Number of Participants With Any Serious and/or Non-Serious Grades 3, 4, and/or 5 Adverse Events Due to Drug | Dose Level 1, 2 mg of Baricitinib -> Dose Level 2, 4 mg of Baricitinib | Grade 3 | 2 | Participants | |
| Phase 2: Number of Participants With Any Serious and/or Non-Serious Grades 3, 4, and/or 5 Adverse Events Due to Drug | Dose Level 1, 2 mg of Baricitinib -> Dose Level 2, 4 mg of Baricitinib | Grade 4 | 0 | Participants | |
| Phase 2: Number of Participants With Any Serious and/or Non-Serious Grades 3, 4, and/or 5 Adverse Events Due to Drug | Dose Level 1, 2 mg of Baricitinib -> Dose Level 2, 4 mg of Baricitinib | Grade 5 | 0 | Participants | |
| Phase 2: Overall Response at 24 Weeks | Dose Level 1, 2 mg of Baricitinib -> Dose Level 2, 4 mg of Baricitinib | Complete Response | 0 | Participants | |
| Phase 2: Overall Response at 24 Weeks | Dose Level 1, 2 mg of Baricitinib -> Dose Level 2, 4 mg of Baricitinib | Partial Response | 16 | Participants | |
| Phase 2: Overall Response at 24 Weeks | Dose Level 1, 2 mg of Baricitinib -> Dose Level 2, 4 mg of Baricitinib | Mixed Response | 3 | Participants | |
| Phase 2: Overall Response at 24 Weeks | Dose Level 1, 2 mg of Baricitinib -> Dose Level 2, 4 mg of Baricitinib | Unchanged | 0 | Participants | |
| Phase 2: Overall Response at 24 Weeks | Dose Level 1, 2 mg of Baricitinib -> Dose Level 2, 4 mg of Baricitinib | Disease Progression | 0 | Participants |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 results by groupParticipant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Dose Level 1, 2 mg of Baricitinib -> Dose Level 2, 4 mg of Baricitinib | 24 | |
| Overall Study | COMPLETED | Dose Level 1, 2 mg of Baricitinib -> Dose Level 2, 4 mg of Baricitinib | 16 | |
| Overall Study | NOT COMPLETED | Dose Level 1, 2 mg of Baricitinib -> Dose Level 2, 4 mg of Baricitinib | 8 |
Source ClinicalTrials.gov
Adverse events86
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 | Abdominal pain | Gastrointestinal disorders | Dose Level 1, 2 mg of Baricitinib -> Dose Level 2, 4 mg of Baricitinib | 1 | 24 | 1 |
| other | Alanine aminotransferase increased | Investigations | Dose Level 1, 2 mg of Baricitinib -> Dose Level 2, 4 mg of Baricitinib | 1 | 24 | 1 |
| other | Alkaline phosphatase increased | Investigations | Dose Level 1, 2 mg of Baricitinib -> Dose Level 2, 4 mg of Baricitinib | 1 | 24 | 1 |
| other | Allergic reaction | Immune system disorders | Dose Level 1, 2 mg of Baricitinib -> Dose Level 2, 4 mg of Baricitinib | 1 | 24 | 1 |
| other | Allergic rhinitis | Respiratory, thoracic and mediastinal disorders | Dose Level 1, 2 mg of Baricitinib -> Dose Level 2, 4 mg of Baricitinib | 1 | 24 | 1 |
| other | Anemia | Blood and lymphatic system disorders | Dose Level 1, 2 mg of Baricitinib -> Dose Level 2, 4 mg of Baricitinib | 1 | 24 | 1 |
| other | Back pain | Musculoskeletal and connective tissue disorders | Dose Level 1, 2 mg of Baricitinib -> Dose Level 2, 4 mg of Baricitinib | 1 | 24 | 1 |
| other | Bloating | Gastrointestinal disorders | Dose Level 1, 2 mg of Baricitinib -> Dose Level 2, 4 mg of Baricitinib | 1 | 24 | 1 |
| other | Blood and lymphatic system disorders - Other, Lymphadenopathy (CT) | Blood and lymphatic system disorders | Dose Level 1, 2 mg of Baricitinib -> Dose Level 2, 4 mg of Baricitinib | 1 | 24 | 1 |
| other | Carbon monoxide diffusing capacity decreased | Investigations | Dose Level 1, 2 mg of Baricitinib -> Dose Level 2, 4 mg of Baricitinib | 3 | 24 | 3 |
1 to 10 of 86Source ClinicalTrials.gov
See all 86 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Dose Level 1, 2 mg of Baricitinib -> Dose Level 2, 4 mg of Baricitinib | 0 | 24 |
| Total, other adverse events | Dose Level 1, 2 mg of Baricitinib -> Dose Level 2, 4 mg of Baricitinib | 21 | 24 |
| Total, serious adverse events | Dose Level 1, 2 mg of Baricitinib -> Dose Level 2, 4 mg of Baricitinib | 8 | 24 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 42200447 | 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 comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Dose Level 1, 2 mg of Baricitinib vs Dose Level 2, 4 mg of Baricitinib: Phase 1: Number of Participants With Dose-Limiting Toxicities (DLT) |
Source 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/NCT02759731
GET https://conductscience.org/api/trials/v1/NCT02759731/events?page=2