Trial · NCT05123040
Ruxolitinib, Human Chorionic Gonadotropin (uhCG/EGF), and Dose De-escalated Corticosteroids
NCT05123040, Phase 1, Phase 2, Terminated, Masonic Cancer Center, University of Minnesota
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Ruxolitinib, Human Chorionic Gonadotropin (uhCG/EGF), and Dose De-escalated Corticosteroids. Trials, record NCT05123040. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05123040
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Ruxolitinib, Human Chorionic Gonadotropin (uhCG/EGF), and Dose De-escalated Corticosteroids
- NCT number
- NCT05123040
- Status
- Terminated
- Phases
- Phase 1, Phase 2
- Enrollment
- 10 participants, actual
- Lead sponsor
- Masonic Cancer Center, University of Minnesota
- Conditions
- Acute-graft-versus-host Disease
- Interventions
- Ruxolitinib 10 MG Oral Tablet, hCG, Corticosteroids
- First posted
- 2021-11-17
- Last updated
- 2026-03-24
Source ClinicalTrials.gov
Registered outcomes11
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Recommend the lowest possible dose for Phase II of corticosteroids when given in combination with ruxolitinib and uhCG/EGF in pediatric based on DLT frequency | 28 days after therapy | Plan report patients proportions and their 95% confidence intervals of paitents who experience dose limiting toxicity. Determine best dose based on DLT criteria by CTCAE v5.0 * Thrombosis requiring anticoagulation * Ascites (grade 3-5) * Ovarian hyperstimulation syndrome |
| Primary | Best response of treatment in adult and children | 28 days after therapy | proportions of complete, partial, mixed, and no response among surviving patients at days 28 after initiation of protocol therapy in pediatric and adult patients with Minnesota high-risk aGVHD |
| Secondary | Number of participants with treatment-related adverse events as assessed by CTCAE v5.0 | 30 days after treatment | Report any type of adverse event caused by a drug cause by dose of steroids in combination of ruxolitinib and uhCG/EGF. Due to the complex medical condition of the GVHD patient, monitoring for adverse events will focus on the following events beginning with the date consent is signed and continuing for 30 days after the subject has completed or discontinued from the study or has taken last dose of the study drug. * Rehospitalization * Death * Hematologic (grade 3-5 cytopenia) * Infections (grade 3-5) * Hyperglycemia (grade 3-5) * Steroid myopathy (grade 3-5) |
| Secondary | Incidence of acute GVHD flare after CR/PR requiring increase of steroids or other systemic treatment | 28 days after treatment | Find proportion of incidence of acute GVHD |
| Secondary | Incidence of acute GVHD flare after CR/PR requiring increase of steroids or other systemic treatment | 56 days after treatment | Find proportion of incidence of acute GVHD |
| Secondary | Compare the rate of treatment failure for acute GVHD after initiation of protocol therapy to historical controls | 28 days after treatment | Compare count of treatment failure to other number of failures in other historical protocols |
| Secondary | Compare the rate of treatment failure for acute GVHD after initiation of protocol therapy to historical controls | 56 days after treatment | Compare count of treatment failure to other number of failures in other historical protocols |
| Secondary | To assess patient quality of life on study | 6 month after treatment | Have participants take an overall survival survey |
| Secondary | Determine 1-year overall survival | 1 year post treatment | Provide proportions and their 95% confidence intervals of patients still alive at one year post-treatment |
| Secondary | Non-relapse mortality (death without recurrent or progressive disease after allo-HSCT) | 1 year post treatment | Provide proportions and their 95% confidence intervals of patients who expedience a non-relapse mortality. |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 registered outcomesOutcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
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/NCT05123040
GET https://conductscience.org/api/trials/v1/NCT05123040/registered