Trial · NCT05123040
Registered outcomes11
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 11 of 11
Download this page as JSON| 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. |
| Secondary | Collect blood samples and rectosigmoid biopsies for future correlative studies | 1 year after treament | Give a count of the number of patients who had blood and rectosigmoid biopsies |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
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 list from software.
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GET https://conductscience.org/api/trials/v1/NCT05123040/registered