Trial · NCT03139604
Outcomes20
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 20 of 20
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Overall Response Rate Based on Center for International Blood and Marrow Transplant Research (CIBMTR) Response Index | Day 28 | Full Analysis Set (FAS) Population | Percentage of Participants | NUMBER |
| SECONDARY | Nonrelapse Mortality | Month 6,9,12 and 24 | Full Analysis Set (FAS) Population | participants | NUMBER |
| SECONDARY | Duration of Response | Baseline through 30-35 days after end of treatment, total particpation expected to average 24 months | Full Analysis Set (FAS) Population | days | MEDIAN |
| SECONDARY | Cmax of Itacitinib When Administered in Combination With Corticosteroids | Protocol-defined timepoints up to Day 28 | All subjects who receive at least 1 dose of study drug and provide at least 1 plasma sample after study drug administration will be considered as potential PK evaluable subjects. The data presented is from Day 7. | nM | MEAN |
| SECONDARY | Cmin of Itacitinib When Administered in Combination With Corticosteroids | Protocol-defined timepoints up to Day 28 | All subjects who receive at least 1 dose of study drug and provide at least 1 plasma sample after study drug administration will be considered as potential PK evaluable subjects. The data presented is from Day 7 as this is more representative of true steady state. Day 28 is positively biased as non responders are withdrawn from study by D28. | nM | MEAN |
| SECONDARY | Tmax of Itacitinib When Administered in Combination With Corticosteroids | Protocol-defined timepoints up to Day 28 | All subjects who receive at least 1 dose of study drug and provide at least 1 plasma sample after study drug administration will be considered as potential PK evaluable subjects. The data presented is from Day 7. | hrs | MEDIAN |
| SECONDARY | AUC of Itacitinib When Administered in Combination With Corticosteroids | Protocol-defined timepoints up to Day 28 | All subjects who receive at least 1 dose of study drug and provide at least 1 plasma sample after study drug administration will be considered as potential PK evaluable subjects. The data presented is from Day 7. | nM*h | MEAN |
| SECONDARY | CL/F of Itacitinib When Administered in Combination With Corticosteroids | Protocol-defined timepoints up to Day 28 | All subjects who receive at least 1 dose of study drug and provide at least 1 plasma sample after study drug administration will be considered as potential PK evaluable subjects. The data presented is from Day 7. | L/h | MEAN |
| SECONDARY | Time to Response | End of Study, total particpation expected to average 24 months | Full Analysis Set (FAS) Population who were responders | days | MEAN |
| SECONDARY | Relapse Rate of Malignant and Nonmalignant Hematologic Disease | Randomization through end of Study, study duration expected to average 24 months | Full Analysis Set (FAS) Population | percentage | NUMBER |
| SECONDARY | Malignancy Relapse-related Mortality Rate | Randomization through end of Study, study duration expected to average 24 months | Full Analysis Set (FAS) Population | percentage | NUMBER |
| SECONDARY | Failure-free Survival | 6 months from randomization | Full Analysis Set (FAS) Population | proportion of participants | NUMBER |
| SECONDARY | Overall Survival (OS) | End of Study up to approximately 24 months | Full Analysis Set (FAS) Population | days | MEDIAN |
| SECONDARY | Number of Treatment-emergent Adverse Events With INCB39110 | 30-35 days after end of treatment, approximately 24 months | Safety Analysis Set | participants | NUMBER |
| SECONDARY | Incidence Rate of Secondary Graft Failure | Randomization through end of Study, study duration expected to average 24 months | Full Analysis Set (FAS) Population | participants | NUMBER |
| SECONDARY | Proportion of Subjects Who Discontinue Corticosteroids | Days 28, 56, 100, and 180 | Safety Analysis Set | participants | NUMBER |
| SECONDARY | Proportion of Subjects Who Discontinue Immunosuppressive Medications | Days 56 and 100 | Full Analysis Set (FAS) Population | participants | NUMBER |
| SECONDARY | Incidence Rate of aGVHD Flares | up to day 100 | Full Analysis Set (FAS) Population | participants | NUMBER |
| SECONDARY | Incidence Rate of cGVHD | Days 180 and 365 | Full Analysis Set (FAS) Population | participants | NUMBER |
| SECONDARY | Objective Response Rate | Days 14, 56 and 100 | Full Analysis Set (FAS) Population | participants | NUMBER |
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.
Twenty rows a page, as JSON. No key.
GET https://conductscience.org/api/trials/v1/NCT03139604/outcomes