Trial · NCT03139604
Registered outcomes20
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 20
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Overall Response Rate Based on Center for International Blood and Marrow Transplant Research (CIBMTR) Response Index | Day 28 | Defined as the percentage of participants demonstrating a complete response (CR), very good partial response (VGPR), or partial response (PR). |
| Secondary | Nonrelapse Mortality | Month 6,9,12 and 24 | Defined as the percentage of participants who died due to causes other than malignancy relapse. |
| Secondary | Duration of Response | Baseline through 30-35 days after end of treatment, total particpation expected to average 24 months | Defined as the interval from first response until GVHD progression or death. |
| Secondary | Cmax of Itacitinib When Administered in Combination With Corticosteroids | Protocol-defined timepoints up to Day 28 | Defined as maximum observed plasma concentration. |
| Secondary | Cmin of Itacitinib When Administered in Combination With Corticosteroids | Protocol-defined timepoints up to Day 28 | Defined as minimum observed plasma concentration. |
| Secondary | Tmax of Itacitinib When Administered in Combination With Corticosteroids | Protocol-defined timepoints up to Day 28 | Defined as time to maximum plasma concentration. |
| Secondary | AUC of Itacitinib When Administered in Combination With Corticosteroids | Protocol-defined timepoints up to Day 28 | Defined as area under the concentration-time curve. |
| Secondary | CL/F of Itacitinib When Administered in Combination With Corticosteroids | Protocol-defined timepoints up to Day 28 | Defined as oral dose clearance. |
| Secondary | Time to Response | End of Study, total particpation expected to average 24 months | Defined as the interval from treatment initiation to first response |
| Secondary | Relapse Rate of Malignant and Nonmalignant Hematologic Disease | Randomization through end of Study, study duration expected to average 24 months | Defined as the proportion of subjects whose underlying hematologic disease relapses |
| Secondary | Malignancy Relapse-related Mortality Rate | Randomization through end of Study, study duration expected to average 24 months | Defined as the proportion of subjects whose malignancy relapses and has a fatal outcome. |
| Secondary | Failure-free Survival | 6 months from randomization | Defined as the proportion of subjects who are still alive, have not relapsed, have not required additional therapy for aGVHD, and have not demonstrated signs or symptoms of chronic graft-versus-host disease (cGVHD) |
| Secondary | Overall Survival (OS) | End of Study up to approximately 24 months | Defined as the interval from study enrollment to death due to any cause. |
| Secondary | Number of Treatment-emergent Adverse Events With INCB39110 | 30-35 days after end of treatment, approximately 24 months | Adverse events reported for the first time or worsening of a pre-existing event after the first dose of study treatment |
| Secondary | Incidence Rate of Secondary Graft Failure | Randomization through end of Study, study duration expected to average 24 months | Defined as \> 95% recipient cells any time after engraftment with no signs of relapse, OR retransplantation because of secondary neutropenia (\< 0.5 × 109/L) and/or thrombocytopenia (\< 20 × 109/L) within 2 months of transplantion |
| Secondary | Proportion of Subjects Who Discontinue Corticosteroids | Days 28, 56, 100, and 180 | Average and cumulative corticosteroid dose usage will be calculated and proportion of subjects discontinuing corticosteroids will be tabulated |
| Secondary | Proportion of Subjects Who Discontinue Immunosuppressive Medications | Days 56 and 100 | Summary statistics of subjects discontinuing immunosuppressive medications will be calculated |
| Secondary | Incidence Rate of aGVHD Flares | up to day 100 | |
| Secondary | Incidence Rate of cGVHD | Days 180 and 365 | |
| Secondary | Objective Response Rate | Days 14, 56 and 100 |
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/registered