Trial · NCT06986382
Registered outcomes15
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 15 of 15
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of patients with myeloid engraftment | Day 42 post-HSCT | Cumulative incidence of donor myeloid engraftment by Day +42 post-HSCT. Myeloid engraftment is defined as ANC of \> 0.5 x 109/L for three consecutive laboratory values obtained on different days. Date of myeloid engraftment is the first date of the three lab values taken. |
| Primary | Number of patients with Grade III-IV acute graft vs host disease (GVHD) | Day 90 and 180 post-HSCT | Cumulative incidence of acute GvHD (graded as II-IV and III-IV using the Magic criteria) Cumulative incidence of acute GvHD (graded as II-IV and III-IV using the Magic criteria) Cumulative incidence of acute GvHD (graded as II-IV and III-IV using the Magic criteria) Cumulative incidence of acute GvHD (graded using the Magic criteria) |
| Primary | Number of patients in remission of Crohn disease (Calprotectin) | 2 years post-HSCT | Cumulative incidence of patient who achieve remission defined by fecal calprotectin values less than 250 mg/g |
| Primary | Number of patients in remission of Crohn disease (wPCDAI or CDAI) | 2 years post-HSCT | Cumulative incidence of remission demonstrated by weighted Pediatric Crohn's Disease Activity Index (wPCDAI) \<12.5 or Crohn's Disease Activity Index (CDAI) of \<150 if adult |
| Secondary | Number of patients who achieve normal immune function derived from donor cells | 1 year post-HSCT | Cumulative incidence of patients with age-appropriate normalization of peripheral blood lymphocyte numbers including T, NK and B cells |
| Secondary | Number of patients who achieve full donor chimerism | 1 year post-HSCT | Cumulative incidence of patient chimerism defined as \>95% of donor cells as assessed by peripheral blood (total, CD15+, CD3+, CD56+, CD19+, and CD34+) chimerism by short tandem repeat (STR) or next generation sequencing (NGS) analysis |
| Secondary | Number of patients with healthy immune cell function | 1 year post-HSCT | Cumulative incidence of patients who have mitogen and antigen specific T-cell proliferation or cytokine release in response to in vitro stimulation |
| Secondary | Number of patients who regain CD3 cells | Day 90 and 180 post-HSCT | CD3 cell count of \>200/ uL |
| Secondary | Number of patients who experience moderate and severe chronic GvHD | 1 year post-HSCT | Cumulative incidence of patients experiencing moderate or severe chronic GvHD by NIH Consensus Criteria for Organ scoring of cGVHD |
| Secondary | Number of patients who experience severe infections | 1 year post-HSCT | Cumulative incidence of patients experiencing Grade 3 or higher CTCAE infections after HSCT |
| Secondary | Patient survival | 2 and 5 years post-HSCT | |
| Secondary | Number of patients with response in Crohn disease activity - 50% CRP or higher | 1 and 2 years post-HSCT | Cumulative incidence of patients who have a \<0.5 mg/dL reduction in C-reactive protein (CRP) |
| Secondary | Number of patients with response in Crohn disease activity - wPCDAI/CDAI | 1 year post-HSCT | Cumulative incidence of patients who achieve wPCDAI score reduced by 17.5 points from baseline if pediatric, CDAI reduced by at least 100 points from baseline if adult |
| Secondary | Number of patients with endoscopic healing | 2 years post-HSCT | Endoscopic healing defined as ≤1 SEMA score |
| Secondary | Number of patients with sustained steroid-free remission | 2 years post-HSCT | Cumulative incidence of patients who are able to discontinue steroids for 3 or more months |
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/NCT06986382/registered