Trial · NCT05787574
Registered outcomes19
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 19 of 19
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Engraftment | Day 100 post-alloHCT | Engraftment is defined as the first of three days of absolute neutrophil count \>500,000/µL and the first of seven days of platelets \>20,000/µL in the absence of transfusional support. |
| Secondary | Overall Survival (OS) | 1 year | Overall Survival (OS) is defined as the duration of time between allo-HCT and death due to any cause. |
| Secondary | Event Free Survival (EFS) | Up to 2 years post-alloHCT | Event-Free Survival (EFS) is the length of time from the start of a treatment or study until a patient experiences a defined negative "event" (such as disease recurrence, progression, or death). |
| Secondary | Non-Relapse Mortality (TRM) | 1 year | Participants who die for any reason after disease recurrence are considered to have experienced disease related mortality, and will be counted as competing events. Patients alive will be censored at the day of last follow up. |
| Secondary | GVHD free/relapse free survival (GRFS) | 1 year | Duration of time between transplantation and development of grade III-IV GVHD, chronic GVHD requiring systemic therapy, disease relapse, or death, whichever occurs first. |
| Secondary | Chronic graft vs host disease/relapse free survival (CRFS) | 1 year | Duration of time between transplantation and development of moderate or severe chronic GVHD (NIH consensus criteria), or death, whichever occurs first. |
| Secondary | All-cause mortality at 1 & 2 years | 1 year and 2 years post-alloHCT | |
| Secondary | Incidence of viral reactivations | 1 year | Incidence of viral reactivations including: Cytomegalovirus (CMV), Adenovirus, Epstein-Barr Virus (EBV), Human Herpes-6 (HHV6), BK-virus defined as viral reactivations necessitating use of anti-viral treatment. |
| Secondary | Incidence of Acute graft versus host disease (GVHD) at Day 100, 180, and 1-year follow-up | Day 100, 180, and 1 year post-alloHCT | |
| Secondary | Incidence of Chronic GVHD at Day 180 and 1-year follow-up | Day 180 and 1 year post-alloHCT | |
| Secondary | Time to neutrophil engraftment | 100 days | Neutrophil engraftment is defined as the first of 3 consecutive days of absolute neutrophil count (ANC) ≥ 500 K/µL. |
| Secondary | Time to platelet engraftment | 100 days | Platelet engraftment is defined as the first of 7 consecutive days with a platelet count exceeding 20,000/µL without transfusion support. |
| Secondary | Incidence of primary engraftment failure | Day 30 post-alloHCT | Primary engraftment failure is defined as failure to achieve neutrophil engraftment by Day 30 after transplantation. |
| Secondary | Incidence of secondary engraftment failure | 1 year post-alloHCT | Secondary engraftment failure is defined as \<500/µL circulating neutrophils at any time after primary engraftment that is not attributed to disease recurrence or drug therapy. |
| Secondary | Donor Chimerism | Day 30, 100, 180, and 1 year post-alloHCT | The percentage of donor contribution to hematopoiesis (chimerism) will be determined using short tandem repeat (STR) based analysis of the peripheral blood (Chimerism - all lineages on Day 30, 100, 180, and 365) and bone marrow (all samples obtained post-alloHCT). |
| Secondary | Incidence of grade ≥ 3 non-hematologic adverse events | Day 100, 180, and 1 year post-alloHCT | Incidence of grade ≥ 3 non-hematologic adverse events as defined by CTCAE version 5.0 at Day 100, 180, and 1 year post allo-HCT. |
| Secondary | Lymphocyte Reconstitution | Day 30, 60, 100, 180, and 1 year and 2 years post-alloHCT | CD4+ Immune Reconstitution (CD4+IR) is defined at CD4+ \> 50u/L at two consecutive measures within 100 days post-alloHCT. Lymphocyte subsets (includes CD3, CD4, CD8, CD19, CD56+16, CD45RA, CD45) will be documented by flow cytometry. |
| Secondary | Quality of Life (PROMIS score) | up to 3 years post-alloHCT | Patient-reported outcomes will be self-reported using the PROMIS Profile Measure Scores. Scores are reported as standardized T-scores based on a U.S. general population average of 50 and a standard deviation of 10. |
| Secondary | Percentage of patients who are eligible to proceed to transplant after receiving an immune suppression prophase | 30 days |
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
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