Trial · NCT06517641
Clinical Trial of Upfront Haploidentical or Unrelated Donor BMT to Restore Normal Hematopoiesis in Aplastic Anemia
NCT06517641, Phase 2, Recruiting, Medical College of Wisconsin
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Clinical Trial of Upfront Haploidentical or Unrelated Donor BMT to Restore Normal Hematopoiesis in Aplastic Anemia. Trials, record NCT06517641. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT06517641
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Clinical Trial of Upfront Haploidentical or Unrelated Donor BMT to Restore Normal Hematopoiesis in Aplastic Anemia
- NCT number
- NCT06517641
- Status
- Recruiting
- Phases
- Phase 2
- Enrollment
- 60 participants, estimated
- Lead sponsor
- Medical College of Wisconsin
- Conditions
- Severe Aplastic Anemia
- Interventions
- Haploidentical donor bone marrow transplant, Unrelated donor bone marrow transplant
- First posted
- 2024-07-24
- Last updated
- 2026-02-17
Source ClinicalTrials.gov
Registered outcomes13
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Graft versus host disease (GVHD)-free failure-free survival (GFFS) at One year | 1 year after initiation of conditioning | The primary endpoint is GFFS at 1 year after initiation of conditioning. Events for GFFS include Grade III-IV aGVHD, cGVHD requiring immunosuppression, primary or secondary graft failure requiring second definitive therapy, failure to receive an HSCT infusion, and death. GFFS is defined as the time interval from start of conditioning until the first of these events occurs. For failure to receive an HSCT infusion, the date will be at the time the decision not to proceed to HSCT is made. |
| Secondary | Percentage of Participants with Overall survival (OS) at One year post conditioning | 1 year after initiation of conditioning | Events for OS include death from any cause. OS is defined as the time interval from initiation of conditioning until death. The OS probability will be assessed at 1 year after initiation of conditioning. |
| Secondary | Percentage of Participants with Failure-Free Survival (FFS) at One year post conditioning | 1 year after initiation of conditioning | Events for FFS include treatment failure or death. Treatment failure is defined as the initiation of treatment with a second definitive therapy. FFS is defined as the time interval from start of conditioning until the start date of a second definitive therapy or death, whichever occurs first. |
| Secondary | Participants Alive and Engrafted at One year post conditioning | 1 year after initiation of conditioning | The proportion of patients who are alive with donor cells present at 1 year after initiation of conditioning will be described, where the presence of donor cells is defined as achieving at least 5% myeloid donor chimerism (whole blood or marrow) in the most recent measurement through 1 year. |
| Secondary | Percentage of Participants with Neutrophil Recovery post-transplant | Day 28 and Day 56 post-HSCT | Neutrophil recovery is achieving an ANC ≥ 0.5 x109/L for 3 consecutive measurements on different days, with the first of the 3 days being defined as the day of neutrophil recovery. The cumulative incidences of neutrophil recovery at Day +28 and Day +56 post-HSCT will be estimated. |
| Secondary | Percentage of Participants with Red Blood Cell Recovery post-transplant | Day 100, Day 180, and Day 365 post-HSCT | Red blood cell (RBC) recovery is defined as Hb level ≥ 7 g/dL with no red cell transfusion in the preceding 7 days. The first day of the 7 days will be defined as the day of RBC recovery. The cumulative incidences of RBC recovery at Day +100, Day +180, and Day +365 post-HSCT will be estimated. |
| Secondary | Percentage of Participants with Platelet Recovery post-transplant | Day 100 post-HSCT | Platelet recovery is defined by achieving a platelet count ≥ 20 x 109/L with no platelet transfusions in the preceding 7 days. The first 7 days of the sustained platelet count will be defined as the day of platelet recovery. The cumulative incidence of platelet recovery at Day +100 post-HSCT will be estimated. |
| Secondary | Percentage of Participants with Primary Graft Failure post-transplant | Day 56 post-HSCT | * Primary Graft Failure is defined as the occurrence of any of the following: 1. Lack of neutrophil recovery by Day +56 post-HSCT. 2. Failure to achieve at least 5% myeloid donor chimerism any measurement up to and including Day +56 post-HSCT. 3. Administration of a second definitive therapy, which is defined as a second transplant or a course of ATG. * The proportion of patients with primary graft failure through Day +56 post-HSCT will be estimated. |
| Secondary | Percentage of Participants with Secondary Graft Failure post-transplant | 1 year post-HSCT | * Secondary Graft Failure is defined as the occurrence of any of the following: 1. Initial neutrophil recovery with donor chimerism greater than or equal to 5%, followed by sustained subsequent decline in ANC with donor chimerism declining to less than 5%. 2. Administration of a second definitive therapy, which is defined as a second transplant or a course of ATG. * The cumulative incidence of secondary graft failure at 1 year post-HSCT will be estimated. |
| Secondary | Percentage of Participants with any Graft Failure (primary or secondary) post-transplant | 1 year post-HSCT | The time from transplant until any graft failure (primary or secondary) will be described for each transplant cohort using the Aalen-Johansen estimator, with death treated as a competing risk. Estimates and 90% CIs of the cumulative incidence of any graft failure will be provided at Day +365 post-HSCT for each cohort. |
1 to 10 of 13Source ClinicalTrials.gov
See all 13 registered outcomesOutcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
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 trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT06517641
GET https://conductscience.org/api/trials/v1/NCT06517641/registered