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Trial · NCT06995521

Vorinostat for Graft-versus-host Disease (GVHD) Prevention in Non-Malignant Adolescent and Young Adults (AYA) Population

NCT06995521, Phase 2, Recruiting, Sung Won Choi

3 sourcestrials-2026-11-12-0.5.0

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ConductScience Library. Vorinostat for Graft-versus-host Disease (GVHD) Prevention in Non-Malignant Adolescent and Young Adults (AYA) Population. Trials, record NCT06995521. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT06995521

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title
Vorinostat for Graft-versus-host Disease (GVHD) Prevention in Non-Malignant Adolescent and Young Adults (AYA) Population
NCT number
NCT06995521
Status
Recruiting
Phases
Phase 2
Enrollment
55 participants, estimated
Lead sponsor
Sung Won Choi
Conditions
GVHD
Interventions
Vorinostat
First posted
2025-05-29
Last updated
2026-10-16

Source ClinicalTrials.gov

Registered outcomes15

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

ListOutcomeTime frameDescription
PrimaryGVHD-free relapse-free Survival1 year
Composite endpoint of 1-year GVHD-free, event free survival (GEFS) with the addition of vorinostat to standard serotherapy-free GVHD prophylaxis. Grade III-IV acute GVHD and chronic GVHD requiring immunosuppression will be considered in this assessment. Events contributing to this endpoint will include death due to any cause, primary or secondary graft failure/rejection, or second HSCT, whichever occurs first.
PrimaryPrimary graft failure/rejectionBy day+42 post-Hematopoietic stem cell transplant
Defined as never achieving an absolute neutrophil count (ANC) ≥500/microliters (µL) or never achieving ≥5% donor myeloid chimerism assessed by peripheral blood chimerism assays by day +42 post-Hematopoietic stem cell transplant (HSCT). Second infusion of hematopoietic stem cells is also considered indicative of primary graft failure by day +42 post-HSCT.
PrimarySecondary graft failure/rejectionBeyond day +42 post-HSCTDefined as \<5% donor myeloid chimerism in peripheral blood beyond day +42 post-HSCT in patients with prior documentation of hematopoietic recovery with ≥5% donor cells by day +42 post-HSCT.
PrimarySecondary graft failure/rejectionBy day +42 post-HSCTSecond infusion of hematopoietic stem cells is also considered indicative of primary graft failure by day +42 post-HSCT
SecondaryOverall survival (OS) at day 100, 6-months, and 1-year post-HSCTDay 100, 6-months, and 1-year post-HSCTThis will be measured after HSCT.
SecondaryEvent Free Survival (EFS) at 1-year post-HSCT1 year post-HSCTAn event will be defined as death due to any cause, graft rejection/failure, or second transplant, whichever occurs first.
SecondaryNeutrophil engraftment at day 42Day 42 post-HSCT
The time to engraftment of neutrophils \>500/microliter (μl) was defined as per Center for International Blood and Marrow Transplant Research (CIBMTR) standards, requiring donor chimerism for neutrophil engraftment.
SecondaryPlatelet engraftment at day 100 post-HSCTDay 100 post-HSCTPlatelet engraftment is defined as independence from platelet transfusion for at least 3 days with a platelet count of more than ≥20 × 10\^9/L.
SecondaryDonor chimerism at day 28, 100, and 1-year post-HSCTDay 28, 100, and 1-year post-HSCTNumber of participants with full (95-100%), mixed (5-94%), and no (0-4%) donor cells. Chimerism is reported for unsorted whole blood and T cells.
SecondaryPrimary graft failure at day 42Day 42 post-HSCT

Outcomes0

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.

ClinicalTrials.gov
2026-11-12
ClinicalTrials.gov
Results, from AACT
2026-03-23
AACT
NIH grant links
2026-11-13
NIH RePORTER

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/NCT06995521

GET https://conductscience.org/api/trials/v1/NCT06995521/registered