NCT04945096 is a Phase 3 clinical trial of decitabine in Engraft Failure, sponsored by The First Affiliated Hospital of Soochow University.

Who is sponsoring NCT04945096?

NCT04945096 is sponsored by The First Affiliated Hospital of Soochow University.

What drugs are being tested in NCT04945096?

Interventions in NCT04945096: decitabine, Acetylcysteine, Semustine, Cytarabine, Busulfan, Cyclophosphamide, Cyclosporin A, Anti-thymocyte globulin, Mycophenolate.

What condition does NCT04945096 study?

NCT04945096 studies Engraft Failure, Relapse, GVHD.

Is NCT04945096 still recruiting?

NCT04945096 is currently status unknown. Last updated 30 June 2021.

Last reviewed 2021-06-30 · How we verify

NCT04945096

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Outcomes of Patients After Allo-HSCT With Decitabine and NAC

Status unknown Phase 3 Last updated 30 June 2021

What this trial tests

Phase 3 trial testing decitabine in Engraft Failure in 100 participants. Status unknown.

Timeline

1 July 2021

Primary endpoint
1 July 2025

1 December 2025

Quick facts

Lead sponsor	The First Affiliated Hospital of Soochow University
Phase	Phase 3
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	100
Start date	1 July 2021
Primary completion	1 July 2025
Estimated completion	1 December 2025

Drugs / interventions tested

decitabine (decitabine) — full drug profile →
Acetylcysteine (Acetylcysteine) — full drug profile →
Semustine
Cytarabine — full drug profile →
Busulfan
Cyclophosphamide (cyclophosphamide) — full drug profile →
Cyclosporin A
Anti-thymocyte globulin
Mycophenolate (MYCOPHENOLIC ACID) — full drug profile →

Conditions studied

Engraft Failure — all drugs for Engraft Failure →
Relapse — all drugs for Relapse →
GVHD — all drugs for GVHD →

Sponsor

The First Affiliated Hospital of Soochow University

Who can join

Adults 10 to 70, any sex, with Engraft Failure or Relapse. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The investigators will conduct this prospective and randomized clinical trial, to evaluate the hematopoietic reconstitution, GVHD and relapse rate of patients after allo-HSCT with decitabine containing conditional regimen and NAC treatment.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

The Development of New Agents for Post-Hematopoietic Stem Cell Transplantation Non-Infectious Complications in Children.
Ilan U, Brivio E, Algeri M, Balduzzi A, et al · · 2023 · cited 2× · PMID 36983151 · DOI 10.3390/jcm12062149
The effects of adding decitabine to conditioning regimen for patients with acute myeloid leukemia or myelodysplastic syndrome undergoing allogeneic hematopoietic stem cell transplantation: a systematic review and meta-analysis.
Luo C, Zhang J, Huang X, Wu G, et al · · 2025 · PMID 41432753 · DOI 10.1007/s00277-025-06342-w

Verify or expand the search:

Other trials of decitabine

Trials testing the same drug.

NCT06429098 — Study of A Venetoclax-based, Anthracycline-free Regimen in Newly Diagnosed CBFβ::MYH11(+) AML · Phase 2 · recruiting
NCT05669079 — Decitabine and Umbilical Cord Blood for Poor Graft Function Post Allo-HSCT · Phase 3 · not yet recruiting
NCT05201066 — Roll-over Study for Patients Who Have Completed a Prior Novartis-sponsored Sabatolimab (MBG453) Study and Are Judged by · Phase 2 · active not recruiting
NCT04025593 — Biomarker Guided Treatment in DLBCL · Phase 2 · unknown
NCT03045510 — Efficacy and Safety of Ultra Small Dose Decitabine for the Lower Risk MDS Patients With Transfusion Dependent · Phase 2 · unknown

Other recruiting trials for Engraft Failure

Currently open trials in the same condition.

NCT03818334 — Post Transplant Cyclophosphamide in Matched Unrelated Donor Stem Cell Transplantation for Hematological Malignancies · Phase 2, PHASE3 · recruiting

Other The First Affiliated Hospital of Soochow University trials

Trials by the same sponsor.

NCT07350863 — U69-CART-Cells For R/R T-ALL · Phase 1 · recruiting
NCT06985498 — Immunotherapy Combined With Auto-HSCT and CD22/CD19 CAR-T Sandwich Strategy for B-ALL · Phase 2 · not yet recruiting
NCT07463651 — MRD-guided Maintenance Post-HCT: Gilteritini vs Sorafenib · Phase 3 · recruiting
NCT07500753 — A Single-arm, Prospective Study of a Clad-LABU Conditioning Regimen in HSCT for R/R MDS/AML in Elderly Patients · NA · recruiting
NCT07511426 — U96-CAR-T-Cells For R/R B-ALL · Phase 1 · recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT04945096 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by The First Affiliated Hospital of Soochow University
Last refreshed: 30 June 2021

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04945096.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing