---
title: Decitabine for Poor Graft Function Post Allo-HSCT
nct_id: NCT05907499
overall_status: NOT_YET_RECRUITING
phase: PHASE3
sponsor: The First Affiliated Hospital of Soochow University
study_type: INTERVENTIONAL
primary_condition: Poor Graft Function
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT05907499.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT05907499"
ct_last_update_post_date: 2023-06-18
last_seen_at: "2026-05-12T07:24:42.185Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# Decitabine for Poor Graft Function Post Allo-HSCT

**Official Title:** Low Dose Decitabine for Poor Graft Function Post Allogenic Hematopoietic Stem Cell Transplantation

**NCT ID:** [NCT05907499](https://clinicaltrials.gov/study/NCT05907499)

## Key Facts

- **Status:** NOT_YET_RECRUITING
- **Phase:** PHASE3
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 76
- **Lead Sponsor:** The First Affiliated Hospital of Soochow University
- **Conditions:** Poor Graft Function
- **Start Date:** 2023-07-01
- **Completion Date:** 2026-11-01
- **CT.gov Last Update:** 2023-06-18

## Brief Summary

This randomized trial aims at validating the efficacy and safety of low-dose decitabine for PGF post allo-HSCT.

## Detailed Description

Poor graft function (PGF), defined by the presence of multilineage cytopenias in the presence of 100% donor chimerism, is a serious complication of allogeneic stem cell transplant (allo-HSCT). Emerging evidence demonstrates that the inadequate stem cells infusion, bone marrow microenvironment and immune dysregulation play a crucial role in maintaining and regulating hematopoiesis. Current therapies remain debatable, including selected CD34+ cells infusion, mesenchymal stromal cells infusion, prophylactic N-acetyl cysteine administration, etc. Thereafter, the investigators conduct a randomized trial aiming at validating the efficacy and safety of low-dose decitabine in PGF post allo-HSCT patients.

## Eligibility

- **Minimum age:** 16 Years
- **Maximum age:** 70 Years
- **Sex:** ALL
- **Healthy Volunteers:** No

```
Inclusion Criteria:

1. Diagnosed as PGF at day 28 post-HSCT or later. PGF was defined as two or three cytopenias, absolute neutrophil count ≤ 1.5 × 109/L, platelet count ≤ 30 × 109/L, hemoglobin ≤ 85g/L, lasting for more than 2 consecutive weeks;
2. Full donor chimerism;
3. Primary disease in remission;
4. No severe GVHD and relapse;
5. ECOG: 0-2;
6. Expected survival longer than 1 month

Exclusion Criteria:

1. Allergic to decitabine;
2. Active infections;
3. Uncontrolled GVHD;
4. Severe organ dysfunction;
5. Relapse of underlying malignancies;
6. Graft failure;
7. Received decitabine or participated in other clinical trials within one month before screening.
```

## Arms

- **Arm A** (EXPERIMENTAL) — Decitabine 6 mg/m2 daily subcutaneously for consecutive 3 days (day 1 to day 3)
- **Arm B** (ACTIVE_COMPARATOR) — The hematologic growth factors (granulocyte-colony stimulating factor, thrombopoietin receptor agonists, recombinant human erythropoietin)

## Interventions

- **Decitabine** (DRUG) — Decitabine 6 mg/m2 daily subcutaneously for consecutive 3 days (day 1 to day 3)
- **Granulocyte Colony-Stimulating Factor** (DRUG) — 5ug/kg/d when absolute neutrophil count ≤ 1.5 × 109/L
- **Thrombopoietin Receptor Agonist** (DRUG) — Eltrombopag initial dose: 25 mg orally once a day, may increase to up to 75 mg/day, when platelet count ≤ 30 × 109/L; Avatrombopag initial dose: 20 mg orally once a day, may increase to up to 60 mg/day, when platelet count ≤ 30 × 109/L.
- **Recombinant human erythropoietin** (DRUG) — 10000 U/day when hemoglobin ≤ 85 g/L

## Primary Outcomes

- **The treatment response** _(time frame: day +28)_ — The rate of hematological response of after HSCT
- **Survival** _(time frame: 1 year)_ — The rate of overall survival

## Secondary Outcomes

- **Bone marrow recovery** _(time frame: day +28)_
- **Relapse and GVHD** _(time frame: 3-month)_
- **Event free survival** _(time frame: 1 year)_

## Recent Field Changes (last 30 days)

- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.maxAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_

---

*Canonical: https://parkinsonspathways.com/agent/trials/NCT05907499.md*  
*Source data (authoritative): https://clinicaltrials.gov/study/NCT05907499*  
*This page is a raw mirror with no AI summary, no editorial enrichment, and no Parkinson's-specific filtering.*