Decitabine for Poor Graft Function Post Allo-HSCT

Phase 3

Not yet recruiting

• Conditions: Poor Graft Function
• Interventions: Drug: Decitabine; Drug: Granulocyte Colony-Stimulating Factor; Drug: Thrombopoietin Receptor Agonist; Drug: Recombinant human erythropoietin

• Registration Number: NCT05907499
• Lead Sponsor: The First Affiliated Hospital of Soochow University

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.

Study Timeline

• Status Verified: 2023-06
• Study First Submitted: 2023-06-08
• Study First Submitted QC: 2023-06-08
• Last Update Submitted: 2023-06-08
• Study First Posted: 2023-06-18
• Last Update Posted: 2023-06-18
• Study Start: 2023-07-01
• Primary Completion: 2026-07-01
• Study Completion: 2026-11-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 76

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm A	Thrombopoietin Receptor Agonist	Decitabine 6 mg/m2 daily subcutaneously for consecutive 3 days (day 1 to day 3)
Arm B	Thrombopoietin Receptor Agonist	The hematologic growth factors (granulocyte-colony stimulating factor, thrombopoietin receptor agonists, recombinant human erythropoietin)
Arm A	Granulocyte Colony-Stimulating Factor	Decitabine 6 mg/m2 daily subcutaneously for consecutive 3 days (day 1 to day 3)
Arm A	Decitabine	Decitabine 6 mg/m2 daily subcutaneously for consecutive 3 days (day 1 to day 3)
Arm A	Recombinant human erythropoietin	Decitabine 6 mg/m2 daily subcutaneously for consecutive 3 days (day 1 to day 3)
Arm B	Granulocyte Colony-Stimulating Factor	The hematologic growth factors (granulocyte-colony stimulating factor, thrombopoietin receptor agonists, recombinant human erythropoietin)
Arm B	Recombinant human erythropoietin	The hematologic growth factors (granulocyte-colony stimulating factor, thrombopoietin receptor agonists, recombinant human erythropoietin)

Primary Outcome Measures

Name	Time	Method
The treatment response	day +28	The rate of hematological response of after HSCT
Survival	1 year	The rate of overall survival

Secondary Outcome Measures

Name	Time	Method
Bone marrow recovery	day +28	Number of participants with granulopoiesis, erythropoiesis and megakaryopoiesis recovery of bone marrow after HSCT
Relapse and GVHD	3-month	The rate of relapse and GVHD after HSCT
Event free survival	1 year	The rate of event free survival after HSCT