Decitabine for Poor Graft Function Post Allo-HSCT

Soochow University

Status and phase: Not yet enrolling; Phase 3

Conditions: Poor Graft Function

Treatments: Drug: Decitabine; Drug: Thrombopoietin Receptor Agonist; Drug: Granulocyte Colony-Stimulating Factor; Drug: Recombinant human erythropoietin

Study type: Interventional

Funder types: Other

Identifiers

NCT05907499

SOOCHOW-HY-2023-06-06

Details and patient eligibility

About

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

Full 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.

Enrollment: 76 estimated patients

Sex: All

Ages: 16 to 70 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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76 participants in 2 patient groups

Arm A

Experimental group

Description:

Decitabine 6 mg/m2 daily subcutaneously for consecutive 3 days (day 1 to day 3)

Treatment:

Drug: Recombinant human erythropoietin

Drug: Granulocyte Colony-Stimulating Factor

Drug: Thrombopoietin Receptor Agonist

Drug: Decitabine

Arm B

Active Comparator group

Description:

The hematologic growth factors (granulocyte-colony stimulating factor, thrombopoietin receptor agonists, recombinant human erythropoietin)

Treatment:

Drug: Recombinant human erythropoietin

Drug: Granulocyte Colony-Stimulating Factor

Drug: Thrombopoietin Receptor Agonist