Decitabine for Poor Graft Function Post Allo-HSCT

Phase 3Not Yet RecruitingNCT05907499

The First Affiliated Hospital of Soochow University76 enrolled

Overview

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

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Poor Graft Function

Interventions

DecitabineDRUG

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

Granulocyte Colony-Stimulating FactorDRUG

5ug/kg/d when absolute neutrophil count ≤ 1.5 × 109/L

Thrombopoietin Receptor AgonistDRUG

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.

Eligibility

Sex: ALLMin age: 16 YearsMax age: 70 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

The treatment response

The rate of hematological response of after HSCT

Time frame: day +28

Survival

The rate of overall survival

Time frame: 1 year

Secondary Outcomes

Bone marrow recovery

Number of participants with granulopoiesis, erythropoiesis and megakaryopoiesis recovery of bone marrow after HSCT

Time frame: day +28

Relapse and GVHD

The rate of relapse and GVHD after HSCT

Time frame: 3-month

Event free survival

The rate of event free survival after HSCT

Time frame: 1 year

Central Contacts

Yaqiong Tang, Doctor

CONTACT

18896588075 tangyaqiong@suda.edu.cn

Data from ClinicalTrials.gov

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