Decitabine for Poor Graft Function Post Allo-HSCT

NCT ID: NCT05907499

Last Updated: 2023-06-18

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE3
• Total Enrollment: 76 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-07-01
• Study Completion Date: 2026-11-01

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.

Conditions

Poor Graft Function

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Arm A

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

Group Type: EXPERIMENTAL

Decitabine

Intervention Type: DRUG

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

Granulocyte Colony-Stimulating Factor

Intervention Type: DRUG

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

Thrombopoietin Receptor Agonist

Intervention Type: 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

Intervention Type: DRUG

10000 U/day when hemoglobin ≤ 85 g/L

Arm B

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

Group Type: ACTIVE_COMPARATOR

Granulocyte Colony-Stimulating Factor

Intervention Type: DRUG

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

Thrombopoietin Receptor Agonist

Intervention Type: 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

Intervention Type: DRUG

10000 U/day when hemoglobin ≤ 85 g/L

Interventions

Decitabine

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

Intervention Type: DRUG

Granulocyte Colony-Stimulating Factor

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

Intervention Type: DRUG

Thrombopoietin Receptor Agonist

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.

Intervention Type: DRUG

Recombinant human erythropoietin

10000 U/day when hemoglobin ≤ 85 g/L

Intervention Type: DRUG

Other Intervention Names

Dec; G-CSF; Eltrombopag / Avatrombopag; EPO

Eligibility Criteria

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.

• Minimum Eligible Age: 16 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The First Affiliated Hospital of Soochow University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Yue Han, Professor

Role: PRINCIPAL_INVESTIGATOR

The First Affiliated Hospital of Soochow University

Central Contacts

Yaqiong Tang, Doctor

Role: CONTACT

tangyaqiong@suda.edu.cn

18896588075

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Other Identifiers

SOOCHOW-HY-2023-06-06

Identifier Type: -

Identifier Source: org_study_id