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NCT Number: NCT05907499

Decitabine for Poor Graft Function Post Allo-HSCT

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

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Key information

Conditions

Age range

16 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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;
  • Full donor chimerism;
  • Primary disease in remission;
  • No severe GVHD and relapse;
  • ECOG: 0-2;
  • Expected survival longer than 1 month

Exclusion criteria

  • Allergic to decitabine;
  • Active infections;
  • Uncontrolled GVHD;
  • Severe organ dysfunction;
  • Relapse of underlying malignancies;
  • Graft failure;
  • Received decitabine or participated in other clinical trials within one month before screening.

Treatment and study plan

decitabine

Drug

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

Other names: Dec

Granulocyte Colony-Stimulating Factor

Drug

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

Other names: G-CSF

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.

Other names: Eltrombopag / Avatrombopag

Recombinant human erythropoietin

Drug

10000 U/day when hemoglobin ≤ 85 g/L

Other names: EPO

Primary outcomes

  1. The treatment response

    Time frame: day +28

    The rate of hematological response of after HSCT

  2. Survival

    Time frame: 1 year

    The rate of overall survival

Secondary outcomes

  1. Bone marrow recovery

    Time frame: day +28

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

  2. Relapse and GVHD

    Time frame: 3-month

    The rate of relapse and GVHD after HSCT

  3. Event free survival

    Time frame: 1 year

    The rate of event free survival after HSCT

Study contacts

Contact information is provided by the study sponsor or research team.

Yaqiong Tang, Doctor

CONTACT

[email protected]

18896588075

Sponsors and collaborators

Lead sponsor

The First Affiliated Hospital of Soochow University

Other

Registry information

Official study title

Low Dose Decitabine for Poor Graft Function Post Allogenic Hematopoietic Stem Cell Transplantation

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Jun 18, 2023
Registry last updated
Jun 18, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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