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Decitabine for Poor Graft Function Post Allo-HSCT

Sponsor
The First Affiliated Hospital of Soochow University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05907499
Collaborator
(none)
76
Enrollment
2
Arms
40
Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Drug: Decitabine
  • Drug: Granulocyte Colony-Stimulating Factor
  • Drug: Thrombopoietin Receptor Agonist
  • Drug: Recombinant human erythropoietin
 Phase 3

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 Design

Study Type:
Interventional
Anticipated Enrollment :
76 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Low Dose Decitabine for Poor Graft Function Post Allogenic Hematopoietic Stem Cell Transplantation
Anticipated Study Start Date :
Jul 1, 2023
Anticipated Primary Completion Date :
Jul 1, 2026
Anticipated Study Completion Date :
Nov 1, 2026

Arms and Interventions

Arm Intervention/Treatment
Experimental: Arm A

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

Drug: Decitabine
Decitabine 6 mg/m2 daily subcutaneously for consecutive 3 days (day 1 to day 3)
Other Names:
  • Dec

    • Drug: Granulocyte Colony-Stimulating Factor
    5ug/kg/d when absolute neutrophil count ≤ 1.5 × 109/L
    Other Names:
  • G-CSF

    • 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.
    Other Names:
  • Eltrombopag / Avatrombopag

    • Drug: Recombinant human erythropoietin
    10000 U/day when hemoglobin ≤ 85 g/L
    Other Names:
  • EPO

    		•
    Active Comparator: Arm B

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

    Drug: Granulocyte Colony-Stimulating Factor
    5ug/kg/d when absolute neutrophil count ≤ 1.5 × 109/L
    Other Names:
  • G-CSF

    • 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.
    Other Names:
  • Eltrombopag / Avatrombopag

    • Drug: Recombinant human erythropoietin
    10000 U/day when hemoglobin ≤ 85 g/L
    Other Names:
  • EPO

    		•

    Outcome Measures

    Primary Outcome Measures

    1. The treatment response [day +28]

      The rate of hematological response of after HSCT

    2. Survival [1 year]

      The rate of overall survival

    Secondary Outcome Measures

    1. Bone marrow recovery [day +28]

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

    2. Relapse and GVHD [3-month]

      The rate of relapse and GVHD after HSCT

    3. Event free survival [1 year]

      The rate of event free survival after HSCT

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    16 Years to 70 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • The First Affiliated Hospital of Soochow University

    Investigators

    • Principal Investigator: Yue Han, Professor, The First Affiliated Hospital of Soochow University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    The First Affiliated Hospital of Soochow University
    ClinicalTrials.gov Identifier:
    NCT05907499
    Other Study ID Numbers:
    • SOOCHOW-HY-2023-06-06
    First Posted:
    Jun 18, 2023
    Last Update Posted:
    Jun 18, 2023
    Last Verified:
    Jun 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by The First Affiliated Hospital of Soochow University
    poor graft function
    hematopoietic stem cell transplantation
    Additional relevant MeSH terms:
    Decitabine
    Epoetin Alfa
    Lenograstim

    Study Results

    No Results Posted as of Jun 18, 2023