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Not yet recruitingNCT05907499Updated Jun 18, 2023

Decitabine for Poor Graft Function Post Allo-HSCT

A Phase 3 interventional study of Decitabine and Granulocyte Colony-Stimulating Factor in Poor Graft Function, sponsored by The First Affiliated Hospital of Soochow University. Not yet recruiting. Open to participants aged 16 Years to 70 Years. Per ClinicalTrials.gov, last updated 2023-06-18.

Sponsored by The First Affiliated Hospital of Soochow University · Phase 3, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Jul 2026, 3 months ago, but the record still lists the study as not yet recruiting.
Phase
Phase 3
Study type
Interventional
Enrollment
76
Allocation
Randomized
Ages
16 Years to 70 Years
Sex
All
01

Study summary

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

Read the 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.

02

Conditions studied

  • Poor Graft Function

Keywords

  • poor graft function
  • hematopoietic stem cell transplantation
03

In context

Lead sponsor

The First Affiliated Hospital of Soochow University is the lead sponsor of 252 studies on the registry; 148 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
16 Years to 70 Years
Sexes eligible
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

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.
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
76 participants (estimated)

Study arms

  • Experimental
    Arm A

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

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

  • Active comparator
    Arm B

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

    Drug: Granulocyte Colony-Stimulating Factor · Drug: Thrombopoietin Receptor Agonist · Drug: Recombinant human erythropoietin

Interventions

  • DrugDecitabine

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

    Also known as: Dec

  • DrugGranulocyte Colony-Stimulating Factor

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

    Also known as: G-CSF

  • DrugThrombopoietin 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.

    Also known as: Eltrombopag / Avatrombopag

  • DrugRecombinant human erythropoietin

    10000 U/day when hemoglobin ≤ 85 g/L

    Also known as: EPO

06

What researchers measure

Primary outcomes

  1. The treatment response

    The rate of hematological response of after HSCT

    Time frame: day +28

  2. Survival

    The rate of overall survival

    Time frame: 1 year

Secondary outcomes

  1. Bone marrow recovery

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

    Time frame: day +28

  2. Relapse and GVHD

    The rate of relapse and GVHD after HSCT

    Time frame: 3-month

  3. Event free survival

    The rate of event free survival after HSCT

    Time frame: 1 year

07

Study locations

No study locations are listed for this record.

08

References and documents

Publications

  • Alchalby H, Yunus DR, Zabelina T, Ayuk F, Kroger N. Incidence and risk factors of poor graft function after allogeneic stem cell transplantation for myelofibrosis. Bone Marrow Transplant. 2016 Sep;51(9):1223-7. doi: 10.1038/bmt.2016.98. Epub 2016 Apr 18. PubMed 27088376 ↗
  • Larocca A, Piaggio G, Podesta M, Pitto A, Bruno B, Di Grazia C, Gualandi F, Occhini D, Raiola AM, Dominietto A, Bregante S, Lamparelli T, Tedone E, Oneto R, Frassoni F, Van Lint MT, Pogliani E, Bacigalupo A. Boost of CD34+-selected peripheral blood cells without further conditioning in patients with poor graft function following allogeneic stem cell transplantation. Haematologica. 2006 Jul;91(7):935-40. PubMed 16818281 ↗
  • Prabahran A, Koldej R, Chee L, Ritchie D. Clinical features, pathophysiology, and therapy of poor graft function post-allogeneic stem cell transplantation. Blood Adv. 2022 Mar 22;6(6):1947-1959. doi: 10.1182/bloodadvances.2021004537. PubMed 34492685 ↗
  • Ghobadi A, Fiala MA, Ramsingh G, Gao F, Abboud CN, Stockerl-Goldstein K, Uy GL, Grossman BJ, Westervelt P, DiPersio JF. Fresh or Cryopreserved CD34+-Selected Mobilized Peripheral Blood Stem and Progenitor Cells for the Treatment of Poor Graft Function after Allogeneic Hematopoietic Cell Transplantation. Biol Blood Marrow Transplant. 2017 Jul;23(7):1072-1077. doi: 10.1016/j.bbmt.2017.03.019. Epub 2017 Mar 18. PubMed 28323004 ↗
  • Lubbert M, Suciu S, Baila L, Ruter BH, Platzbecker U, Giagounidis A, Selleslag D, Labar B, Germing U, Salih HR, Beeldens F, Muus P, Pfluger KH, Coens C, Hagemeijer A, Eckart Schaefer H, Ganser A, Aul C, de Witte T, Wijermans PW. Low-dose decitabine versus best supportive care in elderly patients with intermediate- or high-risk myelodysplastic syndrome (MDS) ineligible for intensive chemotherapy: final results of the randomized phase III study of the European Organisation for Research and Treatment of Cancer Leukemia Group and the German MDS Study Group. J Clin Oncol. 2011 May 20;29(15):1987-96. doi: 10.1200/JCO.2010.30.9245. Epub 2011 Apr 11. PubMed 21483003 ↗
  • Han P, Yu T, Hou Y, Zhao Y, Liu Y, Sun Y, Wang H, Xu P, Li G, Sun T, Hu X, Liu X, Li L, Peng J, Zhou H, Hou M. Low-Dose Decitabine Inhibits Cytotoxic T Lymphocytes-Mediated Platelet Destruction via Modulating PD-1 Methylation in Immune Thrombocytopenia. Front Immunol. 2021 Feb 17;12:630693. doi: 10.3389/fimmu.2021.630693. eCollection 2021. PubMed 33679776 ↗
  • Han P, Hou Y, Zhao Y, Liu Y, Yu T, Sun Y, Wang H, Xu P, Li G, Sun T, Hu X, Liu X, Li L, Peng J, Zhou H, Hou M. Low-dose decitabine modulates T-cell homeostasis and restores immune tolerance in immune thrombocytopenia. Blood. 2021 Aug 26;138(8):674-688. doi: 10.1182/blood.2020008477. PubMed 33876188 ↗
  • Zambuzi FA, Cardoso-Silva PM, Castro RC, Fontanari C, Emery FDS, Frantz FG. Decitabine Promotes Modulation in Phenotype and Function of Monocytes and Macrophages That Drive Immune Response Regulation. Cells. 2021 Apr 12;10(4):868. doi: 10.3390/cells10040868. PubMed 33921194 ↗
  • Kopp LM, Ray A, Denman CJ, Senyukov VS, Somanchi SS, Zhu S, Lee DA. Decitabine has a biphasic effect on natural killer cell viability, phenotype, and function under proliferative conditions. Mol Immunol. 2013 Jul;54(3-4):296-301. doi: 10.1016/j.molimm.2012.12.012. Epub 2013 Jan 16. PubMed 23328088 ↗
  • Tang Y, Chen J, Liu Q, Chu T, Pan T, Liang J, He XF, Chen F, Yang T, Ma X, Wu X, Hu S, Cao X, Hu X, Hu J, Liu Y, Qi J, Shen Y, Ruan C, Han Y, Wu D. Low-dose decitabine for refractory prolonged isolated thrombocytopenia after HCT: a randomized multicenter trial. Blood Adv. 2021 Mar 9;5(5):1250-1258. doi: 10.1182/bloodadvances.2020002790. PubMed 33646303 ↗
  • Han Y, Tang Y, Chen J, Liang J, Ye C, Ruan C, Wu D. Low-Dose Decitabine for Patients With Thrombocytopenia Following Allogeneic Hematopoietic Stem Cell Transplantation: A Pilot Therapeutic Study. JAMA Oncol. 2015 May;1(2):249-51. doi: 10.1001/jamaoncol.2014.316. No abstract available. PubMed 26181032 ↗
  • DeSimone J, Koshy M, Dorn L, Lavelle D, Bressler L, Molokie R, Talischy N. Maintenance of elevated fetal hemoglobin levels by decitabine during dose interval treatment of sickle cell anemia. Blood. 2002 Jun 1;99(11):3905-8. doi: 10.1182/blood.v99.11.3905. PubMed 12010787 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 18, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05907499
Lead sponsor
The First Affiliated Hospital of Soochow University
Responsible party
Sponsor
First posted
Jun 18, 2023
Start date
Jul 1, 2023 (estimated)
Primary completion
Jul 1, 2026 (estimated)
Completion
Nov 1, 2026 (estimated)
Last update
Jun 18, 2023

Study contacts

Yaqiong Tang, Doctor
Contact
tangyaqiong@suda.edu.cn
18896588075
Yue Han, Professor
principal investigator · The First Affiliated Hospital of Soochow University

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Jun 2023. You cannot join it, but the record below documents what was studied.

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