Decitabine and Umbilical Cord Blood for Poor Graft Function Post Allo-HSCT

NCT05669079 | Not Yet Recruiting Phase 3 DMC

• 1 other identifier: SOOCHOW-HY-2022-12-15
• Study Type: interventional
• Target: 100
• Locations: 0 countries
• Sites: N/A

Brief Summary

This randomized trial aimed at validating the efficacy and safety of low-dose decitabine, together with umbilical cord blood in PGF post allo-HSCT patients.

Conditions

Poor Graft Function

Outcome Measures

Primary Outcomes (2)

• The treatment response

  The rate of hematological improvement and hematological response of 2 arms

  day +28

• Survival

  The rate of overall survival

  1 year

Secondary Outcomes (3)

• Bone marrow recovery

  day +28

• relapse and GVHD

  3-month

• Event free survival

  1-year

Study Arms (2)

Arm A

EXPERIMENTAL

decitabine (Chia Tai Tianqing Pharma) 15 mg/m2 daily intravenously for consecutive 3 days (day 1 to day 3), combined with umbilical cord blood infusion (day 8)

Drug: decitabine; Biological: umbilical cord blood; Drug: Granulocyte-colony stimulating factor; Drug: Recombinant human thrombopoietin / thrombopoietin receptor agonist; Drug: Recombinant human erythropoietin

Arm B

ACTIVE COMPARATOR

Supportive therapy: G-CSF for patients with absolute neutrophil count ≤ 1.5 × 109/L, rhTPO/TPO-R with platelet count ≤ 30 × 109/L, EPO with hemoglobin ≤ 85g/L.

Drug: Granulocyte-colony stimulating factor; Drug: Recombinant human thrombopoietin / thrombopoietin receptor agonist; Drug: Recombinant human erythropoietin

Interventions

decitabine DRUG

15 mg/m2 daily intravenously for consecutive 3 days

Also known as: Dec

Arm A

umbilical cord blood BIOLOGICAL

MNC ≥ 3\*108 cells; HLA compatibility ≥ 5/6

Also known as: UCB

Arm A

Granulocyte-colony stimulating factor DRUG

Granulocyte-colony stimulating factor will be used when absolute neutrophil count ≤ 1.5 × 109/L

Also known as: G-CSF

Arm A; Arm B

Recombinant human thrombopoietin / thrombopoietin receptor agonist DRUG

Recombinant human thrombopoietin or thrombopoietin receptor agonist will be used when platelet count ≤ 30 × 109/L

Also known as: rhTPO/TPO-RA

Arm A; Arm B

Recombinant human erythropoietin DRUG

Recombinant human erythropoietin will be used when hemoglobin ≤ 85 g/L

Also known as: EPO

Arm A; Arm B

Eligibility Criteria

• Age: 16 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Allergic to decitabine or any components of frozen preservation of umbilical cord blood;
• 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.

Sponsors & Collaborators

• The First Affiliated Hospital of Soochow University: lead

Related Publications (5)

• 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.

  PMID: 27088376 RESULT

• 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.

  PMID: 16818281 RESULT

• 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.

  PMID: 34492685 RESULT

• 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.

  PMID: 33646303 RESULT

• 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.

  PMID: 26181032 RESULT

MeSH Terms

Interventions

Decitabine; Granulocyte Colony-Stimulating Factor; Thrombopoietin

Intervention Hierarchy (Ancestors)

Azacitidine; Aza Compounds; Organic Chemicals; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Ribonucleosides; Colony-Stimulating Factors; Glycoproteins; Glycoconjugates; Carbohydrates; Hematopoietic Cell Growth Factors; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors

Study Officials

• Yue Han

  The First Affiliated Hospital of Soochow University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yaqiong Tang

CONTACT

18896588075; tangyaqiong@suda.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 19, 2022
• First Posted: December 30, 2022
• Study Start: August 1, 2023
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): November 1, 2026
• Last Updated: June 9, 2023

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will not share