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

June 8, 2023 updated by: The First Affiliated Hospital of Soochow University

Decitabine and Umbilical Cord Blood for Poor Graft Function Post Allogenic Hematopoietic Stem Cell Transplantation

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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, together with umbilical cord blood in PGF post allo-HSCT patients.

Patients were eligible if they were 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 14 consecutive weeks, in the presence of full donor chimerism and primary disease in remission without severe graft-versus- host disease (GVHD) and relapse.

Patients with the following conditions or diagnoses were excluded: 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. Patients were also excluded if they had received decitabine or participated in other clinical trials within one month before screening.

Hematological improvement is defined as recovery of two or three blood lineages: absolute neutrophil count>1.5 × 109/L, platelet count>30 × 109/L, hemoglobin>85g/L, without G-CSF, red blood cell or platelet infusion.

Hematological response is defined as recovery of three blood lineages: absolute neutrophil count>2.5 × 109/L, platelet count>60 × 109/L, hemoglobin>100g/L, without G-CSF, red blood cell or platelet infusion.

No response: failed to achieve hematological improvement or response.

Study Type

Interventional

Enrollment (Estimated)

100

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 65 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Arm A
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
15 mg/m2 daily intravenously for consecutive 3 days
Other Names:
  • Dec
Biological: umbilical cord blood
MNC ≥ 3*108 cells; HLA compatibility ≥ 5/6
Other Names:
  • UCB
Drug: Granulocyte-colony stimulating factor
Granulocyte-colony stimulating factor will be used when absolute neutrophil count ≤ 1.5 × 109/L
Other Names:
  • G-CSF
Drug: Recombinant human thrombopoietin / thrombopoietin receptor agonist
Recombinant human thrombopoietin or thrombopoietin receptor agonist will be used when platelet count ≤ 30 × 109/L
Other Names:
  • rhTPO/TPO-RA
Drug: Recombinant human erythropoietin
Recombinant human erythropoietin will be used when hemoglobin ≤ 85 g/L
Other Names:
  • EPO
Active Comparator: Arm B
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
Granulocyte-colony stimulating factor will be used when absolute neutrophil count ≤ 1.5 × 109/L
Other Names:
  • G-CSF
Drug: Recombinant human thrombopoietin / thrombopoietin receptor agonist
Recombinant human thrombopoietin or thrombopoietin receptor agonist will be used when platelet count ≤ 30 × 109/L
Other Names:
  • rhTPO/TPO-RA
Drug: Recombinant human erythropoietin
Recombinant human erythropoietin will be used when hemoglobin ≤ 85 g/L
Other Names:
  • EPO

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The treatment response
Time Frame: day +28
The rate of hematological improvement and hematological response of 2 arms
day +28
Survival
Time Frame: 1 year
The rate of overall survival
1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Bone marrow recovery
Time Frame: day +28
Number of participants with granulopoiesis, erythropoiesis and megakaryopoiesis recovery of bone marrow
day +28
relapse and GVHD
Time Frame: 3-month
The rate of relapse and GVHD
3-month
Event free survival
Time Frame: 1-year
The rate of event free survival
1-year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The First Affiliated Hospital of Soochow University

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

August 1, 2023

Primary Completion (Estimated)

August 1, 2026

Study Completion (Estimated)

November 1, 2026

Study Registration Dates

First Submitted

December 19, 2022

First Submitted That Met QC Criteria

December 29, 2022

First Posted (Actual)

December 30, 2022

Study Record Updates

Last Update Posted (Actual)

June 9, 2023

Last Update Submitted That Met QC Criteria

June 8, 2023

Last Verified

December 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SOOCHOW-HY-2022-12-15

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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