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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

PHASE3

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-08-01

Study Completion Date

2026-11-01

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Poor Graft Function

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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)

Group Type EXPERIMENTAL

decitabine

Intervention Type DRUG

15 mg/m2 daily intravenously for consecutive 3 days

umbilical cord blood

Intervention Type BIOLOGICAL

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

Granulocyte-colony stimulating factor

Intervention Type DRUG

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

Recombinant human thrombopoietin / thrombopoietin receptor agonist

Intervention Type DRUG

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

Recombinant human erythropoietin

Intervention Type DRUG

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

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.

Group Type ACTIVE_COMPARATOR

Granulocyte-colony stimulating factor

Intervention Type DRUG

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

Recombinant human thrombopoietin / thrombopoietin receptor agonist

Intervention Type DRUG

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

Recombinant human erythropoietin

Intervention Type DRUG

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

Interventions

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decitabine

15 mg/m2 daily intravenously for consecutive 3 days

Intervention Type DRUG

umbilical cord blood

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

Intervention Type BIOLOGICAL

Granulocyte-colony stimulating factor

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

Intervention Type DRUG

Recombinant human thrombopoietin / thrombopoietin receptor agonist

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

Intervention Type DRUG

Recombinant human erythropoietin

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

Intervention Type DRUG

Other Intervention Names

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Dec UCB G-CSF rhTPO/TPO-RA EPO

Eligibility Criteria

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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.

Minimum Eligible Age

16 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No