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

ConditionPoor Graft Function
Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age16-65
SponsorThe First Affiliated Hospital of Soochow University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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

Active infections;

Uncontrolled GVHD;

Severe organ dysfunction;

Trial design

Design model

Parallel

Treatments tested in this trial

  • decitabine

    Drug

    15 mg/m2 daily intravenously for consecutive 3 days

  • umbilical cord blood

    Biological/Vaccine

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

  • Granulocyte-colony stimulating factor

    Drug

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

  • Recombinant human thrombopoietin / thrombopoietin receptor agonist

    Drug

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

  • Recombinant human erythropoietin

    Drug

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

Treatment groups

100 Participants
are divided into 2 treatment groups
Group A: Arm AExperimental treatment 5 interventions
Group B: Arm BActive comparator 3 interventions

Trial outcomes

Primary outcomes

1

The treatment response

The rate of hematological improvement and hematological response of 2 arms

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

Time frame
day +28
2

relapse and GVHD

The rate of relapse and GVHD

Time frame
3-month
3

Event free survival

The rate of event free survival

Time frame
1-year

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

The First Affiliated Hospital of Soochow University

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: