Prospective Study of Patients With Thrombocytopenia Following HSCT

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

97 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-10-31

Study Completion Date

2019-04-12

Brief Summary

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Isolated thrombocytopenia is a common and severe complication of HSCT, which often leads to an increased risk of life-threatening hemorrhage, frequent requirement of platelet transfusions and extended hospital stays, representing a challenging clinical problem. Current treatments for thrombocytopenia after HSCT are frequently unsatisfactory in platelet recovery and for preventing potentially fatal bleeding complications. Therefore, it is urgent to explore an effective therapy to improve the outcomes of thrombocytopenia after HSCT. Previous studies have demonstrated that decitabine, a hypomethylating agent, may reduce platelet transfusions in myelodysplastic syndrome (MDS) patients. The investigators conducted an prospective clinical trial to evaluate the safety and efficiency of rhTPO and decitabine in the treatment of thrombocytopenia following HSCT.

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Detailed Description

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Isolated thrombocytopenia is a frequent and severe complication of hematopoietic stem cell transplantation (HSCT). It often leads to an increased risk of life-threatening hemorrhage, frequent requirement of platelet transfusions and extended hospital stays, representing a challenging clinical problem. Current treatments for thrombocytopenia after HSCT, including thrombopoietin, interleukin-11, immunoglobulin, methylprednisolone and rituximab, are frequently unsatisfactory in platelet recovery. Therefore, it is urgent to explore an effective therapy to improve the outcomes of thrombocytopenia after HSCT. Thrombopoietin (TPO) is a cytokine that drives thrombopoiesis by stimulating the differentiation of stem cells into megakaryocytes and promoting megakaryocyte proliferation and polyploidization. Decitabine was approved for the treatment of myelodysplastic syndrome (MDS) as a DNA methylation inhibitors. Studies in vitro show that decitabine enhances platelet release and megakaryocyte maturation. Here, the investigators performed a prospective clinical trial, in order to investigate the safety and efficiency of rhTPO and decitabine in the treatment of thrombocytopenia following HSCT.

Conditions

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Thrombocytopenia Hematologic Diseases

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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Experimental Group 1

Decitabine in combination with rhTPO.

Group Type EXPERIMENTAL

Decitabine

Intervention Type DRUG

Decitabine

rhTPO

Intervention Type DRUG

rhTPO

Experimental Group 2

Decitabine

Group Type EXPERIMENTAL

Decitabine

Intervention Type DRUG

Decitabine

Control Group

Conventional treatment except decitabine.

Group Type ACTIVE_COMPARATOR

Conventional Treatment

Intervention Type OTHER

immunoglobulin, glucocorticoid etc

Interventions

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Decitabine

Intervention Type DRUG

rhTPO

Intervention Type DRUG

Conventional Treatment

immunoglobulin, glucocorticoid etc

Intervention Type OTHER

Other Intervention Names

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5-Aza-2'-deoxycytidine Thrombopoietin

Eligibility Criteria

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Inclusion Criteria

1. Platelet count ≤ 30 × 109/L persistently at day 60 post-HSCT or later;
2. Neutrophil and hemoglobin were well recovered;
3. Full donor chimerism was achieved;
4. No response to conventional treatments (e.g. thrombopoietin, immunoglobulin, glucocorticoid alone or in combination) for a duration of at least 4 weeks;

Exclusion Criteria

1. Patients with malignancy relapse;
2. Active infections;
3. Grade Ⅲ-Ⅳ acute GVHD or severe chronic GVHD according to National Institute of Health criteria;
4. Severe organ damage;
5. Thrombosis requiring treatment;
6. Received decitabine following the current transplantation.

Eligible Sex

ALL

Accepts Healthy Volunteers

No