The Use of N-acetylcysteine for Thrombotic Events After Allogenic Hematopoietic Stem Cell Transplantation

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

260 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-08-01

Study Completion Date

2025-12-01

Brief Summary

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We aim to assess the the efficiency and safety of N-acetylcysteine for prevention of thrombotic events after allogenic hematopoietic stem cell transplantation.

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Detailed Description

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The thrombotic events are increasingly recognized complications of hematopoietic cell transplantation (HCT) associated with significant morbidity and mortality, which include transplantation-associated thrombotic microangiopathy (TA-TMA), sinusoidal obstructive syndrome (SOS), deep vein thrombosis (DVT), pulmonary thromboembolism (PTE), catheter-related thrombosis (CRT), superficial vein thrombosis (SVT), etc. There is a complex interplay on balancing the risk for thrombosis and bleeding in these patients, making treatment decisions particularly challenging. Emerging studies revealed that endothelial injury is the common underlying mechanism among different thrombotic disorders. There is increasing data that N-acetyl-cysteine (NAC) may prevent or improve endothelial dysfunction by inhibiting ROS production and preventing endothelial apoptosis. Our previous study showed low dose NAC could decrease the incidence of TA-TMA. In this study, we aim to assess the the efficiency and safety of N-acetylcysteine for prevention of thrombotic events after allogenic hematopoietic stem cell transplantation.

Conditions

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Thrombotic Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Arm A

Modified BUCY conditioning regimen: busulfan (3.2mg/kg, day-7 to day -5), cytarabine (2g/m2, day -8), cyclophosphamide (1.8g/m2, day -4 to day -3), followed by stem cells infusion; N-acetyl-cysteine (Zambon Pharma, Hainan, China) : 8g/d (\>=45kg); 200mg/kg.d (\<45kg), intravenously for at least 4 hours, day -9 to day +45.

Group Type EXPERIMENTAL

N-acetyl-cysteine

Intervention Type DRUG

8g/d (\>=45kg); 200mg/kg.d (\<45kg), intravenously for at least 4 hours, day -9 to day +45

Busulfan

Intervention Type DRUG

3.2mg/kg, day-7 to day -5, intravenously

Cytarabine

Intervention Type DRUG

2g/m2, day -8, intravenously

Cyclophosphamide

Intervention Type DRUG

1.8g/m2, day -4 to day -3, intravenously

Arm B

Modified BUCY conditioning regimen: busulfan (3.2mg/kg, day-7 to day -5), cytarabine (2g/m2, day -8), cyclophosphamide (1.8g/m2, day -4 to day -3), followed by stem cells infusion.

Group Type ACTIVE_COMPARATOR

Busulfan

Intervention Type DRUG

3.2mg/kg, day-7 to day -5, intravenously

Cytarabine

Intervention Type DRUG

2g/m2, day -8, intravenously

Cyclophosphamide

Intervention Type DRUG

1.8g/m2, day -4 to day -3, intravenously

Interventions

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N-acetyl-cysteine

8g/d (\>=45kg); 200mg/kg.d (\<45kg), intravenously for at least 4 hours, day -9 to day +45

Intervention Type DRUG

Busulfan

3.2mg/kg, day-7 to day -5, intravenously

Intervention Type DRUG

Cytarabine

2g/m2, day -8, intravenously

Intervention Type DRUG

Cyclophosphamide

1.8g/m2, day -4 to day -3, intravenously

Intervention Type DRUG

Other Intervention Names

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NAC BU Ara-C CTX

Eligibility Criteria

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Inclusion Criteria

1. Aged 16-70 years old
2. Diagnosed as myeloid malignancies, and about to undergo allo-HSCT;
3. ECOG: 0-2;
4. Expected survival longer than 1 month

Exclusion Criteria

1. Allergic to any components of NAC;
2. Severe dysfunction of heart, liver, lung and kidney;
3. Relapse before HSCT;
4. A history of bronchial asthma, bronchospasm or moderate / severe gastrohelcosis.

Minimum Eligible Age

16 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No