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

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

The Efficiency and Safety of N-acetylcysteine for Prevention of Thrombotic Events After Allogenic Hematopoietic Stem Cell Transplantation

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

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Estimated)

260

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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

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: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Drug: N-acetyl-cysteine
8g/d (>=45kg); 200mg/kg.d (<45kg), intravenously for at least 4 hours, day -9 to day +45
Other Names:
  • NAC
Drug: Busulfan
3.2mg/kg, day-7 to day -5, intravenously
Other Names:
  • BU
Drug: Cytarabine
2g/m2, day -8, intravenously
Other Names:
  • Ara-C
Drug: Cyclophosphamide
1.8g/m2, day -4 to day -3, intravenously
Other Names:
  • CTX
Active Comparator: 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.
Drug: Busulfan
3.2mg/kg, day-7 to day -5, intravenously
Other Names:
  • BU
Drug: Cytarabine
2g/m2, day -8, intravenously
Other Names:
  • Ara-C
Drug: Cyclophosphamide
1.8g/m2, day -4 to day -3, intravenously
Other Names:
  • CTX

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The incidence of thrombotic disorders
Time Frame: 1 year
The incidence of thrombotic disorders (TA-TMA, SOS, DVT, PTE, CRT, SVT) after allogenic hematopoietic stem cell transplantation
1 year
Overall survival
Time Frame: 1 year
The rate of overall survival after allogenic hematopoietic stem cell transplantation
1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The incidence of relapse
Time Frame: 1 year
The incidence of relapse after allogenic hematopoietic stem cell transplantation
1 year
The incidence of GVHD
Time Frame: 1 year
The incidence of GVHD after allogenic hematopoietic stem cell transplantation
1 year
The incidence of hematopoietic reconstitution
Time Frame: 1 year
The incidence of hematopoietic reconstitution after allogenic hematopoietic stem cell transplantation
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

  • Study Chair: Yue Han, Professor, 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, 2025

Study Completion (Estimated)

December 1, 2025

Study Registration Dates

First Submitted

June 8, 2023

First Submitted That Met QC Criteria

June 8, 2023

First Posted (Estimated)

June 16, 2023

Study Record Updates

Last Update Posted (Estimated)

June 16, 2023

Last Update Submitted That Met QC Criteria

June 8, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SOOCHOW-HY-2023-05-30

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

product manufactured in and exported from the U.S.

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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