Status:
UNKNOWN
Efficacy of N-acetylcysteine Versus Placebo as Prophylaxis of Sinusoidal Obstruction Syndrome in Patients Undergoing Hematopoietic Stem Cell Transplantation
Lead Sponsor:
Instituto Brasileiro de Controle do Cancer
Conditions:
Sinusoidal Obstruction Syndrome (SOS)
Hematopoietic Stem Cell Transplant (HSCT)
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
Sinusoidal obstruction syndrome (SOS) or hepatic veno-occlusive disease (VOD) is a serious complication that occurs, most often occurring in patients undergoing hematopoietic stem cell transplantation...
Detailed Description
This is a single-center, randomized, placebo-controlled study to evaluate the efficacy and safety of N-acetylcysteine as prophylaxis of sinusoidal obstruction syndrome in patients undergoing hematopoi...
Eligibility Criteria
Inclusion
- Men or women
- Age ≥ 18 years
- A proven diagnosis of one of the hematological malignancies: Acute Myeloid Leukemia, Acute Lymphoid Leukemia, Chronic Myeloid Leukemia, Chronic Lymphoid Leukemia, Multiple Myeloma, Non-Hodgkin's Lymphoma, Hodgkin's Lymphoma
- Patients must be scheduled to undergo of Allogeneic hematopoietic transplantation or HLA (Human Leukocyte Antigen) haploidentical related or Unrelated or HLA-matched related or autologous stem cell transplant
- Patients must be able to understand and sign a written informed consent
Exclusion
- Patient has a serious active disease or co-morbid medical condition, as judged by the investigator, which would interfere with the conduct of this study
- Patient, in the opinion of the investigator, may not be able to comply with the safety monitoring requirements of the study
- Known hypersensitivity to N-acetylcysteine
- Contraindications to perform any procedure provided for in this study
- Patients who have already undergone a previous transplant
Key Trial Info
Start Date :
April 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 31 2023
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT04712435
Start Date
April 1 2021
End Date
March 31 2023
Last Update
March 9 2021
Active Locations (1)
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1
Jamilla Neves Cavalcante
São Paulo, São Paulo, Brazil, 03102-002