Overview

Efficacy of N-acetylcysteine Versus Placebo as Prophylaxis of Sinusoidal Obstruction Syndrome in Patients Undergoing Hematopoietic Stem Cell Transplantation

Status:
Not yet recruiting
Trial end date:
2023-03-31
Target enrollment:
0
Participant gender:
All
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 (HSCT), especially in its first thirty days. The morbidity and mortality in this syndrome are considerable, since severe SOS is associated with a mortality of more than 90% in the first hundred days of HSCT. Some risk factors are modifiable, especially those related to transplantation, but when non-alterable factors are present, preventive measures are needed that can reduce the incidence and / or severity of SOS.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Instituto Brasileiro de Controle do Cancer
Treatments:
Acetylcysteine
N-monoacetylcystine
Criteria
Inclusion Criteria:

- 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 Criteria:

- 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