Efficacy of N-acetylcysteine Versus Placebo as Prophylaxis of Sinusoidal Obstruction Syndrome in Patients Undergoing Hematopoietic Stem Cell Transplantation (ALISON)
Sinusoidal Obstruction Syndrome (SOS), Hematopoietic Stem Cell Transplant (HSCT)
About this trial
This is an interventional prevention trial for Sinusoidal Obstruction Syndrome (SOS) focused on measuring Stem cell transplant, Hematopoietic stem cell transplant (HSCT), Sinusoidal obstruction syndrome (SOS), Veno-occlusive disease (VOD), N-acetylcysteine
Eligibility 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
Sites / Locations
- Jamilla Neves Cavalcante
Arms of the Study
Arm 1
Arm 2
Experimental
Placebo Comparator
Experimental: N-acetylcysteine
Placebo Comparator: Placebo
Sachets containing N-acetylcysteine 200 mg Powder for Oral Solution administered every 8 hours (Daily dose 600 mg/day). is administered on the first day of conditioning and will continue until Day +30 post HSCT or hospital discharge, whichever is sooner
200mg granulated solution of matching placebo administered every 8 hours (Daily dose 600 mg/day), is administered on the first day of conditioning and will continue until Day +30 post HSCT or hospital discharge, whichever is sooner