Prospective, Randomized Study Using N-Acetylcysteine as Prophylaxis of Sinusoidal Obstruction Syndrome in Patients Undergoing Hematopoietic Stem Cell Transplantation
| Registry | NCT04712435, acronym ALISON |
|---|---|
| Status | Unknown |
| Phase | Phase 2 |
| Study type | Interventional; randomized, parallel, masking: double, prevention |
| Enrollment | 80 (Estimated) |
| Sponsor | Instituto Brasileiro de Controle do Cancer (Other) |
| Conditions | Sinusoidal Obstruction Syndrome (SOS), Hematopoietic Stem Cell Transplant (HSCT) |
| Interventions | N-acetylcysteine, Placebo (Drug) |
| Dates | start 2021-04-01 (estimated), primary completion 2023-03-31 (estimated), completion 2023-03-31 (estimated), first posted 2021-01-15, last updated 2021-03-09 |
| Locations | 1 site in Brazil |
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All trials for Sinusoidal Obstruction Syndrome (SOS) All trials for Hematopoietic Stem Cell Transplant (HSCT) All trials of N-acetylcysteine All trials of Placebo
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.
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 hematopoietic stem cell transplantation Up to date, no approved medications are available for prophylactic treatment of sinusoidal obstruction syndrome in patients undergoing hematopoietic stem cell transplantation. N-acetylcysteine is a drug that has been long used as a mucolytic. And placebo responses contribute to help assess the appropriateness of randomized clinical trials in determining the size of drug effect.
The study will enroll patients undergoing hematopoietic stem cell transplantation to receive sequentially one of two treatment: N-acetylcysteine or Placebo.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Experimental: N-acetylcysteine | Experimental | Drug: N-acetylcysteine | 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 |
| Placebo Comparator: Placebo | Placebo comparator | Drug: Placebo | 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 |
Sex: All, ages: 18 Years to any
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
| Facility | City | Country | Status |
|---|---|---|---|
| Jamilla Neves Cavalcante | São Paulo, São Paulo | Brazil |