Venetoclax and Decitabin Based Conditioning Regimen Followed With Post-HSCT Decitabin Maintenance Therapy in TP53 Mutant AML/MDS Patients

Launched by ZHEJIANG UNIVERSITY · Sep 2, 2022

Keywords

ClinConnect Summary

This clinical trial is investigating a new treatment approach for patients with specific blood cancers called Acute Myeloid Leukemia (AML) or Myelodysplastic Syndromes (MDS) that have a mutation in a gene known as TP53. The study will use a combination of two medications, Venetoclax and Decitabine, as part of a preparation for a procedure called hematopoietic stem cell transplantation (HSCT). After the transplantation, participants will continue to receive Decitabine to help maintain their health. The main goals are to see how effective this treatment is and to ensure it is safe for patients.

To participate in this trial, patients must be between 12 and 70 years old and have a confirmed diagnosis of AML or MDS with a TP53 mutation. They should also be in reasonably good health, as indicated by certain medical tests. However, individuals with serious heart issues, active autoimmune diseases, or other significant health problems may not be eligible. If you join the trial, you can expect regular check-ups and treatments, and you will be closely monitored throughout the process. This trial is currently recruiting participants, so it's an opportunity for eligible patients to potentially benefit from this new treatment approach.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. AML or MDS diagnosed according to 2016 WHO criteria with TP53 mutation before enrollment;
• • 2. Aged from 12 to 70 years;
• • 3. The Eastern Cooperative Oncology Group (ECOG) performance score of 0-2;
• • 4. Creatinine clearance rate ≥ 60 mL/min (according to Cockcroft-Gault formula);
• • 5. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≥ 3× upper limit of normal range (ULN), total bilirubin ≤ 2×ULN;
• • 6. Left ventricular ejection fraction (LVEF) assessed by echocardiography (ECHO) ≥ 45%;
• • 7. Life expectancy \> 8 weeks;
• • 8. Sign the informed consent voluntarily, understand and comply with all trial requirements.
• Exclusion Criteria:
• • 1. Active autoimmune diseases, such as SLE, rheumatoid arthritis, etc.
• • 2. Current active cardiovascular disease with clinically significance, such as uncontrolled arrhythmias, uncontrolled hypertension, congestive heart failure, any grade 3 or 4 heart disease determined by the New York Heart Association (NYHA) functional classification, or a history of myocardial infarction within the 6 months prior to screening;
• • 3. Other serious medical conditions (e.g., advanced infection) that may limit the patient's participation in the trial;
• • 4. Known human immunodeficiency virus (HIV) infection, or drug-uncontrolled chronic infection of hepatitis B virus (HBV-DNA \> 1000IU/ml) or hepatitis C virus (anti-HCV positive);
• • 5. Pregnant or lactating women;
• • 6. Fail to understand, comply with the study protocol or sign the informed consent form.