Adaptive Treatment for Acute Myeloid Leukemia Based on D14 MRD Results

Launched by SHANGHAI TONG REN HOSPITAL · Feb 12, 2023

Keywords

ClinConnect Summary

This clinical trial, called "Adaptive Treatment for Acute Myeloid Leukemia Based on D14 MRD Results," is studying a new treatment approach for adults with acute myeloid leukemia (AML) who are newly diagnosed and unable to undergo intensive chemotherapy. The trial will look at how well the combination of three medications—selinexor, azacitidine, and venetoclax—works based on specific test results taken 14 days after starting treatment. The goal is to see if this treatment can effectively control the disease while keeping patients safe.

To be eligible for this trial, participants must be at least 18 years old and have been diagnosed with AML. They should not be suitable for more aggressive chemotherapy due to age (75 years or older) or certain health conditions that could make standard treatment risky. Participants will need to provide informed consent, meaning they agree to join the study after understanding what it involves. Throughout the trial, participants can expect close monitoring and support from the research team as they undergo treatment. This study is currently recruiting participants, and it aims to provide new options for those facing this challenging diagnosis.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Known and written informed consent voluntarily
• • Age ≥ 18 years
• * Newly diagnosed AML patients (per WHO 2022 classification criteria for AML diagnosis), who are not suitable for intensive chemotherapy:
• • 75 years or Aged 18 to 74 years with at least one of the following comorbidities: Eastern Cooperative Oncology Group (ECOG) performance status score of 2 or 3 or 4; Cardiac history of Congestive Heart Failure (CHF) requiring treatment or Ejection Fraction \<= 50% or chronic stable angina; Diffusing capacity of the Lung for Carbon Monoxide (DLCO) \<= 65% or Forced Expiratory Volume in 1 second (FEV1) \<= 65%; Creatinine clearance \>= 30 mL/min to \< 45 ml/min; Moderate hepatic impairment with total bilirubin \> 1.5 to \<= 3.0 × Upper Limit of Normal (ULN); Any other comorbidity that the physician judges to be incompatible with intensive chemotherapy .
• • Liver function meets the following criteria: aspartate aminotransferase (AST) ≤ 3.0×ULN\*; alanine aminotransferase (ALT) ≤3.0×ULN\*; Bilirubin≤1.5×ULN\*; For subjects \<75 years old, the bilirubin level can be ≤3.0×ULN; Unless due to leukemic organ involvement.
• • Renal function meets the following criteria: creatinine clearance ≥ 30 mL/min (Cockroft-Gault formula)
• • Life expectancy ≥ 4 weeks
• Exclusion Criteria:
• • History of any malignancies prior to study entry with exception noted in the protocol.
• • Participant has known HIV infection, active hepatitis B virus (HBV) and/or hepatitis C virus (HCV) .
• • Participant has known active central nervous system (CNS) involvement with AML.
• • Must not have received prior anti-AML treatment except for hydroxyurea