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Clinical Trials in China / NCT05736978
Recruiting Phase 2

Adaptive Treatment for Acute Myeloid Leukemia Based on D14 MRD Results

NCT05736978 · tracked via the Priya Life Science China tracker
Sponsor
Shanghai Tong Ren Hospital
Phase
Phase 2
Started
2023-03-31
Last updated
2023-03-15

Condition(s) studied

AMLMRD

Investigational drug(s) / intervention(s)

AzacitidineVenetoclaxSelinexor

Azacitidine: 75mg/m2 d1-7

Venetoclax: d1 100mg, d2 200mg, d3-28 400mg

Selinexor: if MRD positive in C1D14, selinexor 60mg D15, D22

Study summary

This is a prospective, single-arm, multi-center clinical trial to evaluate the efficacy and safety of selinexor in combination with azacitidine and venetoclax for untreated acute myeloid leukemia based on MRD results on day 14 of the first cycle.

Eligibility

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
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

Primary outcome measure(s)

Trial sites (4)

FacilityCityRegionStatus
Beizhan Hospital Shanghai China Not Yet Recruiting
Pla Navy Feature Medical Center Shanghai China Not Yet Recruiting
Shanghai Ruijin Hospital Shanghai China Not Yet Recruiting
Shanghai Tong Ren hospital Shanghai China Recruiting

On this site

📄 Venclexta (venetoclax) drug profile →

More Shanghai Tong Ren Hospital trials in China

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05736978 on ClinicalTrials.gov ↗ ← All trials in China