AML Clinical Trial
— AVSOfficial title:
Clinical Efficacy and Safety of Adaptive Treatment of Acute Myeloid Leukemia (AML) Based on D14 MRD results-a Multicenter, Single-arm, Prospective Clinical Study
NCT number | NCT05736978 |
Other study ID # | AVS |
Secondary ID | |
Status | Recruiting |
Phase | Phase 2 |
First received | |
Last updated | |
Start date | March 31, 2023 |
Est. completion date | March 15, 2027 |
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.
Status | Recruiting |
Enrollment | 58 |
Est. completion date | March 15, 2027 |
Est. primary completion date | March 1, 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
China | Beizhan Hospital | Shanghai | |
China | Pla Navy Feature Medical Center | Shanghai | |
China | Shanghai Ruijin Hospital | Shanghai | |
China | Shanghai Tong Ren hospital | Shanghai |
Lead Sponsor | Collaborator |
---|---|
Shanghai Tong Ren Hospital |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Percentage of Participants With Composite Complete Remission | From the study start up to death (up to approximately 2 years; ) | ||
Secondary | overall survival (OS) | From the study start up to death (up to approximately 4 years; ) | ||
Secondary | Overall response rate(ORR) | From the study start up to death (up to approximately 4 years; ) | ||
Secondary | percentage of patients who achieved MRD negativity | From the study start up to death (up to approximately 4 years; ) | ||
Secondary | Recurrence Free Survival(RFS) | From the study start up to death (up to approximately 4 years; ) |
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