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Recruiting NCT05736978

Adaptive Treatment for Acute Myeloid Leukemia Based on D14 MRD Results

Phase II Interventional AML MRD

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Azacitidine, Venetoclax, Selinexor.
Who it may be relevant to
Registry conditions: AML, MRD. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official 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

Overview

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.

Detailed description

Azacitidine and Venetoclax will be given at the approved dose regimen for 75mg/m2, d1-7(azacitidine) and 100mg on day 1 and 200mg on day 2, 400mg on day 3-28 (venetoclax), 28 days per cycle. Based on MRD results on C1D14, MRD negative patients will go on azacitidine and venetoclax regimen and for patients with MRD positive, selinexor 60mg on D15 and D22 will be added. Patients can receive transplants at any time once they achieved complete remission and other patients will continue to receive treatment until disease progression or unacceptable toxic effects.

Interventions

  • Drug Azacitidine
    75mg/m2 d1-7
  • Drug Venetoclax
    d1 100mg, d2 200mg, d3-28 400mg
  • Drug Selinexor
    if MRD positive in C1D14, selinexor 60mg D15, D22

Primary outcome measures

  • Percentage of Participants With Composite Complete Remission [Time frame: From the study start up to death (up to approximately 2 years; )]
Secondary outcome measures (4)
  • overall survival (OS) [Time frame: From the study start up to death (up to approximately 4 years; )]
  • Overall response rate(ORR) [Time frame: From the study start up to death (up to approximately 4 years; )]
  • percentage of patients who achieved MRD negativity [Time frame: From the study start up to death (up to approximately 4 years; )]
  • Recurrence Free Survival(RFS) [Time frame: From the study start up to death (up to approximately 4 years; )]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

China · 4 centers
  • Beizhan Hospital — Shanghai
  • Pla Navy Feature Medical Center — Shanghai
  • Shanghai Ruijin Hospital — Shanghai
  • Shanghai Tong Ren hospital — Shanghai

Identifiers

NCT: NCT05736978 · AVS

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗