Health TrialsbyHealthPanel

Adaptive Treatment for Acute Myeloid Leukemia Based on D14 MRD Results

ConditionsAMLMRD
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorShanghai Tong Ren Hospital

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

Known and written informed consent voluntarily

Age ≥ 18 years

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.

Disqualifiers

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

Trial design

Design model

Single group

Treatments tested in this trial

  • Azacitidine

    Drug

    75mg/m2 d1-7

  • Venetoclax

    Drug

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

  • Selinexor

    Drug

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

Treatment groups

58 Participants
are divided into 1 treatment group
Group A: Treatment regimen based on C1D14 MRDExperimental treatment 3 interventions

Trial outcomes

Primary outcomes

1

Percentage of Participants With Composite Complete Remission

Time frame
From the study start up to death (up to approximately 2 years; )

Secondary outcomes

1

overall survival (OS)

Time frame
From the study start up to death (up to approximately 4 years; )
2

Overall response rate(ORR)

Time frame
From the study start up to death (up to approximately 4 years; )
3

percentage of patients who achieved MRD negativity

Time frame
From the study start up to death (up to approximately 4 years; )
4

Recurrence Free Survival(RFS)

Time frame
From the study start up to death (up to approximately 4 years; )

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Shanghai Tong Ren Hospital

Lead sponsor

Source ClinicalTrials.gov
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