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A Study of Selinexor in Combination With Azacitidine and Venetoclax (SAV Regimen) in Treatment Naïve Participants With Acute Myeloid Leukemia

ConditionAML, Adult
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.

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 .

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

  • Selinexor

    Drug

    Selinexor 60mg, PO d3,10,17

  • Azacitidine

    Drug

    Azacitidine 75mg/m2, IV d1-3, 8-9, 15-16

  • Venetoclax

    Drug

    Venetoclax 100mg PO on day 1 and 200mg on day 2, 400mg on day 3-14

Treatment groups

58 Participants
are divided into 1 treatment group
Group A: SAV armExperimental treatment 3 interventions

Trial outcomes

Primary outcomes

1

Percentage of Participants With Composite Complete Remission

composite complete remission(CR , CRh, CRi) was calculated based on ELN2022 criteria.

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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