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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE2

Total Enrollment

58 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-02-20

Study Completion Date

2027-04-30

Brief Summary

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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.

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Detailed Description

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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.

Selinexor will be given orally at 60mg, d3,10,17 Azacitidine will be given at 75mg/m2, d1-3, 8-9, 15-16 Venetoclax will be given orally at 100mg on day 1 and 200mg on day 2, 400mg on day 3-14

28 days per cycle, 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.

Conditions

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AML, Adult

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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SAV arm

Untreated acute myeloid leukemia who are ineligible for intensive chemotherapy or who refuse to receive intensive chemotherapy will receive selinexor in combination with azacitidine and venetoclax, 28 days per cycle, patients can receive transplants at any time once they achieved complete remission and other patients will continue to receive SAV regimen until disease progression or unacceptable toxic effects.

Group Type EXPERIMENTAL

Selinexor

Intervention Type DRUG

Selinexor 60mg, PO d3,10,17

Azacitidine

Intervention Type DRUG

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

Venetoclax

Intervention Type DRUG

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

Interventions

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Selinexor

Selinexor 60mg, PO d3,10,17

Intervention Type DRUG

Azacitidine

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

Intervention Type DRUG

Venetoclax

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

Intervention Type DRUG

Other Intervention Names

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xpo1 inhibitor ABT199

Eligibility Criteria

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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 .
* patients who are suitable for intensive chemotherapy but refuse it
* 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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Liu Ligen

Director

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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