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

Recruiting now · Phase 2

Conditions studied: AML, Adult

In brief

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.

Key facts

Study ID

NCT05736965

Run by

Shanghai Tong Ren Hospital

People needed

58

Starts

2023-02-20

Expected to finish

2027-04-30

Last updated by the study team

2023-03-15

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Shanghai Tong Ren hospital — Shanghai, China (enrolling)
• Sichuan Provincial People's Hospital — Chengdu, China
• Jilin University China Japan Union Hospital — Ch’ang-ch’un, China
• Harbin Institute of Hematology and Oncology — Ha’erbin, China
• Anhui Provincial Hospital — Hefei, China
• the first hospital of Jiaxing affiliated hospital of Jiaxing University — Jiaxing, China
• Gansu Provincial People's Hospital — Lanzhou, China
• Lanzhou University NO.2 Hospital — Lanzhou, China
• Ningbo Medical Center Lihuili Huspital — Ningbo, China
• Shanghai Ruijin Hospital — Shanghai, China
• The First Hospital of China Medical University — Shenyang, China
• The First Hospital of Hebei Medical University — Shijia Zhuang, China
• The Second Hospital of Hebei Medical University — Shijia Zhuang, China
• First Affiliated Hospital of Xinjiang Medical University — Ürümqi, China
• the Second Affiliated Hospital of Wannan Medical College — Wuhu, China
• Xi'an International Medical Center — Xi'an, China
• Northern Jiangsu People's Hospital — Yangzhou, China
• Changzhou Municipal No.1 People's Hospital — Changzhou, China
• Yixing People's Hospital — Yixing, China

Full record on ClinicalTrials.gov

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