Combination treatment for untreated acute myeloid leukemia

Clinical Efficacy and Safety of Selinexol Combined With Azacitidine and Venetoclax (SAV Regimen) in the Treatment of Acute Myeloid Leukemia (AML)-a Multi-center, Single-arm, Prospective Clinical Study

This study is testing a new combination of three medications to see if they can help people with untreated acute myeloid leukemia go into remission.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 58 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Shanghai Tong Ren Hospital (Academic / other)
• Drugs / interventions: chemotherapy
• Locations: 19 sites (Changzhou and 18 other locations)
• Trial ID: NCT05736965 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the safety and efficacy of a combination therapy using selinexor, azacitidine, and venetoclax in patients with untreated acute myeloid leukemia (AML). It is a prospective, single-arm, multi-center trial where participants will receive these medications over a 28-day cycle. The treatment aims to achieve complete remission, after which patients may proceed to receive transplants or continue treatment until disease progression or unacceptable side effects occur.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 and older with newly diagnosed AML who are not suitable for intensive chemotherapy due to age or comorbidities.

Not a fit: Patients who are suitable for intensive chemotherapy and choose to undergo that treatment may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new effective option for patients with untreated acute myeloid leukemia who are not suitable for intensive chemotherapy.

How similar studies have performed: While this approach is novel, similar combination therapies have shown promise in treating AML in other studies.

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 .
* 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

Where this trial is running

Changzhou and 18 other locations

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

Study contacts

• Study coordinator: Ligen Liu, MD

Conditions AML, Adult; selinexor; untreated AML; azacitidine; venetoclax