Combination treatment for untreated acute myeloid leukemia

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Shanghai Tong Ren hospital
  Shanghai, China Recruiting
• 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

Study contacts

• Study coordinator: Ligen Liu, MD
• Email: llg3532@shtrhospital.com
• Phone: 18017337037

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Venetoclax plus Azacitidine versus Daunorubicin/Idarubicin plus Cytarabine induction for fit older adults with AML

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• Venetoclax plus a short (3-day) decitabine schedule for untreated elderly or unfit adults with AML

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• Observational study of older patients with acute myeloid leukemia receiving intensive treatment

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  Recruiting at 27 sites French Innovative Leukemia Organisation · Angers and 26 other locations · NCT06891144

• Using eganelisib alone and with cytarabine for treating relapsed/refractory AML

  This study is testing if a new drug called eganelisib, used alone or with another drug called cytarabine, can help people with relapsed or hard-to-treat acute myeloid leukemia feel better.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.