Adaptive treatment for acute myeloid leukemia based on early results

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 efficacy and safety of selinexor in combination with azacitidine and venetoclax for patients with untreated acute myeloid leukemia (AML). The approach is based on minimal residual disease (MRD) results obtained on day 14 of the first treatment cycle. Patients who test MRD negative will continue with azacitidine and venetoclax, while those who are MRD positive will receive selinexor in addition to these medications. The trial aims to determine the best treatment strategy for patients who are not suitable for intensive chemotherapy.

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 .
* 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
• Beizhan Hospital
  Shanghai, China Not yet recruiting
• Pla Navy Feature Medical Center
  Shanghai, China Not yet recruiting
• Shanghai Ruijin Hospital
  Shanghai, China Not yet recruiting

Study contacts

• Study coordinator: Ligen Liu, MD
• Email: liuligen@shsmu.edu.cn
• Phone: 18017337037

Similar studies

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

• 6MW5311 in adults with relapsed or refractory blood cancers

  This study tests increasing doses of 6MW5311 in adults with multiple myeloma, AML, or CMML to see if it is safe and tolerable and to find a suitable dose for later studies.

  Recruiting Phase 1 Mabwell (Shanghai) Bioscience Co., Ltd. · Shanghai, Shanghai Municipality · NCT07914556

• CRD3874-SI in People with Leukemia

  A small early-stage study tests CRD3874-SI to see if it is safe for adults with relapsed or refractory acute myeloid leukemia.

  Recruiting at 7 sites Phase 1 Memorial Sloan Kettering Cancer Center · Basking Ridge, New Jersey and 6 other locations · NCT07661095

• Allogeneic CAR-T CT0890B for relapsed/refractory AML

  This study tests whether a universal CAR-T cell therapy called CT0890B is safe and potentially effective for adults with relapsed or refractory acute myeloid leukemia who express NKG2D ligands.

  Recruiting Phase 1 Peking University People's Hospital · Beijing · NCT07617285

• Biomarkers in Bone Marrow to Predict AML Chemosensitivity

  This study tests whether markers in bone marrow can predict how adults with AML will respond to chemotherapy.

  Recruiting Fujian Medical University Union Hospital · Fuzhou, Fujian · NCT07587944

• Azacitidine plus venetoclax maintenance vs azacitidine alone in AML

  This trial tests whether adding venetoclax to azacitidine maintenance helps people with AML stay disease-free after achieving first remission.

  Recruiting Phase 3 Institute of Hematology & Blood Diseases Hospital, China · Tianjin, Tianjin Municipality · NCT07539818

• Azacitidine with APG1252 in high-risk AML (Phase 1b/2)

  This study tests whether adding APG1252 to azacitidine is safe and helps some patients with high-risk AML feel better or respond to treatment.

  Recruiting Phase 1/2 M.D. Anderson Cancer Center · Houston, Texas · NCT07508982

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.