Adaptive treatment for acute myeloid leukemia based on early results
Clinical Efficacy and Safety of Adaptive Treatment of Acute Myeloid Leukemia (AML) Based on D14 MRD results-a Multicenter, Single-arm, Prospective Clinical Study
This study is testing a new treatment plan for people with untreated acute myeloid leukemia to see if adding a drug called selinexor helps those who still have cancer after two weeks of initial therapy.
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 | 4 sites (Shanghai and 3 other locations) |
| Trial ID | NCT05736978 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with newly diagnosed AML who are not suitable for intensive chemotherapy.
Not a fit: Patients with AML who are eligible for intensive chemotherapy may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could improve outcomes for patients with untreated AML by personalizing therapy based on early response indicators.
How similar studies have performed: Other studies have shown promise in using adaptive treatment strategies based on MRD results, indicating potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion 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 . * 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
Shanghai and 3 other locations
- 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)
- Shanghai Tong Ren hospital — Shanghai, China (Recruiting)
Study contacts
- Study coordinator: Ligen Liu, MD
- Email: liuligen@shsmu.edu.cn
- Phone: 18017337037
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.