NCT05736965 A Study of Selinexor in Combination With Azacitidine and Venetoclax (SAV Regimen) in Treatment Naïve Participants With Acute Myeloid Leukemia
| NCT ID | NCT05736965 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Shanghai Tong Ren Hospital |
| Condition | AML, Adult |
| Study Type | INTERVENTIONAL |
| Enrollment | 58 participants |
| Start Date | 2023-02-20 |
| Primary Completion | 2025-03-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 58 participants in total. It began in 2023-02-20 with a primary completion date of 2025-03-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT05736965 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying AML, Adult. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05736965 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT05736965 currently recruiting?
Yes, NCT05736965 is actively recruiting participants. Contact the research team at llg3532@shtrhospital.com for enrollment information.
Where is the NCT05736965 trial being conducted?
This trial is being conducted at Changzhou, China, Chengdu, China, Ch’ang-ch’un, China, Ha’erbin, China and 11 additional locations.
Who is sponsoring the NCT05736965 clinical trial?
NCT05736965 is sponsored by Shanghai Tong Ren Hospital. The trial plans to enroll 58 participants.