NCT05736965 (SAV) is a Phase 2 clinical trial of Selinexor in AML, Adult, sponsored by Shanghai Tong Ren Hospital.

Who is sponsoring NCT05736965?

NCT05736965 is sponsored by Shanghai Tong Ren Hospital.

What drugs are being tested in NCT05736965?

Interventions in NCT05736965: Selinexor, Azacitidine, Venetoclax.

What condition does NCT05736965 study?

NCT05736965 studies AML, Adult.

Is NCT05736965 still recruiting?

NCT05736965 is currently recruiting now. Last updated 15 March 2023.

Last reviewed 2023-03-15 · How we verify

NCT05736965: SAV

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

A Study of Selinexor in Combination With Azacitidine and Venetoclax (SAV Regimen) in Treatment Naïve Participants With Acute Myeloid Leukemia

Recruiting now Phase 2 Last updated 15 March 2023

What this trial tests

Phase 2 trial testing Selinexor in AML, Adult in 58 participants. Currently enrolling.

Timeline

20 February 2023

Primary endpoint
30 March 2025

30 April 2027

Quick facts

Lead sponsor	Shanghai Tong Ren Hospital
Phase	Phase 2
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	58
Start date	20 February 2023
Primary completion	30 March 2025
Estimated completion	30 April 2027
Sites	19 locations across China

Drugs / interventions tested

Selinexor — full drug profile →
Azacitidine (azacitidine) — full drug profile →
Venetoclax (venetoclax) — full drug profile →

Conditions studied

AML, Adult — all drugs for AML, Adult →

Sponsor

Shanghai Tong Ren Hospital

Who can join

18 and older, any sex, with AML, Adult. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

Azacitidine Is Synergistically Lethal with XPO1 Inhibitor Selinexor in Acute Myeloid Leukemia by Targeting XPO1/eIF4E/c-MYC Signaling.
Long H, Hou Y, Li J, Song C, et al · · 2023 · cited 19× · PMID 37047788 · DOI 10.3390/ijms24076816
Unraveling Venetoclax Resistance: Navigating the Future of HMA/Venetoclax-Refractory AML in the Molecular Era.
Chatzilygeroudi T, Karantanos T, Pappa V. · · 2025 · cited 9× · PMID 40361510 · DOI 10.3390/cancers17091586
Comprehensive view on chemotherapy-free management of acute myeloid leukemia by using venetoclax in combination with targeted and/or immune therapies.
Kegyes D, Tat A, Vizitiu AS, Vazar-Tripon D, et al · · 2025 · cited 6× · PMID 40804253 · DOI 10.1038/s41420-025-02678-4
Novel-and Not So Novel-Inhibitors of the Multifunctional CRM1 Protein.
Aumann WK, Kazi R, Harrington AM, Wechsler DS. · · 2024 · cited 3× · PMID 39161560 · DOI 10.3389/or.2024.1427497
Factors affecting response and resistance to venetoclax in acute myeloid leukemia.
Diamantidis MD. · · 2025 · cited 1× · PMID 41030943 · DOI 10.3389/fonc.2025.1577908
Selinexor in acute myeloid leukemia: therapeutic applications and current challenges.
Qie Z, Ma L, Tan J, Peng X. · · 2025 · cited 1× · PMID 40463909 · DOI 10.3389/fphar.2025.1602911
Prognostic and functional role of the nuclear export receptor 1 (XPO1) in gastrointestinal cancers: a potential novel target?
Sokolova V, Gruber R, Pammer LM, Kocher F, et al · · 2024 · cited 1× · PMID 39729162 · DOI 10.1007/s11033-024-10169-5
[The development of selective XPO1 inhibitors in the treatment of acute myeloid leukemia].
Tong X, Zhang Y, Chen J, Wu DP. · · 2023 · PMID 38049328 · DOI 10.3760/cma.j.issn.0253-2727.2023.09.017

Verify or expand the search:

Other trials of Selinexor

Trials testing the same drug.

NCT07447817 — Selinexor and Pacritinib in JAK Inhibitor-naïve MF Patients With Cytopenias · Phase 2 · not yet recruiting
NCT07200102 — Selinexor Maintenance Post CAR-T Cell Therapy for Multiple Myeloma · Phase 1 · recruiting
NCT07204041 — Efficacy and Safety of XTD Regimen (Selinexor, Thalidomide and Dexamethasone) in Adult Patients With Relapsed/Refractory · Phase 2 · active not recruiting
NCT06966154 — A Phase Ib/II Clinical Study Evaluating the Safety and Efficacy of Tislelizumab in Combination With Golidocitinib and Se · Phase 1, PHASE2 · recruiting
NCT06900088 — Selinexor Combined With Azacitidine Therapy in High-Risk Myeloid Neoplasms Patients · Phase 2 · not yet recruiting

Other recruiting trials for AML, Adult

Currently open trials in the same condition.

NCT07328191 — Quality of Life-Guided Transfusion in Refractory MDS or AML · NA · recruiting
NCT07132684 — Comparison of VA and D/IA Induction Regimens in Elderly Fit Acute Myeloid Leukemia Patients · Phase 3 · recruiting
NCT06533761 — Eganelisib as Monotherapy and in Combination With Cytarabine in Relapsed/Refractory AML · Phase 1 · recruiting
NCT07117422 — Venetoclax-Decitabine in Untreated Elderly/Unfit AML · NA · recruiting
NCT06313437 — Revumenib in Combination With 7+3 + Midostaurin in AML · Phase 1 · recruiting

Other Shanghai Tong Ren Hospital trials

Trials by the same sponsor.

NCT06583564 — The Prognosis Effect of Indocyanine Green (ICG) Fluorescence Guided Surgery on Disease-free Survival (DFS) of Stage III · NA · not yet recruiting
NCT06508541 — The Prognosis of Colorectal Cancer Patients After Indocyanine Green Fluorescence-guided Radical Surgery · completed
NCT05736978 — Adaptive Treatment for Acute Myeloid Leukemia Based on D14 MRD Results · Phase 2 · recruiting
NCT05526300 — Intelligent Hypertension Intervention Study · NA · completed
NCT06533124 — Parameters of Cardiac Indices on the Ultrasonic Cardiac Output Monitor As Potential Indicators for Predicting the Achiev · NA · completed

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT05736965 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Shanghai Tong Ren Hospital
Last refreshed: 15 March 2023

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05736965.

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