Maintenance Therapy With Selinexor and Azacitidine in TP53 Mutant AML/MDS After Transplantation
NCT ID: NCT07094464
Last Updated: 2025-07-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE1
20 participants
INTERVENTIONAL
2025-06-01
2028-12-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Assigned Interventions
1）Treatment will begin approximately 3 months post-transplant. The study duration will be 1 year with treatment cycles every 3 months, totaling 4 cycles.
1. Selinexor: Single-arm phase I study with sequential dose escalation of Selinexor.
Three dose levels will be tested in separate cohorts:
* Cohort 1: Selinexor, 20 mg, twice a week for 2 weeks
* Cohort 2: Selinexor, 40 mg, twice a week for 2 weeks
* Cohort 3: Selinexor, 60 mg, twice a week for 2 weeks
2. Azacitidine: 35 mg/m² for 5 days. 2）Bone marrow morphology, characteristic gene mutation or fusion gene quantification, immunophenotyping, chimerism, or transplant-related FISH will be assessed before and after each treatment cycle, according to the follow-up schedule post-transplant. Patients with hematological relapse at any time will discontinue from the experimental group and receive an alternative treatment.
Maintenance Therapy with Selinexor and Azacitidine
1. Selinexor: Oral administration in 4 cycles:
\- Dose Escalation Phase: Cohort 1: Selinexor, 20 mg, twice a week for 2 weeks Cohort 2: Selinexor, 40 mg, twice a week for 2 weeks Cohort 3: Selinexor, 60 mg, twice a week for 2 weeks
\- Dose Expansion: MTD/RP2D will be determined based on safety.
2. Azacitidine: 35 mg/m² for 5 days.
Interventions
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Maintenance Therapy with Selinexor and Azacitidine
1. Selinexor: Oral administration in 4 cycles:
\- Dose Escalation Phase: Cohort 1: Selinexor, 20 mg, twice a week for 2 weeks Cohort 2: Selinexor, 40 mg, twice a week for 2 weeks Cohort 3: Selinexor, 60 mg, twice a week for 2 weeks
\- Dose Expansion: MTD/RP2D will be determined based on safety.
2. Azacitidine: 35 mg/m² for 5 days.
Eligibility Criteria
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Inclusion Criteria
(2) Age below 75 years at screening; gender not restricted. (3) Diagnosed with AML or MDS with TP53 mutation (VAF ≥ 2%) and post-allo-HCT. (4) No severe allergic constitution. (5) Liver function: ALT and AST ≤ 2.5 times the upper limit of normal, bilirubin ≤ 2 times the upper limit of normal.
(6) Renal function: creatinine ≤ upper limit of normal. (7) No uncontrolled infections or severe psychiatric disorders. (8) ECOG performance score of 0-3; life expectancy of 4 months or more. (9) Peripheral blood counts for granulocytes and platelets.
Exclusion Criteria
(5) Patients with psychiatric disorders or conditions preventing informed consent, unable to comply with treatment and assessment requirements.
(6) Patients who underwent major surgery on important organs less than 6 weeks prior.
(7) Abnormal liver function: ALT or AST \> 2.5 times the upper limit of normal; bilirubin \> 2 times the upper limit of normal; renal function: creatinine \> upper limit of normal.
(8) Patients deemed unsuitable for this clinical trial by the investigator (e.g., poor compliance, substance abuse).
14 Years
75 Years
ALL
No
Sponsors
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Daihong Liu
OTHER
Responsible Party
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Daihong Liu
Dr.
Principal Investigators
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Dai-hong Liu, Dr.
Role: PRINCIPAL_INVESTIGATOR
Chinese PLA General Hospital
Locations
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Chinese PLA General Hospital
Beijing, Beijing Municipality, China
Countries
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References
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Mishra A, Tamari R, DeZern AE, Byrne MT, Gooptu M, Chen YB, Deeg HJ, Sallman D, Gallacher P, Wennborg A, Hickman DK, Attar EC, Fernandez HF. Eprenetapopt Plus Azacitidine After Allogeneic Hematopoietic Stem-Cell Transplantation for TP53-Mutant Acute Myeloid Leukemia and Myelodysplastic Syndromes. J Clin Oncol. 2022 Dec 1;40(34):3985-3993. doi: 10.1200/JCO.22.00181. Epub 2022 Jul 11.
Sakabe K, Nishikado A, Wakatsuki T, Oki T, Ito S. Right atrial potential profiles during atrial fibrillation predict the success of atrial defibrillation. J Electrocardiol. 1998 Jan;31(1):39-44. doi: 10.1016/s0022-0736(98)90005-x.
Santini V, Stahl M, Sallman DA. TP53 Mutations in Acute Leukemias and Myelodysplastic Syndromes: Insights and Treatment Updates. Am Soc Clin Oncol Educ Book. 2024 Jun;44(3):e432650. doi: 10.1200/EDBK_432650.
Peng F, Chen Nan-xian. Amplification of the interface-phonon population under an intense laser field. Phys Rev B Condens Matter. 1992 Sep 15;46(12):7627-7631. doi: 10.1103/physrevb.46.7627. No abstract available.
Najima Y. Overcoming relapse: prophylactic or pre-emptive use of azacitidine or FLT3 inhibitors after allogeneic transplantation for AML or MDS. Int J Hematol. 2023 Aug;118(2):169-182. doi: 10.1007/s12185-023-03596-w. Epub 2023 Apr 10.
Lutz S. Columbia/HCA backs hospital's expansion. Mod Healthc. 1994 Aug 29;24(35):42. No abstract available.
Berkhout TA, Gohil J, Gonzalez P, Nicols CL, Moores KE, Macphee CH, White JR, Groot PH. Selective binding of the truncated form of the chemokine CKbeta8 (25-99) to CC chemokine receptor 1(CCR1). Biochem Pharmacol. 2000 Mar 1;59(5):591-6. doi: 10.1016/s0006-2952(99)00354-8.
Minowa M, Orito S, Tsuchiaki M, Tsukamoto T. Search for resonances in the e+e---> gamma gamma process in the mass region around 1.062 MeV/c2. Phys Rev Lett. 1989 Mar 6;62(10):1091-1094. doi: 10.1103/PhysRevLett.62.1091. No abstract available.
Reading NS, Aust SD. Engineering a disulfide bond in recombinant manganese peroxidase results in increased thermostability. Biotechnol Prog. 2000 May-Jun;16(3):326-33. doi: 10.1021/bp0000151.
Masuda Y, Sadato D, Toya T, Hosoda Y, Hirama C, Shimizu H, Najima Y, Harada H, Harada Y, Doki N. Transplantation outcomes of TP53-mutant AML and MDS: a single transplantation center experience of 63 patients. Int J Hematol. 2025 Jun;121(6):820-832. doi: 10.1007/s12185-025-03951-z. Epub 2025 Feb 26.
Other Identifiers
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S2025-055-01
Identifier Type: -
Identifier Source: org_study_id
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