Selinexor Combined With Venetoclax Maintenance Therapy After Allo-HSCT

NCT06765928 | Not Yet Recruiting Phase 2 DMC

• 1 other identifier: RJBMT-010
• Study Type: interventional
• Target: 73
• Locations: 1 country
• Sites: 1

Brief Summary

A multicenter, single-arm clinical study of evaluate the efficacy and safety of selinexor combined with venetoclax as maintenance therapy following allogeneic hematopoietic stem cell transplantation for acute myeloid leukemia patients.

Conditions

MDS; AML, Adult

Keywords

MDS/AML; allogeneic hematopoietic stem cell transplantation; maintenance therapy

Outcome Measures

Primary Outcomes (1)

• Progress-free survival

  disease progression or death as a result of any causes

  through study completion, an average of 2 year

Secondary Outcomes (2)

• Overall survival

  through study completion, an average of 2 year

• Non-relapse survial

  through study completion, an average of 2 year

Study Arms (1)

Experimental arm

EXPERIMENTAL

Post allo-HSCT maintenance with selinexor in combination with venetoclax for intermediate to high-risk MDS/AML

Drug: selinexor in combination with venetoclax

Interventions

selinexor in combination with venetoclax DRUG

After allo-HSCT, intermediate-high risk MDS/AML patients are maintenanced with selinexor given in combination with venetoclax for 2 years

Also known as: XPO1 inhibitor combined with Bcl-2 inhibitor

Experimental arm

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• de novo AML in the ELN2022 high-risk group or MDS in the IPSS-M intermediate-high/high/very-high risk group
• Age 18-75 years old, gender is not limited
• First hematopoietic stem cell transplant with at least one eligible donor
• ECOG physical status score of 0-2
• The subject has received an allogeneic hematopoietic stem cell transplant within 90-120 days and STR-PCR shows complete donor chimerism;
• Have appropriate organ function, and laboratory results within 7 days prior to the start of trial treatment need to meet the following criteria:
• AST and ALT) ≤ 3x ULN; Total serum bilirubin ≤ 1.5x ULN unless the patient has Gilbert syndrome; patients with Gilbert-Meulengracht syndrome with bilirubin ≤ 3.0 times the upper limit of normal and direct bilirubin ≤ 1.5 times the upper limit of normal may be included; HB ≥ 70 g/L (had not received a red blood cell transfusion within 1 week prior to administration); ANC ≥ 0.8 x 10\^9/L (had not received long-acting colony-stimulating factor (LACSF) within 1 week prior to administration and short-acting colony-stimulating factor (SACSF) within 3 days prior to administration); Platelet count ≥ 20 x 10\^9/L (had not received a platelet transfusion within 1 week prior to administration); serum creatinine ≤ 1.5x ULN or creatinine clearance ≥ 60 mL/min; Coagulation function: International Normalized Ratio (INR) ≤1.5×ULN, Activated Partial Thromboplastin Time (APTT) ≤1.5×ULN; Left ventricular ejection fraction (LVEF) ≥45%;
• Life expectancy ≥ 12 weeks;
• Voluntarily sign the informed consent form and understand and comply with the requirements of the study.

You may not qualify if:

• bone marrow examination after allo-HSCT suggestive of relapse or measurable residual disease (MRD) before the initiation of maintenance therapy;
• Other malignant tumors within 5 years prior to screening, except adequately treated carcinoma in situ of the cervix, basal cell or squamous epithelial cell skin cancers, post-radical thyroid cancer, and post-radical ductal carcinoma in situ;
• Current active cardiovascular disease of clinical significance, such as uncontrolled arrhythmias, uncontrolled hypertension, congestive heart failure, any grade 3 or 4 heart disease as determined by the New York Heart Association (NYHA) functional class, or a history of myocardial infarction within the 6 months prior to screening;
• Other serious medical conditions that may limit the patient's participation in this trial (e.g., active infection, uncontrolled diabetes);
• Known HIV infection, or chronic infection with hepatitis B virus (HBsAg-positive) or hepatitis C virus (anti-HCV-positive) that cannot be controlled by medications;
• Patients with other tumors in combination, not cured;
• Patients with neurologic or psychiatric disorders; clinically significant active cerebrovascular disease (e.g., cerebral edema, posterior reversible encephalopathy syndrome);
• Those who are allergic to the test drug;
• Those who are unable to understand or comply with the study protocol or are unable to sign the informed consent form;
• Those who have received other maintenance drugs after hematopoietic stem cell transplantation or have the desire to receive other maintenance therapy;
• Patients who, in the investigator's judgment and/or clinical criteria, have contraindications to any of the study procedures or have other medical conditions that may place them at unacceptable risk.

Sponsors & Collaborators

• Ruijin Hospital: lead

Study Sites (1)

Ruijin Hospital of Shanghai Jiaotong University

Shanghai, Shanghai Municipality, China

Location

MeSH Terms

Conditions

Leukemia, Myeloid, Acute

Interventions

selinexor; venetoclax

Condition Hierarchy (Ancestors)

Leukemia, Myeloid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases

Central Study Contacts

Xiaoxia HU, Doctor

CONTACT

02164370045; hxx12276@rjh.com.cn

Xiaoxia HU

CONTACT

02164370045; hu_xiaoxia@126.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 5, 2025
• First Posted: January 9, 2025
• Study Start: January 1, 2025
• Primary Completion: January 1, 2026
• Study Completion (Estimated): January 1, 2028
• Last Updated: January 9, 2025

Record last verified: 2025-01

Locations

CN (1)