Loading clinical trials...

Selinexor Combined With Venetoclax Maintenance Therapy After Allo-HSCT | Clinical Trials | Clareo Health

NOT_YET_RECRUITINGPHASE2

Selinexor Combined With Venetoclax Maintenance Therapy After Allo-HSCT

A Multicenter, Single-arm Study of the Efficacy and Safety of Selinexor Combined With Venetoclax as Maintenance Therapy After Allogeneic Hematopoietic Stem Cell Transplantation for Acute Myeloid Leukemia/Myelodysplastic Syndrome

NCT06765928•Ruijin Hospital

View on ClinicalTrials.gov

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.

Detailed Description

Allogeneic hematopoietic stem cell transplantation (allo-HSCT) is a curative treatment for intermediate- to high-risk acute myeloid leukemia (AML) and myelodysplastic syndromes (MDS).However, there are still some patients who relapse after transplantation, resulting in treatment failure. Therefore, post-transplantation maintenance therapy is needed for AML/MDS patients with poor prognosis to further reduce recurrence and prolong survival. In in vitro studies, XPO1 inhibitor combined with venetoclax was found to have a promising anti-leukemic effect, and venetoclax increased ROS levels in the bone marrow microenvironment and improved the post-transplant immune microenvironment. Accordingly, we propose to carry out XPO1 inhibitor combined with venetoclax as maintenance therapy after allo-HSCT in patients with intermediate- to high-risk AML/MDS. There is a lack of prospective, controlled studies to clarify the efficacy and safety of XPO1 inhibitor combined with venetoclax as maintenance therapy after allo-HSCTin patients with intermediate- to high-risk AML/MDS, especially those with out specific gene mutation which would be targeted with commerically available inhibitors. Therefore, this multicenter, single-arm study is designed to assess the efficacy and safety of selinexor combined with venetoclax as maintenance therapy after intermediate to high-risk MDS/AML after allo-HSCT, with the aim of providing a reference for clinical treatment.

Eligibility

Age

18 - 75 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•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.

Exclusion Criteria

•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;
+2 more criteria

Locations (1)

Ruijin Hospital of Shanghai Jiaotong University

Shanghai, Shanghai Municipality, China

Key Dates

Start Date

January 1, 2025

Primary Completion Date

January 1, 2026

Completion Date

January 1, 2028

Last Updated

January 9, 2025

Enrollment

ESTIMATED participants

Conditions

MDSAML, Adult

Interventions

selinexor in combination with venetoclax

DRUG

Contacts

Xiaoxia HU, Doctor

CONTACT

02164370045 hxx12276@rjh.com.cn

Xiaoxia HU

CONTACT

02164370045 hu_xiaoxia@126.com

Haplo-identical Transplantation for Severe Aplastic Anemia, Hypo-plastic MDS and PNH Using Peripheral Blood Stem Cells and Post-transplant Cyclophosphamide for GVHD Prophylaxis

NCT03520647

Severe Aplastic Anemia (SAA)Hypo-Plastic Myelodysplastic Syndrome (MDS)+1 more

View study

RECRUITINGPHASE2

A Platform Protocol to Investigate Post-Transplant Cyclophosphamide-Based Graft-Versus-Host Disease Prophylaxis in Patients With Hematologic Malignancies Undergoing Mismatched Unrelated Donor Peripheral Blood Stem Cell Transplantation

NCT06859424

AML (Acute Myelogenous Leukemia)Acute Lymphoid Leukemia (ALL)+9 more

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 9, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Selinexor Combined With Venetoclax Maintenance Therapy After Allo-HSCT

Inclusion Criteria

Exclusion Criteria

Haplo-identical Transplantation for Severe Aplastic Anemia, Hypo-plastic MDS and PNH Using Peripheral Blood Stem Cells and Post-transplant Cyclophosphamide for GVHD Prophylaxis

A Platform Protocol to Investigate Post-Transplant Cyclophosphamide-Based Graft-Versus-Host Disease Prophylaxis in Patients With Hematologic Malignancies Undergoing Mismatched Unrelated Donor Peripheral Blood Stem Cell Transplantation

National Longitudinal Cohort of Hematological Diseases

Familial Investigations of Childhood Cancer Predisposition

CLN-049 in Patients With Relapsed/Refractory Acute Myeloid Leukemia (AML) or Myelodysplastic Syndrome (MDS)

BMT-06: Study of Intensity Modulated Total Marrow Irradiation (IM-TMI)