Evaluating Selinexor for Maintenance Treatment in PTCL Patients

An Open, Single Center, Non-randomized, Single Arm Clinical Study of Evaluating the Efficacy of Selinexor in the Maintenance Treatment of Peripheral T-cell Lymphomas (PTCL)

This study is testing if Selinexor can help keep patients with Peripheral T-cell Lymphoma feeling well after their initial treatment has worked.

Quick facts

• Phase: PHASE2; PHASE3
• Study type: Interventional
• Enrollment: 20 (estimated)
• Ages: 18 Years to 85 Years
• Sex: All
• Sponsor: The First Hospital of Jilin University (other)
• Locations: 1 site (Changchun, Jilin)
• Trial ID: NCT05822050 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the efficacy and safety of Selinexor as a maintenance therapy for patients with Peripheral T-cell Lymphoma (PTCL) who have achieved complete response from frontline treatment. The study is non-randomized and single-arm, focusing on patients aged 18 to 85 with confirmed PTCL subtypes. Additionally, it aims to analyze the relationship between gene mutations in PTCL and disease prognosis using next-generation sequencing (NGS).

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 85 with a confirmed diagnosis of PTCL who have achieved complete remission after initial treatment.

Not a fit: Patients who have not achieved complete remission or have other types of lymphoma may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could improve maintenance therapy options for PTCL patients, potentially leading to better long-term outcomes.

How similar studies have performed: While there is ongoing research in PTCL treatments, this specific approach using Selinexor in maintenance therapy is novel and has not been extensively tested.

Eligibility criteria

Inclusion Criteria:

* Patients fully understand the study, voluntarily participate and sign the informed consent (ICF);
* Age range from 18 to 85 years old (including upper and lower limits);
* ECOG (Eastern Cooperative Oncology Group) score 0 \~ 2;
* PTCL confirmed by histopathology falls into one of the following subtypes according to the WHO classification standard revised in 2016:1) Peripheral T-cell lymphoma non-specific type (PTCL-NOS) 2) vascular immunoblastic T-cell lymphoma (AITL) 3) ALK+ systemic anaplastic large T-cell lymphoma (ALK+ALCL) 4) Alk-systemic anaplastic large T-cell lymphoma (ALK-AlCl) 5) extranasal NK/ T-cell lymphoma (NK/TCL)6) Other subtypes of PTCL that the researchers considered suitable for inclusion.
* Subjects achieved complete remission by radiographic assessment at mid-stage.
* Subjects must provide a written pathological/histological diagnosis report during the screening period and must agree to provide tumor tissue sections or tumor/lymph node tissue samples for central laboratory testing.
* Expected survival is at least 12 weeks.
* Patients must meet the following requirements for laboratory tests at screening time and have not received cell growth factor, platelet, or granulocyte infusion within 7 days prior to screening hematological evaluation.1) Neutrophil absolute value ≥1.5×109/L in subjects without bone marrow involvement and ≥1.0×109/L in subjects with bone marrow involvement;2) Hemoglobin ≥90g/L in subjects without bone marrow involvement (in the absence of red blood cell infusion within 14 days), hemoglobin ≥75g/L in subjects with bone marrow involvement;3) Platelets ≥75×109/L in subjects without bone marrow involvement and ≥50×109/L in subjects with bone marrow involvement;4) Serum total bilirubin ≤1.5× upper limit of normal (ULN) (total bilirubin ≤3×ULN if elevated bilirubin level is caused by lymphoma invading the liver);5) Aspartate aminotransferase (AST), alanine aminotransferase (ALT) ≤2.5×ULN;If elevated AST and ALT are caused by lymphoma invading liver, both AST and ALT should be ≤5×ULN).6) Creatinine \<1.5×ULN.
* Eligible patients (male and female) who are fertile must agree to use a reliable contraceptive method (hormonal or barrier method or abstinence) with their partner during the trial period and for at least 7 months after the last medication;Female patients of reproductive age must have had a negative blood pregnancy test within 14 days prior to inclusion.

Exclusion Criteria:

* Patients with leukemic PTCL (such as adult T-cell leukemia/lymphoma, etc.), or lymphoma leukemia stage (bone marrow examination lymphoma cell proportion ≥20%), or central nervous system (CNS) involvement, or complicated hemophagocytic syndrome.
* Allergic history to similar drugs and excipients of the study drug.
* Participated in other clinical studies and used the study drug within 4 weeks prior to the first administration of the study drug.
* The toxic reactions of previous antitumor therapy have not recovered, and there are still more than grade 1 toxic reactions, except hair loss and pigmentation.
* Impaired heart function or significant heart disease, including but not limited to: 1) myocardial infarction, congestive heart failure, viral myocarditis in the 6 months prior to screening;Heart disease with symptoms that require therapeutic intervention, such as unstable angina, arrhythmia, etc.;2) Cardiac function grade Ⅱ to Ⅳ (New York College of Cardiology Cardiac Function Grade NYHA);3) Echocardiographic examination of cardiac ejection fraction (EF) below 50% or below the lower limit of laboratory test value;
* Active hepatitis B (surface antigen positive with HBV-DNA titers higher than 2000IU/ml) or hepatitis C (HCV antibody positive with HCV ribonucleic acid (HCV RNA) titers higher than the upper limit of the study center's normal).
* History of severe autoimmune diseases and immunodeficiency, including positive human immunodeficiency virus (HIV) antibodies;Or other acquired or congenital immunodeficiency diseases;Or have a history of organ transplantation.
* History of other malignant tumors within 5 years (except cured basal cell carcinoma of the skin and carcinoma in situ of the cervix).
* Major surgery was performed within 6 weeks prior to screening or was expected to be performed during the study period.
* There are significant gastrointestinal disorders at the time of screening that may affect drug intake, transport or absorption (e.g., inability to swallow, chronic diarrhea, intestinal obstruction, etc.).
* Uncontrolled hypertension (refers to patients with type 2 diabetes whose blood pressure still reaches the level 3 hypertension standard after antihypertensive treatment, with systolic blood pressure ≥180mmHg and/or diastolic blood pressure ≥110mmHg) or who cannot be controlled by oral hypoglycemic drugs and insulin therapy.
* History of active bleeding within 3 months prior to screening.
* History of mental illness or psychotropic substance abuse or dependence.
* Pregnant or lactating women.
* Other conditions considered inappropriate for participation in the study

Where this trial is running

Changchun, Jilin

• The First Bethune Hospital of Jilin University — Changchun, Jilin, China (RECRUITING)

Study contacts

• Study coordinator: xingtong wang, doctor

Conditions: PTCL Patients Who Achieved Complete Response From Frontline Treatment