Selinexor Combined With R-GemOx as Second-line Treatment in Patients With Diffuse Large B-cell Lymphoma

Trial Title: Selinexor Combined With R-GemOx as Second-line Treatment in Patients With Diffuse Large B-cell Lymphoma

NCT ID: NCT05786989

Condition: Diffuse Large B-Cell Lymphoma, Not Otherwise Specified

Conditions: Official terms:
Lymphoma
Lymphoma, B-Cell
Lymphoma, Large B-Cell, Diffuse

Study type: Interventional

Study phase: Phase 4

Overall status: Recruiting

Study design:

Allocation: N/A

Intervention model: Single Group Assignment

Primary purpose: Treatment

Masking: None (Open Label)

Intervention:

Intervention type: Drug
Intervention name: selinexor
Description: Given PO
Arm group label: Treatment

Other name: Selective Inhibitor of Nuclear

Other name: KPT-330

Summary: The goal of this interventional study is to evaluate efficiency and safety in prior one-line treated diffuse large B-cell lymphoma. The main questions it aims to answer are: - Complete remission rate - Objective remission rate - Progression-free survival - tolerance Participants will recevied a minimum of 2 and a maximum of 6 cycles of R-GemOx(rituximab 375 mg/m2 IV on day 1 , Gemcitabine 1000 mg/m2, Oxaliplatin 100 mg/m2 IV on day 2) and 60 mg selinexor on days 1, 8, and 15 of each cycle

Detailed description: After the subject has completed at least 2 courses of treatment with Serenixol and R-GemOx for up to 6 courses, the patients who have reached ≥ partial remission (PR) and meet the conditions of transplantation can receive transplantation according to the institutional standards, and those who are not suitable for transplantation can receive maintenance treatment with Serenixol. In the maintenance treatment, the dose of Serenixol is 60 mg on the first day of the week until the disease progresses In case of intolerable toxicity or if the researcher believes that the patient is no longer suitable for study treatment, re-examine every 3 months in the first year, the second year and every 6 months after the end of transplantation or maintenance treatment; Patients with stable disease (SD) or disease progression (PD) after 2~6 courses of treatment will end the trial, and no survival follow-up will be conducted

Criteria for eligibility:
Criteria:
Inclusion Criteria: - Have pathologically confirmed CD20 positive de novo DLBCL or DLBCL transformed from previously diagnosed indolent lymphoma (e.g., follicular lymphoma) - HIV-seropositive - Age 18-75 years - ECOG PS≤2 - Positron emission tomography (PET) positive measurable disease with at least one node having the longest diameter (LDi)>1.5cm or one extranodal lesion with LDi>1cm (per the Lugano Criteria 2014) (Documentation to be provided) - Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) ≤ 2.5 × Upper limit of normal value (ULN), or ≤ 5 in the presence of known lymphoma involving the liver × ULN; Total serum bilirubin ≤ 2 × ULN, or ≤ 5 when Gilbert syndrome or known lymphoma affects the liver × ULN; Creatinine clearance (CrCl) calculated according to Cockcroft Gault formula ≥ 30 mL/min; - Absolute neutrophil count (ANC)≥1.5×10^9/L,or Platelet count≥75×10^9/L(No platelet were transfused within 14 days before the treatment of the study drug),or Hemoglobin≥80g/L(No red blood cells were transfused within 14 days before the treatment of the study drug) - Written informed consent in accordance with federal, local, and institutional guidelines - Patients understanding the characteristics of the disease and voluntarily joins the study program for treatment and follow-up - No other serious diseases in conflict with this program - Investigator believe that subjects can benefit Exclusion Criteria: - Patients with known central nervous system involvement by lymphoma; - Patients with a history of autoimmune diseases or syndrome requiring systemic use of steroid, such as hypophysitis, pneumonia, colitis, hepatitis, nephritis, hyperthyroidism and hypothyroidism - Patients received systemic glucocorticoid (prednisone >20mg/d) or any other immunosuppressive therapy within 7 days before the first administration,excluding nasal spray inhalation or other topical glucocorticoids; - Uncontrolled heart diseases, including unstable angina pectoris, acute myocardial infarction 6 months before randomization, congestive heart failure (NYHA), cardiac function grade greater than grade III or IV, or left ventricular ejection fraction<50%; - Patients previously treated with selinexor; - History of severe allergic reactions (as determined by treating physician) attributed to the drugs being used in the study; - Patients undergoing organ transplantation; - Diagnosed as malignant tumor other than lymphoma or receiving treatment,excluding: 1. Malignant tumors that have received treatment for the purpose of cure and have not developed known active diseases for ≥ 5 years before enrollment 2. Basal cell carcinoma of the skin (excluding melanoma) with adequate treatment and no signs of disease 3. Cervical carcinoma in situ with adequate treatment and no signs of disease - Patients with grade 2 or more neurotoxicity occurred within two weeks before treatment; - Severe infection; - Drug abuse, medical psychological or social conditions that may interfere with the subject's participation in the study or the evaluation of the results of the study; - Any active, serious psychiatric, medical, or other conditions/situations which, in the treating physician's opinion, could compromise the patient's safety

Gender: All

Minimum age: 18 Years

Maximum age: 75 Years

Healthy volunteers: No

Locations:

Facility:
Name: Chongqing University Cancer Hospital

Address:
City: Chongqing
Zip: 400030
Country: China

Status: Recruiting

Contact:
Last name: Yao Liu, MD

Phone: 13228684685
Email: liuyao77@cqu.edu.cn

Start date: February 28, 2023

Completion date: September 30, 2024

Lead sponsor:
Agency: Chongqing University Cancer Hospital
Agency class: Other

Source: Chongqing University Cancer Hospital

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT05786989
http://ashpublications.org/blood/article/136/Supplement%201/11/471859/Selinexor-in-Combination-with-R-CHOP-for-Frontline
http://ashpublications.org/blood/article/138/Supplement%201/1411/480310/Selinexor-in-Combination-with-R-GDP-for-Patients
http://www.semanticscholar.org/paper/Hitting-a-moving-target%3A-inhibition-of-the-nuclear-Sendino-Omaetxebarria/e3eebd3e1f9632d8cc3d012346a7f93dfc3bc906