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

NCT ID: NCT05786989

Last Updated: 2023-03-28

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 32 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-02-28
• Study Completion Date: 2024-09-30

Brief 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

Conditions

Diffuse Large B-Cell Lymphoma, Not Otherwise Specified

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Treatment

Patients will receive selinexor PO on days 1, 8, and 15 of a 21 week cycle. R-GemOx will be given at standard dosing every 21 days

Group Type: EXPERIMENTAL

selinexor

Intervention Type: DRUG

Given PO

Interventions

selinexor

Given PO

Intervention Type: DRUG

Other Intervention Names

Selective Inhibitor of Nuclear; KPT-330

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Chongqing University Cancer Hospital

OTHER

Sponsor Role: lead

Responsible Party

Yao Liu

Chief physician

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Chongqing University Cancer Hospital

Chongqing, Chongqing Municipality, China

Site Status: RECRUITING

Countries

China

Central Contacts

Yao Liu, MD

Role: CONTACT

liuyao77@cqu.edu.cn

13228684685

Facility Contacts

Yao Liu, MD

Role: primary

liuyao77@cqu.edu.cn

13228684685

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Related Links

http://ashpublications.org/blood/article/136/Supplement%201/11/471859/Selinexor-in-Combination-with-R-CHOP-for-Frontline

Related Info

http://www.semanticscholar.org/paper/Hitting-a-moving-target%3A-inhibition-of-the-nuclear-Sendino-Omaetxebarria/e3eebd3e1f9632d8cc3d012346a7f93dfc3bc906

Related Info

Other Identifiers

Chongqingcancer v3.0_20220908

Identifier Type: -

Identifier Source: org_study_id