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

March 27, 2023 updated by: Yao Liu, Chongqing University Cancer Hospital

Selinexor Combined With R-GemOx as Second-line Treatment in Patients With Diffuse Large B-cell Lymphoma： a Single-arm, Single-centre, Open-label Trial

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Anticipated)

32

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Chongqing
      • Chongqing, Chongqing, China, 400030
        • Recruiting
        • Chongqing University Cancer Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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
Drug: selinexor
Given PO
Other Names:
  • KPT-330
  • Selective Inhibitor of Nuclear

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Complete remission rate
Time Frame: UP to 2 years
Response rates will be estimated as proportions with 95% Wilson confidence intervals
UP to 2 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression-free survival
Time Frame: From baseline to disease progression or death from any cause, assessed up to 2 years
PFS will be described with Kaplan-Meier curves and estimated medians with 95% confidence intervals
From baseline to disease progression or death from any cause, assessed up to 2 years
Objective remission rate
Time Frame: UP to 2 years
Response rates will be estimated as proportions with 95% Wilson confidence intervals
UP to 2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chongqing University Cancer Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 28, 2023

Primary Completion (Anticipated)

March 31, 2024

Study Completion (Anticipated)

September 30, 2024

Study Registration Dates

First Submitted

March 2, 2023

First Submitted That Met QC Criteria

March 27, 2023

First Posted (Actual)

March 28, 2023

Study Record Updates

Last Update Posted (Actual)

March 28, 2023

Last Update Submitted That Met QC Criteria

March 27, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Chongqingcancer v3.0_20220908

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

After the paper is published

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Diffuse Large B-Cell Lymphoma, Not Otherwise Specified

Clinical Trials on selinexor

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Panama

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe