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

Primary Purpose

Diffuse Large B-Cell Lymphoma, Not Otherwise Specified

Status
Recruiting
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
selinexor
Sponsored by
Chongqing University Cancer Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diffuse Large B-Cell Lymphoma, Not Otherwise Specified

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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: Malignant tumors that have received treatment for the purpose of cure and have not developed known active diseases for ≥ 5 years before enrollment Basal cell carcinoma of the skin (excluding melanoma) with adequate treatment and no signs of disease 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

Sites / Locations

  • Chongqing University Cancer HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Treatment

Arm Description

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

Outcomes

Primary Outcome Measures

Complete remission rate
Response rates will be estimated as proportions with 95% Wilson confidence intervals

Secondary Outcome Measures

Progression-free survival
PFS will be described with Kaplan-Meier curves and estimated medians with 95% confidence intervals
Objective remission rate
Response rates will be estimated as proportions with 95% Wilson confidence intervals

Full Information

First Posted
March 2, 2023
Last Updated
March 27, 2023
Sponsor
Chongqing University Cancer Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05786989
Brief Title
Selinexor Combined With R-GemOx as Second-line Treatment in Patients With Diffuse Large B-cell Lymphoma
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 28, 2023 (Actual)
Primary Completion Date
March 31, 2024 (Anticipated)
Study Completion Date
September 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chongqing University Cancer Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diffuse Large B-Cell Lymphoma, Not Otherwise Specified

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
32 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Treatment
Arm Type
Experimental
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
selinexor
Other Intervention Name(s)
Selective Inhibitor of Nuclear, KPT-330
Intervention Description
Given PO
Primary Outcome Measure Information:
Title
Complete remission rate
Description
Response rates will be estimated as proportions with 95% Wilson confidence intervals
Time Frame
UP to 2 years
Secondary Outcome Measure Information:
Title
Progression-free survival
Description
PFS will be described with Kaplan-Meier curves and estimated medians with 95% confidence intervals
Time Frame
From baseline to disease progression or death from any cause, assessed up to 2 years
Title
Objective remission rate
Description
Response rates will be estimated as proportions with 95% Wilson confidence intervals
Time Frame
UP to 2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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: Malignant tumors that have received treatment for the purpose of cure and have not developed known active diseases for ≥ 5 years before enrollment Basal cell carcinoma of the skin (excluding melanoma) with adequate treatment and no signs of disease 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yao Liu, MD
Phone
13228684685
Email
liuyao77@cqu.edu.cn
Facility Information:
Facility Name
Chongqing University Cancer Hospital
City
Chongqing
State/Province
Chongqing
ZIP/Postal Code
400030
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yao Liu, MD
Phone
13228684685
Email
liuyao77@cqu.edu.cn

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
After the paper is published
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Links:
URL
http://www.semanticscholar.org/paper/Hitting-a-moving-target%3A-inhibition-of-the-nuclear-Sendino-Omaetxebarria/e3eebd3e1f9632d8cc3d012346a7f93dfc3bc906
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Selinexor Combined With R-GemOx as Second-line Treatment in Patients With Diffuse Large B-cell Lymphoma

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