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

NCT05786989 | Unknown Phase 4

• 1 other identifier: Chongqingcancer v3.0_20220908
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

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

Conditions

Diffuse Large B-Cell Lymphoma, Not Otherwise Specified

Outcome Measures

Primary Outcomes (1)

• Complete remission rate

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

  UP to 2 years

Secondary Outcomes (2)

• Progression-free survival

  From baseline to disease progression or death from any cause, assessed up to 2 years

• Objective remission rate

  UP to 2 years

Study Arms (1)

Treatment

EXPERIMENTAL

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

Interventions

selinexor DRUG

Given PO

Also known as: Selective Inhibitor of Nuclear, KPT-330

Treatment

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Chongqing University Cancer Hospital: lead

Study Sites (1)

Chongqing University Cancer Hospital

Chongqing, Chongqing Municipality, 400030, China

RECRUITING

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• Deng M, Zhang M, Xu-Monette ZY, Pham LV, Tzankov A, Visco C, Fang X, Bhagat G, Zhu F, Dybkaer K, Chiu A, Tam W, Zu Y, Hsi ED, Choi WWL, Huh J, Ponzoni M, Ferreri AJM, Moller MB, Parsons BM, van Krieken JH, Piris MA, Winter JN, Hagemeister F, Alinari L, Li Y, Andreeff M, Xu B, Young KH. XPO1 expression worsens the prognosis of unfavorable DLBCL that can be effectively targeted by selinexor in the absence of mutant p53. J Hematol Oncol. 2020 Nov 4;13(1):148. doi: 10.1186/s13045-020-00982-3.

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MeSH Terms

Conditions

Lymphoma, Large B-Cell, Diffuse

Interventions

selinexor

Condition Hierarchy (Ancestors)

Lymphoma, B-Cell; Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Central Study Contacts

Yao Liu, MD

CONTACT

13228684685; liuyao77@cqu.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief physician

Study Record Dates

• First Submitted: March 2, 2023
• First Posted: March 28, 2023
• Study Start: February 28, 2023
• Primary Completion: March 31, 2024
• Study Completion: September 30, 2024
• Last Updated: March 28, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)