A Phase II, Prospective, Multicenter Study Ofrelabrutinib in Combination With Gemox in Refractory / Relapsed Diffuse Large B-cell Lymphoma

Sun Yat-sen University8 sites in 1 country77 target enrollmentJuly 2022

ConditionsDLBCL

InterventionsOrelabrutinib and Gemox

DrugsOrelabrutinib and Gemox

Overview

Phase: Phase 2
Intervention: Orelabrutinib and Gemox
Conditions: DLBCL
Sponsor: Sun Yat-sen University
Enrollment: 77
Locations: 8
Primary Endpoint: Overall response rate
Status: Not yet recruiting
Last Updated: 3 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

This study aims to investigate the treatment of refractory or relapsed DLBCL with orelabrutinib and gemox. The primary endpoint is response rate (complete response rate and overall response rate), and the second endpoints are survival time (OS and PFS) and toxicities.

Registry

clinicaltrials.gov

Start Date

July 2022

End Date

December 2025

Last Updated

3 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Sun Yat-sen University

Responsible Party

Principal Investigator

Li Zhiming

Professor

Sun Yat-sen University

Eligibility Criteria

Inclusion Criteria

•Histologically confirmed relapsed or refractory Diffuse Large B-cell Lymphoma. There must be at least one evaluate able or measurable lesion that meets the Lugano criteria
•Age beyond18 years old;
•ECOG performance status 0-
•Estimated survival time \> 12 weeks.
•Adequate first-line treatment with CD20-containing monoclonal antibody
•DLBCL patients confirmed as non-GCB by Han's classification
•The main organs function well, namely, the following requirements were met one week before admission: Blood routine ANC ≥ 1.5×109/L, Hb ≥ 100g/L and PLT ≥ 100×109/L; liver function were normal (total bilirubin ≤1.5×ULN, ALT and AST ≤ 2.5×ULN), renal function was normal (serum creatinine ≤1×upper limitation of normal (ULN)), and without abnormal coagulation function.
•Pregnant women of childbearing age must have a pregnancy test (serum or urine) within 14 days before enrollment and the result is negative, and they are willing to use reliable methods of contraception during the test.
•The subjects who volunteer to join the study and sign the informed consent form, have good compliance and cooperate with the follow-up.

Exclusion Criteria

•Patients with central nervous system involvement
•Patients with Myc gene and BCL2/BCL6 gene rearrangement at the same time;
•Patients who have received BTK inhibitor therapy in the past;
•Patients who have received Gemox or GDP chemotherapy in the past;
•History of other malignancy within the last 5 years prior to enrollment, except for cured basal cell carcinoma of skin, cervix in situ carcinoma and superficial bladder cancer;
•Suffering from the following cardiovascular diseases: myocardial ischemia or myocardial infarction above grade II, poorly controlled arrhythmia (including QTc interval ≥ 450 ms for men and ≥ 470 ms for women); according to NYHA standards, grades III to IV cardiac function Incomplete, or echocardiography showed left ventricular ejection fraction (LVEF) \<50%;
•Abnormal coagulation function (INR\>1.5 or prothrombin time (PT)\>ULN+4 seconds or APTT\>1.5 ULN), with bleeding tendency or receiving thrombolysis or anticoagulation therapy;
•Arterial/venous thrombotic events, such as cerebrovascular accident (including temporary ischemic attack, cerebral hemorrhage, cerebral infarction), deep venous thrombosis and pulmonary embolism, that occurred within 12 months before enrollment;
•Known hereditary or acquired bleeding and thrombotic tendencies (such as hemophiliacs, coagulation disorders, thrombocytopenia, hypersplenism, etc.);
•Received major surgical operation or suffered severe traumatic injury, fracture or ulcer within 4 weeks of enrollment;