Study of Orelabrutinib in Combination With Gemox in Refractory / Relapsed Diffuse Large B-cell Lymphoma

NCT05381506 | Unknown Phase 2

• 1 other identifier: 2022-FXY-102-内科
• Study Type: interventional
• Target: 77
• Locations: 1 country
• Sites: 8

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.

Conditions

DLBCL

Keywords

Orelabrutinib; Gemox

Outcome Measures

Primary Outcomes (1)

• Overall response rate

  overall response rate after treated by Orelabrutin and Gemox

  12 weeks after the initiation of the treatment

Secondary Outcomes (4)

• Progression Free Survival (PFS)

  Up to two years after the start of the study

• Overall Survival (OS)

  Up to two years after the start of the study

• Duration of Response（DOR）

  Up to three years after the start of the study

• Adverse events

  Up to one year after the start of the study

Study Arms (1)

Orelabrutinib and Gemox

EXPERIMENTAL

Orelabrutinib and Gemox for 6 cycles

Drug: Orelabrutinib and Gemox

Interventions

Orelabrutinib and Gemox DRUG

Drug: Orelabrutinib Orelabrutinib 200mg, po, qd Drug: Gemox14 Gemcitabine, Oxaliplatin

Also known as: O-Gemox

Orelabrutinib and Gemox

Eligibility Criteria

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

You may qualify if:

• 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 0-2.
• 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.

You may not qualify if:

• 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;
• There are factors that obviously affect the absorption of oral drugs, such as inability to swallow, chronic diarrhea and intestinal obstruction;
• Active infection requires antimicrobial treatment (for example, antibiotics and antiviral drugs are required, excluding chronic hepatitis B, anti-hepatitis B treatment, and antifungal drug treatment);
• Active hepatitis B (HBV DNA ≥ 2000IU/mL or 104 copies/mL) or hepatitis C (positive hepatitis C antibody, and HCV RNA is higher than the detection limit of the analytical method);
• Those who have a history of psychotropic substance abuse and cannot quit or have mental disorders;
• Participated in clinical trials of other anti-tumor drugs within 4 weeks before enrollment;

Sponsors & Collaborators

• Sun Yat-sen University: lead

Study Sites (8)

Chongqing Cancer Hospital

Chongqing, Chongqing Municipality, China

Location

Guangxi Medical University Cancer Hospital

Naning, Guangxi, China

Location

Hubei Cancer Hospital

Wuhan, Hubei, China

Location

Hunan Cancer Hospital

Changsha, Hunan, China

Location

West China Hospital.Sichuan University

Chengdu, Sichuan, China

Location

Tianjin Medical University Cancer Hospital

Tianjin, Tianjin Municipality, China

Location

The Second Affiliated Hospital of Kunming Medical University

Kunming, Yunnan, China

Location

Zhejiang Cancer Hospital

Hangzhou, Zhejiang, China

Location

MeSH Terms

Interventions

orelabrutinib

Study Officials

• Zhiming Li, Dr.

  Sun Yat-sen University

  STUDY CHAIR

Central Study Contacts

Zhiming Li, Dr.

CONTACT

+86-020-87343765; lizhm@sysucc.org.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: May 15, 2022
• First Posted: May 19, 2022
• Study Start: July 1, 2022
• Primary Completion: December 1, 2023
• Study Completion: December 1, 2025
• Last Updated: July 8, 2022

Record last verified: 2022-05

Locations

CN (8)