Orelabrutinib Plus Rituximab Followed by Maintenance With Orelabrutinib for Relapsed and Refractory Follicular Lymphoma(RR FL)

Follicular Lymphoma Clinical Trial

Official title:

Orelabrutinib Plus Rituximab Followed by Maintenance With Orelabrutinib for Relapsed and Refractory Follicular Lymphoma(RR FL) ：a Single Arm, Open Label, Multi-center Phase II Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04989621
• Other study ID #: B2021-144
• Status: Recruiting
• Phase: Phase 2
• Start date: August 1, 2021
• Est. completion date: August 2023

Study information

• Verified date: March 2022
• Source: Sun Yat-sen University
• Contact: Qingqing Cai
• Phone: 0086-20-87342823
• Email: caiqq[@]sysucc.org.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This phase 2 trial studies the efficacy and safety of orelabrutinib plus rituximab followed by maintenance with orelabrutinib for relapsed and refractory follicular lymphoma(RR FL)

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 32
• Est. completion date: August 2023
• Est. primary completion date: August 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Histologically confirmed grade 1, 2, or 3A FL;

• Patients received prior anti-lymphoma treatment;

• At least one evaluable lesion according to 2014 Lugano criteria;

• Age 18 years or older;

• Eastern Cooperative Oncology Group (ECOG) of 0-2;

• Life expectancy > 3 months;

• Able to participate in all required study procedures;

• Proper functioning of the major organs:

Exclusion Criteria:

• Patients who required warfarin or had a history of stroke or intracranial hemorrhage within 6 months, active transformed disease;

• Histological transformation of follicular lymphoma;

• Known central nervous system lymphoma;

• Received a prior allogeneic hematopoietic stem cell transplant. Prior autologous hematopoietic stem cell transplant is allowed;

• Subjects who have received prior treatment with ibrutinib, or other BTK inhibitors;

• Uncontrolled active infection, with the exception of tumor-related B symptom fever;

• Prior nitrosoureas within 6 weeks, chemotherapy within 3 weeks, therapeutic anticancer antibodies within 4 weeks, radio- or toxin-immunoconjugates within 10 weeks, radiation therapy or other investigational agents within 3 weeks, or major surgery within 4 weeks of first dose of study drug;

• Subjects who progressed or become refractory while on treatment with PI3K inhibitors are excluded. However, subjects who were responding to PI3K inhibitors, but had treatment discontinued due to toxicity, are eligible;

• Patients require treatment with strong CYP3A inhibitors;

• Clinically significant cardiovascular disease such as uncontrolled or symptomatic arrhythmias, congestive heart failure, or myocardial infarction within 6 months of Screening;

• Patients with active hepatitis B or active hepatitis C. Patients who are positive for hepatitis B Surface Antigen (HBsAg) or hepatitis C Virus (HCV) antibodies at screening stage must pass further detection of hepatitis B Virus (HBV) DNA (no more than 1000 IU/mL) and HCV RNA (no more than the lower limit of the detection method) in the row. Hepatitis B carriers, stable hepatitis B (DNA titer should not be higher than 1000 IU/mL) after drug treatment, and cured hepatitis C patients can be enrolled in the group;

Related Conditions & MeSH terms

• Follicular Lymphoma
• Lymphoma
• Lymphoma, Follicular

Intervention

Drug:
• Orelabrutinib and Rituximab
Orelabrutinib 150mg po qd d1-28; Rituximab 375mg/m2 iv.drip d1.
• Orelabrutinib
Orelabrutinib 150mg po qd

Locations

Country	Name	City	State
China	Guangdong General Hospital	Guangzhou	Guangdong
China	Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University,	Guangzhou	Guangdong
China	Sun Yat-sen Universitiy Cancer Center, Sun Yat-Sen University,	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Sun Yat-sen University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Objective Response rate	Objective Response rate will be determined on the basis of investigator assessments according to 2014 Lugano criteria.	2 years
Secondary	Complete remission rate	Complete remission rate will be determined on the basis of investigator	2 years
Secondary	Progression Free Survival	The time from the start of treatment to the progression of the tumor or death (due to any cause).	4 years
Secondary	Overall Survival	The time from the start of treatment to time of death (due to any cause).	4 years
Secondary	Duration of Response	The time from the first assessment of complete remission or partial remission to progressive disease or death (due to any cause).	4 years
Secondary	Percentage of Participants With Adverse Events	Adverse Events will be determined and graded on the basis of investigator assessments according to NCI CTC AE 5.0	4 years