Clinical trial NCT04989621: Orelabrutinib Plus Rituximab Followed by Maintenance With Orelabrutinib for Relapsed and Refractory Follicular Lymphoma(RR FL)
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Follicular Lymphoma
Relapsed and Refractory Follicular Lymphoma
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
First posted: 2021-08-04
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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)


Eligibility criteria: 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;

Primary outcomes:
measure: Objective Response rate
timeFrame: 2 years
Secondary outcomes:
measure: Complete remission rate
timeFrame: 2 years
measure: Progression Free Survival
timeFrame: 4 years
measure: Overall Survival
timeFrame: 4 years
measure: Duration of Response
timeFrame: 4 years
measure: Percentage of Participants With Adverse Events
timeFrame: 4 years
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Guangdong General Hospital
state: Guangdong
city: Guangzhou
country: China
facility: Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University,
state: Guangdong
city: Guangzhou
country: China
facility: Sun Yat-sen Universitiy Cancer Center, Sun Yat-Sen University,
state: Guangdong
Study officials:
affiliation: Sun Yat-sen University
name: Qingqing Cai
role: STUDY_DIRECTOR
References: