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

NCT ID: NCT04989621

Last Updated: 2022-03-24

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 32 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-08-01
• Study Completion Date: 2023-08-31

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)

Conditions

Follicular Lymphoma; Relapsed and Refractory Follicular Lymphoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Orelabrutinib plus Rituximab followed by Maintenance with Orelabrutinib

Induction therapy: Patients receive Orelabrutinib at a dose of 25 mg once daily on days 1-28 and rituximab at a dose of 375mg/m2 on day 1. Treatment cycles repeat every 28 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity.

If patients achieve CR or PR or SD, they will be treated with maintenance therapy Maintenance therapy: Patients receive Orelabrutinib every day at a dose of 150mg for up to two years in the absence of disease progression or unacceptable toxicity.

Group Type: EXPERIMENTAL

Orelabrutinib and Rituximab

Intervention Type: DRUG

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

Orelabrutinib

Intervention Type: DRUG

Orelabrutinib 150mg po qd

Interventions

Orelabrutinib and Rituximab

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

Intervention Type: DRUG

Orelabrutinib

Orelabrutinib 150mg po qd

Intervention Type: DRUG

Other Intervention Names

induction treatment

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;

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sun Yat-sen University

OTHER

Sponsor Role: lead

Responsible Party

Qingqing Cai

Chief physician

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Qingqing Cai

Role: STUDY_DIRECTOR

Sun Yat-sen University

Locations

Guangdong General Hospital

Guangzhou, Guangdong, China

Site Status: RECRUITING

Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University,

Guangzhou, Guangdong, China

Site Status: NOT_YET_RECRUITING

Sun Yat-sen Universitiy Cancer Center, Sun Yat-Sen University,

Guangzhou, Guangdong, China

Site Status: RECRUITING

Countries

China

Central Contacts

Qingqing Cai

Role: CONTACT

caiqq@sysucc.org.cn

0086-20-87342823

Facility Contacts

Wenyu Li, MD

Role: primary

Yudan Wu, MD

Role: primary

Qing qing Cai, MD

Role: primary

Other Identifiers

B2021-144

Identifier Type: -

Identifier Source: org_study_id