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

NCT04989621 | Recruiting Phase 2

• 1 other identifier: B2021-144
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 3

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

Outcome Measures

Primary Outcomes (1)

• Objective Response rate

  Objective Response rate will be determined on the basis of investigator assessments according to 2014 Lugano criteria.

  2 years

Secondary Outcomes (5)

• Complete remission rate

  2 years

• Progression Free Survival

  4 years

• Overall Survival

  4 years

• Duration of Response

  4 years

• Percentage of Participants With Adverse Events

  4 years

Study Arms (1)

Orelabrutinib plus Rituximab followed by Maintenance with Orelabrutinib

EXPERIMENTAL

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.

Drug: Orelabrutinib and Rituximab; Drug: Orelabrutinib

Interventions

Orelabrutinib and Rituximab DRUG

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

Also known as: induction treatment

Orelabrutinib plus Rituximab followed by Maintenance with Orelabrutinib

Orelabrutinib DRUG

Orelabrutinib 150mg po qd

Orelabrutinib plus Rituximab followed by Maintenance with Orelabrutinib

Eligibility Criteria

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

You may qualify if:

• 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:

You may not qualify if:

• 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;

Sponsors & Collaborators

• Sun Yat-sen University: lead

Study Sites (3)

Guangdong General Hospital

Guangzhou, Guangdong, 510000, China

RECRUITING

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

Guangzhou, Guangdong, 51000, China

NOT YET RECRUITING

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

Guangzhou, Guangdong, 51000, China

RECRUITING

MeSH Terms

Conditions

Lymphoma, Follicular; Recurrence

Interventions

orelabrutinib; Rituximab

Condition Hierarchy (Ancestors)

Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Murine-Derived; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Qingqing Cai

  Sun Yat-Sen University Cancer Center

  STUDY DIRECTOR

Central Study Contacts

Qingqing Cai

CONTACT

0086-20-87342823; caiqq@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: Chief physician

Study Record Dates

• First Submitted: July 29, 2021
• First Posted: August 4, 2021
• Study Start: August 1, 2021
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): August 1, 2028
• Last Updated: April 23, 2026

Record last verified: 2026-04

Locations

CN (3)