ClinicalTrials.Veeva

Menu

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

Sun Yat-sen University logo

Sun Yat-sen University

Status and phase

Unknown
Phase 2

Conditions

Relapsed and Refractory Follicular Lymphoma
Follicular Lymphoma

Treatments

Drug: Orelabrutinib and Rituximab
Drug: Orelabrutinib

Study type

Interventional

Funder types

Other

Identifiers

NCT04989621
B2021-144

Details and patient eligibility

About

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)

Enrollment

32 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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;

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

32 participants in 1 patient group

Orelabrutinib plus Rituximab followed by Maintenance with Orelabrutinib
Experimental group
Description:
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.
Treatment:
Drug: Orelabrutinib
Drug: Orelabrutinib and Rituximab

Trial contacts and locations

3

Loading...

Central trial contact

Qingqing Cai

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2025 Veeva Systems