Follicular LymphomaPhase 2NCT04989621
Orelabrutinib Plus Rituximab Followed by Maintenance With Orelabrutinib for Relapsed and Refractory Follicular Lymphoma(RR FL)
A Phase 2 study testing Orelabrutinib and Rituximab and Orelabrutinib in people with Follicular Lymphoma and Relapsed and Refractory Follicular Lymphoma, run by Sun Yat-sen University at 3 sites in China.
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) Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Follicular Lymphoma, Relapsed and Refractory Follicular Lymphoma
- What is being tested?
- Orelabrutinib and Rituximab and Orelabrutinib
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 3 sitesChina
- Study dates
- 1 Aug 2021to Aug 2028
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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:
Who cannot join
- 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;
Show all 11Show fewer
- 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 locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China3 sites, 3 recruiting
- Recruiting
Guangdong General Hospital
Guangzhou, Guangdong, 510000
Wenyu Li, MD
- Not yet recruiting
Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University,
Guangzhou, Guangdong, 51000
Yudan Wu, MD
- Recruiting
Sun Yat-sen Universitiy Cancer Center, Sun Yat-Sen University,
Guangzhou, Guangdong, 51000
Qing qing Cai, MD
About this study
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
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)
- Being tested
- Orelabrutinib and Rituximab, Orelabrutinib
- Medical subject headings
- Lymphoma, Follicular, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Orelabrutinib and RituximabDrug
Also called induction treatment
Orelabrutinib 150mg po qd d1-28; Rituximab 375mg/m2 iv.drip d1.
OrelabrutinibDrug
Orelabrutinib 150mg po qd
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Orelabrutinib and Rituximab; Drug: Orelabrutinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective Response rate
Objective Response rate will be determined on the basis of investigator assessments according to 2014 Lugano criteria.
Measured: 2 years
Secondary outcomes (5)
Complete remission rate
Complete remission rate will be determined on the basis of investigator
Measured: 2 years
Progression Free Survival
The time from the start of treatment to the progression of the tumor or death (due to any cause).
Measured: 4 years
Overall Survival
The time from the start of treatment to time of death (due to any cause).
Measured: 4 years
Duration of Response
The time from the first assessment of complete remission or partial remission to progressive disease or death (due to any cause).
Measured: 4 years
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
Measured: 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2021
- Study start1 Aug 2021
- Primary completionAug 2026 (estimated)
- Study completionAug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Follicular LymphomaStudies of the same condition, open and under way.
- More trials run by Sun Yat-sen UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 32 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Qingqing Cai, Sun Yat-sen University
- Investigators
- Qingqing Cai, Study director, Sun Yat-Sen University Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04989621
- Sponsor's protocol ID
- B2021-144
- Status last verified
- Apr 2026
- First submitted
- 29 Jul 2021
- Last updated
- 23 Apr 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04989621
- Acronym / sponsor ID
- B2021-144
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- 1 Aug 2021 (actual)
- Primary completion
- Aug 2026 (estimated)
- Study completion
- Aug 2028 (estimated)
- First posted
- 4 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Orelabrutinib plus Rituximab followed by Maintenance with Orelabrutinib | Experimental | Drug: Orelabrutinib and Rituximab, Drug: OrelabrutinibInduction 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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;
Key exclusion criteria (11 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Orelabrutinib and RituximabAlso: induction treatmentOrelabrutinib 150mg po qd d1-28; Rituximab 375mg/m2 iv.drip d1. | Drug | Orelabrutinib plus Rituximab followed by Maintenance with Orelabrutinib |
| OrelabrutinibOrelabrutinib 150mg po qd | Drug | Orelabrutinib plus Rituximab followed by Maintenance with Orelabrutinib |
Primary outcome
Objective Response rate
Time frame: 2 years
Objective Response rate will be determined on the basis of investigator assessments according to 2014 Lugano criteria.
5 secondary outcomes
Complete remission rate
Time frame: 2 years
Progression Free Survival
Time frame: 4 years
Overall Survival
Time frame: 4 years
Duration of Response
Time frame: 4 years
Percentage of Participants With Adverse Events
Time frame: 4 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Apr 2026.
Related trials for Follicular Lymphoma
RecruitingPhase 1/2
A Platform Trial Evaluating New Drugs or Combination in R/R Peripheral T-cell Lymphomas
Peripheral T Cells Lymphoma (PTCL), Follicular Helper T-Cell Lymphoma
Active, not recruiting
EXHIT ENTRE Implementation Trial of High Intensity Versus Low Intensity Strategy
Substance Use Disorders, Opioid Use Disorder, Severe
RecruitingPhase 1/2
Dose Escalation and Dose Expansion Study of MDX2003 in Patients With Different Types of Lymphoma
Lymphoma, Waldenström Macroglobulinemia (WM)
Active, not recruitingPhase 1
A Rollover Study of CC-122
Non-Hodgkin Lymphoma
Recruiting
STEpwise Research Program to Promote INGeniouS ONline Supportive Solutions in the Relief of Cancer-related Fatigue
Cancer Diagnosis, Moderate or Severe Score of Cancer-related Fatigue (CRF)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Qingqing Cai study director
Sun Yat-Sen University Cancer Center
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Orelabrutinib and Rituximab and Orelabrutinib in people with Follicular Lymphoma and Relapsed and Refractory Follicular Lymphoma, run by Sun Yat-sen University at 3 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 23 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Qingqing Cai (0086-20-87342823, caiqq@sysucc.org.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective Response rate (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Apr 2026.