AzTrials
AzTrials

Follicular Lymphoma ( FL)Phase 3NCT07719855

A Multicenter, Prospective, Open-Label, Randomized Controlled Clinical Study of Orelabrutinib Combined With Obinutuzumab and Lenalidomide Versus Obinutuzumab Plus Chemotherapy for Treatment-Naive Follicular Lymphoma

A Phase 3 study testing Orelabrutinib, obinutuzumab and Lenalidomide in people with Follicular Lymphoma ( FL), run by Ruijin Hospital at 1 site in China.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
Search all trials

Trial summary

This study intends to conduct a prospective, multicenter, open-label, randomized controlled clinical trial to systematically evaluate the efficacy and safety of the orelabrutinib plus obinutuzumab and lenalidomide (RO2) regimen versus the obinutuzumab-combined chemotherapy (O-chemo) regimen in patients with previously… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Follicular Lymphoma ( FL)
What is being tested?
Orelabrutinib, obinutuzumab and Lenalidomide
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
652 participants
Where
1 siteChina
Study dates
Jul 2026to Dec 2033
Phase
Phase 3
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

  • Subjects with histopathologically confirmed follicular lymphoma (FL) Grade 1-3A;
  • Subjects who have never received prior anti-lymphoma therapy;
  • Age ≥ 18 years old;
  • Eastern Cooperative Oncology Group (ECOG) performance status score of 0-2;
  • Adequate bone marrow, hepatic and renal function, defined as:
  • 1）Absolute neutrophil count (ANC) > 1,000/μL; platelet count > 50,000/mm³; hemoglobin > 80 g/dL; 2）Alanine transaminase (ALT) and aspartate transaminase (AST) < 3 × upper limit of normal (ULN); 3）Total serum bilirubin < 1.5 × ULN (patients with Gilbert syndrome are eligible); serum creatinine < 2 × ULN OR creatinine clearance > 50 mL/min; 6、Tumor tissue available for testing (fresh tissue preferred; archived paraffin-embedded tissue is acceptable); 7、Women of childbearing potential with a negative pregnancy test prior to Day 1 of treatment, who agree to use effective contraception throughout the study period and for at least 1 year after completion of study treatment; 8、Written informed consent obtained from the subject or their legal authorized representative prior to any study-specific examinations or procedures.

Who cannot join

  • Uncontrolled cardiovascular and cerebrovascular diseases, coagulation disorders, connective tissue diseases, severe infectious diseases, etc.
  • Abnormal laboratory parameters at screening (unless attributed to follicular lymphoma):
  • Absolute neutrophil count < 1.5 × 10⁹/L
  • Platelet count < 80 × 10⁹/L; if bone marrow involvement is present, platelet count < 50 × 10⁹/L
  • Alanine transaminase (ALT) or aspartate transaminase (AST) > 2 × upper limit of normal (ULN); alkaline phosphatase (AKP) or bilirubin > 1.5 × ULN
  • Serum creatinine > 1.5 × ULN OR estimated glomerular filtration rate (eGFR) < 40 mL/min/1.73 m² (calculated via the Cockcroft-Gault equation or Modification of Diet in Renal Disease [MDRD] equation)
Show all 15Show fewer
  • Human immunodeficiency virus (HIV)-positive subjects.
  • Left ventricular ejection fraction (LVEF) < 50%.
  • HBV screening requirements: Subjects with positive hepatitis B surface antigen (HBsAg) must undergo HBV DNA testing; those with HBV DNA < 10³ IU/mL are eligible for enrollment. Subjects with negative HBsAg but positive hepatitis B core antibody (HBcAb) (regardless of hepatitis B surface antibody [HBsAb] status) must also undergo HBV DNA testing; those with HBV DNA < 10³ IU/mL are eligible for enrollment.
  • Receiving concurrent anti-tumor therapy (for lymphoma or other malignancies).
  • Subjects with psychiatric disorders, or those with known/suspected poor compliance to the study protocol.
  • Requiring continuous treatment with strong or moderate CYP3A inhibitors or CYP3A inducers (see Appendix 3). Subjects who have taken strong/moderate CYP3A inhibitors or inducers within 7 days prior to the first dose of study drug (or within less than 5 half-lives of such medications) are excluded.
  • History of stroke or intracranial hemorrhage within 6 months before the first dose of study drug.
  • Inability to swallow capsules, or presence of diseases that significantly impair gastrointestinal function, such as malabsorption syndrome, bariatric surgery, inflammatory bowel disease, partial or complete intestinal obstruction.
  • Other uncontrolled concomitant medical conditions deemed by the investigator to interfere with study participation. Any life-threatening disease, medical condition or organ dysfunction that may compromise subject safety, interfere with the absorption or metabolism of oral targeted agents, or expose study outcomes to excessive risk, as judged by the investigator.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Peng-Peng Xu contact

+862164370045 Ext. 610707

pengpeng_xu@126.com

China1 site

  • Ruijin Hosiptal

    Shanghai, Shanghai Municipality, 20025

Other trials in China

About this study

This study intends to conduct a prospective, multicenter, open-label, randomized controlled clinical trial to systematically evaluate the efficacy and safety of the orelabrutinib plus obinutuzumab and lenalidomide (RO2) regimen versus the obinutuzumab-combined chemotherapy (O-chemo) regimen in patients with previously untreated follicular lymphoma. The primary observation is whether the RO2 regimen can maintain or improve therapeutic efficacy while significantly reducing hematological toxicities and other related adverse reactions, so as to provide a novel therapeutic option for improving the prognosis and quality of life of patients with follicular lymphoma (FL).

Keywords
Follicular Lymphoma
Medical subject headings
Lymphoma, Follicular

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • OrelabrutinibDrug

    Orelabrutinib PO will be administered as per the schedule specified in the respective arm.

  • obinutuzumabDrug

    Obinutuzumab IV infusion will be administered as per the schedule specified in the respective arm.

  • LenalidomideDrug

    Lenalidomide PO will be administered as per the schedule specified in the respective arm.

  • CyclophosphamideDrug

    Cyclophosphamide IV infusion will be administered as per the schedule specified in the respective arm.

  • DoxorubicinDrug

    Doxorubicin IV infusion will be administered as per the schedule specified in the respective arm.

  • PrednisoneDrug

    Prednisone PO will be administered as per the schedule specified in the respective arm.

  • VincristineDrug

    Vincristine infusion will be administered as per the schedule specified in the respective arm.

  • BendamustineDrug

    Bendamustine infusion will be administered as per the schedule specified in the respective arm.

Study groups in NCT07719855
Study groupRoleWhat they receive
RO2ExperimentalPatients in the study group will receive six cycles of the RO2 regimen, with each cycle repeated every 21 days. Routine efficacy assessments will be performed upon completion of each cycle during treatment. PET-CT scanning will be used for efficacy evaluation after three cycles of therapy. Patients with stable disease (SD) or progressive disease (PD) will discontinue study treatment, and the investigator will determine the salvage therapy regimen. Patients achieving a complete response (CR) or partial response (PR) will continue the original regimen for cycles 4 to 6. After completion of six cycles of treatment, PET-CT will be conducted for efficacy reassessment. Patients with CR or PR will finish induction therapy and enter the maintenance phase. The study group will receive obinutuzumab maintenance therapy once every three months for a total of two years, combined with lenalidomide maintenance administered for 10 days per month over six months.
Receives: Drug: Orelabrutinib; Drug: obinutuzumab; Drug: Lenalidomide
O-ChemoActive comparatorPatients in the study group will receive six cycles of the O-chemo regimen, with each cycle repeated every 21 days. Routine efficacy assessments will be performed upon completion of each cycle during treatment. PET-CT scanning will be used for efficacy evaluation after three cycles of therapy. Patients with stable disease (SD) or progressive disease (PD) will discontinue study treatment, and the investigator will determine the salvage therapy regimen. Patients achieving a complete response (CR) or partial response (PR) will continue the original regimen for cycles 4 to 6. After completion of six cycles of treatment, PET-CT will be conducted for efficacy reassessment. Patients with CR or PR will finish induction therapy and enter the maintenance phase. The study group will receive obinutuzumab maintenance therapy once every three months for a total of two years.
Receives: Drug: obinutuzumab; Drug: Cyclophosphamide; Drug: Doxorubicin; Drug: Prednisone; Drug: Vincristine; Drug: Bendamustine

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Progression-free survival

    PFS, defined as the time from diagnosis to the first occurrence of disease progression or relapse using the 2014 Lugano Response Criteria or death due to any cause, whichever occurs first; as determined by the investigator

    Measured: From enrollment to the first occurrence of disease progression or relapse, or death from any cause, whichever occurs earlier (a maximum of 6 years)

Secondary outcomes (4)

  1. Complete response rate

    CR rate at the end of treatment by FDG-PET defined as the proportion of participants with CR at the end of treatment according to the 2014 Lugano Response Criteria; as determined by the investigator and IRC (separately)

    Measured: End of treatment visit (6-8 weeks after last dose on Day 1 of Cycle 6 [Cycle length=21 days]

  2. Objective response rate

    ORR at treatment completion or discontinuation defined as the proportion of participants with CR or partial response (PR) at the end of treatment according to the 2014 Lugano Response Criteria; as determined by the investigator and IRC(separately)

    Measured: End of treatment visit (6-8 weeks after last dose on Day 1 of Cycle 6 [Cycle length=21 days]

  3. Overall survival

    OS defined as the time from diagnosis to death from any cause

    Measured: up to approximately 6 years

  4. Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE v6.0

    Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE v6.0

    Measured: From enrollment to study completion, a maximum of 6 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Jul 2026
  2. Study startJul 2026 (estimated)
  3. Primary completionJul 2030 (estimated)
  4. Study completionDec 2033 (estimated)

Resources

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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
652 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07719855
Sponsor's protocol ID
Future
Status last verified
Jul 2026
First submitted
10 Jul 2026
Last updated
22 Jul 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Orelabrutinib, obinutuzumab and Lenalidomide in people with Follicular Lymphoma ( FL), run by Ruijin Hospital at 1 site 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 6 inclusion and 15 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: opening soon, as of the sponsor's last update on 22 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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 Peng-Peng Xu (+862164370045 Ext. 610707, pengpeng_xu@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression-free survival (time frame: From enrollment to the first occurrence of disease progression or relapse, or death from any cause, whichever occurs earlier (a maximum of 6 years)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07719855.

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 22 Jul 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in