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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

ConditionFollicular Lymphoma ( FL)
Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorRuijin Hospital

About this trial

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).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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;

Disqualifiers

Uncontrolled cardiovascular and cerebrovascular diseases, coagulation disorders, connective tissue diseases, severe infectious diseases, etc.

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Orelabrutinib

    Drug

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

  • obinutuzumab

    Drug

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

  • Lenalidomide

    Drug

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

  • Cyclophosphamide

    Drug

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

  • Doxorubicin

    Drug

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

  • Prednisone

    Drug

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

  • Vincristine

    Drug

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

  • Bendamustine

    Drug

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

Treatment groups

652 Participants
are divided into 2 treatment groups
Group A: RO2Experimental treatment 3 interventions
Group B: O-ChemoActive comparator 6 interventions

Trial outcomes

Primary outcomes

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

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)

Secondary outcomes

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)

Time frame
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)

Time frame
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

Time frame
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

Time frame
From enrollment to study completion, a maximum of 6 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Ruijin Hospital

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: