A Real-world Study of Obinutuzumab-based Therapy for Previously Untreated FL

Sponsor
Ruijin Hospital
Study ID
NCT05899621
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • 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.
  • Bendamustine — DRUG
    Bendamustine IV infusion 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.
  • Vincristine — DRUG
    Vincristine 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.

Study Details

This study aims to observe and explore the efficacy and safety of obinutuzumab-based therapy for previously untreated follicular lymphoma

Key Dates

First listed
Jun 12, 2023
Start date
Jun 1, 2023
Status verified
Jun 2023
Primary completion
Jun 30, 2025
Completion
Jun 30, 2027

Study Design

Enrollment
332 participants (estimated)

Arms

  • Arm: GR
    Induction(six 21-day cycles): obinutuzumab (G), 1000mg, IV, D1/8/15 (C1), D1 (C2-6); lenalidomide (R), 25mg, PO, D2-11; Maintenance: obinutuzumab (G), 1000mg, every 3 months for 2 years; lenalidomide (R), 25mg, PO, D1-10, every 28 days for 6 cycles
  • Arm: GB
    Induction(six 21-day cycles): obinutuzumab (G) 1000mg, IV, D1/8/15 (C1), D1 (C2-6); bendamustine (B), 90 mg/m2, IV, D1-2; Maintenance: obinutuzumab (G), 1000mg, IV, every 3 months for 2 years
  • Arm: GCHOP
    Induction(six 21-day cycles): obinutuzumab (G), 1000mg, IV, D1/8/15 (C1), D1 (C2-6); prednisone (P), 100 mg, PO, D1-5；cyclophosphamide (C), 750 mg/m2, IV, D1; vincristine (O), 1.4 mg/m2 (maximum 2 mg), IV, D1; doxorubicin (H), 50 mg/m2, IV, D1; Maintenance: obinutuzumab (G), 1000mg, IV, every 3 months for 2 years

Primary Outcome Measure

Objective response rate (ORR) [ Time Frame: End of treatment visit (6 weeks after last dose on Day 1 of Cycle 6 [Cycle length=21 days] ]

Central Contacts

  • Weili Zhao, +862164370045
    +862164370045
    [email protected]
  • Pengpeng Xu, PhD，MD
    +862164370045

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