A Real-world Study of Obinutuzumab-based Therapy for Previously Untreated FL
NCT ID: NCT05899621
Last Updated: 2023-06-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
332 participants
OBSERVATIONAL
2023-06-01
2027-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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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
Obinutuzumab
Obinutuzumab IV infusion will be administered as per the schedule specified in the respective arm.
Lenalidomide
Lenalidomide PO will be administered as per the schedule specified in the respective 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
Obinutuzumab
Obinutuzumab IV infusion will be administered as per the schedule specified in the respective arm.
Bendamustine
Bendamustine IV infusion will be administered as per the schedule specified in the respective 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
Obinutuzumab
Obinutuzumab IV infusion will be administered as per the schedule specified in the respective arm.
Cyclophosphamide
Cyclophosphamide IV infusion will be administered as per the schedule specified in the respective arm.
Doxorubicin
Doxorubicin IV infusion will be administered as per the schedule specified in the respective arm.
Vincristine
Vincristine IV infusion will be administered as per the schedule specified in the respective arm.
Prednisone
Prednisone PO will be administered as per the schedule specified in the respective arm.
Interventions
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Obinutuzumab
Obinutuzumab IV infusion will be administered as per the schedule specified in the respective arm.
Lenalidomide
Lenalidomide PO will be administered as per the schedule specified in the respective arm.
Bendamustine
Bendamustine IV infusion will be administered as per the schedule specified in the respective arm.
Cyclophosphamide
Cyclophosphamide IV infusion will be administered as per the schedule specified in the respective arm.
Doxorubicin
Doxorubicin IV infusion will be administered as per the schedule specified in the respective arm.
Vincristine
Vincristine IV infusion will be administered as per the schedule specified in the respective arm.
Prednisone
Prednisone PO will be administered as per the schedule specified in the respective arm.
Eligibility Criteria
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Inclusion Criteria
* Treatment naive
* Age ≥ 18 years
* Indications for treatment confirmed
* Must has measurable lesion in CT or PET-CT prior to treatment
* Considered suitable for GR, GB or GCHOP regimens
* Informed consented
Exclusion Criteria
* HBsAg positive and / or HBcAb positive with HBV DNA titer; HCV antibody positive with HCV-RNA; or HIV positive
* Central nervous system or meninges involved
* Any drug contraindication in the treatment plan
* Patients judged by other researchers to be unsuitable for inclusion in the study
18 Years
ALL
No
Sponsors
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Ruijin Hospital
OTHER
Responsible Party
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Zhao Weili
First Deputy Director, Hematology Department Affiliation: Ruijin Hospital
Principal Investigators
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Weili Zhao
Role: STUDY_CHAIR
Ruijin Hospital
Locations
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Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, China
Countries
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Central Contacts
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Pengpeng Xu, PhD，MD
Role: CONTACT
Facility Contacts
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Other Identifiers
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FL-Gbased
Identifier Type: -
Identifier Source: org_study_id
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