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

Shanghai Jiao Tong University

Status: Enrolling

Conditions: Follicular Lymphoma

Treatments: Drug: Prednisone; Drug: Cyclophosphamide; Drug: Doxorubicin; Drug: Obinutuzumab; Drug: Vincristine; Drug: Lenalidomide; Drug: Bendamustine

Study type: Observational

Funder types: Other

Identifiers

NCT05899621

FL-Gbased

Details and patient eligibility

About

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

Full description

This study aims to observe and explore the efficacy and safety of obinutuzumab-based therapy for previously untreated follicular lymphoma. This study is a non-interventional real world, observational study and all registered data are collected from real clinical practice cases. The medical data includes patient demographic, tumor characteristics, laboratory examination, history of treatments, adverse reactions, efficacy results and possible prognostic factors.

Enrollment: 332 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Pathologically confirmed CD20 positive follicular lymphoma grade 1, 2, or 3A based on 2016 WHO classification
• 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

• Transformed follicular lymphoma or 3B follicular lymphoma;
• 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

Trial design

332 participants in 3 patient groups

GR

Description:

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

Treatment:

Drug: Lenalidomide

Drug: Obinutuzumab

GB

Description:

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

Treatment:

Drug: Obinutuzumab

Drug: Bendamustine

GCHOP

Description:

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

Treatment:

Drug: Cyclophosphamide

Drug: Doxorubicin

Drug: Obinutuzumab

Drug: Vincristine

Drug: Prednisone