Rituximab Maintenance Treatment of Newly Diagnosed Follicular Lymphoma After BR or RCHOP or R2: a Multicenter Clinical Study

Shanghai Jiao Tong University

Status and phase: Unknown; Phase 4

Conditions: Follicular Lymphoma

Treatments: Drug: BR for 6 cycles +R for 8 cycles; Drug: RCHOP for 6 cycles +R for 8 cycles; Drug: R2 for 6 cycles + R2 maintenance

Study type: Interventional

Funder types: Other

Identifiers

NCT04842318

FL-001

Details and patient eligibility

About

This multi-center clinical study will evaluate the efficacy of Rituximab maintenance treatment of newly diagnosed follicular lymphoma after induction therapy of BR, RCHOP or R2.

Full description

Follicular lymphoma (FL) is a lymphoma of B cells in follicular center. It is a common pathological subtype of lymphoma, and its incidence rate is only next to diffuse large B cell lymphoma (DLBCL). The initial remission rate is high, but the tumor generally recurrent, making it difficult to be completely cured. This study attempts to explore the efficacy and safety of rituximab monotherapy maintenance after BR, RCHOP, R2 regimen induction therapy in the treatment of follicular patients, and to find the best way to maximize survival benefit and reduce treatment toxicity for FL patients. The study can improve the quality of life, prolong the survival and avoid the transformation to invasive lymphoma in patients with follicular lymphoma.

Enrollment: 789 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 RCHOP, BR or R2 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

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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789 participants in 3 patient groups

BR+R

Experimental group

Description:

Induction Therapy: Rituximab Combined With Bendamustine Maintenance Treatment: Rituximab

Treatment:

Drug: BR for 6 cycles +R for 8 cycles

RCHOP+R

Experimental group

Description:

Induction Therapy: Rituximab Combined With Cyclophosphamide, Vincristine, Doxorubicin, Prednisone Maintenance Treatment: Rituximab

Treatment:

Drug: RCHOP for 6 cycles +R for 8 cycles

R2+R2

Experimental group

Description:

Induction Therapy: Lenalidomide Combined With Rituximab Maintenance Treatment: Lenalidomide Combined With Rituximab

Treatment:

Drug: R2 for 6 cycles + R2 maintenance