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

NCT04842318 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 789

Last updated 2021-04-13

No results posted yet for this study

Summary

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.

Conditions

Interventions

DRUG

BR for 6 cycles +R for 8 cycles

The patients will be given Bendamustine (90mg/m2 d1,2, every 28 days for total 6 courses) combined with Rituximab (375mg/m2 d0, every 28 days for total 6 courses) followed by Rituximab (375mg/m2 d1, every 3 months for total 8 courses)

DRUG

RCHOP for 6 cycles +R for 8 cycles

The patients will be given RCHOP (Rituximab 375mg/m2 ivgtt, D0, Cyclophosphamide 750mg/m2, ivgtt D1, doxorubicin 50mg/m2,ivgtt D1, Vincristine 1.4mg/m2（max 2mg）, ivgtt D1 Prednisone 60mg/m2 （max 100mg）,PO,D1-D5 every 21 days for total 6 courses) followed by Rituximab (375mg/m2 d1, every 3 months for total 8 courses)

DRUG

R2 for 6 cycles + R2 maintenance

The patients will be given Lenalidomide (25mg/d, po, D1-10, every 21 days for total 6 courses) combined with Rituximab (375mg/m2 d0, every 21 days for total 6 courses) followed by Lenalidomide (25mg/d, po, D1-10, every 28 days for total 6 courses) combined with Rituximab (375mg/m2 d1, every 3 months for total 8 courses)

Sponsors & Collaborators

  • Ruijin Hospital

    lead OTHER

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-03-01
Primary Completion
2023-03-01
Completion
2024-03-01

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04842318 on ClinicalTrials.gov