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

  • STATUS
    Recruiting
  • End date
    Mar 1, 2024
  • participants needed
    789
  • sponsor
    Ruijin Hospital
Updated on 21 April 2021

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.

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.

Details
Condition Follicular Lymphoma, Follicular Lymphoma, Lymphoma, Non-Hodgkin's Lymphoma, Non-Hodgkin's Lymphoma
Treatment BR for 6 cycles +R for 8 cycles, RCHOP for 6 cycles +R for 8 cycles, R2 for 6 cycles + R2 maintenance
Clinical Study IdentifierNCT04842318
SponsorRuijin Hospital
Last Modified on21 April 2021

Eligibility

Yes No Not Sure

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
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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