Rituximab Maintenance Treatment of Newly Diagnosed Follicular Lymphoma After BR or RCHOP or R2: a Multicenter Clinical Study
- Conditions
- Follicular Lymphoma
- Interventions
- Drug: BR for 6 cycles +R for 8 cyclesDrug: R2 for 6 cycles + R2 maintenanceDrug: RCHOP for 6 cycles +R for 8 cycles
- Registration Number
- NCT04842318
- Lead Sponsor
- Ruijin Hospital
- Brief 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.
- Detailed 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 789
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description BR+R BR for 6 cycles +R for 8 cycles Induction Therapy: Rituximab Combined With Bendamustine Maintenance Treatment: Rituximab R2+R2 R2 for 6 cycles + R2 maintenance Induction Therapy: Lenalidomide Combined With Rituximab Maintenance Treatment: Lenalidomide Combined With Rituximab RCHOP+R RCHOP for 6 cycles +R for 8 cycles Induction Therapy: Rituximab Combined With Cyclophosphamide, Vincristine, Doxorubicin, Prednisone Maintenance Treatment: Rituximab
- Primary Outcome Measures
Name Time Method MRD negative rate of bone marrow at 24 weeks At 24 weeks Percentage of participants with negative MRD estimated by q-RT-PCR of bone marrow
- Secondary Outcome Measures
Name Time Method Event-free survival Baseline up to data cut-off (up to approximately 4 years) Event-free survival was defined as the time from the date of diagnosis until the date of the first documented day of events.
Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE v4.0 Up to 30 days after completion of study treatment An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as adverse events
MRD negative rate of peripheral blood at 24 weeks At 24 weeks Percentage of participants with negative MRD estimated by q-RT-PCR of peripheral blood
Overall survival Baseline up to data cut-off (up to approximately 4 years) Overall survival was defined as the time from the date of diagnosis to the date of death from any cause. Reported is the percentage of participants with event. of disease progression or relapse, using 2014 Lugano criteria,or death from any cause, whichever occurred first.
Time to Progression Baseline up to data cut-off (up to approximately 4 years) Time to Progression was defined as the time from the date of diagnosis until the date of the first documented day of disease progression, using 2014 Lugano criteria, whichever occurred first.
Progression Free Survival Baseline up to data cut-off (up to approximately 4 years) Progression-free survival was defined as the time from the date of diagnosis until the date of the first documented day of disease progression or relapse, using 2014 Lugano criteria, or death from any cause, whichever occurred first.
Overall response rate 21 days after 6 cycles of induction therapy (each cycle is 21 days) Percentage of participants with overall response was determined on the basis of investigator assessments according to 2014 Lugano criteria
Progression of disease within 24 months Baseline up to data cut-off (24 months) Progression of disease within 24 months was defined as the rate of disease progression or relapse, using 2014 Lugano criteria, or death from any cause, whichever occurred first.
Duration of response Baseline up to data cut-off (up to approximately 4 years) Duration of response was defined as the time from the date of diagnosis until the date of the first documented day of disease relapse, using 2014 Lugano criteria, or death from any cause, whichever occurred first.
Time to Next Anti-lymphoma Treatment Baseline up to data cut-off (up to approximately 4 years) Time to Next Anti-lymphoma Treatment was defined as the time from the date of first treatment until the date patients need to receive next anti-lymphoma treatment on the basis of investigator assessments according to 2014 Lugano criteria
Trial Locations
- Locations (1)
Ruijin Hospital
🇨🇳Shanghai, China