Back to resultsRituximab Maintenance Treatment of Newly Diagnosed Follicular Lymphoma After BR or RCHOP or R2: a Multicenter Clinical Study
Primary Purpose
Follicular Lymphoma
Status
Recruiting
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
BR for 6 cycles +R for 8 cycles
RCHOP for 6 cycles +R for 8 cycles
R2 for 6 cycles + R2 maintenance
Sponsored by
About this trial
This is an interventional treatment trial for Follicular Lymphoma focused on measuring Follicular lymphoma, Rituximab, maintenance treatment
Eligibility Criteria
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
Sites / Locations
- Ruijin HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
BR+R
RCHOP+R
R2+R2
Arm Description
Induction Therapy: Rituximab Combined With Bendamustine Maintenance Treatment: Rituximab
Induction Therapy: Rituximab Combined With Cyclophosphamide, Vincristine, Doxorubicin, Prednisone Maintenance Treatment: Rituximab
Induction Therapy: Lenalidomide Combined With Rituximab Maintenance Treatment: Lenalidomide Combined With Rituximab
Outcomes
Primary Outcome Measures
MRD negative rate of bone marrow at 24 weeks
Percentage of participants with negative MRD estimated by q-RT-PCR of bone marrow
Secondary Outcome Measures
Overall response rate
Percentage of participants with overall response was determined on the basis of investigator assessments according to 2014 Lugano criteria
Overall survival
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.
Progression of disease within 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.
Event-free survival
Event-free survival was defined as the time from the date of diagnosis until the date of the first documented day of events.
Time to Progression
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.
Duration of response
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
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
Progression Free Survival
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.
Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE v4.0
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
Percentage of participants with negative MRD estimated by q-RT-PCR of peripheral blood
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04842318
Brief Title
Rituximab Maintenance Treatment of Newly Diagnosed Follicular Lymphoma After BR or RCHOP or R2: a Multicenter Clinical Study
Official Title
Rituximab Maintenance Treatment of Newly Diagnosed Follicular Lymphoma After Induction Therapy of Rituximab Combined With Bendamustine (BR) or Cyclophosphamide, Vincristine, Doxorubicin, Prednisone (RCHOP) or Lenalidomide (R2): a Multicenter Clinical Study
Study Type
Interventional
2. Study Status
Record Verification Date
April 2021
Overall Recruitment Status
Recruiting
Study Start Date
March 1, 2021 (Actual)
Primary Completion Date
March 1, 2023 (Anticipated)
Study Completion Date
March 1, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ruijin Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Follicular Lymphoma
Keywords
Follicular lymphoma, Rituximab, maintenance treatment
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
789 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
BR+R
Arm Type
Experimental
Arm Description
Induction Therapy: Rituximab Combined With Bendamustine Maintenance Treatment: Rituximab
Arm Title
RCHOP+R
Arm Type
Experimental
Arm Description
Induction Therapy: Rituximab Combined With Cyclophosphamide, Vincristine, Doxorubicin, Prednisone Maintenance Treatment: Rituximab
Arm Title
R2+R2
Arm Type
Experimental
Arm Description
Induction Therapy: Lenalidomide Combined With Rituximab Maintenance Treatment: Lenalidomide Combined With Rituximab
Intervention Type
Drug
Intervention Name(s)
BR for 6 cycles +R for 8 cycles
Intervention Description
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)
Intervention Type
Drug
Intervention Name(s)
RCHOP for 6 cycles +R for 8 cycles
Intervention Description
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)
Intervention Type
Drug
Intervention Name(s)
R2 for 6 cycles + R2 maintenance
Intervention Description
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)
Primary Outcome Measure Information:
Title
MRD negative rate of bone marrow at 24 weeks
Description
Percentage of participants with negative MRD estimated by q-RT-PCR of bone marrow
Time Frame
At 24 weeks
Secondary Outcome Measure Information:
Title
Overall response rate
Description
Percentage of participants with overall response was determined on the basis of investigator assessments according to 2014 Lugano criteria
Time Frame
21 days after 6 cycles of induction therapy (each cycle is 21 days)
Title
Overall survival
Description
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 Frame
Baseline up to data cut-off (up to approximately 4 years)
Title
Progression of disease within 24 months
Description
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.
Time Frame
Baseline up to data cut-off (24 months)
Title
Event-free survival
Description
Event-free survival was defined as the time from the date of diagnosis until the date of the first documented day of events.
Time Frame
Baseline up to data cut-off (up to approximately 4 years)
Title
Time to Progression
Description
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.
Time Frame
Baseline up to data cut-off (up to approximately 4 years)
Title
Duration of response
Description
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 Frame
Baseline up to data cut-off (up to approximately 4 years)
Title
Time to Next Anti-lymphoma Treatment
Description
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
Time Frame
Baseline up to data cut-off (up to approximately 4 years)
Title
Progression Free Survival
Description
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.
Time Frame
Baseline up to data cut-off (up to approximately 4 years)
Title
Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE v4.0
Description
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
Time Frame
Up to 30 days after completion of study treatment
Title
MRD negative rate of peripheral blood at 24 weeks
Description
Percentage of participants with negative MRD estimated by q-RT-PCR of peripheral blood
Time Frame
At 24 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Weili Zhao, PhD, MD
Phone
+862164370045
Email
zwl_trial@163.com
First Name & Middle Initial & Last Name or Official Title & Degree
Pengpeng Xu, PhD, MD
Phone
+862164370045
Email
pengpeng_xu@126.com
Facility Information:
Facility Name
Ruijin Hospital
City
Shanghai
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Weili Zhao
Phone
+862164370045
Email
zwl_trial@163.com
First Name & Middle Initial & Last Name & Degree
Weili Zhao
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Rituximab Maintenance Treatment of Newly Diagnosed Follicular Lymphoma After BR or RCHOP or R2: a Multicenter Clinical Study
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