This was a single center, single arm, phase II study. Patients with previously untreated follicular lymphoma were enrolled from the department of lymphoma, Tianjin Medical University Cancer Institute and Hospital. The bulky disease was received radiation (dose:18~24Gy) before RCHOP. Patients began chemoimmunotherapy 1~2 weeks later than radiation. Treatment included Tiselizumab (200 mg iv d1) plus R-CHOP (rituximab 375 mg/m2 intravenous \[IV\] day 2, cyclophosphamide 750 mg/m2 IV day 3, doxorubicin 50 mg/m2 IV day 3, vincristine 1.4 mg/m2 \[maximum 2.0 mg total\] IV day 3, and prednisone 100 mg oral days 3-7, 21~28 days for one cycle ) for six cycles. Rituximab was given every 2 months to patients who were complete metabolic response /partial metabolic response(CMR/PMR)after first-line chemo until 2 years. Response was assessed by PET/CT scan after cycle 4 and cycle 6.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
20
received radiation (dose:18~24Gy)
200 mg iv day 1
375 mg/m2 intravenous \[IV\] day 2
750 mg/m2 IV day 3
50 mg/m2 IV day 3
1.4 mg/m2 \[maximum 2.0 mg total\] IV day 3
100 mg oral days 3-7
Tianjin Cancer Hospital
Tianjin, Tianjin Municipality, China
RECRUITINGBest Complete response (CR) rate
Percentage of participants with complete response was determined on the basis of investigator assessments according to 2014 Lugano criteria
Time frame: Through completion of treatment (estimated to be 2.5 year)
Best overall response rate (ORR)
Objective Response rate will be determined on the basis of investigator assessments according to 2014 Lugano criteria.
Time frame: Through completion of treatment (estimated to be 2.5 year)
2 year progression-free survival
The date of enrollment until disease progression or death from any cause.
Time frame: From date of patients sign informed consent until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 2 years
Percentage of Participants With Adverse Events
Adverse Events will be determined and graded on the basis of investigator assessments according to NCI CTC AE 5.0
Time frame: Up to 30 days after completion of study treatment
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