Tianjin Cancer Hospital
Tianjin, Tianjin Municipality, 300060, China
Location status: Recruiting
NCT Number: NCT06704555
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.
Interested in participating?
Request Info18 year–70 year
All sexes
Interventional
Phase 2
Tianjin, Tianjin Municipality, 300060, China
Location status: Recruiting
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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
Time frame: Through completion of treatment (estimated to be 2.5 year)
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)
Objective Response rate will be determined on the basis of investigator assessments according to 2014 Lugano criteria.
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
The date of enrollment until disease progression or death from any cause.
Time frame: Up to 30 days after completion of study treatment
Adverse Events will be determined and graded on the basis of investigator assessments according to NCI CTC AE 5.0
Contact information is provided by the study sponsor or research team.
Tianjin Medical University Cancer Institute and Hospital
Other
A Study of the Radiotherapy Followed by Tiselizumab Combined With RCHOP in the Frontline Treatment of Follicular Lymphoma Patients With Bulky Disease
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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