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Clinical Trials in China / NCT06704555
Recruiting Phase 2

Radiotherapy Followed by Tiselizumab Combined With RCHOP in Previously Untreated Bulky Follicular Lymphoma

NCT06704555 · tracked via the Priya Life Science China tracker
Sponsor
Tianjin Medical University Cancer Institute and Hospital
Phase
Phase 2
Started
2024-12-20
Last updated
2024-11-26

Condition(s) studied

Follicular Lymphoma

Investigational drug(s) / intervention(s)

radiation therapyTiselizumabRituximabCyclophosphamideDoxorubicinVincristinePrednisone

radiation therapy: received radiation (dose:18~24Gy)

Tiselizumab: 200 mg iv day 1

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

Prednisone: 100 mg oral days 3-7

Study summary

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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
70 Years
Healthy volunteers
No
Inclusion Criteria: * Histologically confirmed CD20 positive (+) follicular lymphoma, grade 1, 2, or 3a,bulky disease (Mass diameter ≥ 7 cm) * Have had no prior systemic treatment for lymphoma * Meeting Groupe d'Etude des Lymphomes Folliculaires (GELF) criteria for initiation of treatment * Age 18-75 years * ECOG Performance Status of 0-2 .Stage II, III, or IV by Ann Arbor staging system. * Demonstrate adequate organ function as defined below; all screening labs to be obtained within 28 days prior to registration. 1. Hematological: WBC≥3.5×109/L, Platelets ≥ 75×109/L,Absolute Neutrophil Count (ANC) ≥ 1.0×109/L,Hemoglobin (Hgb) ≥ 80 g/L 2. Renal: Calculated creatinine clearance ≥ 50 mL/min 3. Hepatic: Bilirubin ≤ 1.5 × upper limit of normal (ULN), AST/ALT ≤ 2.5×ULN * Females of childbearing potential must be willing to abstain from vaginal intercourse or use an effective method(s) of contraception from the time of informed consent, during the study and for 6 months after the last dose of study drug(s). Males able to father a child must be willing to abstain * Life expectancy ≥6 months * Sign (or their legally-acceptable representatives must sign) an informed consent document indicating that they understand the purpose of and procedures required for the study, including biomarkers, and are willing to participate in the study Exclusion Criteria: * Known active central nervous system lymphoma or leptomeningeal disease, * Evidence of diffuse large B-cell transformation * Grade 3b FL * Concurrent malignancy or malignancy within the last 3 years (except for ductal breast cancer in situ, non-melanoma skin cancer, prostate cancer not requiring treatment, and cervical carcinoma in situ) whose natural history or treatment has the potential to interfere with the safety or efficacy assessment of the investigational regimen are not eligible for this trial * Known history of human immunodeficiency virus (HIV), or active hepatitis C Virus, or active hepatitis B Virus infection, or any uncontrolled active significant infection, including suspected or confirmed John Cunningham (JC) virus infection,any class 3 (moderate) or class 4 (severe) cardiac disease as defined by the New York Heart Association functional classification. Or left ventricular ejection fraction \<50%; * Known history of human immunodeficiency virus (HIV), or active hepatitis C Virus, or active hepatitis B Virus infection, or any uncontrolled active significant infection * Known pneumonia associated with idiopathic pulmonary fibrosis, machine (for example, occlusive bronchiolitis), history of drug induced pneumonia, or screening during the chest computed tomography (CT) showed active pneumonia * Have serious neurological or psychiatric history, can't normal study, including dementia, epilepsy, severe depression and mania * Patients who were deemed by the investigator to be ineligible for enrollment

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Tianjin Cancer Hospital Tianjin Tianjin Municipality Recruiting

On this site

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06704555 on ClinicalTrials.gov ↗ ← All trials in China