Radiation and Tiselizumab with RCHOP for Bulky Follicular Lymphoma
A Study of the Radiotherapy Followed by Tiselizumab Combined With RCHOP in the Frontline Treatment of Follicular Lymphoma Patients With Bulky Disease
This study is testing if adding radiation to a combination of Tiselizumab and R-CHOP chemotherapy can help people with bulky follicular lymphoma feel better and improve their treatment results.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | Tianjin Medical University Cancer Institute and Hospital Academic / other |
| Drugs / interventions | Tiselizumab, rituximab, radiation, cyclophosphamide, doxorubicin, prednisone |
| Locations | 1 site (Tianjin, Tianjin Municipality) |
| Trial ID | NCT06704555 on ClinicalTrials.gov |
What this trial studies
This phase II clinical trial investigates the effectiveness of combining radiation therapy with Tiselizumab and R-CHOP chemotherapy in patients with previously untreated bulky follicular lymphoma. Patients receive radiation therapy followed by a regimen of Tiselizumab and R-CHOP, with treatment response assessed through PET/CT scans after specific cycles. The study aims to evaluate the safety and efficacy of this combined approach in improving patient outcomes.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-75 with histologically confirmed CD20 positive bulky follicular lymphoma who have not received prior systemic treatment.
Not a fit: Patients with non-bulky follicular lymphoma or those who have received prior treatment for lymphoma may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a more effective option for patients with bulky follicular lymphoma, potentially leading to better response rates and improved survival.
How similar studies have performed: While this approach is innovative, similar studies combining radiation with immunotherapy and chemotherapy have shown promise in other lymphoma types, suggesting potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Tianjin, Tianjin Municipality
- Tianjin Cancer Hospital — Tianjin, Tianjin Municipality, China (Recruiting)
Study contacts
- Study coordinator: Huilai Zhang, MD,PhD
- Email: 18526812877@163.com
- Phone: 02223359337
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.