Follicular Lymphoma
Conditions
Interventions
Group1:Involved-site radiotherapy (ISRT) to PET-CT–defined residual disease: 3 Gy × 4 fractions (total dose, 12 Gy), followed by standard anti-CD20 maintenance
Sponsors
Cancer Hospital, Chinese Academy of Medical Sciences (CAMS) / Peking Union Medical College (PUMC)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Age and informed consent Age >=18 years; After being fully informed of the study purpose, procedures, and potential risks, voluntarily signs a written informed consent form and is able to comply with all protocol requirements. 2. Diagnosis and staging Histologically confirmed follicular lymphoma (WHO 2022, grades 1–3A); PET–CT staging shows Ann Arbor stage III–IV (see Appendix 5), or stage II with bulky disease (longest diameter >=5 cm). 3. Prior therapy and current disease status Has received only one line of standard first-line immunochemotherapy (R/G-CHOP, R/G-CVP, R/G-bendamustine, R^2, etc.) for 6 +/- 2 cycles, with no prior radiotherapy, other targeted/cellular therapy, or other systemic anti-tumor therapy; Within 4–12 weeks after completion of induction, centrally blinded PET–CT assessment shows partial response (PR; Deauville score 4–5); Residual metabolically active lesions =24 weeks; ECOG performance status 0–2 (see Appendix 6). 5. Maintenance plan Planned anti-CD20 maintenance therapy, or—if already initiated—enrollment within 1 month after the first cycle of maintenance.
Exclusion criteria
Exclusion criteria: A candidate will be excluded if any of the following apply: 1. Persistent bone marrow involvement after induction therapy. 2. Prior radiotherapy to any site planned for irradiation in this study. 3. Inability to tolerate radiotherapy, including: ANC < 1.0 × 10^9/L or platelets < 50 × 10^9/L without expectation of short-term recovery; For the predominant residual lesion, the dosimetric/OAR constraints required by this study cannot be met, or comorbidities (e.g., severe interstitial pulmonary fibrosis) are expected to confer life-threatening toxicity with radiotherapy; Any uncontrolled skin infection, open wound, or severe chronic ulcer within the intended radiation field; Any other circumstance, in the radiation oncologist’s judgment, that precludes safe radiotherapy. 4. History of hypersensitivity to rituximab or obinutuzumab, or any other condition (per the medical oncologist’s assessment) that precludes CD20-directed maintenance therapy. 5. History of another malignancy, except for completely excised carcinoma in situ or completely resected early-stage thyroid cancer. 6. Pregnant or breastfeeding women, or women planning pregnancy during the study period. 7. Serious psychiatric, neurologic, or social factors that, in the investigator’s judgment, would prevent completion of imaging follow-up, e-PRO reporting, or the radiotherapy process.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 12-month complete response rate (CR12) by IRC on PET-CT; | — |
Secondary
| Measure | Time frame |
|---|---|
| 12-month CR (CR12), investigator-assessed (PET-CT);24-month CR (CR24) by PET-CT;Best overall response;Progression-free survival;Overall survival;Local control rate; | — |
Countries
China
Contacts
Public ContactShunan Qi
Cancer Hospital, Chinese Academy of Medical Sciences (CAMS) / Peking Union Medical College (PUMC)
Outcome results
None listed