NCT06651853

Large Fraction Radiation Therapy Combined With Lenalidomide, and Glofitamab in Refractory Relapsed DLBCL

The Efficacy and Safety of Large Fraction Radiation Therapy Combined With Lenalidomide, and Glofitamab Monoclonal Antibody in the Treatment of Refractory Relapsed Diffuse Large B-cell Lymphoma Patients

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 22 (estimated)
• Sponsor: The First Affiliated Hospital of Xiamen University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

To prospectively evaluate the efficacy and safety of large fraction radiation therapy combined with granulocyte-macrophage colony-stimulating factor, lenalidomide, and glofitamab monoclonal antibody in the treatment of refractory relapsed diffuse large B-cell lymphoma patients

Conditions

• Diffuse Large B-cell Lymphoma
• Relapsed and Refractory

Interventions

Type	Name	Description
DRUG	Large fraction radiotherapy in combined with GM-CSF, Lenalidomide, and Glofitamab	Large fraction radiotherapy is administered at 5Gy/day for 3 days, with one to two courses carried out on a single target lesion as determined by the investigator. Granulocyte-macrophage colony-stimulating factor (GM-CSF) is administered at 400µg per day for 3 days starting on the first day after the end of radiotherapy. Lenalidomide is administered at 25mg per day for 14 days starting on the first day after the end of radiotherapy. Glofitamab is administered starting on the 7th day after the end of radiotherapy. For cycles 2-6, each cycle is 21 days. GM-CSF is administered at 400µg per day for 3 days starting on the first day of each cycle. Glofitamab is administered at 30mg on the 4th day of each cycle. Lenalidomide is administered at 25mg per day for 14 days starting on the first day. Treatment consists of 6 cycles or until disease progression, death, intolerable toxicity, withdrawal of informed consent.

Timeline

• Start date: 2024-10-21
• Primary completion: 2027-12-31
• Completion: 2028-07-30
• First posted: 2024-10-22
• Last updated: 2025-07-23

Locations

1 site across 1 country: China