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

Sponsor
The First Affiliated Hospital of Xiamen University
Study ID
NCT06651853
Phase
PHASE2
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Large fraction radiotherapy in combined with GM-CSF, Lenalidomide, and Glofitamab — DRUG
    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.

Study Details

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

Key Dates

Start date
Oct 21, 2024
Status verified
Jul 2025
Primary completion
Dec 31, 2027
Completion
Jul 30, 2028

Study Design

Enrollment
22 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment arm
    Large fraction radiation therapy plus GM-CSF, Lenalidomide, and Glofitamab

Primary Outcome Measure

CR [ Time Frame: Up to 36 months ]

Central Contacts

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