RecruitingPhase 2NCT06651853

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


Sponsor

The First Affiliated Hospital of Xiamen University

Enrollment

22 participants

Start Date

Oct 21, 2024

Study Type

INTERVENTIONAL

Conditions

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


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a combination of high-dose targeted radiation (given in fewer, larger doses), plus two cancer drugs — lenalidomide (an immune-boosting pill) and glofitamab (a type of immunotherapy) — for people with a type of aggressive blood cancer called diffuse large B-cell lymphoma (DLBCL) that has come back or stopped responding to treatment. **You may be eligible if...** - You are 18 or older with a confirmed diagnosis of DLBCL - Your cancer has relapsed or did not respond to at least one prior treatment - You have not previously received a type of drug called a bispecific antibody - You are reasonably active and expected to live more than 3 months - Your heart, liver, and kidney function are within acceptable ranges **You may NOT be eligible if...** - You have previously received bispecific antibody therapy - Your cancer has spread to the brain in a way that cannot be treated - Your overall health or organ function is too poor to tolerate treatment - You have certain other serious medical conditions Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGLarge 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.


Locations(1)

The First Affiliated Hospital of Xiamen University

Xiamen, Fujian, China

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NCT06651853


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