RecruitingPhase 2NCT04737889

Rituximab, Lenalidomide Combined With Methotrexate and Temozolomide For Primary Central Nervous System Lymphoma

A Single Arm, Multi-center, Phase II Clinical Trial of Rituximab, Lenalidomide Combined With High-dose Methotrexate and Temozolomide (RL-MT) in the First-line Treatment for Patients With Primary Central Nervous System Lymphoma

Sponsor

Henan Cancer Hospital

Enrollment

30 participants

Start Date

Jan 13, 2021

Study Type

INTERVENTIONAL

Conditions

Primary Central Nervous System Lymphoma

Summary

This is a prospective single arm, multi-center, phase II clinical trial to observe the efficacy and safety of Rituximab, Lenalidomide combined with high-dose Methotrexate and Temozolomide (RL-MT) in the first-line treatment for patients with primary central nervous system lymphoma.

Eligibility

Min Age: 18 YearsMax Age: 70 Years

Plain Language Summary

Simplified for easier understanding

This study tests a new combination chemotherapy regimen — rituximab, lenalidomide, methotrexate, and temozolomide — for people with primary central nervous system lymphoma (PCNSL), a rare cancer that affects the brain, spinal cord, or eyes. **You may be eligible if...** - You are between 18 and 70 years old - You have a new diagnosis of primary CNS lymphoma (limited to the brain, spinal cord, lining of the brain, or eyes — no spread elsewhere) - You have not received any prior anti-cancer treatment (except surgery, biopsy, or steroids to reduce brain swelling) - You have at least one measurable tumor on imaging - You are in reasonably good health (adequate organ function) **You may NOT be eligible if...** - Your lymphoma has spread outside the CNS - You have previously received chemotherapy or radiation for this lymphoma - You have significant kidney, liver, or heart problems - You are pregnant or breastfeeding 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

DRUGRituximab

Induction Chemotherapy: 375mg/m2, Intravenous administration on day 0 of each 3-week cycle until disease progression/stable disease or unacceptable toxicity develops, up to 6 cycles.

DRUGLenalidomide

Induction Chemotherapy: 25mg, oral administration on day 1 to 10 of each 3-week cycle until disease progression/stable disease or unacceptable toxicity develops, up to 6 cycles. Maintenance Treatment: 10mg oral administration on day 1 to 21 repeated every 4 weeks until disease progression or unacceptable toxicity develops, up to 12 cycles.

DRUGMethotrexate

Induction Chemotherapy: 3mg/m2, Intravenous administration (pumping for 3h) on day 1 of each 3-week cycle until disease progression/stable disease or unacceptable toxicity develops, up to 6 cycles.

DRUGTemozolomide

Induction Chemotherapy: 150mg/m2/d oral administration on day 1 to 10 of each 3-week cycle until disease progression/stable disease or unacceptable toxicity develops, up to 6 cycles.