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

Recruiting now · Phase 2

Conditions studied: Primary Central Nervous System Lymphoma

In brief

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.

Key facts

Study ID

NCT04737889

Run by

Henan Cancer Hospital

People needed

30

Starts

2021-01-13

Expected to finish

2026-01-13

Last updated by the study team

2025-04-23

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age between 18 to 70 years old (including 18 and 70)
• Diagnosed as primary central nervous system lymphoma (limited to the brain, spinal cord, meninges and eyeballs, without involvement of other parts)
• Having not received anti-tumor therapy before enrollment (except for tumor resection and biopsy and the use of glucocorticoids to reduce central nervous system symptoms)
• Having at least one measurable lesions
• World health organization-Eastern Cooperative Oncology Group Performance Status (ECOG) 0-2 ( ECOG 3 due to tumors can be included after being fully assessed by the investigator)
• Life expectancy no less than 1 month
• enough main organ function
• Pregnancy test within 7 days must be negative for women of childbearing period, and appropriate measures should be taken for contraception for women in childbearing period during the study and six months after this study
• Agreeing to sign the written informed consents

You may not qualify if…

• Diagnosed as secondary central nervous system lymphoma
• Diagnosed as CD20 negative large B cell primary central nervous system lymphoma
• Active malignant tumor need be treated at the same time
• Other malignant tumor history
• Serious surgery and trauma less than two weeks
• Patients with active tuberculosis
• Systemic therapy for serious acute/chronic infection
• Congestive heart failure, uncontrolled coronary heart disease, arrhythmia and heart infarction less than 6 months
• HIV-positive, AIDS patients and untreated active hepatitis
• Patients with a history of deep vein thrombosis or pulmonary embolism less than 12 months
• Patients with a history of mental illness or drug abuse
• Poor compliance during the trial and/or follow-up phase
• Allergies or people who are known to be allergic to any active ingredients, excipients, mouse-derived products or heterologous protein contained in this trial
• Researchers determine unsuited to participate in this trial

Where it is running

• Henan Cancer Hospital/The affiliated Cancer Hospital of ZhengZhou university — Zhengzhou, Henan, China (enrolling)

Full record on ClinicalTrials.gov

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