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

Launched by HENAN CANCER HOSPITAL · Jan 30, 2021

Keywords

ClinConnect Summary

This clinical trial is studying a combination treatment for patients with primary central nervous system lymphoma, which is a type of cancer that affects the brain and spinal cord. The treatment being tested uses four medications: Rituximab, Lenalidomide, high-dose Methotrexate, and Temozolomide. Researchers want to see how well this combination works and how safe it is for patients who have not received prior cancer treatments. The trial is currently recruiting participants who are between 18 and 70 years old and have been diagnosed specifically with this type of lymphoma.

To be eligible for the trial, participants need to have at least one measurable tumor and must not have any other serious health issues that could interfere with the study. They also need to agree to follow specific guidelines, such as using birth control if they are women of childbearing age. Those who join the trial can expect regular monitoring and support throughout their treatment. It’s important to note that patients with certain medical conditions or a history of other cancers might not be able to participate. Overall, this study aims to find a potentially effective treatment option for a challenging condition.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Age between 18 to 70 years old (including 18 and 70)
• • 2. Diagnosed as primary central nervous system lymphoma (limited to the brain, spinal cord, meninges and eyeballs, without involvement of other parts)
• • 3. 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)
• • 4. Having at least one measurable lesions
• • 5. 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)
• • 6. Life expectancy no less than 1 month
• • 7. enough main organ function
• • 8. 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
• • 9. Agreeing to sign the written informed consents
• Exclusion Criteria:
• • 1. Diagnosed as secondary central nervous system lymphoma
• • 2. Diagnosed as CD20 negative large B cell primary central nervous system lymphoma
• • 3. Active malignant tumor need be treated at the same time
• • 4. Other malignant tumor history
• • 5. Serious surgery and trauma less than two weeks
• • 6. Patients with active tuberculosis
• • 7. Systemic therapy for serious acute/chronic infection
• • 8. Congestive heart failure, uncontrolled coronary heart disease, arrhythmia and heart infarction less than 6 months
• • 9. HIV-positive, AIDS patients and untreated active hepatitis
• • 10. Patients with a history of deep vein thrombosis or pulmonary embolism less than 12 months
• • 11. Patients with a history of mental illness or drug abuse
• • 12. Poor compliance during the trial and/or follow-up phase
• • 13. Allergies or people who are known to be allergic to any active ingredients, excipients, mouse-derived products or heterologous protein contained in this trial
• • 14. Researchers determine unsuited to participate in this trial