Combination treatment 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
This study is testing a new combination of medications to see if it can help people with primary central nervous system lymphoma feel better and improve their treatment outcomes.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | Henan Cancer Hospital Government |
| Drugs / interventions | Rituximab, Methotrexate |
| Locations | 1 site (Zhengzhou, Henan) |
| Trial ID | NCT04737889 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the efficacy and safety of a combination therapy involving Rituximab, Lenalidomide, high-dose Methotrexate, and Temozolomide for patients diagnosed with primary central nervous system lymphoma. It is a prospective, single-arm, multi-center phase II trial aimed at first-line treatment for this specific type of lymphoma. Participants will be monitored for treatment outcomes and side effects to determine the effectiveness of this regimen.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 70 with a confirmed diagnosis of primary central nervous system lymphoma who have not received prior anti-tumor therapy.
Not a fit: Patients with extensive disease involvement outside the central nervous system or those who have previously undergone anti-tumor therapy may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a new effective option for patients with primary central nervous system lymphoma.
How similar studies have performed: While this approach is being tested in this specific context, similar combination therapies have shown promise in treating other types of lymphomas, indicating potential for success.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Zhengzhou, Henan
- Henan Cancer Hospital/The affiliated Cancer Hospital of ZhengZhou university — Zhengzhou, Henan, China (Recruiting)
Study contacts
- Study coordinator: Zhihua Yao, M.D. Ph.D
- Email: zlyyyaozhihua1260@zzu.edu.cn
- Phone: +8613592622292
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.