Combination treatment for primary central nervous system lymphoma

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Testing a four-drug regimen (methotrexate, rituximab, sintilimab, pirtobrutinib) versus investigator-selected care for newly diagnosed PCNSL

  This trial will try a combination of methotrexate, rituximab, sintilimab and pirtobrutinib as first treatment for adults with newly diagnosed primary central nervous system lymphoma to see if it increases complete remissions and is safe compared with standard doctor-selected treatments.

  Recruiting at 3 sites Phase 2 Tongji Hospital · Xiamen, Fujian and 3 other locations · NCT07350850

• Orelabrutinib Combined With Teniposide, Rituximab and Methotrexate for Newly Diagnosed PCNSL

  In this study, adults with newly diagnosed primary CNS lymphoma try different induction regimens to see which one works best before consolidation therapy.

  Recruiting at 9 sites Phase 2/3 Huashan Hospital · Beijing and 14 other locations · NCT07185373

• Using RMTT regimen as first-line therapy for primary central nervous system lymphoma

  This study is testing if a new combination treatment called RMTT can help people with primary central nervous system lymphoma who haven't had treatment before.

  Recruiting Zhejiang Cancer Hospital · Hangzhou, Zhejiang · NCT06832267

• Combination treatment for newly diagnosed primary central nervous system lymphoma

  This study is testing a new combination of treatments for people with newly diagnosed primary central nervous system lymphoma to see if it helps them respond better and live longer.

  Recruiting Phase 2 Second Affiliated Hospital, Zhejiang University, School of Medicine · Hanzhou, Zhejiang · NCT05600660

• R-PMDT Regimen for Newly Diagnosed PCNSL

  This study tests the R-PMDT treatment approach in people newly diagnosed with primary CNS lymphoma to see how many respond.

  Recruiting Phase 2 Institute of Hematology & Blood Diseases Hospital, China · Tianjin · NCT07604987

• PD‑1 blocker with rituximab, high‑dose methotrexate, and orelabrutinib for newly diagnosed primary or secondary CNS lymphoma

  This trial will test whether combining a PD‑1 blocker with rituximab, high‑dose methotrexate, and orelabrutinib helps people with newly diagnosed primary or secondary central nervous system diffuse large B‑cell lymphoma.

  Recruiting Phase 2 The First Affiliated Hospital with Nanjing Medical University · Nanjing, Jiangsu · NCT07410520

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.