Combining orelabrutinib and pemetrexed for treating relapsed 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 is a phase II, single-arm study designed to evaluate the efficacy and safety of orelabrutinib, a BTK inhibitor, in combination with pemetrexed for patients suffering from relapsed or refractory central nervous system lymphoma. Participants will be monitored for treatment response and safety outcomes, with a focus on those who have measurable lesions and meet specific health criteria. The study aims to provide insights into a potentially effective treatment option for this challenging condition.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Age between 18 to 75 years old (including 18 and 75)
2. Diagnosed as diffuse large B-cell lymphoma; Recurrence or progression of central nervous system disease confirmed by imaging ± tissue biopsy pathology or cerebrospinal fluid flow cytometry; Secondary central nervous system lymphoma can also be admitted when the systemic disease is well controlled
3. Having at least one measurable lesions
4. 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)
5. Life expectancy no less than 1 month
6. enough main organ function
7. 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
8. Agreeing to sign the written informed consents

Exclusion Criteria:

1. Poor peripheral disease control of secondary central nervous system lymphoma
2. Patients used pemetrexed or orelabrutinib in the past
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.

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• Orelabrutinib with Obinutuzumab and Short-Course Venetoclax in Treatment-Naïve Mantle Cell Lymphoma

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  Recruiting at 2 sites Phase 2 The First Affiliated Hospital with Nanjing Medical University · Changzhou, Jiangsu and 1 other locations · NCT07719556

• Orelabrutinib plus standard immunochemotherapy with or without auto-HSCT for newly diagnosed DLBCL

  This study tests whether adding orelabrutinib to standard chemotherapy, with or without autologous stem cell transplantation, helps newly diagnosed DLBCL patients.

  Recruiting Phase 2 The Affiliated Hospital of Xuzhou Medical University · Xuzhou, Jiangsu · NCT07680933

• High-dose dexamethasone plus orelabrutinib versus placebo for newly diagnosed adult ITP

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  Recruiting Phase 3 Shandong University · Jinan, Shandong · NCT07559331

• Ultra-low-dose radiation followed by orelabrutinib for early-stage MALT lymphoma

  This study will test whether a short course of very low-dose radiation followed by daily orelabrutinib helps adults with stage I–II MALT lymphoma keep their disease controlled with acceptable side effects.

  Recruiting at 2 sites Phase 2 Zhejiang Cancer Hospital · Hangzhou, Zhejiang and 1 other locations · NCT07554898

• Orelabrutinib for relapsed or refractory AIHA

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  Recruiting Phase 2 Peking Union Medical College Hospital · Beijing, Beijing Municipality · NCT07453368

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.