Combining orelabrutinib and pemetrexed for treating relapsed central nervous system lymphoma
A Single Arm, Phase II Clinical Trial of Orelabrutinib Combined With Pemetrexed in the Treatment for Patients With Relapsed/Refractory Central Nervous System Lymphoma
This study is testing if combining orelabrutinib with pemetrexed can help people with relapsed 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 75 Years |
| Sex | All |
| Sponsor | Henan Cancer Hospital Government |
| Drugs / interventions | orelabrutinib |
| Locations | 1 site (Zhengzhou, Henan) |
| Trial ID | NCT05209620 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 to 75 with a diagnosis of diffuse large B-cell lymphoma and measurable lesions.
Not a fit: Patients with poor peripheral disease control or those who do not meet the inclusion criteria may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could offer a new therapeutic option for patients with relapsed or refractory central nervous system lymphoma.
How similar studies have performed: While this approach is novel in the context of central nervous system lymphoma, similar studies involving BTK inhibitors have shown promise in other hematological malignancies.
Eligibility criteria
Show full inclusion / exclusion criteria
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 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.