Orelabrutinib Combined With Pemetrexed For Relapsed/Refractory Central Nervous System Lymphoma
Recruiting now · Phase 2
Conditions studied: Central Nervous System Lymphoma
In brief
This is a prospective single arm, phase II clinical trial to observe the efficacy and safety of orelabrutinib combined with pemetrexed in the treatment for patients with relapsed/refractory central nervous system lymphoma.
Key facts
- Study ID
- NCT05209620
- Run by
- Henan Cancer Hospital
- People needed
- 30
- Starts
- 2021-12-21
- Expected to finish
- 2026-12-21
- Last updated by the study team
- 2025-04-23
Who can join
Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Age between 18 to 75 years old (including 18 and 75)
- 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
- Having at least one measurable lesions
- 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)
- Life expectancy no less than 1 month
- enough main organ function
- 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
- Agreeing to sign the written informed consents
You may not qualify if…
- Poor peripheral disease control of secondary central nervous system lymphoma
- Patients used pemetrexed or orelabrutinib in the past
- Active malignant tumor need be treated at the same time
- Other malignant tumor history
- Serious surgery and trauma less than two weeks
- Patients with active tuberculosis
- Systemic therapy for serious acute/chronic infection
- Congestive heart failure, uncontrolled coronary heart disease, arrhythmia and heart infarction less than 6 months
- HIV-positive, AIDS patients and untreated active hepatitis
- Patients with a history of deep vein thrombosis or pulmonary embolism less than 12 months
- Patients with a history of mental illness or drug abuse
- Poor compliance during the trial and/or follow-up phase
- Allergies or people who are known to be allergic to any active ingredients, excipients, mouse-derived products or heterologous protein contained in this trial
- Researchers determine unsuited to participate in this trial
Where it is running
- Henan Cancer Hospital/The affiliated Cancer Hospital of ZhengZhou university — Zhengzhou, Henan, China (enrolling)
Full record on ClinicalTrials.gov
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