RecruitingPhase 2NCT05209620

Orelabrutinib Combined With Pemetrexed For Relapsed/Refractory 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


Sponsor

Henan Cancer Hospital

Enrollment

30 participants

Start Date

Dec 21, 2021

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a combination of two drugs — orelabrutinib (a targeted therapy) and pemetrexed (a chemotherapy) — for people whose large B-cell lymphoma has come back in or spread to the brain or central nervous system. This type of cancer in the brain is very difficult to treat, and new options are needed. **You may be eligible if...** - You are 18–75 years old - You have been diagnosed with diffuse large B-cell lymphoma that has recurred in the central nervous system (brain/spinal area) - You have at least one measurable tumor - You are in reasonable physical condition (ECOG score of 0–2) - You have adequate organ function **You may NOT be eligible if...** - You have previously been treated with pemetrexed or orelabrutinib - You have another active cancer requiring treatment - You have had a serious infection (like tuberculosis or active hepatitis) or active HIV/AIDS - You have had a blood clot (deep vein thrombosis or pulmonary embolism) in the past 12 months - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGICP-022

Induction Chemotherapy: Orelabrutinib, 150mg/d continuous oral administration (3 weeks/cycle, total 6 cycles). Maintenance Treatment: Orelabrutinib, 150mg/d continuous oral administration (28d/cycle).

DRUGPemetrexed

Induction Chemotherapy: Pemetrexed, 500mg/m2, Intravenous administration on day 5 of each 3-week cycle (Total 6 cycles).


Locations(1)

Henan Cancer Hospital/The affiliated Cancer Hospital of ZhengZhou university

Zhengzhou, Henan, China

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NCT05209620


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