Orelabrutinib Combined With Pemetrexed For Relapsed/Refractory Central Nervous System Lymphoma

Launched by HENAN CANCER HOSPITAL · Jan 22, 2022

Keywords

ClinConnect Summary

This clinical trial is studying the combination of two medications, orelabrutinib and pemetrexed, to see how well they work together in treating patients with relapsed or refractory central nervous system lymphoma, a type of cancer that affects the brain and spinal cord. The trial is currently looking for participants aged 18 to 75 years who have been diagnosed with a specific type of lymphoma called diffuse large B-cell lymphoma. To be eligible, participants must have measurable cancer lesions and a life expectancy of at least one month. Additionally, they should have good overall health and organ function.

If you decide to participate, you will receive the study medications and be monitored closely for their effects. Participants will need to agree to follow certain safety guidelines, such as taking pregnancy tests if they are women of childbearing age. This trial is important because it aims to find a new treatment option for patients whose cancer has not responded to previous therapies. Overall, the goal is to improve outcomes for individuals with this challenging condition.

Gender

ALL

Eligibility 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