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Orelabrutinib Combined With Pemetrexed For Relapsed/Refractory Central Nervous System Lymphoma | Clinical Trials | Clareo Health

RECRUITINGPHASE2

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

NCT05209620•Henan Cancer Hospital

View on ClinicalTrials.gov

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

Age

18 - 75 years

Sex

ALL

Healthy Volunteers

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
+4 more criteria

Locations (1)

Henan Cancer Hospital/The affiliated Cancer Hospital of ZhengZhou university

Zhengzhou, Henan, China

Key Dates

Start Date

December 21, 2021

Primary Completion Date

June 30, 2025

Completion Date

December 21, 2026

Last Updated

April 23, 2025

Enrollment

ESTIMATED participants

Conditions

Central Nervous System Lymphoma

Interventions

ICP-022

DRUG

Pemetrexed

DRUG

Contacts

Zhihua Yao, M.D. Ph.D

CONTACT

+8613592622292 zlyyyaozhihua1260@zzu.edu.cn

Yanyan Liu, M.D. Ph.D

CONTACT

+8613838176375 yyliu@zzu.edu.cn

Phase 1 Study of Ibrutinib and Immuno-Chemotherapy Using Temozolomide, Etoposide, Doxil, Dexamethasone, Ibrutinib,Rituximab (TEDDI-R) in Primary CNS Lymphoma

NCT02203526

Primary Central Nervous System Lymphoma

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RECRUITINGPHASE2

Thiotepa in Combination With Pirtobrutinib (a BTK Inhibitor) and Sintilimab (a PD-1 Inhibitor) for Frail or Relapsed/Refractory Primary or Secondary Central Nervous System Lymphoma

NCT07416890

PirtobrutinibSintilimab+1 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: April 23, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

Phase 1 Study of Ibrutinib and Immuno-Chemotherapy Using Temozolomide, Etoposide, Doxil, Dexamethasone, Ibrutinib,Rituximab (TEDDI-R) in Primary CNS Lymphoma

Thiotepa in Combination With Pirtobrutinib (a BTK Inhibitor) and Sintilimab (a PD-1 Inhibitor) for Frail or Relapsed/Refractory Primary or Secondary Central Nervous System Lymphoma

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