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UNKNOWNPHASE1/PHASE2

Orelabrutinib in Combination With Thiotepa in Refractory and Relapsed Primary CNS Lymphoma

Safety and Efficacy of Orelabrutinib（O） in Combination With Thiotepa（T） in Refractory and Relapsed Primary CNS Lymphoma： A Single-arm, Multicenter Phase Ib/II Study（OT）

NCT05021770•Huiqiang Huang

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Summary

The purpose of this study was to investigate the maximum tolerated dose and efficacy of Orelabrutinib combined with Thiotepa in refractory and relapsed primary central nervous system lymphoma (PCNSL).

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Men and woman who aged 18 or older on the day of consenting to the study.
•2. Participants must be able to understand and willing to sign a written informed consent document.
•3. ECOG performance status of 0 to 2.
•4. Histologically documented primary central nervous system(CNS) lymphoma.
•5. Participants should have evidence of 1 measurable or evaluable enhancing disease on MRI, PET-CT or PET-MRI.
•6. Relapsed or refractory disease with at least 1 prior HD-MTX-based therapy.
•7. Life expectancy of \> 3 months (in the opinion of the investigator).
•8. Any non-hematologic toxicity associated with prior treatment should be stable and recovered to ≤ Grade 1 (according to NCI CTCAE V5.0，except for alopecia)
•9. Demonstrate adequate organ function as defined below: (all screening labs should be performed within 14 days of treatment initiation)
•* Absolute neutrophil count (ANC) ≥ 1.0 x 10\^9/L, Platelets ≥ 75 x 10\^9/L，Hb ≥80 g/L;
+9 more criteria

Exclusion Criteria

•1. The pathological diagnosis was T-cell lymphoma.
•2. Prior therapy with a checkpoint inhibitor or BTK inhibitor.
•3. Participation in another clinical study with an investigational product during the 12 weeks prior to the first day of study treatment.
•4. Participants requires more than 5 mg of dexamethasone daily or the equivalent for control of primary CNS symptoms lasting for more than 5 days within 14 days.
•5. Active bleeding within 4 weeks prior to first administration, or ongoing use of anticoagulant/antiplatelet agents, or tendency to bleeding (e.g., esophageal varices at risk for bleeding, locally active ulcerative lesions) or coagulation disorder as considered by the investigator.
•6. Has an uncontrolled or significant cardiovascular disease, including (but not limited to) :
•* Any of the following conditions within 6 months prior to initial administration: congestive heart failure (NYHA class III or IV), myocardial infarction, unstable angina, or arrhythmia requiring treatment at the time of screening, left ventricular ejection fraction (LVEF) \<50%;
•* Primary or secondary cardiomyopathy (e.g., dilated cardiomyopathy, hypertrophic cardiomyopathy, arrhythmic right ventricular cardiomyopathy, restricted cardiomyopathy, undefined cardiomyopathy);
•* Clinical history of prolonged QTc phase, grade II type II atrioventricular block or grade III atrioventricular block or QTc interval (F method) \& GT;470 msec (female) or \>;480msec (male).
•* Hypertension, which is difficult to control, is not suitable for this study
+13 more criteria

Locations (1)

Department of Medical Oncology, Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, China

Key Dates

Start Date

December 1, 2021

Primary Completion Date

December 1, 2022

Completion Date

June 1, 2024

Last Updated

August 26, 2021

Enrollment

ESTIMATED participants

Conditions

Refractory and Relapsed Primary CNS LymphomaPCNSLNon Hodgkin Lymphoma

Interventions

Orelabrutinib

DRUG

Orelabrutinib

DRUG

Thiotepa

DRUG

Contacts

Huiqiang Huang, Professor

CONTACT

+86 020 87343350 huanghq@sysucc.org.cn

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Mantle Cell LymphomaNon Hodgkin Lymphoma+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: August 26, 2021Data 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 in Combination With Thiotepa in Refractory and Relapsed Primary CNS Lymphoma

Inclusion Criteria

Exclusion Criteria

Phase II Study of Pirtobrutinib With Venetoclax In Relapsed-Refractory MCL (Mantle Cell Lymphoma) Patients

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