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

NCT05209620 | Recruiting Phase 2 DMC

• 1 other identifier: HNSZLYYNHL06
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Central Nervous System Lymphoma

Keywords

Central Nervous System Lymphoma; BTK inhibitor; Relapsed and Refractory

Outcome Measures

Primary Outcomes (1)

• objective response rate

  the total proportion of patients with complete response (CR) and partial response (PR)

  every 6 weeks from the day of the first cycle of induction chemotherapy treatment (each cycle is 21 days) and every 8 weeks from the day of the first cycle of maintenance treatment to 5 years after last patient's enrollment (each cycle is 28 days)

Secondary Outcomes (3)

• progression-free survival

  every 6 weeks from the day of the first cycle of induction chemotherapy treatment (each cycle is 21 days) and every 8 weeks from the day of the first cycle of maintenance treatment to 5 years after last patient's enrollment (each cycle is 28 days)

• overall survival

  every 6 weeks from the day of the first cycle of induction chemotherapy treatment (each cycle is 21 days) and every 8 weeks from the day of the first cycle of maintenance treatment to 5 years after last patient's enrollment (each cycle is 28 days)

• The incidence of grade 3-4 adverse events

  up to 5 years

Study Arms (1)

Orelabrutinib Combined with Pemetrexed

EXPERIMENTAL

Induction Chemotherapy: Orelabrutinib, 150mg/d continuous oral administration, Pemetrexed, 500mg/m2, Intravenous administration on day 5 of each 3-week cycle (Total 6 cycles). Maintenance Treatment: Orelabrutinib, 150mg/d continuous oral administration (28d/cycle).

Drug: ICP-022; Drug: Pemetrexed

Interventions

ICP-022 DRUG

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

Also known as: orelabrutinib

Orelabrutinib Combined with Pemetrexed

Pemetrexed DRUG

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

Also known as: Pemetrexed injection

Orelabrutinib Combined with Pemetrexed

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Henan Cancer Hospital: lead

Study Sites (1)

Henan Cancer Hospital/The affiliated Cancer Hospital of ZhengZhou university

Zhengzhou, Henan, China

RECRUITING

MeSH Terms

Conditions

Recurrence

Interventions

orelabrutinib; Pemetrexed

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Guanine; Hypoxanthines; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Glutamates; Amino Acids, Acidic; Amino Acids; Amino Acids, Peptides, and Proteins; Amino Acids, Dicarboxylic

Study Officials

• Zhihua Yao, M.D. Ph.D

  Henan Cancer Hospital

  STUDY DIRECTOR

• Yanyan Liu, M.D. Ph.D

  Henan Cancer Hospital

  STUDY DIRECTOR

Central Study 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

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director

Study Record Dates

• First Submitted: December 26, 2021
• First Posted: January 26, 2022
• Study Start: December 21, 2021
• Primary Completion: June 30, 2025
• Study Completion (Estimated): December 21, 2026
• Last Updated: April 23, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)