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

Central Nervous System Lymphoma Clinical Trial

Official title:

A Single Arm, Phase II Clinical Trial of Orelabrutinib Combined With Pemetrexed in the Treatment for Patients With Relapsed/Refractory Central Nervous System Lymphoma

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05209620
• Other study ID #: HNSZLYYNHL06
• Status: Recruiting
• Phase: Phase 2
• Start date: December 21, 2021
• Est. completion date: December 21, 2026

Study information

• Verified date: May 2023
• Source: Henan Cancer Hospital
• Contact: Zhihua Yao, M.D. Ph.D
• Phone: +8613592622292
• Email: zlyyyaozhihua1260[@]zzu.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: December 21, 2026
• Est. primary completion date: December 21, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Central Nervous System Lymphoma
• Lymphoma

Intervention

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

Locations

Country	Name	City	State
China	Henan Cancer Hospital/The affiliated Cancer Hospital of ZhengZhou university	Zhengzhou	Henan

Sponsors (1)

Lead Sponsor	Collaborator
Henan Cancer Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	progression-free survival	the total proportion of patients with no progression from date of the first day of treatment to the date of confirmed progressive disease or death which one occurs first	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	overall survival	from date of first day of treatment to the date of death by any cause	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	The incidence of grade 3-4 adverse events	the incidence of grade 3 or 4 adverse events (based on NCI CTC-AE v5.0)	up to 5 years