Phase II Study of Orelabrutinib Combined With PD-1 Inhibitor in Relapsed/Refractory Primary Central Nervous System Lymphoma

NCT04899427 | Unknown Phase 2

• 1 other identifier: PUMCH-NHL-009
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

This is a prospective multicenter single-arm phase II study, and the purpose of this study is to evaluate the efficiency of Orelabrutinib combined with PD-1 inhibitor regimen relapsed/refractory primary intraocular lymphoma. Overall response rate （ORR） after 4 cycles is the primary endpoint.

Conditions

Primary Central Nervous System Lymphoma

Keywords

Primary Central Nervous System Lymphoma; orelabrutinib; PD-1 inhibitor; Overall response rate

Outcome Measures

Primary Outcomes (1)

• overall response rate

  ORR was calculated by the proportion of patients who achieved complete remission and partial remission.

  3 weeks after the end of 4 cycles of induction (each cycle is 21 days)

Secondary Outcomes (1)

• 1 years progression-free survival

  from the date of treatment to the subject finished his 1 years follow-up phase or the disease relapsed or the death due to lymphoma

Study Arms (1)

orelabrutinib combined with PD-1 inhibitor

EXPERIMENTAL

The experimental arm will be treated orelabrutinib plus PD-1(programmed death）inhibitor every 21 days as one cycle. The responses will be evaluated every 2 cycles during the first 6 cycles and every 3 months until progression. The investigators can choose Sintilimab Injection or Tislelizumab Injection at the beginning of treatment，but they can't exchange to another during the whole treatment.

Drug: orelabrutinib; Drug: Sintilimab; Drug: Tislelizumab

Interventions

orelabrutinib DRUG

Orelabrutinib will be given as 150mg per day orally, until progression of the disease (PD), unacceptable toxicity, or patient/investigator discretion.

orelabrutinib combined with PD-1 inhibitor

Sintilimab DRUG

Sintilimab 200mg intravenous infusion d1, every 21 days for 1 cycle. The medicine will be given until progression of the disease (PD), unacceptable toxicity, or patient/investigator discretion.

orelabrutinib combined with PD-1 inhibitor

Tislelizumab DRUG

Tislelizumab 200mg intravenous infusion d1, every 21 days for 1 cycle. The medicine will be given until progression of the disease (PD), unacceptable toxicity, or patient/investigator discretion.

orelabrutinib combined with PD-1 inhibitor

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 ≥18 years old ≤75 Years old, male or female
• Primary Central nerves system lymphoma confirmed by cytology or histology according to WHO2016 criteria
• No evidence of systemic lymphoma
• Patients with a clear diagnosis of relapsed and/or refractory PCNSL: they received at least one regimen containing methotrexate.
• At least one measurable lesion according to Lugano 2014 criteria
• Adequate organ function and adequate bone marrow reserve

You may not qualify if:

• Malignant tumors other than B-NHL within 5 years prior to screening, except cervical carcinoma in situ, basal cell or squamous cell skin cancer, local prostate cancer after radical surgery, and breast ductal carcinoma in situ after radical surgery
• Active HIV, HBV, HCV or treponema pallidum infection
• Any instability of systemic disease, including but not limited to active infection (except local infection), severe cardiac, liver, kidney, or metabolic disease need therapy
• Female subjects who have been pregnant or breastfeeding, or who plan to conceive during or within 1 year after treatment, or male subjects' partner plans to conceive within 1 year after their cell transfusion
• Active or uncontrolled infections requiring systemic treatment within 14 days before enrollment
• Any systemic antitumor therapy performed within 2 weeks before enrollment
• Previous use of other BTK inhibitors or PD-1 inhibitors.

Sponsors & Collaborators

• Peking Union Medical College Hospital: lead
• Beijing Hospital: collaborator
• Beijing Tongren Hospital: collaborator
• Beijing Luhe Hospital: collaborator
• Shanxi Province Renmin Hospital: collaborator
• Henan Cancer Hospital: collaborator
• Henan Province Renmin Hospital: collaborator
• The Second Affiliated Hospital of Dalian Medical University: collaborator
• Hebei Medical University Fourth Hospital: collaborator
• The First Hospital of Chinese Medical University: collaborator
• Qilu Hospital of Shandong University: collaborator
• The First Hospital of Zhengzhou University: collaborator

Study Sites (1)

Wei Zhang

Beijing, Beijing Municipality, 100730, China

RECRUITING

MeSH Terms

Interventions

orelabrutinib; sintilimab; tislelizumab

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 19, 2021
• First Posted: May 24, 2021
• Study Start: March 24, 2021
• Primary Completion: March 24, 2023
• Study Completion: October 24, 2023
• Last Updated: May 24, 2021

Record last verified: 2021-05

Locations

CN (1)