Orelabrutinib Combined With Rituximab and Chemotherapy for Relapsed/Refractory B-Cell Lymphoma Patients With Central Nervous System Involvement

NCT05926427 | Recruiting Phase 2 DMC

• 1 other identifier: Oreo
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief Summary

This single-center, open, single-arm study aim to evaluate the efficacy and tolerability of a therapy introducing orelabrutinib on the basis of rituximab and chemotherapy in treating patients with relapsed or refractory B-cell lymphoma invloving central nervous system.

Conditions

CNS Lymphoma

Keywords

CNS Lymphoma; Relapse; Refractory; orelabrutinib

Outcome Measures

Primary Outcomes (1)

• Objective Response Rate (ORR)

  The ORR is defined as percentage of participants with overall response including complete response (CR) and partial response (PR), on the basis of investigator assessments, according to 2014 Lugano criteria.

  At the end-of-therapy response evaluation, 6 weeks after the end of Cycle 6, each cycle lasting 4 weeks

Secondary Outcomes (1)

• 2-year Progression-Free Survival

  2 years

Other Outcomes (3)

• Overall Survival (OS)

  Baseline up to data cut-off (up to approximately 2 years)

• Complete Response (CR) Rate

  At the end-of-therapy response evaluation, 6 weeks after the end of Cycle 6, each cycle lasting 4 weeks

• Adverse Events

  Baseline up to data cut-off (up to approximately 2 years)

Study Arms (1)

OR-chemo

EXPERIMENTAL

Drug: Orelabrutinib, Rituximab and recommended chemotherapy according to histopathologic type

Drug: Orelabrutinib; Drug: Rituximab; Drug: Chemotherapy

Interventions

Orelabrutinib DRUG

150 mg qd po, until disease progression, intolerance of drug toxicity or death, otherwise maintaining during 2 years of follow-up

Also known as: ICP-022

OR-chemo

Rituximab DRUG

375 mg/m\^2 ivgtt, D0 of each 28-day cycle

OR-chemo

Chemotherapy DRUG

Not specified, recommended regimen according to histopathologic type

OR-chemo

Eligibility Criteria

• Age: 14 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• to 80 years old;
• Histopathologically confirmed CD20 positive B-cell lymphoma according to the 5th edition of the World Health Organization (WHO) Classification of Haematolymphoid Tumours;
• After systemic treatment of the CNS lesions;
• Life expectancy of \> 3 months (in the opinion of the investigator);
• No non-haematologic adverse events, except alopecia, higher than grade 1 according to Common Terminology Criteria for Adverse Events (CTCAE) v5.0;
• Absolute Neutrophil Count (ANC) ≥ 1.0×10\^9/L, Platelet Count ≥ 50×10\^9/L and Haemoglobin ≥ 60 g/L, without transfusion or any use of pharmacologically hematopoietic drugs in 2 weeks;
• Serum Creatinine (SCr) ≤ 1.5 times the Upper Limit of Normal (ULN) or Creatinine Clearance Rate (CCR) ≥ 30 mL/min;
• Serum total Bilirubin (tBil) ≤ 1.5 × ULN and both Aspartate aminotransferase (AST) and Alanine aminotransferase (ALT) ≤ 2.5 × ULN without hepatic metastases, otherwise tBil ≤ 3 × ULN and AST, ALT ≤ 5 × ULN respectively;
• International Normalized Ratio (INR) ≤ 1.5 and activated Partial Thromboplastin Time (aPTT) ≤ 1.5 × ULN;
• Left Ventricular Ejection Fraction (LVEF) ≥ 50%;
• Agreeing to provide written informed consent prior to any special examination or procedure for the research on their own or legal representative.

You may not qualify if:

• Pregnant or lactating women;
• Known Hepatitis B Virus (HBV) and/or Hepatitis C Virus (HCV) infection (HBV infection refers to HBV-DNA \> detectable limit);
• With acquired or congenital immunodeficiency;
• With congestive heart failure in 6 months before enrollment, New York Heart Association (NYHA) heart function class III or IV, or LVEF \< 50%;
• Known to be allergic to the test drug ingredients;
• Diagnosed with or being treated for malignancy other than lymphoma;
• With severe infection;
• Substance abuse, medical, psychological, or social conditions that may interfere with the subjects' participation in the study or evaluation of the study results;
• Deemed unsuitable for the group.

Sponsors & Collaborators

• Ruijin Hospital: lead

Study Sites (1)

Ruijin Hospital, Shanghai Jiao Tong University School of Medicine

Shanghai, Shanghai Municipality, 200025, China

RECRUITING

MeSH Terms

Conditions

Recurrence

Interventions

orelabrutinib; Rituximab; Drug Therapy

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Murine-Derived; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Therapeutics

Central Study Contacts

Weili Zhao, Doctor

CONTACT

+86-64370045; zwl_trial@163.com

Li Wang, Doctor

CONTACT

+86-64370045; wl_wangdong@126.com

Study Design

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

Model Details: Single Group

Study Record Dates

• First Submitted: June 22, 2023
• First Posted: July 3, 2023
• Study Start: August 10, 2023
• Primary Completion: April 30, 2026
• Study Completion: April 30, 2026
• Last Updated: September 5, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)