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

Shanghai Jiao Tong University

Status and phase

Enrolling

Phase 2

Conditions

CNS Lymphoma

Treatments

Drug: Chemotherapy

Drug: Rituximab

Drug: Orelabrutinib

Study type

Interventional

Funder types

Other

Identifiers

NCT05926427

Oreo

Details and patient eligibility

About

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.

Full description

Participants will receive orelabrutinib in addition to second-line therapy consisting of rituximab and recommended chemotherapy according to histopathologic type. After treatment of 6 cycles with the new regimen, the patients achieving CR or PR would go on to receive autologous haematopoietic stem cell transplantation (auto-HSCT) with or without orelabrutinib maintenance of 2 years (if tolerable) or orelabrutinib maintenance alone if intolerant to auto-HSCT.

Enrollment

25 estimated patients

Sex

All

Ages

14 to 80 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

14 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.

Exclusion criteria

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.