CNS Lymphoma
Conditions
Keywords
CNS Lymphoma, Relapse, Refractory, orelabrutinib
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.
Detailed 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.
Interventions
DRUGOrelabrutinib
150 mg qd po, until disease progression, intolerance of drug toxicity or death, otherwise maintaining during 2 years of follow-up
DRUGRituximab
375 mg/m\^2 ivgtt, D0 of each 28-day cycle
DRUGChemotherapy
Not specified, recommended regimen according to histopathologic type
Sponsors
Ruijin Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Single Group
Eligibility
Sex/Gender
ALL
Age
14 Years to 80 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Objective Response Rate (ORR) | At the end-of-therapy response evaluation, 6 weeks after the end of Cycle 6, each cycle lasting 4 weeks | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 2-year Progression-Free Survival | 2 years | Progression-free survival was defined as the time from the date of first treatment until the date of the first documented day of disease progression or relapse, according to 2014 Lugano criteria, or death from any cause, whichever occurred first. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Overall Survival (OS) | Baseline up to data cut-off (up to approximately 2 years) | Overall survival is defined as the time from the date of first treatment to the date of death from any cause. |
| Complete Response (CR) Rate | At the end-of-therapy response evaluation, 6 weeks after the end of Cycle 6, each cycle lasting 4 weeks | The CR rate is defined as the percentage of participants with CR, on the basis of investigator assessments, according to 2014 Lugano criteria. |
| Adverse Events | Baseline up to data cut-off (up to approximately 2 years) | Any harmful reaction that occurs during the treatment of a disease according to the normal usage and dosage of a drug, which is unrelated to the purpose of treatment. |
Countries
China
Contacts
Primary ContactWeili Zhao, Doctor
Backup ContactLi Wang, Doctor
Outcome results
None listed