Orelabrutinib treatment for patients with difficult-to-treat B-cell lymphoma
Observational Study of Orelabrutinib Therapy in Patients With Relapsed or Refractory B-cell Lymphoma Intolerant to Other Bruton Tyrosine Kinase Inhibitors
This study is testing a new treatment called Orelabrutinib for patients with hard-to-treat B-cell lymphoma who can't tolerate other similar medications.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 30 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Peking University People's Hospital Academic / other |
| Drugs / interventions | ibrutinib, zanubrutinib, Orelabrutinib, obrutinib |
| Locations | 1 site (Beijing, Beijing) |
| Trial ID | NCT05495828 on ClinicalTrials.gov |
What this trial studies
This study evaluates the safety and efficacy of Orelabrutinib therapy in patients with relapsed or refractory B-cell lymphoma who are intolerant to other Bruton Tyrosine Kinase inhibitors like ibrutinib and zanubrutinib. The focus is on patients who have experienced significant adverse reactions to these treatments, which often lead to discontinuation. Orelabrutinib is designed to be highly selective, potentially reducing the incidence of severe side effects compared to first-generation BTK inhibitors. The study aims to provide insights into the effectiveness of this therapy in a population that has limited treatment options.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with relapsed or refractory B-cell lymphoma who have previously experienced poor tolerance to ibrutinib or zanubrutinib.
Not a fit: Patients who have not previously been treated with BTK inhibitors or those with other types of lymphoma may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could offer a safer and more effective option for patients with B-cell lymphoma who cannot tolerate existing therapies.
How similar studies have performed: While the approach of using Orelabrutinib is relatively novel, previous studies have indicated its potential effectiveness and safety in similar patient populations.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 1) Age ≥18 years, both sexes; 2) Confirmed by the following diagnostic criteria CLL/SLL: relapsed or refractory chronic lymphocytic leukemia/small lymphocytic lymphoma confirmed by flow cytometry or histopathology according to iwCLL2018 criteria MCL: Recurrent or refractory mantle cell lymphoma histopathologically confirmed: including cytogenetic testing T (11;14) Mantle cell lymphoma with positive/high immunohistochemical expression of Cyclin D1 3) Previous treatment with ibrutinib/zanubrutinib/or other BTK inhibitors and any of the following conditions were defined by the investigator as poor tolerance to ibrutinib/zanubrutinib or other BTK inhibitors: A) Grade ≥2 nonhematologic toxicity lasting \>7 days with or without treatment; B) any non-hematological toxicity of ≥ grade 3 ; C) Grade 3 neutropenia with infection or fever; D) Grade 4 hematologic toxicity that persisted until the investigator chose to discontinue ibrutinib/ zanubrutinib or other BTK inhibitors due to toxicity rather than disease progression 4) The investigator-initiated treatment decision to use Orelabrutinib (before study enrollment); 5) Life expectancy ≥3 months; 6) The patient or his or her legal representative voluntarily signed written informed consent Exclusion Criteria: * 1) Richter conversion (CLL/SLL) or disease progression during treatment with ibrutinib/ zanubrutinib or other BTK inhibitors; 2) Past treatment with Orelabrutinib; 3) Absolute neutrophil ANC\<0.75×109/L, platelet PLT\<50×109/L; 4) Blood biochemistry: total bilirubin (TBIL) \>2 times the upper limit of normal ULN (unless Gilbert syndrome is diagnosed), AST or ALT\>2.5× ULN; Serum creatinine (Cr) \>1.5×ULN 5) Coagulation function: INR and APTT ≤1.5 × ULN; 6) Grade 3 or 4 adverse events related to ongoing unresponded treatment with ibrutinib/ zanubrutinib or other BTK inhibitors 7) Participate in research projects that use interventions outside the scope of routine clinical practice
Where this trial is running
Beijing, Beijing
- Deparment of Hematology, Peking University People's Hospital — Beijing, Beijing, China (Recruiting)
Study contacts
- Principal investigator: Shenmiao Yang — Peking University People's Hospital
- Study coordinator: Shenmiao Yang, Dr.
- Email: yangshenmiao@hotmail.com
- Phone: 8601088326666
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.