Orelabrutinib Therapy in Patients With r/r B-cell Lymphoma Intolerant to Other Bruton Tyrosine Kinase Inhibitors

NCT05495828 | Unknown

• 1 other identifier: intolerant to BTK inhibitors
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

To evaluate the safety and effecacy of Orelabrutinib therapy in patients with relapsed or refractory B-cell lymphoma (including R /rCLL/SLL and R /rMCL) who are intolerant to ibrutinib/zanubrutinib or other BTK inhibitors

Conditions

B-cell Lymphoma

Outcome Measures

Primary Outcomes (1)

• the adverse events of Special interest

  the adverse events of Special interest: Diarrhea, atrial fibrillation/flutter, rash

  up to two years

Secondary Outcomes (5)

• ORR

  up to two years

• DCR

  up to two years

• DOR

  up to two years

• PFS

  up to two years

• OS

  up to two years

Study Arms (1)

Orelabrutinib

Patients with relapsed or refractory B-cell lymphoma (including r/rCLL/SLL, r/rMCL) intolerant to ibrutinib/zanubrutinib or other BTK inhibitors who have decided to receive Orelabrutinib therapy

Drug: Orelabrutinib

Interventions

Orelabrutinib DRUG

Orelabrutinib, 150mg, po, qd

Also known as: ICP-022

Orelabrutinib

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with relapsed or refractory B-cell lymphoma (including r/rCLL/SLL, r/rMCL) intolerant to ibrutinib/zanubrutinib or other BTK inhibitors who have decided to receive Orelabrutinib therapy

You may qualify if:

• \) 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

You may not qualify if:

• \) 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

Sponsors & Collaborators

• Peking University People's Hospital: lead

Study Sites (1)

Deparment of Hematology, Peking University People's Hospital

Beijing, Beijing Municipality, 100044, China

RECRUITING

MeSH Terms

Conditions

Lymphoma, B-Cell

Interventions

orelabrutinib

Condition Hierarchy (Ancestors)

Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Shenmiao Yang

  Peking University People's Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Shenmiao Yang, Dr.

CONTACT

8601088326666; yangshenmiao@hotmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof.

Study Record Dates

• First Submitted: August 9, 2022
• First Posted: August 10, 2022
• Study Start: November 10, 2023
• Primary Completion: December 10, 2024
• Study Completion: March 10, 2025
• Last Updated: October 26, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)