Orelabrutinib treatment for patients with difficult-to-treat B-cell lymphoma

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Orelabrutinib plus Pola-R-CHP as first-line treatment for intermediate- to high-risk DLBCL

  This trial tests whether adding orelabrutinib to the Pola-R-CHP regimen can improve outcomes for adults with intermediate- to high-risk newly diagnosed DLBCL.

  Recruiting at 2 sites The First Affiliated Hospital of Xiamen University · Xiamen, Fujian and 1 other locations · NCT07778212

• In Vivo CD19/CD20 CAR T-Cell Therapy for Relapsed or Refractory B-Cell Lymphoma

  This early-phase trial tests a one-time in vivo CAR T-cell therapy (SL1617) for people with relapsed or refractory B-cell lymphoma to see if it is safe and tolerable.

  Recruiting Phase 1 Chinese PLA General Hospital · Beijing · NCT07775508

• Orelabrutinib with Obinutuzumab and Short-Course Venetoclax in Treatment-Naïve Mantle Cell Lymphoma

  This trial tests whether a combo of orelabrutinib, obinutuzumab, and a short course of venetoclax is safe and effective for adults with newly diagnosed mantle cell lymphoma.

  Recruiting at 2 sites Phase 2 The First Affiliated Hospital with Nanjing Medical University · Changzhou, Jiangsu and 1 other locations · NCT07719556

• Orelabrutinib plus standard immunochemotherapy with or without auto-HSCT for newly diagnosed DLBCL

  This study tests whether adding orelabrutinib to standard chemotherapy, with or without autologous stem cell transplantation, helps newly diagnosed DLBCL patients.

  Recruiting Phase 2 The Affiliated Hospital of Xuzhou Medical University · Xuzhou, Jiangsu · NCT07680933

• Toxin exposure and immune factors in B-cell non-Hodgkin lymphoma

  This study tests how toxin exposure, genetics, and immune issues relate to B-cell non-Hodgkin lymphoma in active-duty service members and other Military Health System beneficiaries.

  Recruiting Henry M. Jackson Foundation for the Advancement of Military Medicine · Bethesda, Maryland and 2 other locations · NCT07652580

• FXS0683 in relapsed or refractory blood cancers

  This first‑in‑human study tests FXS0683 in adults with relapsed or refractory B‑cell lymphoma, AML, MDS, or ALL to see if it is safe, how the drug behaves in the body, and whether it shows any antitumor activity.

  Recruiting Phase 1 Shanghai Fosun Pharmaceutical Industrial Development Co. Ltd. · Tianjin, Tianjin Municipality · NCT07616089

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.