Study of BI-1206 for Indolent B-Cell Non-Hodgkin Lymphoma
This study is testing a new treatment called BI-1206 in combination with rituximab, and sometimes also with acalabrutinib, for people with indolent B-cell Non-Hodgkin Lymphoma (a type of slow-growing blood cancer) that has returned or didn't respond to previous rituximab treatment. The study aims to find the safest and most effective dose of BI-1206 when given with these other medications. You might be able to join if you are 18 or older, have specific types of B-cell NHL (follicular lymphoma, marginal zone lymphoma, or mantle cell lymphoma), and have measurable disease. The study is currently recruiting about 140 participants.
- Study design
- This is a Phase 1/2a, multi-center, open-label study involving dose escalation and expansion, with approximately 140 participants.
- What's involved
- You would undergo lymph node biopsies or biopsies of other involved tissue. The study involves a 28-day treatment period on induction therapy.
- Compensation
- Not stated in the trial record.
- Follow-up
- Safety and dose-limiting toxicities are measured during the 28-day treatment period on induction therapy.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
A Study of BI-1206 in Combination With Rituximab With or Without Acalabrutinib in Subjects With Indolent B-Cell NHL
At a glance
Conditions
NCT03571568
Where you'd take part
This study runs at 27 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.
A.C. Camargo Cancer Center
São Paulo, Brazilstudy coordinator listed
Recruiting
Hospital Amaral Carvalho
São Paulo, Brazilstudy coordinator listed
Not yet recruiting
Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo
São Paulo, Brazilstudy coordinator listed
Not yet recruiting
Hospital de Clínicas de Porto Alegre
Porto Alegre, Rio Grande do Sul, Brazilstudy coordinator listed
Recruiting
Hospital de la Santa Creu i Sant Pau, Dep Hematologia
Barcelona, Spainstudy coordinator listed
Recruiting
Hospital Erasto Gaertner - Liga Paranaense de Combate ao Câncer
Curitiba, Brazilstudy coordinator listed
Not yet recruiting
Hospital General Universitario Gregorio Marañon-Oncología Médica
Madrid, Spainstudy coordinator listed
Recruiting
Hospital ICO, Trias i Pujol
Badalona, Barcelona, Spainstudy coordinator listed
Recruiting
Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.
Who to contact
Opens a ready-to-send draft in your own email app — review before sending.
What this trial measures
- Documenting AEs and SAEs and determining causality in relation to BI-1206 and/or rituximab and/or acalabrutinibDuring the 28-day treatment period on induction therapy
Assess the safety and tolerability profile of BI-1206 when administered intravenously (IV) or subcutaneously (SC) in combination with rituximab or rituximab and acalabrutinib in subjects with relapsed or refractory B-cell non-Hodgkin lymphoma (NHL), subtypes follicular lymphoma (FL)(except FL grade 3B), marginal zone lymphoma (MZL), and mantle cell lymphoma (MCL). Assessment will be done according to National Cancer Institute (NCI-CTCAE) criteria v. 5.0.
- Determining the MTD of BI-1206 at the same dose level experiencing a BI-1206 or Rituximab-related or possibly related dose-limiting toxicity (DLT)During the 28-day treatment period on induction therapy
Phase 1: Select the recommended Phase 2 dose (RP2D) by establishing the maximum tolerated dose (MTD) of BI-1206 given once weekly for 4 weeks, via IV infusion or SC injection in combination with rituximab.
- Determine the recommended dose of BI-1206 in combination with rituximab and acalabrutinibDuring the 28-day treatment period on induction therapy
Phase 2a: Select the recommended dose of BI-1206 in combination with rituximab and acalabrutinib.