RecruitingPhase 1Phase 2NCT03571568

A Study of BI-1206 in Combination With Rituximab With or Without Acalabrutinib in Subjects With Indolent B-Cell NHL

Phase 1/2a Trial of BI-1206, a Monoclonal Antibody to CD32b (FcyRIIB), in Combination With Rituximab With or Without Acalabrutinib in Subjects With Indolent B-Cell Non-Hodgkin Lymphoma That Has Relapsed or is Refractory to Rituximab

Sponsor

BioInvent International AB

Enrollment

140 participants

Start Date

May 16, 2018

Study Type

INTERVENTIONAL

Conditions

Indolent B-Cell Non-Hodgkin Lymphoma

Summary

Phase 1/2a Clinical Trial of BI-1206, a Monoclonal Antibody to CD32b (FcyRIIB), in Combination with Rituximab with or without Acalabrutinib in Subjects with Indolent B-Cell Non-Hodgkin Lymphoma That has Relapsed or is Refractory to Rituximab

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests a combination of two drugs — BI-1206 and rituximab, with or without a third drug called acalabrutinib — in patients with a slow-growing type of blood cancer called indolent B-cell non-Hodgkin's lymphoma (NHL) that has come back or stopped responding to treatment. **You may be eligible if...** - You are 18 years of age or older - You have a B-cell lymphoma confirmed by biopsy — specifically follicular lymphoma (FL, except grade 3B), mantle cell lymphoma (MCL), or marginal zone lymphoma (MZL) - Your lymphoma has measurable disease on scans - Your cancer has relapsed or stopped responding to conventional treatment, or no standard treatment exists - You have had at least one prior treatment that included rituximab - You are willing to have a lymph node biopsy **You may NOT be eligible if...** - You have not yet tried at least one rituximab-based treatment - You have grade 3B follicular lymphoma or a different type of lymphoma - You are unwilling to undergo a biopsy Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BIOLOGICALBI-1206

BI-1206 150 mg / 225 mg Subcutaneous injection BI-1206 50 mg /100 mg Intravenous infusion

BIOLOGICALRituximab

Rituximab 375 mg/m2, as per SmPC

BIOLOGICALAcalabrutinib

Acalabrutinib 100 mg orally as per SmPC

Locations(27)

Emory University Hospital

Atlanta, Georgia, United States

Norton Cancer Institute - St. Matthews 3991 Dutchmans Lane Medical Plaza II, Suite 405

Louisville, Kentucky, United States

Hospital São Rafael

Salvador, Estado de Bahia, Brazil

Hospital de Clínicas de Porto Alegre

Porto Alegre, Rio Grande do Sul, Brazil

Hospital Erasto Gaertner - Liga Paranaense de Combate ao Câncer

Curitiba, Brazil

Ruschel Medicina e Pesquisa Clínica

Rio de Janeiro, Brazil

A.C. Camargo Cancer Center

São Paulo, Brazil

Hospital Amaral Carvalho

São Paulo, Brazil

Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo

São Paulo, Brazil

Hospital Israelita Albert Einstein

São Paulo, Brazil

Hospital Samaritano

São Paulo, Brazil

Hospital Sírio-Libanês

São Paulo, Brazil

Krankenhaus Nordwest Klinik für Onkologie und Hämatologie

Frankfurt am Main, Hesse, Germany

Robert Bosch Hospital, Dep of Hematology, Oncology and Palliative care

Stuttgart, Germany

Szpital Specjlistyczny

Grudziądz, Poland

Małopolskie Centrum Medyczne

Krakow, Poland

Hospital ICO, Trias i Pujol

Badalona, Barcelona, Spain

Hospital de la Santa Creu i Sant Pau, Dep Hematologia

Barcelona, Spain

Hospital Universitari Vall d'Hebron

Barcelona, Spain

Institut Català d'Oncologia, L'Hospitalet de Llobregat

Barcelona, Spain

Hospital General Universitario Gregorio Marañon-Oncología Médica

Madrid, Spain

Hospital Universitario HM Sanchinarro

Madrid, Spain

University Hospital Fundacion Jimenez Diaz

Madrid, Spain

Hospital Universitario Virgen de la Arrixaca

Murcia, Spain

Hospital University Virgen Macarene

Seville, Spain

Department of Oncology, Skåne University Hospital

Lund, Sweden

Department of Oncology, Academical Hospital

Uppsala, Sweden

View Full Details on ClinicalTrials.gov

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