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Clinical Trials in Spain / NCT03571568
Recruiting Phase 1/2

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

NCT03571568 · tracked via the Priya Life Science Spain tracker
Phase
Phase 1/2
Started
2018-05-16
Last updated
2025-04-24

Condition(s) studied

Indolent B-Cell Non-Hodgkin Lymphoma

Investigational drug(s) / intervention(s)

BI-1206Rituximab →Acalabrutinib →

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

Rituximab: Rituximab 375 mg/m2, as per SmPC

Acalabrutinib: Acalabrutinib 100 mg orally as per SmPC

Study 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

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: 1. Are ≥ 18 years of age by initiation of study treatment. 2. Have B-cell NHL proven by histology, with histological subtypes limited to follicular lymphoma (FL) (except FL grade 3B), MCL and marginal zone lymphoma (MZL) 3. Have measurable nodal disease 4. Are willing to undergo lymph node biopsies or biopsies of other involved tissue 5. Have relapsed disease or disease refractory to conventional treatment or for which no standard therapy exists 6. Have received at least one line of conventional previous therapy which must include at least one rituximab-based regimen 7. Have a life expectancy of at least 12 weeks 8. Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0-2 9. Have CD20+ malignancy 10. Have hematological and biochemical indices within prespecified ranges Exclusion Criteria: 1. Have had an allogenic bone marrow or stem cell transplant within 12 months 2. Have presence of active chronic graft versus host disease 3. Have current leptomeningeal lymphoma or compromise of the central nervous system 4. Have transformed lymphoma from a pre-existing indolent lymphoma 5. Have Waldenstrom's Macroglobulinemia or FL grade 3B, 6. Need systemic doses of prednisolone \>10 mg daily (or equipotent doses of other corticosteroids) while on the study trial other than as pre-medication. 7. Have known or suspected hypersensitivity to rituximab or BI-1206 8. Have cardiac or renal amyloid light-chain amyloidosis 9. Have received any of the following: 1. Chemotherapy or small molecule products with 2 weeks of first dose of BI-1206 2. Radiotherapy (except for focal symptomatic control of lymphadenopathy) within 4 weeks 3. Immunotherapy within 8 weeks 4. Previous lines of treatment containing BTK inhibitors for Subjects receiving BI-1206 in combination with rituximab and acalabrutinib 10. Have ongoing toxic manifestations of previous treatments. 11. Have the ability to become pregnant (or already pregnant or lactating/breastfeeding). 12. Have had major surgery from which the subject has not yet recovered. 13. Are at high medical risk because of non-malignant systemic disease including active infection on treatment with antibiotics, antifungals or antivirals. 14. Are serologically positive for hepatitis B, hepatitis C or human immunodeficiency virus (HIV). 15. Have an active, known or suspected autoimmune disease. 16. Have concurrent congestive heart failure, prior history of class III/ IV cardiac disease (New York Heart Association \[NYHA\]) 17. Have current malignancies of other types

Primary outcome measure(s)

Trial sites (27)

FacilityCityRegionStatus
Emory University Hospital Atlanta Georgia Active Not Recruiting
Norton Cancer Institute - St. Matthews 3991 Dutchmans Lane Medical Plaza II, Suite 405 Louisville Kentucky Recruiting
Hospital São Rafael Salvador Estado de Bahia Recruiting
Hospital de Clínicas de Porto Alegre Porto Alegre Rio Grande do Sul Recruiting
Hospital Erasto Gaertner - Liga Paranaense de Combate ao Câncer Curitiba Brazil Not Yet Recruiting
Ruschel Medicina e Pesquisa Clínica Rio de Janeiro Brazil Not Yet Recruiting
A.C. Camargo Cancer Center São Paulo Brazil Recruiting
Hospital Amaral Carvalho São Paulo Brazil Not Yet Recruiting
Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo São Paulo Brazil Not Yet Recruiting
Hospital Israelita Albert Einstein São Paulo Brazil Recruiting
Hospital Samaritano São Paulo Brazil Not Yet Recruiting
Hospital Sírio-Libanês São Paulo Brazil Not Yet Recruiting
Krankenhaus Nordwest Klinik für Onkologie und Hämatologie Frankfurt am Main Hesse Not Yet Recruiting
Robert Bosch Hospital, Dep of Hematology, Oncology and Palliative care Stuttgart Germany Withdrawn
Szpital Specjlistyczny Grudziądz Poland Terminated
Małopolskie Centrum Medyczne Krakow Poland Terminated
Hospital ICO, Trias i Pujol Badalona Barcelona Recruiting
Hospital de la Santa Creu i Sant Pau, Dep Hematologia Barcelona Spain Recruiting
Hospital Universitari Vall d'Hebron Barcelona Spain Recruiting
Institut Català d'Oncologia, L'Hospitalet de Llobregat Barcelona Spain Recruiting
Hospital General Universitario Gregorio Marañon-Oncología Médica Madrid Spain Recruiting
Hospital Universitario HM Sanchinarro Madrid Spain Recruiting
University Hospital Fundacion Jimenez Diaz Madrid Spain Recruiting
Hospital Universitario Virgen de la Arrixaca Murcia Spain Not Yet Recruiting
Hospital University Virgen Macarene Seville Spain Recruiting
Department of Oncology, Skåne University Hospital Lund Sweden Terminated
Department of Oncology, Academical Hospital Uppsala Sweden Terminated

On this site

📄 Rituxan (rituximab) drug profile → 📄 Calquence (acalabrutinib) drug profile →

More BioInvent International AB trials in Spain

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT03571568 on ClinicalTrials.gov ↗ ← All trials in Spain