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NCT03571568 · ClinicalTrials.gov registry record · Phase 1
A Study of BI-1206 in Combination With Rituximab With or Without Acalabrutinib in Subjects With Indolent B-Cell NHL
A Phase 1 study of Indolent B-Cell Non-Hodgkin Lymphoma, sponsored by BioInvent International AB.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 140
- Enrollment target
- 20
- Study locations
NCT03571568: Recruiting Phase 1 study of Indolent B-Cell Non-Hodgkin Lymphoma, sponsored by BioInvent International AB.
NCT03571568 is a Phase 1 study of Indolent B-Cell Non-Hodgkin Lymphoma that is actively recruiting participants, run by BioInvent International AB. The registered enrollment target is 140 participants, above the 48-participant average among 6 other Indolent B-Cell Non-Hodgkin Lymphoma trials with a reported enrollment target (192% higher). The trial reports 20 study locations across 7 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03571568, a Phase 1 study of Indolent B-Cell Non-Hodgkin Lymphoma, is actively recruiting participants, sponsored by BioInvent International AB.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 140 participants
- Enrollment target
- 20
- Study locations
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
Primary Outcome
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.
Conditions Studied
Interventions
- BIOLOGICAL Rituximab
- BIOLOGICAL BI-1206
- BIOLOGICAL Acalabrutinib
Study Locations (20)
Other
- Hospital Erasto Gaertner - Liga Paranaense de Combate ao Câncer - Curitiba
- Ruschel Medicina e Pesquisa Clínica - Rio de Janeiro
- A.C. Camargo Cancer Center - São Paulo
- Hospital Amaral Carvalho - São Paulo
- Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo - São Paulo
- Hospital Israelita Albert Einstein - São Paulo
- Hospital Samaritano - São Paulo
- Hospital Sírio-Libanês - São Paulo
- Robert Bosch Hospital, Dep of Hematology, Oncology and Palliative care - Stuttgart
- Szpital Specjlistyczny - Grudziądz
- Małopolskie Centrum Medyczne - Krakow
- Hospital de la Santa Creu i Sant Pau, Dep Hematologia - Barcelona
- Hospital Universitari Vall d'Hebron - Barcelona
- Institut Català d'Oncologia, L'Hospitalet de Llobregat - Barcelona
Georgia
- Emory University Hospital - Atlanta
Kentucky
- Norton Cancer Institute - St. Matthews 3991 Dutchmans Lane Medical Plaza II, Suite 405 - Louisville
Estado de Bahia
- Hospital São Rafael - Salvador
Rio Grande do Sul
- Hospital de Clínicas de Porto Alegre - Porto Alegre
Hesse
- Krankenhaus Nordwest Klinik für Onkologie und Hämatologie - Frankfurt am Main
Barcelona
- Hospital ICO, Trias i Pujol - Badalona
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 140 participants |
| Start Date | 2018-05-16 |
| Est. Completion | 2026-09-30 |
| Phase | Phase 1 |
What NCT03571568 shows while recruiting
NCT03571568 is an interventional study that assigns participants to a tested intervention. The registered 140 participants enrollment target is mid-sized for trials with a published cap, above the 48-participant average among 6 other Indolent B-Cell Non-Hodgkin Lymphoma trials with a reported enrollment target (192% higher).
The record links to 1 condition, with Indolent B-Cell Non-Hodgkin Lymphoma appearing as the primary indexed condition, and to 3 interventions - of which Rituximab is the first listed.
NCT03571568 names 20 study sites across 7 states, led by Other, Georgia, Kentucky.
Frequently Asked Questions
What is clinical trial NCT03571568 about?
NCT03571568 is a clinical study titled "A Study of BI-1206 in Combination With Rituximab With or Without Acalabrutinib in Subjects With Indolent B-Cell NHL". 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
What is the current status of trial NCT03571568?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 140 participants. The study started on 2018-05-16. Estimated completion is 2026-09-30.
What conditions does trial NCT03571568 study?
This clinical trial studies the following conditions: Indolent B-Cell Non-Hodgkin Lymphoma.
What interventions are being tested in trial NCT03571568?
The interventions under investigation include: Rituximab (BIOLOGICAL), BI-1206 (BIOLOGICAL), Acalabrutinib (BIOLOGICAL).
Who is sponsoring clinical trial NCT03571568?
This trial is sponsored by BioInvent International AB, which has 5 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03571568 being conducted?
This trial has 20 study locations across Georgia, Kentucky, Estado de Bahia, Rio Grande do Sul, Hesse. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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