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)
Documenting AEs and SAEs and determining causality in relation to BI-1206 and/or rituximab and/or acalabrutinib — During 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 acalabrutinib — During the 28-day treatment period on induction therapy Phase 2a:
Select the recommended dose of BI-1206 in combination with rituximab and acalabrutinib.
Trial sites (27)
Facility
City
Region
Status
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
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.
We use cookies to analyse site traffic and improve your experience. With your consent, we may also use cookies for advertising. You can change your choice at any time.