A Study of BI-1206 in Combination With Rituximab With or Without Acalabrutinib in Subjects With Indolent B-Cell NHL
NCT ID: NCT03571568
Last Updated: 2025-04-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1/PHASE2
140 participants
INTERVENTIONAL
2018-05-16
2026-09-30
Brief Summary
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Detailed Description
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Phase 2a, consists of signal seeking cohorts followed by a randomized, parallel, two-arm dose optimization.
The trial consists of 2 main parts:
Phase 1
\- Dose Escalation, with two different Arms assessing IV or SC dosing of BI-1206 in combination with rituximab, with dose escalation cohorts and selection of the IV and SC doses of BI-1206 for Phase 2a
Phase 2a
* Dose Expansion, with one expansion cohort evaluating the selected IV dose of BI-1206 in combination with rituximab
* Signal Seeking, assessing IV and SC dosing of BI-1206 in combination with rituximab and acalabrutinib. The Signal Seeking will consist of a Safety Run-in and an Expansion
* Dose Optimization to select the recommended dose of BI-1206 in combination with rituximab and acalabrutinib
Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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BI-1206 IV Dose Escalation
Standard 3+3 Dose-Escalation of BI-1206 IV in combination with Rituximab
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
BI-1206 SC Dose Escalation
Adaptive Dose Escalation of BI-1206 SC (Bayesian logistic regression model (BLRM) in combination with Rituximab
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
Phase 2a IV Dose expansion
BI-1206 IV in Combination with Rituximab
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
Phase 2a SC Signal seeking
SC Arm, BI-1206 in Combination with Rituximab and 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
Phase 2a IV Signal Seeking
IV Arm, BI-1206 in Combination with Rituximab and 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
Interventions
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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
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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
18 Years
ALL
No
Sponsors
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BioInvent International AB
INDUSTRY
Responsible Party
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Locations
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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
Countries
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Central Contacts
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Facility Contacts
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Role: primary
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Role: primary
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Other Identifiers
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17-BI-1206-02
Identifier Type: -
Identifier Source: org_study_id
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