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New treatment option for Indolent B-Cell Non-Hodgkin Lymphoma
Official title A Study of BI-1206 in Combination With Rituximab With or Without Acalabrutinib in Subjects With Indolent B-Cell NHL
ClinicalTrials.gov ID: NCT03571568
What this study is testing
What is BI-1206?
BI-1206 is an investigational medicine, given as an injection under the skin, being studied as a potential treatment for indolent b-cell non-hodgkin lymphoma.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Are ≥ 18 years of age by initiation of study treatment.
- Have B-cell NHL proven by histology, with histological subtypes limited to follicular lymphoma (FL) (except FL grade 3B), MCL and marginal zone...
- Have measurable nodal disease
- Are willing to undergo lymph node biopsies or biopsies of other involved tissue
- Have relapsed disease or disease refractory to conventional treatment or for which no standard therapy exists
You likely can't join if
- Have had an allogenic bone marrow or stem cell transplant within 12 months
- Have presence of active chronic graft versus host disease
- Have current leptomeningeal lymphoma or compromise of the central nervous system
- Have transformed lymphoma from a pre-existing indolent lymphoma
- Have Waldenstrom's Macroglobulinemia or FL grade 3B,
- Need systemic doses of prednisolone \>10 mg daily (or equipotent doses of other corticosteroids) while on the study trial other than as...
See the full eligibility criteria
- Are ≥ 18 years of age by initiation of study treatment.
- 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)
- Have measurable nodal disease
- Are willing to undergo lymph node biopsies or biopsies of other involved tissue
- Have relapsed disease or disease refractory to conventional treatment or for which no standard therapy exists
- Have received at least one line of conventional previous therapy which must include at least one rituximab-based regimen
- Have a life expectancy of at least 12 weeks
- Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
- Have CD20+ malignancy
- Have hematological and biochemical indices within prespecified ranges
- Have had an allogenic bone marrow or stem cell transplant within 12 months
- Have presence of active chronic graft versus host disease
- Have current leptomeningeal lymphoma or compromise of the central nervous system
- Have transformed lymphoma from a pre-existing indolent lymphoma
- Have Waldenstrom's Macroglobulinemia or FL grade 3B,
- Need systemic doses of prednisolone \>10 mg daily (or equipotent doses of other corticosteroids) while on the study trial other than as pre-medication.
- Have known or suspected hypersensitivity to rituximab or BI-1206
- Have cardiac or renal amyloid light-chain amyloidosis
- Have received any of the following:
- Chemotherapy or small molecule products with 2 weeks of first dose of BI-1206
- Radiotherapy (except for focal symptomatic control of lymphadenopathy) within 4 weeks
- Immunotherapy within 8 weeks
- Previous lines of treatment containing BTK inhibitors for people receiving BI-1206 in combination with rituximab and acalabrutinib
- Have ongoing toxic manifestations of previous treatments.
- Have the ability to become pregnant (or already pregnant or lactating/breastfeeding).
- Have had major surgery from which the subject has not yet recovered.
- Are at high medical risk because of non-malignant systemic disease including active infection on treatment with antibiotics, antifungals or antivirals.
- Are serologically positive for hepatitis B, hepatitis C or human immunodeficiency virus (HIV).
- Have an active, known or suspected autoimmune disease.
- Have concurrent congestive heart failure, prior history of class III/ IV cardiac disease (New York Heart Association [NYHA])
- Have current malignancies of other types
The study team makes the final eligibility decision.
Where it's taking place
- Atlanta, Georgia, United States
- Louisville, Kentucky, United States
- Salvador, Estado de Bahia, Brazil
- Porto Alegre, Rio Grande do Sul, Brazil
- Curitiba, Brazil
- Rio de Janeiro, Brazil
- São Paulo, Brazil
- Frankfurt am Main, Hesse, Germany
- Stuttgart, Germany
- Grudziądz, Poland
- Krakow, Poland
- Badalona, Barcelona, Spain
- Barcelona, Spain
- Madrid, Spain
- Murcia, Spain
- Seville, Spain
- Lund, Sweden
- Uppsala, Sweden
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Atlanta, Georgia, United States; Louisville, Kentucky, United States; Salvador, Estado de Bahia, Brazil; Porto Alegre, Rio Grande do Sul, Brazil; Curitiba, Brazil; Rio de Janeiro, Brazil and 12 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.