A Study of BI-1206 in Combination With Rituximab With or Without Acalabrutinib in Subjects With I… (NCT03571568) | Clinical Trial Compass
RecruitingPhase 1/2
A Study of BI-1206 in Combination With Rituximab With or Without Acalabrutinib in Subjects With Indolent B-Cell NHL
United States, Brazil140 participantsStarted 2018-05-16
Plain-language 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
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion 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
Exclusion criteria
✕. 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,
What they're measuring
1
Documenting AEs and SAEs and determining causality in relation to BI-1206 and/or rituximab and/or acalabrutinib
Timeframe: During the 28-day treatment period on induction therapy
2
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)
Timeframe: During the 28-day treatment period on induction therapy
3
Determine the recommended dose of BI-1206 in combination with rituximab and acalabrutinib
Timeframe: During the 28-day treatment period on induction therapy
✕. 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