What this phase means
Phase 1: the first tests in people. The main question is safety and dose, not whether it cures the condition. Groups are small. Side effects are watched closely.
Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.
What the registry says happens
If you join, the listed intervention(s) are Biopsy Procedure, Biospecimen Collection, or Bone Marrow Aspiration. The registry lists allocation as na. This phase I trial studies the safety and side effects of glofitamab plus a chemoimmunotherapy regimen called R-CHOP (rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone) in treating patients newly-diagnosed with HIV-associated large B-cell lymphoma.
They plan to enroll about 15 people at Rockville. Taking part typically means taking a study drug (or dummy pill), an infusion or injection of a biologic, a procedure as part of the study plus check-ins.
Official title (unrewritten)
A Feasibility Study of Glofitamab Plus Chemoimmunotherapy in Newly Diagnosed HIV-Associated Large B-Cell Lymphoma
Interventions: Biopsy Procedure, Biospecimen Collection, Bone Marrow Aspiration, Bone Marrow Biopsy, Computed Tomography, Cyclophosphamide, Doxorubicin Hydrochloride, Echocardiography Test, Glofitamab, Positron Emission Tomography, Prednisone, Questionnaire Administration, Rituximab, Vincristine Sulfate
Primary outcome (registry wording): Ability to deliver at least 4 full cycles of glofitamab-rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone (Glofit-RCHOP) (Feasibility)