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 Biospecimen Collection, Bone Marrow Aspiration, or Bone Marrow Biopsy. The registry lists allocation as na. This phase I trial tests the safety, side effects and best dose of ruxolitinib in combination with cyclophosphamide, doxorubicin, vincristine, prednisone (CHOP) chemotherapy and how well the combination works in treating patients with untreated nodal T-follicular helper (TFH) cell lymphoma.
They plan to enroll about 20 people at Duarte. 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)
Ruxolitinib in Combination With Chemotherapy for Untreated Nodal T-Follicular Helper (TFH) Cell Lymphomas
Interventions: Biospecimen Collection, Bone Marrow Aspiration, Bone Marrow Biopsy, Computed Tomography, Cyclophosphamide, Doxorubicin, Echocardiography Test, FDG-Positron Emission Tomography, Filgrastim, Fludeoxyglucose F-18, Multigated Acquisition Scan, Pegfilgrastim, Prednisone, Questionnaire Administration, Ruxolitinib Phosphate, Vincristine
Primary outcome (registry wording): Maximum tolerated dose (MTD) of ruxolitinib when given in combination with cyclophosphamide, doxorubicin, vincristine, prednisone (CHOP) chemotherapy