Polatuzumab Vedotin in Combination With Chemotherapy in Subjects With Richter's Transformation
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorWeill Medical College of Cornell University
About this trial
This study evaluates the effectiveness and safety of Polatuzumab vedotin plus infusional chemoimmunotherapy containing rituximab, etoposide, prednisone, cyclophosphamide and hydroxydaunorubicin. This is a single arm study. Enrolled patients will receive up to six cycles (21-day cycles) of therapy. While on study, subjects will be monitored weekly until end of treatment, then followed for 52 weeks or until disease progression or discontinuation due to toxicity or death. After completion of the 52-week follow-up/End of study visit, Subjects will be followed for an additional 104 week period, with an assessment occurring every 12 weeks to evaluate survival outcomes and next line of treatments only.
Eligibility criteria
Qualifiers
Subject must have confirmed diagnosis of CLL or small lymphocytic lymphoma (SLL) based upon 2018 International Workshop on CLL (IwCLL) criteria, with biopsy proven Richter's Transformation to a DLBCL subtype.
Subject must be ≥18 years of age.
Subject must be able to sign informed consent
Ability and willingness to comply with the study protocol procedures
Disqualifiers
Diagnosis of Richter's Transformation not of DLBCL subtype (including but not limited to Hodgkin lymphoma, PLL)
Prior therapy targeting Richter's transformation.
Any subject that initiates a targeted agent such as BTKi, venetoclax, or PI3K prior to enrollment (Continuation of a targeted CLL directed therapy such as a BTKi, venetoclax, or PI3K will be permitted as a bridge through screening but add on therapies or change in therapy will be exclusionary. These continuation therapies will be permitted up 72 hours prior to study initiation. Bridging therapy with steroid up to equivalent of 40mg of Dexamethasone daily will be allowed prior to study treatment and can be continued up to 24 hours prior to study treatment)
Subject has undergone an allogeneic stem cell transplant for CLL within 6 months of study entry.
Trial design
Treatments tested in this trial
- Polatuzumab Vedotin
- Rituximab
- Etoposide
- Prednisone
- Cyclophosphamide
- Hydroxydaunomycin
Treatment groups
20 Participants
are divided into 1 treatment groupSponsors and collaborators
Weill Medical College of Cornell University
Lead sponsor
Genentech, Inc.
Collaborator
Source ClinicalTrials.gov