Safety and Tolerability of Myeloablative Conditioning and Autologous Stem Cell Transplantation Followed by Polatuzumab Vedotin (PV) Immunoconjugate Therapy in Patients With B-cell Non-Hodgkin and Hodgkin Lymphoma
Summary
Patients will receive one of two conditioning regimens (BEAM or CBV) before receiving an autologous stem cell transplant (ASCT). If patients achieve either complete, partial, or stable response following ASCT, they will receive an IV dose of Polatuzumab Vedotin once every 21 days until they receive 8 doses. After Polatuzumab Vedotin therapy is completed, patients will be followed every 4 months for about 2 years.
Arms & interventions
- DrugPolatuzumab vedotin
All patients will receive a myeloablative conditioning regimens (BEAM or CBV, as selected by the treating physician) followed by autologous stem cell transplant (ASCT). All patients on this study will receive an autologous stem cell transplant (ASCT) on Day 0 followed by supportive care including the drugs sargarmostim and filgrastim until blood counts are stable. If a complete, partial, or stable response is achieved following ASCT, the patient will receive an IV dose of Polatuzumab Vedotin once every 21 days until he/she receives 8 doses.
Outcome measures
Primary
Safety and tolerability
To evaluate the safety and tolerability of Polatuzumab vedotin (PV) immunoconjugate therapy post myeloablative conditioning (MAC) and autologous stem cell transplantation (AutoSCT) in patients with B-cell non-Hodgkin lymphoma (NHL). Patients receiving 1 dose of Polatuzumab Vedotin will be evaluable for safety. To determine the safety events: Number of participants with treatment-related Grade III or higher adverse events as assessed by CTCAE v5.0. To determine the occurrence of any Grade ≥ 3 non hematologic toxicity (per CTCAE v.5) which is possibly, probably, or definitely related to polatuzumab vedotin.
Time frame: 1 year
Secondary
EFS, PFS, and OS
Time frame: 2 years
ORR
Time frame: 2 years
Eligibility criteria
Study locations (1)
New York Medical Center
Valhalla, New York, 10595