A Phase 1/2 interventional study of Polatuzumab vedotin in B-cell Lymphoma, Burkitt Lymphoma and Diffuse Large B Cell Lymphoma, sponsored by New York Medical College. Recruiting at 1 site in United States. Open to participants aged 12 Years to 70 Years. Per ClinicalTrials.gov, last updated 2026-04-15.
Sponsored by New York Medical College · Phase 1/2, Interventional, and Treatment
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.
1,411 studies on the registry are indexed under Lymphoma, B-Cell; 329 are open to participants now.
This study's planned enrollment of 20 is below the median of 36 across 1,218 interventional studies indexed under Lymphoma, B-Cell.
Browse Lymphoma, B-Cell studies →New York Medical College is the lead sponsor of 69 studies on the registry; 23 are open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
Counted across the registry records on this site, refreshed daily.
Prior Therapy Patients must have fully recovered from the acute toxic effects of all prior chemotherapy, immunotherapy, or radiotherapy prior to entering this study.
Adequate Renal Function Defined As:
Age Maximum Serum Creatinine (mg/dL) Male Female
16 years 1.7 1.4
Adequate Liver Function Defined As:
Adequate Cardiac Function Defined As:
Adequate Pulmonary Function Defined As:
Peripheral Blood Stem Cell Collection
Exclusion Criteria:
Evaluable patients for safety Patients receiving 1 dose of Polatuzumab Vedotin will be evaluable for safety. Evaluable patients for response Only in patients who are in PR or SD prior to PV and received a minimum of 3 doses will be evaluable. Evaluable patients for EFS, PFS, OS All patients who have completed conditioning and autoSCT will be evaluable for EFS, PFS, and OS.
Drug: Polatuzumab 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.
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
EFS, PFS, and OS
To measure event free survival (EFS), progression free survival (PFS) and overall survival (OS) in patients with B-cell NHL following MAC and AutoSCT and post AutoSCT PV maintenance therapy. All patients who have completed conditioning and autoSCT will be evaluable for EFS, PFS, and OS. EFS, PFS and OS will utilize Kaplan Meier product limit curve method. Response will be defined for patients with non-Hodgkin's lymphoma who had either measurable or detectable disease at the time of study entry in accordance with the revised IPNHL response criteria (Appendix VI) for patients ≤ 21 years of age and with the Lugano classification (Appendix VII) for patients \> 21 years of age.
Time frame: 2 years
ORR
To measure overall response rate (ORR) of PV in B-cell NHL patients who are in PR or SD post MAC AutoSCT. Only in patients who are in PR or SD prior to PV and received a minimum of 3 doses will be evaluable. EFS, PFS and OS will utilize Kaplan Meier product limit curve method. Response will be defined for patients with non-Hodgkin's lymphoma who had either measurable or detectable disease at the time of study entry in accordance with the revised IPNHL response criteria (Appendix VI,\[24\]) for patients ≤ 21 years of age and with the Lugano classification (Appendix VII, \[25\]) for patients \> 21 years of age.
Time frame: 2 years
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