Trials / Recruiting

RecruitingNCT04491370

Autologous Stem Cell Transplant Followed by Polatuzumab Vedotin in Patients With B-cell Non-Hodgkin and Hodgkin Lymphoma

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

Status: Recruiting
Phase: Phase 1 / Phase 2
Study type: Interventional
Enrollment: 20 (estimated)

Sponsor: New York Medical College · Academic / Other
Sex: All
Age: 12 Years – 70 Years
Healthy volunteers: Not accepted

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.

Conditions

Interventions

Type	Name	Description
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.

Timeline

Start date: 2021-08-01
Primary completion: 2026-08-15
Completion: 2027-08-15
First posted: 2020-07-29
Last updated: 2026-04-15

Locations

1 site across 1 country: United States

Regulatory

FDA-regulated drug study

Source: ClinicalTrials.gov record NCT04491370. Inclusion in this directory is not an endorsement.