NCT04334174

Study of Brentuximab Vedotin as Therapy After Autologous Stem Cell Transplant in Cluster of Differentiation Antigen 30 (CD30) Positive Peripheral TCell Lymphomas

A Phase II Single Arm Proof of Concept, Safety, Efficacy, Multicenter Study of Brentuximab Vedotin as Consolidation Therapy After Autologous Stem Cell Transplant in CD30 Expressing Peripheral T Cell Lymphomas

• Status: Withdrawn
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: University of Kansas Medical Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

For participants with CD30 positive Mature T-cell lymphomas who have received brentuximab vedotin, cyclophosphamide, doxorubicin, and prednisone (A-CHP) as induction (4 to 6 cycles) and achieved complete response (CR) or chemo-sensitive partial response (PR) and deemed suitable for autologous stem cell transplant (ASCT) as consolidation, the investigators propose to add brentuximab vedotin after ASCT. There is currently no standard of care treatment to prevent relapse after upfront treatment or ASCT for CD30-positive peripheral T-cell lymphoma's (PTCL)s. An agent that could improve outcomes in this population would be a major contribution to the field and is likely to be practice changing. Therefore, in addition to studying the anti-lymphoma activity of A-CHP as induction therapy, for participants who respond to induction the investigators propose to add brentuximab vedotin consolidation after ASCT in participants treated with consolidative upfront ASCT.

Conditions

• T Cell Lymphoma

Interventions

Type	Name	Description
DRUG	Brentuximab Vedotin	Brentuximab Vedotin will be dosed at 1.8 milligram (mg) per (/) kilogram (Kg) of participants body weight will be infused intravenously every three weeks for up to ten infusions.

Timeline

• Start date: 2020-05-29
• Primary completion: 2022-12-14
• Completion: 2023-02-01
• First posted: 2020-04-06
• Last updated: 2023-02-03

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study