NCT03474133

Brentuximab Vedotin as Alternative to the Autologous Stem Cell Transplantation in Relapsed and Refractory Classical Hodgkin's Lymphoma (BASALT)

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 80 (estimated)
• Sponsor: Federal Research Institute of Pediatric Hematology, Oncology and Immunology · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study evaluate possibility of brentuximab vedotin, administered after first treatment failure (no response or relapse after I line therapy) of Hodgkin's lymphoma, to induce durable response or cure without autologous stem cell transplantation.

Detailed description

Brentuximab vedotin (BV) can induce durable response or cure in some patients with relapsed or refractory Hodgkin's lymphoma (RR HL) after autologous stem cell transplantation (ASCT) failure. It is expecting that BV alone administered earlier (after first treatment failure, without any additional treatment) can cure some RR HL patients and spare them from ASCT-associated risks and toxicity. Therefore in this study full course of BV which confirmed its curative potential in post-ASCT setting will be applicated to the potentially transplant-eligible RR HL patients immediately after first treatment failure, with a aim to assess curative potential of BV in this setting.

Conditions

• Hodgkin's Lymphoma

Interventions

Type	Name	Description
DRUG	Brentuximab Vedotin	brentuximab vedotin 1,8 mg/kg, intravenous infusion every 21 days, up to 16 infusions per patient during study period

Timeline

• Start date: 2019-05-14
• Primary completion: 2023-10-01
• Completion: 2023-12-02
• First posted: 2018-03-22
• Last updated: 2020-07-21

Locations

2 sites across 1 country: Russia