Rescue With Brentuximab Plus PD-1 Blockade Followed by Autotransplantation and Consolidation With Brentuximab Plus PD-1 Blockade in Patients With Relapsed/Refractory Hodgkin Lymphoma: Exploratory Single-arm Analysis

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2/Phase 3
SUMMARY

The choice of the best second-line therapy in patients with high LH R/R risk, it is a niche of knowledge not covered at the moment, especially the role of Brentuximab (BV) plus PD-1 blockade and auto-HSCT. What is the progression-free survival and rate of metabolic responses complete in patients with high-risk R/R HL with the treatment strategy: BV+ PD-1 blockade consolidation with Auto-HSCT and maintenance with BV + PD-blockade 1?

Eligibility
Participation Requirements
Sex: All
Minimum Age: 15
Maximum Age: 90
Healthy Volunteers: t
View:

• Relapsed/refractory Hodgkin lymphoma to ABVD with definition of high risk.

• Age ≥ 18 years and ≤ 90 years.

• Adequate liver function, defined as:

‣ Total serum bilirubin ≤ 1.5 x upper limit of normal (ULN)

⁃ Serum aspartate aminotransferase (AST) ≤ 3.0 x ULN

⁃ Serum alanine aminotransferase (ALT) ≤ 3.0 x ULN

• Adequate renal functions, defined as:

• • Serum creatinine ≤ 1.5x ULN or glomerular filtration rate \> 50ml/min.

• ECOG performance status ≤ 3

• Women of reproductive potential should have a serum pregnancy test or negative urine.

• Prior signature of the informed consent.

Locations
Other Locations
Mexico
Hospital Regional Alta Especialidad Bajio
RECRUITING
León
Contact Information
Primary
Lauro Fabián Amador, PhD
lafab2013@gmail.com
4772697907
Backup
JUAN Ojeda Tovar, MD
juan_ojeda82@hotmail.com
(477) 267 2000
Time Frame
Start Date: 2022-10-18
Estimated Completion Date: 2025-10-18
Participants
Target number of participants: 20
Treatments
Experimental: Brentuximab plus PD-1 blocked plus ASCT plus maintenance Brentuximab plus PD-1
Brentuximab plus PD-1 blocked x 8 cycles plus ASCT plus maintenance Brentuximab plus PD-1 x 8 cycles
Related Therapeutic Areas
Sponsors
Collaborators: Universidad de Guanajuato
Leads: Hospital Regional de Alta Especialidad del Bajio

This content was sourced from clinicaltrials.gov