Hospital Regional Alta Especialidad Bajio
León, Guanajuato, 37660, Mexico
Location status: Recruiting
NCT Number: NCT05595447
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?
Interested in participating?
Request Info15 year–90 year
All sexes
Interventional
Phase 2 / Phase 3
León, Guanajuato, 37660, Mexico
Location status: Recruiting
Patientes with Refractory/relapsed Hodgkin Lymphoma (HL R/R) with multiple failed therapies represent a therapeutic dilemma. The goal of next-line treatment is long-term disease control with manageable adverse reactions. Given the limited therapeutic options for patients with HL R/R, better therapies should be sought, more effective, with better tolerability, less toxicity, with increased overall survival (OS) of the patients, with the aim of improving outcomes in terms of disease-free survival progression (PFS) of the current standard treatment. Since currently only 50% of the patients with high-risk R/R HL treated with the standard regimen achieve healing. The high effectiveness and low toxicity of immunotherapy with prolonged remission or stabilization of the disease make it a new treatment option promising for HL R/R. Based on the above, a treatment strategy is proposed to rescue base with Brentuximab plus PD-1 blockade followed by autotransplantation and consolidation with Brentuximab plus PD-1 blockade in patients with Hodgkin lymphoma High-Risk Relapse/Refractory Compared to Reported OS and PFS Rates in the literature obtained with standard treatment.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Brentuximab plus blocked PD-1 plus ASCT plus maintenance Brentuximab plus blocked PD-1
Other names: Nivolumab, Pembrolizumab
Time frame: 24 months
From date of randomization until the date of first documented progression or date of death from any cause, whichever came first.
Time frame: 24 months
complete absence of any disease assessed by PET after established treatment
Time frame: 24 months
status at last follow-up alive or dead
Contact information is provided by the study sponsor or research team.
JUAN Ojeda Tovar, MD
CONTACT
Lauro Fabián Amador, PhD
CONTACT
Hospital Regional de Alta Especialidad del Bajio
Other
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
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT04938232
Hemic and Lymphatic Diseases, Hodgkin Disease
Chicago, Illinois, United States
View Trial DetailsNCT03618550
Disease Attributes, Hemic and Lymphatic Diseases
Duarte, California, United States
View Trial DetailsNCT06090864
Disease Attributes, Hemic and Lymphatic Diseases
Chapel Hill, North Carolina, United States
View Trial DetailsNCT05798897
Disease Attributes, Hemic and Lymphatic Diseases
Duarte, California, United States
View Trial Details