Treatment Strategy for Relapsed/Refractory Hodgkin Lymphoma

NCT05595447 | Recruiting Phase 2

• 1 other identifier: CI/HRAEB/038/2022
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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?

Conditions

Hodgkin Lymphoma; Refractory Hodgkin Lymphoma; Relapsed Hodgkin's Disease, Adult

Keywords

refractory; relapsed; hodgkin lymphoma

Outcome Measures

Primary Outcomes (1)

• Progression free survival

  From date of randomization until the date of first documented progression or date of death from any cause, whichever came first.

  24 months

Secondary Outcomes (2)

• complete remission

  24 months

• overall survival

  24 months

Study Arms (1)

Brentuximab plus PD-1 blocked plus ASCT plus maintenance Brentuximab plus PD-1

EXPERIMENTAL

Brentuximab plus PD-1 blocked x 8 cycles plus ASCT plus maintenance Brentuximab plus PD-1 x 8 cycles

Drug: Brentuximab Vedotin 50 MG [Adcetris]

Interventions

Brentuximab Vedotin 50 MG [Adcetris] DRUG

Brentuximab plus blocked PD-1 plus ASCT plus maintenance Brentuximab plus blocked PD-1

Also known as: Nivolumab, Pembrolizumab

Brentuximab plus PD-1 blocked plus ASCT plus maintenance Brentuximab plus PD-1

Eligibility Criteria

• Age: 15 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Voluntary withdrawal from the study.
• Develop grade 3 or 4 toxicity according to the INH scale.
• Loss of follow-up

Sponsors & Collaborators

• Hospital Regional de Alta Especialidad del Bajio: lead
• Universidad de Guanajuato: collaborator

Study Sites (1)

Hospital Regional Alta Especialidad Bajio

León, Guanajuato, 37660, Mexico

RECRUITING

Related Publications (1)

• Barrera Chavez ID, Viloria Alvarez JC, Zendejas Sanchez V, Rodriguez Esquivel A, Alvarez Salinas A, Amador Medina LF. Efficacy of Brentuximab-Vedotin Combined with PD-1 Inhibitors in Relapsed/Refractory Hodgkin Lymphoma with ASCT Consolidation and Maintenance Therapy: A Phase 2 Clinical Trial. Indian J Hematol Blood Transfus. 2026 Jan;42(1):93-99. doi: 10.1007/s12288-025-01986-0. Epub 2025 Feb 17.

  PMID: 41522540 DERIVED

MeSH Terms

Conditions

Hodgkin Disease; Recurrence

Interventions

Brentuximab Vedotin; Nivolumab; pembrolizumab

Condition Hierarchy (Ancestors)

Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Oligopeptides; Peptides; Amino Acids, Peptides, and Proteins; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Serum Globulins; Globulins

Study Officials

• Lauro Amador Medina

  Hospital regional Alta especialidad Bajío

  STUDY DIRECTOR

Central Study Contacts

Lauro Fabián Amador, PhD

CONTACT

4772697907; lafab2013@gmail.com

JUAN Ojeda Tovar, MD

CONTACT

(477) 267 2000; juan_ojeda82@hotmail.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Brentuximab plus PD-1 blocked x 8 plus ASCT (PEAM condicioning) plus maintanance Brentuximab plus PD-1 x 8 cycles

Study Record Dates

• First Submitted: October 19, 2022
• First Posted: October 27, 2022
• Study Start: October 18, 2022
• Primary Completion: October 18, 2025
• Study Completion: October 18, 2025
• Last Updated: March 12, 2025

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: request by researcher
• Access Criteria: request by researcher

Locations

ME (1)