Treatment Strategy for Relapsed/Refractory Hodgkin Lymphoma

Hodgkin Lymphoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05595447
• Other study ID #: CI/HRAEB/038/2022
• Status: Recruiting
• Phase: Phase 2/Phase 3
• Start date: October 18, 2022
• Est. completion date: October 18, 2025

Study information

• Verified date: February 2024
• Source: Hospital Regional de Alta Especialidad del Bajio
• Contact: Lauro Fabián Amador, PhD
• Phone: 4772697907
• Email: lafab2013[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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?

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: October 18, 2025
• Est. primary completion date: October 18, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 15 Years to 90 Years

Eligibility

Inclusion Criteria:

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

2. Age = 18 years and = 90 years.

3. 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

4. Adequate renal functions, defined as:

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

5. ECOG performance status = 3

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

7. Prior signature of the informed consent.

Exclusion Criteria:

1. Voluntary withdrawal from the study.

2. Develop grade 3 or 4 toxicity according to the INH scale.

3. Loss of follow-up

Related Conditions & MeSH terms

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

Intervention

Drug:
• Brentuximab Vedotin 50 MG [Adcetris]
Brentuximab plus blocked PD-1 plus ASCT plus maintenance Brentuximab plus blocked PD-1

Locations

Country	Name	City	State
Mexico	Hospital Regional Alta Especialidad Bajio	Leon	Guanajuato

Sponsors (2)

Lead Sponsor	Collaborator
Hospital Regional de Alta Especialidad del Bajio	Universidad de Guanajuato

Country where clinical trial is conducted

Mexico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	complete remission	complete absence of any disease assessed by PET after established treatment	24 months
Secondary	overall survival	status at last follow-up alive or dead	24 months