Treatment Strategy for Relapsed/Refractory Hodgkin Lymphoma

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

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

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Study Overview

• Status: Recruiting
• Conditions: Hodgkin Lymphoma; Refractory Hodgkin Lymphoma; Relapsed Hodgkin's Disease, Adult
• Intervention / Treatment: Drug: Brentuximab Vedotin 50 MG [Adcetris]

Detailed 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.

• Study Type: Interventional
• Enrollment (Estimated): 20
• Phase: Phase 2; Phase 3

Contacts and Locations

• Study Contact: Name: Lauro Fabián Amador, PhD; Phone Number: 4772697907; Email: lafab2013@gmail.com
• Study Contact Backup: Name: JUAN Ojeda Tovar, MD; Phone Number: (477) 267 2000; Email: juan_ojeda82@hotmail.com

Study Locations

• Mexico
  • Guanajuato
    • Leon, Guanajuato, Mexico, 37660
      • Recruiting
      • Hospital Regional Alta Especialidad Bajio
      • Contact: Lauro F Amador, Researcher; Phone Number: 1512 477 2672000; Email: lafab2013@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 13 years to 88 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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	Drug: Brentuximab Vedotin 50 MG [Adcetris]; Brentuximab plus blocked PD-1 plus ASCT plus maintenance Brentuximab plus blocked PD-1; Other Names: Pembrolizumab; Nivolumab

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
complete remission	complete absence of any disease assessed by PET after established treatment	24 months
overall survival	status at last follow-up alive or dead	24 months

Collaborators and Investigators

• Sponsor: Hospital Regional de Alta Especialidad del Bajio
• Collaborators: Universidad de Guanajuato
• Investigators: Study Director: Lauro Amador Medina, Hospital Regional Alta Especialidad Bajio

Study record dates

Study Major Dates

• Study Start (Actual): October 18, 2022
• Primary Completion (Estimated): October 18, 2025
• Study Completion (Estimated): October 18, 2025

Study Registration Dates

• First Submitted: October 19, 2022
• First Submitted That Met QC Criteria: October 24, 2022
• First Posted (Actual): October 27, 2022

Study Record Updates

• Last Update Posted (Estimated): February 23, 2024
• Last Update Submitted That Met QC Criteria: February 22, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: relapsed; refractory; hodgkin lymphoma
• Additional Relevant MeSH Terms: Immune System Diseases; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Lymphoma; Hodgkin Disease; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Antineoplastic Agents; Immunologic Factors; Antineoplastic Agents, Immunological; Immune Checkpoint Inhibitors; Immunoconjugates; Immunotoxins; Nivolumab; Pembrolizumab; Brentuximab Vedotin
• Other Study ID Numbers: CI/HRAEB/038/2022

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: We have plan to share participant data for metanalysis
• IPD Sharing Time Frame: request by researcher
• IPD Sharing Access Criteria: request by researcher
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No