Treatment Strategy for Relapsed/Refractory Hodgkin Lymphoma

Phase 2

Recruiting

• Conditions: Hodgkin Lymphoma; Refractory Hodgkin Lymphoma; Relapsed Hodgkin's Disease, Adult
• Interventions: Drug: Brentuximab Vedotin 50 MG [Adcetris]

• Registration Number: NCT05595447
• Lead Sponsor: Hospital Regional de Alta Especialidad del Bajio

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?

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 Timeline

• Study Start: 2022-10-18
• Study First Submitted: 2022-10-19
• Study First Submitted QC: 2022-10-24
• Study First Posted: 2022-10-27
• Status Verified: 2024-12
• Last Update Submitted: 2025-03-10
• Last Update Posted: 2025-03-12
• Primary Completion: 2025-10-18
• Study Completion: 2025-10-18

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 20

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Brentuximab plus PD-1 blocked plus ASCT plus maintenance Brentuximab plus PD-1	Brentuximab Vedotin 50 MG [Adcetris]	Brentuximab plus PD-1 blocked x 8 cycles plus ASCT plus maintenance Brentuximab plus PD-1 x 8 cycles

Primary Outcome Measures

Name	Time	Method
Progression free survival	24 months	From date of randomization until the date of first documented progression or date of death from any cause, whichever came first.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Hospital Regional Alta Especialidad Bajio; 🇲🇽 Leon, Guanajuato, Mexico