Treatment Strategy for Relapsed/Refractory Hodgkin Lymphoma

Hospital Regional de Alta Especialidad del Bajio

Status and phase: Enrolling; Phase 3; Phase 2

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

Treatments: Drug: Brentuximab Vedotin 50 MG [Adcetris]

Study type: Interventional

Funder types: Other

Identifiers

NCT05595447

CI/HRAEB/038/2022

Details and patient eligibility

About

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?

Full 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.

Enrollment: 20 estimated patients

Sex: All

Ages: 15 to 90 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

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

Experimental group

Description:

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

Treatment:

Drug: Brentuximab Vedotin 50 MG [Adcetris]