Treatment Strategy for Relapsed/Refractory Hodgkin Lymphoma

Sponsor

Hospital Regional de Alta Especialidad del Bajio (Other)

Overall Status

Recruiting

CT.gov ID

NCT05595447

Collaborator

Universidad de Guanajuato (Other)

Enrollment

Location

Arm

Anticipated Duration (Months)

0.8

Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Hodgkin Lymphoma Refractory Hodgkin Lymphoma Relapsed Hodgkin's Disease, Adult	Drug: Brentuximab Vedotin 50 MG [Adcetris]	Phase 2/Phase 3

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 Design

Study Type:

Interventional

Anticipated Enrollment :

20 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Intervention Model Description:

Brentuximab plus PD-1 blocked x 8 plus ASCT (PEAM condicioning) plus maintanance Brentuximab plus PD-1 x 8 cyclesBrentuximab plus PD-1 blocked x 8 plus ASCT (PEAM condicioning) plus maintanance Brentuximab plus PD-1 x 8 cycles

Masking:

None (Open Label)

Primary Purpose:

Treatment

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

Actual Study Start Date :

Oct 18, 2022

Anticipated Primary Completion Date :

Oct 18, 2024

Anticipated Study Completion Date :

Oct 18, 2024

Arms and Interventions

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: Nivolumab Pembrolizumab

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:

Nivolumab

Pembrolizumab

Outcome Measures

Primary Outcome Measures

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

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

15 Years to 90 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

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.