Treatment Strategy for Relapsed/Refractory Hodgkin Lymphoma

NCT ID: NCT05595447

Last Updated: 2025-03-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE2/PHASE3

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-10-18

Study Completion Date

2025-10-18

Brief Summary

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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

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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.

Conditions

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

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Brentuximab plus PD-1 blocked x 8 plus ASCT (PEAM condicioning) plus maintanance Brentuximab plus PD-1 x 8 cycles
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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

Group Type EXPERIMENTAL

Brentuximab Vedotin 50 MG [Adcetris]

Intervention Type DRUG

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

Interventions

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Brentuximab Vedotin 50 MG [Adcetris]

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

Intervention Type DRUG

Other Intervention Names

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Nivolumab Pembrolizumab

Eligibility Criteria

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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
Minimum Eligible Age

15 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Universidad de Guanajuato

OTHER

Sponsor Role collaborator

Hospital Regional de Alta Especialidad del Bajio

OTHER

Sponsor Role lead

Responsible Party

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Lauro Fabian Amador Medina

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Lauro Amador Medina

Role: STUDY_DIRECTOR

Hospital regional Alta especialidad Bajío

Locations

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Hospital Regional Alta Especialidad Bajio

León, Guanajuato, Mexico

Site Status RECRUITING

Countries

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Mexico

Central Contacts

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Lauro Fabián Amador, PhD

Role: CONTACT

4772697907

JUAN Ojeda Tovar, MD

Role: CONTACT

(477) 267 2000

Facility Contacts

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Lauro F Amador, Researcher

Role: primary

477 2672000 ext. 1512

Other Identifiers

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CI/HRAEB/038/2022

Identifier Type: -

Identifier Source: org_study_id

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