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Treatment Strategy for Relapsed/Refractory Hodgkin Lymphoma

Primary Purpose

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

Status
Recruiting
Phase
Phase 2
Locations
Mexico
Study Type
Interventional
Intervention
Brentuximab Vedotin 50 MG [Adcetris]
Sponsored by
Hospital Regional de Alta Especialidad del Bajio
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hodgkin Lymphoma focused on measuring refractory, relapsed, hodgkin lymphoma

Eligibility Criteria

15 Years - 90 Years (Child, Adult, Older Adult)All SexesAccepts 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

Sites / Locations

  • Hospital Regional Alta Especialidad BajioRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

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

Arm Description

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

Outcomes

Primary Outcome Measures

Progression free survival
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
complete absence of any disease assessed by PET after established treatment
overall survival
status at last follow-up alive or dead

Full Information

First Posted
October 19, 2022
Last Updated
October 24, 2022
Sponsor
Hospital Regional de Alta Especialidad del Bajio
Collaborators
Universidad de Guanajuato
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1. Study Identification

Unique Protocol Identification Number
NCT05595447
Brief Title
Treatment Strategy for Relapsed/Refractory Hodgkin Lymphoma
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Recruiting
Study Start Date
October 18, 2022 (Actual)
Primary Completion Date
October 18, 2024 (Anticipated)
Study Completion Date
October 18, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hospital Regional de Alta Especialidad del Bajio
Collaborators
Universidad de Guanajuato

4. Oversight

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
Data Monitoring Committee
No

5. 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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hodgkin Lymphoma, Refractory Hodgkin Lymphoma, Relapsed Hodgkin's Disease, Adult
Keywords
refractory, relapsed, hodgkin lymphoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Single Group Assignment
Model Description
Brentuximab plus PD-1 blocked x 8 plus ASCT (PEAM condicioning) plus maintanance Brentuximab plus PD-1 x 8 cycles
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Brentuximab plus PD-1 blocked plus ASCT plus maintenance Brentuximab plus PD-1
Arm Type
Experimental
Arm Description
Brentuximab plus PD-1 blocked x 8 cycles plus ASCT plus maintenance Brentuximab plus PD-1 x 8 cycles
Intervention Type
Drug
Intervention Name(s)
Brentuximab Vedotin 50 MG [Adcetris]
Other Intervention Name(s)
Nivolumab, Pembrolizumab
Intervention Description
Brentuximab plus blocked PD-1 plus ASCT plus maintenance Brentuximab plus blocked PD-1
Primary Outcome Measure Information:
Title
Progression free survival
Description
From date of randomization until the date of first documented progression or date of death from any cause, whichever came first.
Time Frame
24 months
Secondary Outcome Measure Information:
Title
complete remission
Description
complete absence of any disease assessed by PET after established treatment
Time Frame
24 months
Title
overall survival
Description
status at last follow-up alive or dead
Time Frame
24 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
15 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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. Exclusion Criteria: Voluntary withdrawal from the study. Develop grade 3 or 4 toxicity according to the INH scale. Loss of follow-up
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Lauro Fabián Amador, PhD
Phone
4772697907
Email
lafab2013@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
JUAN Ojeda Tovar, MD
Phone
(477) 267 2000
Email
juan_ojeda82@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lauro Amador Medina
Organizational Affiliation
Hospital regional Alta especialidad Bajío
Official's Role
Study Director
Facility Information:
Facility Name
Hospital Regional Alta Especialidad Bajio
City
Leon
State/Province
Guanajuato
ZIP/Postal Code
37660
Country
Mexico
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lauro F Amador, Researcher
Phone
477 2672000
Ext
1512
Email
lafab2013@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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

Learn more about this trial

Treatment Strategy for Relapsed/Refractory Hodgkin Lymphoma

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