To hear about similar clinical trials, please enter your email below
Trial Title:
Treatment Strategy for Relapsed/Refractory Hodgkin Lymphoma
NCT ID:
NCT05595447
Condition:
Hodgkin Lymphoma
Refractory Hodgkin Lymphoma
Relapsed Hodgkin's Disease, Adult
Conditions: Official terms:
Lymphoma
Hodgkin Disease
Pembrolizumab
Nivolumab
Brentuximab Vedotin
Conditions: Keywords:
refractory
relapsed
hodgkin lymphoma
Study type:
Interventional
Study phase:
Phase 2/Phase 3
Overall status:
Recruiting
Study design:
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 cycles
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Brentuximab Vedotin 50 MG [Adcetris]
Description:
Brentuximab plus blocked PD-1 plus ASCT plus maintenance Brentuximab plus blocked PD-1
Arm group label:
Brentuximab plus PD-1 blocked plus ASCT plus maintenance Brentuximab plus PD-1
Other name:
Nivolumab
Other name:
Pembrolizumab
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.
Criteria for eligibility:
Criteria:
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
Gender:
All
Minimum age:
15 Years
Maximum age:
90 Years
Healthy volunteers:
Accepts Healthy Volunteers
Locations:
Facility:
Name:
Hospital Regional Alta Especialidad Bajio
Address:
City:
Leon
Zip:
37660
Country:
Mexico
Status:
Recruiting
Contact:
Last name:
Lauro F Amador, Researcher
Phone:
477 2672000
Phone ext:
1512
Email:
lafab2013@gmail.com
Start date:
October 18, 2022
Completion date:
October 18, 2025
Lead sponsor:
Agency:
Hospital Regional de Alta Especialidad del Bajio
Agency class:
Other
Collaborator:
Agency:
Universidad de Guanajuato
Agency class:
Other
Source:
Hospital Regional de Alta Especialidad del Bajio
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05595447
