Treatment Strategy for Relapsed/Refractory Hodgkin Lymphoma
NCT ID: NCT05595447
Last Updated: 2025-03-12
Study Results
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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RECRUITING
PHASE2/PHASE3
20 participants
INTERVENTIONAL
2022-10-18
2025-10-18
Brief Summary
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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?
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
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
Brentuximab Vedotin 50 MG [Adcetris]
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
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
2. Develop grade 3 or 4 toxicity according to the INH scale.
3. Loss of follow-up
15 Years
90 Years
ALL
Yes
Sponsors
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Universidad de Guanajuato
OTHER
Hospital Regional de Alta Especialidad del Bajio
OTHER
Responsible Party
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Lauro Fabian Amador Medina
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
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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CI/HRAEB/038/2022
Identifier Type: -
Identifier Source: org_study_id
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