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Treatment Strategy for Relapsed/Refractory Hodgkin Lymphoma

ConditionsHodgkin LymphomaRefractory Hodgkin LymphomaRelapsed Hodgkin's Disease, Adult
Trial statusRecruiting
Trial phasePhase 2, Phase 3
Trial typeInterventional
Biological sexAll
Age15-90
SponsorHospital Regional de Alta Especialidad del Bajio

About this trial

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?

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Relapsed/refractory Hodgkin lymphoma to ABVD with definition of high risk.

Age ≥ 18 years and ≤ 90 years.

Total serum bilirubin ≤ 1.5 x upper limit of normal (ULN)

Serum aspartate aminotransferase (AST) ≤ 3.0 x ULN

Disqualifiers

Voluntary withdrawal from the study.

Develop grade 3 or 4 toxicity according to the INH scale.

Loss of follow-up

Trial design

Design model

Single group

Treatments tested in this trial

  • Brentuximab Vedotin 50 MG [Adcetris]

    Drug

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

Treatment groups

20 Participants
are divided into 1 treatment group
Group A: Brentuximab plus PD-1 blocked plus ASCT plus maintenance Brentuximab plus PD-1Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Progression free survival

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 outcomes

1

complete remission

complete absence of any disease assessed by PET after established treatment

Time frame
24 months
2

overall survival

status at last follow-up alive or dead

Time frame
24 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Hospital Regional de Alta Especialidad del Bajio

Lead sponsor

Universidad de Guanajuato

Collaborator

Source ClinicalTrials.gov
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