Hodgkin LymphomaPhase 2/3NCT05595447
Treatment Strategy for Relapsed/Refractory Hodgkin Lymphoma
A Phase 2/3 study testing Brentuximab Vedotin 50 MG [Adcetris] in people with Hodgkin Lymphoma and Refractory Hodgkin Lymphoma, run by Hospital Regional de Alta Especialidad del Bajio at 1 site in Mexico.
Trial 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. Read more about this study
- Who is it for?
- Ages 15 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Hodgkin Lymphoma, Refractory Hodgkin Lymphoma, Relapsed Hodgkin's Disease, Adult
- What is being tested?
- Brentuximab Vedotin 50 MG [Adcetris]
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteMexico
- Study dates
- 18 Oct 2022to 18 Oct 2025
- Phase
- Phase 2/3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 90 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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
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- 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.
Who cannot join
- Voluntary withdrawal from the study.
- Develop grade 3 or 4 toxicity according to the INH scale.
- Loss of follow-up
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Mexico1 site, 1 recruiting
- Recruiting
Hospital Regional Alta Especialidad Bajio
León, Guanajuato, 37660
Lauro F Amador, Researcher, 477 2672000 ext. 1512, lafab2013@gmail.com
About this study
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
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?
Read the 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.
- Being tested
- Brentuximab Vedotin 50 MG [Adcetris]
- Keywords
- refractory, relapsed, hodgkin lymphoma
- Medical subject headings
- Hodgkin Disease, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Brentuximab Vedotin 50 MG [Adcetris]Drug
Also called Nivolumab, Pembrolizumab
Brentuximab plus blocked PD-1 plus ASCT plus maintenance Brentuximab plus blocked PD-1
| Study group | Role | What they receive |
|---|---|---|
| Brentuximab plus PD-1 blocked plus ASCT plus maintenance Brentuximab plus PD-1 | Experimental | Brentuximab plus PD-1 blocked x 8 cycles plus ASCT plus maintenance Brentuximab plus PD-1 x 8 cycles Receives: Drug: Brentuximab Vedotin 50 MG [Adcetris] |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression free survival
From date of randomization until the date of first documented progression or date of death from any cause, whichever came first.
Measured: 24 months
Secondary outcomes (2)
complete remission
complete absence of any disease assessed by PET after established treatment
Measured: 24 months
overall survival
status at last follow-up alive or dead
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2022
- Study start18 Oct 2022
- Primary completion18 Oct 2025 (estimated)
- Study completion18 Oct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hodgkin LymphomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- 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)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital Regional de Alta Especialidad del Bajio
- Sponsor type
- University, hospital or other
- Collaborators
- Universidad de Guanajuato
- Responsible party
- Principal investigator, Lauro Fabian Amador Medina, Hospital Regional de Alta Especialidad del Bajio
- Investigators
- Lauro Amador Medina, Study director, Hospital regional Alta especialidad Bajío
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05595447
- Sponsor's protocol ID
- CI/HRAEB/038/2022
- Status last verified
- Dec 2024
- First submitted
- 19 Oct 2022
- Last updated
- 12 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: We have plan to share participant data for metanalysis
Publications
Barrera Chavez ID, Viloria Alvarez JC, Zendejas Sanchez V, Rodriguez Esquivel A, Alvarez Salinas A, Amador Medina LF. Efficacy of Brentuximab-Vedotin Combined with PD-1 Inhibitors in Relapsed/Refractory Hodgkin Lymphoma with ASCT Consolidation and Maintenance Therapy: A Phase 2 Clinical Trial. Indian J Hematol Blood Transfus. 2026 Jan;42(1):93-99. doi: 10.1007/s12288-025-01986-0. Epub 2025 Feb 17.
PubMed 41522540
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05595447
- Acronym / sponsor ID
- CI/HRAEB/038/2022
- Keywords
- refractory, relapsed, hodgkin lymphoma
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Hospital Regional de Alta Especialidad del BajioUniversity, hospital or other
- Collaborators
- Universidad de Guanajuato
- Study start
- 18 Oct 2022 (actual)
- Primary completion
- 18 Oct 2025 (estimated)
- Study completion
- 18 Oct 2025 (estimated)
- First posted
- 27 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Brentuximab plus PD-1 blocked x 8 plus ASCT (PEAM condicioning) plus maintanance Brentuximab plus PD-1 x 8 cycles
| Arm | Type | Receives |
|---|---|---|
| Brentuximab plus PD-1 blocked plus ASCT plus maintenance Brentuximab plus PD-1 | Experimental | Drug: Brentuximab Vedotin 50 MG [Adcetris]Brentuximab plus PD-1 blocked x 8 cycles plus ASCT plus maintenance Brentuximab plus PD-1 x 8 cycles |
Who may qualify
- Ages
- 15 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (11 listed)
- Relapsed/refractory Hodgkin lymphoma to ABVD with definition of high risk.
- Age ≥ 18 years and ≤ 90 years.
- Adequate liver function, defined as:
- Adequate renal functions, defined as:
- ECOG performance status ≤ 3
Key exclusion criteria (3 listed)
- Voluntary withdrawal from the study.
- Develop grade 3 or 4 toxicity according to the INH scale.
- Loss of follow-up
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Brentuximab Vedotin 50 MG [Adcetris]Also: Nivolumab, PembrolizumabBrentuximab plus blocked PD-1 plus ASCT plus maintenance Brentuximab plus blocked PD-1 | Drug | Brentuximab plus PD-1 blocked plus ASCT plus maintenance Brentuximab plus PD-1 |
Primary outcome
Progression free survival
Time frame: 24 months
From date of randomization until the date of first documented progression or date of death from any cause, whichever came first.
2 secondary outcomes
complete remission
Time frame: 24 months
overall survival
Time frame: 24 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2025.
- Derived from this study: PubMed 41522540Barrera Chavez ID, Viloria Alvarez JC, Zendejas Sanchez V, Rodriguez Esquivel A, Alvarez Salinas A, Amador Medina LF. Efficacy of Brentuximab-Vedotin Combined with PD-1 Inhibitors in Relapsed/Refractory Hodgkin Lymphoma with ASCT Consolidation and Maintenance Therapy: A Phase 2 Clinical Trial. Indian J Hematol Blood Transfus. 2026 Jan;42(1):93-99. doi: 10.1007/s12288-025-01986-0. Epub 2025 Feb 17.
- Individual participant dataSharing planned: Yes. We have plan to share participant data for metanalysis
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Lauro Amador Medina study director
Hospital regional Alta especialidad Bajío
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Brentuximab Vedotin 50 MG [Adcetris] in people with Hodgkin Lymphoma and Refractory Hodgkin Lymphoma, run by Hospital Regional de Alta Especialidad del Bajio at 1 site in Mexico.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 12 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lauro Fabián Amador, PhD (4772697907, lafab2013@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression free survival (time frame: 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05595447, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Mar 2025.