Hodgkin Lymphoma, AdultPhase 2BRESELIBETNCT04378647
BREntuximab Vedotin in SEcond LIne Therapy BEfore Transplant
A Phase 2 study testing Induction with Brentuximab vedotin (BV), Induction without Brentuximab Vedotin and Consolidation with Brentuximab Vedotin in people with Hodgkin Lymphoma, Adult, run by Grupo Español de Linfomas y Transplante Autólogo de Médula Ósea at 19 sites in Spain.
Trial summary
A Randomized Phase IIb Study, Evaluating Efficacy of Salvage Therapy with Brentuximab Vedotin-ESHAP vs ESHAP in Patients with Relapsed / Refractory Classical Hodgkin's Lymphoma, Followed by Brentuximab Vedotin Consolidation (instead of Autologous Hematopoietic Stem Cell Transplantation) in Those who Attained a… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Hodgkin Lymphoma, Adult
- What is being tested?
- Induction with Brentuximab vedotin (BV), Induction without Brentuximab Vedotin and Consolidation with Brentuximab Vedotin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 19 sitesSpain
- Study dates
- 1 Jun 2020to 30 Aug 2026
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with classical HL CD30+ confirmed histologically (either at the time of diagnosis / at the time of first relapse) will be included in the trial
- Male or female patients 18 to 65 years of age
- Voluntary written informed consent must be given before performance of any study-related procedure not part of standard medical care, with the understanding that consent may be withdrawn by the patient at any time without prejudice to future medical care
- Female patient is either post-menopausal for at least 1 year before the screening visit or surgically sterile or if of childbearing potential, agree to practice 2 effective methods of contraception, at the same time, from the time of signing the informed consent through 6 months after the last dose of study drug, or agrees to completely abstain from heterosexual intercourse
- Male patients, even if surgically sterilized, (i.e., status post-vasectomy) agree to practice effective barrier contraception during the entire study period and through 6 months after the last dose of study drug, or agrees to completely abstain from heterosexual intercourse
- ECOG 0 to 2
Show all 9Show fewer
- Measurable disease at time of enrolment (lymphadenopathy/ extranodal mass of at least 1.5 cm)
- No evidence of neuropathy grade ≥2
- Clinical laboratory values as specified in the protocol below within 7 days before the first dose of study drug
Who cannot join
- Lymphocyte predominant nodular Hodgkin's lymphoma
- Prior treatment with brentuximab vedotin
- Female patient who are both lactating and breast-feeding or have a positive serum pregnancy test during the screening period or a positive pregnancy test on Day 1 before first dose of study drug
- Any serious medical or psychiatric illness that could, in the investigator's opinion, potentially interfere with the completion of treatment according to the protocol.
- Known cerebral or meningeal disease (HL or any other etiology), including signs or symptoms of progressive multifocal leukoencephalopathy (PML)
- Symptomatic neurologic disease compromising normal activities of daily living or requiring medic
Show all 17Show fewer
- Any sensory or motor peripheral neuropathy greater than or equal to Grade 2
- Known history of any of the following cardiovascular conditions defined in the protocol
- Any active systemic viral, bacterial, or fungal infection requiring systemic antibiotics within 2 weeks prior to first study drug dose
- Patients that have not completed any prior treatment chemotherapy and/or other investigational agents within at least 5 half-lives (or 28 days if the half-lives are unknown) of last dose of that prior treatment
- Known hypersensitivity to recombinant proteins, murine proteins, or to any excipient contained in the drug formulation of brentuximab vedotin.
- Known human immunodeficiency virus (HIV) positive
- Known hepatitis B surface antigen-positive, or known or suspected active hepatitis C infection
- Focal radiation therapy within 30 days prior to study recruitment
- Major surgery within 28 days prior to randomization
- Diagnosed or treated for another malignancy within 3 years before the first dose or previously diagnosed with another malignancy and have evidence of residual disease.
- Patients with nonmelanoma skin cancer or carcinoma in situ of any type are not excluded if they have undergone complete resection.
Trial locations and contacts
19 sites in 1 country.
19 sites in 1 country
Spain19 sites, 19 recruiting
- Recruiting
Complexo Hospitalario Universitario A Coruña
A Coruña, 15006
- Recruiting
Institut Català D'Oncologia - Hospital Germans Trias I Pujol
Barcelona, Barceolna, 08916
- Recruiting
Hospital Clínic de Barcelona
Barcelona, 08036
- Recruiting
Hospital de La Santa Creu I Sant Pau
Barcelona, 08041
- Recruiting
Institut Català D'Oncologia - Hospital Duran I Reynals
Barcelona, 08908
- Recruiting
Institut Català D'Oncologia
Barcelona, 08908
- Recruiting
Hospital Universitario de Cruces
Bilbao, 48903
- Recruiting
Hospital Universitario Virgen de Las Nieves
Granada, 18014
- Recruiting
Hospital General Universitario Gregorio Marañón
Madrid, 28007
- Recruiting
Hospital Ramón Y Cajal
Madrid, 28034
- Recruiting
Hospital Universitario Fundación Jiménez Díaz
Madrid, 28040
- Recruiting
Hospital Universitario 12 de Octubre
Madrid, 28041
- Recruiting
Hospital General Universitario J.M. Morales Meseguer
Murcia, 30008
- Recruiting
Hospital Universitario Central de Asturias
Oviedo, Principality of Asturias, 33011
- Recruiting
Hospital Universitario de Salamanca
Salamanca, 37007
- Recruiting
Hospital Universitario Marqués de Valdecilla
Santander, Cantabria, 39008
- Recruiting
Hospital Universitario Virgen Del Rocío
Seville, 41013
- Recruiting
Hospital Universitario Y Politécnico La Fe
Valencia, 46026
- Recruiting
Hospital Clínico Universitario de Valencia
Valencia
About this study
Official title: A Randomized Phase IIb Study, Evaluating Efficacy of Salvage Therapy With Brentuximab Vedotin-ESHAP vs ESHAP in Patients With Relapsed / Refractory Classical Hodgkin's Lymphoma, Followed by Brentuximab Vedotin Consolidation (Instead of Autologous Hematopoietic Stem Cell Transplantation) in Those Who Attained a Metabolic Complete Remission After Salvage Therapy
A Randomized Phase IIb Study, Evaluating Efficacy of Salvage Therapy with Brentuximab Vedotin-ESHAP vs ESHAP in Patients with Relapsed / Refractory Classical Hodgkin's Lymphoma, Followed by Brentuximab Vedotin Consolidation (instead of Autologous Hematopoietic Stem Cell Transplantation) in Those who Attained a Metabolic Complete Remission after Salvage Therapy
Read the detailed description
A phase IIb open label multi-center trial in patients with refractory / relapsed cHL.
Patients are randomized (1:1) to receive:
- ESHAP- BV (Etoposide [40 mg/m2/ day IV, D1-4], Solumedrol [250 mg/day IV, D1-4], high dose Ara-C [2 g/m2 IV, D5] and cisplatinum [25 mg/m2/day IV, D1-4] + BV [1.8 mg/kg IV, D1], every 21 days (3 cycles, q21 days).
Or
- ESHAP (Etoposide [40 mg/m2/ day IV, D1-4], Solumedrol [250 mg/day IV, D1-4], high dose Ara-C [2 g/m2 IV, D5] and cisplatinum [25 mg/m2/day IV, D1-4] (3 cycles, q21 days)
Stem cell collection will be performed in all patients according to institutional guidelines, but preferably after the first / second cycle of ESHAP-BV or ESHAP.
Patients attaining a mCR (Deauville 1, 2) after receiving 3 cycles of ESHAP-BV, will receive up to 13 cycles of BV consolidation (administered every 3 weeks, over 39 weeks).
Patients who were randomized to ESHAP and attained a mCR after receiving 3 cycles will receive up to 16 cycles of BV (same dosage and time intervals).
Patients who attained less than mCR following ESHAP-BV/ESHAP they will be taken out of the trial and will be treated according to their physician's clinical decision. However, they will be followed in order to evaluate their clinical outcome in terms of ORR, CR rate, TTNT2 and OS, that will be analyzed the study separately.
- Conditions
- Hodgkin Lymphoma, Adult
- Being tested
- Induction with Brentuximab vedotin (BV), Induction without Brentuximab Vedotin, Consolidation with Brentuximab Vedotin
- Medical subject headings
- Hodgkin Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Induction with Brentuximab vedotin (BV)Drug
Also called Adcetris treatment + ESHAP as salvage therapy
3 cycles ESHAP plus antibody-drug conjugate brentuximab vedotin (BV) at a dose of 1.8 mg/kg IV
Induction without Brentuximab VedotinDrug
Also called ESHAP treatment as salvage therapy
3 cycles of ESHAP as a standard of care therapy for those patients with primary refractory cHL and those patients relapsing after first-line therapy
Consolidation with Brentuximab VedotinDrug
Also called Adcetris treatment as consolidation
Up to 13 or 16 cycles of antibody-drug conjugate brentuximab vedotin (BV) at doses of 1.8 mg/kg iv every 21 days)
| Study group | Role | What they receive |
|---|---|---|
| Induction ESHAP | Active comparator | 3 Cycles ESHAP ( 21 days) : Etoposide [40 mg/m2/ day IV, D1-4], Solumedrol [250 mg/day IV, D1-4], High dose Ara-C [2 g/m2 IV, D5] Cisplatinum [25 mg/m2/day IV, D1-4] Receives: Drug: Induction without Brentuximab Vedotin; Drug: Consolidation with Brentuximab Vedotin |
| Induction BV-ESHAP | Experimental | 3 Cycles of Brentuximab VEedotin + ESHAP ( 21 days) : Etoposide [40 mg/m2/ day IV, D1-4], Solumedrol [250 mg/day IV, D1-4], High dose Ara-C [2 g/m2 IV, D5] Cisplatinum [25 mg/m2/day IV, D1-4] Brentuximab Vedotin [1.8 mg/kg IV, D1] Receives: Drug: Induction with Brentuximab vedotin (BV); Drug: Consolidation with Brentuximab Vedotin |
What is being measured
The primary outcome is the main question the study is designed to answer.
PET-CT result
PET-CT negative, Deauville scores 1 and 2
Measured: 4-6 weeks after the Cycle 3 started (each cycle is 21 days)
Secondary outcomes (4)
progression-free survival (PFS)
Evaluation of patient without progression of disease
Measured: At the end of two years of last dose of consoldation Brentuximab VEdotin treatment
Duration of response
Lenght of time between date of evidence response and progression of disease or death
Measured: At the end of two years of last dose of consoldation Brentuximab VEdotin treatment
Overall Survival (OS)
Time from entry onto the clinical trial (random assignment in a phase III study) until death as a result of any cause.
Measured: At the end of two years of last dose of consoldation Brentuximab VEdotin treatment
Duration of response (DOR)
Time from first documentation of CR or PR to disease progression
Measured: At the end of two years of last dose of consoldation Brentuximab VEdotin treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2020
- Study start1 Jun 2020
- Primary completion30 Aug 2026 (estimated)
- Study completion30 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hodgkin Lymphoma, AdultStudies 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Grupo Español de Linfomas y Transplante Autólogo de Médula Ósea
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Anna Sureda, PhD, Principal investigator, Institut Català d'Oncologia, Hospital Duran i Reynals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04378647
- Sponsor's protocol ID
- GELTAMO18-HL
- Acronym
- BRESELIBET
- Status last verified
- Feb 2024
- First submitted
- 4 May 2020
- Last updated
- 26 Feb 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Phase IIb Study, Evaluating Efficacy of Salvage Therapy With Brentuximab Vedotin-ESHAP vs ESHAP in Patients With Relapsed / Refractory Classical Hodgkin's Lymphoma, Followed by Brentuximab Vedotin Consolidation (Instead of Autologous Hematopoietic Stem Cell Transplantation) in Those Who Attained a Metabolic Complete Remission After Salvage Therapy
- ClinicalTrials.gov ID
- NCT04378647
- Acronym / sponsor ID
- BRESELIBET / GELTAMO18-HL
- Conditions
- Hodgkin Lymphoma, Adult
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Grupo Español de Linfomas y Transplante Autólogo de Médula ÓseaUniversity, hospital or other
- Study start
- 1 Jun 2020 (actual)
- Primary completion
- 30 Aug 2026 (estimated)
- Study completion
- 30 Aug 2026 (estimated)
- First posted
- 7 May 2020 (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.
A Randomized Phase IIb Study, Evaluating Efficacy of Salvage Therapy with Brentuximab Vedotin-ESHAP vs ESHAP in Patients with Relapsed / Refractory Classical Hodgkin's Lymphoma, Followed by Brentuximab Vedotin Consolidation (instead of Autologous Hematopoietic Stem Cell Transplantation) in Those who Attained a Metabolic Complete Remission after Salvage Therapy
Detailed description
A phase IIb open label multi-center trial in patients with refractory / relapsed cHL.
Patients are randomized (1:1) to receive:
- ESHAP- BV (Etoposide [40 mg/m2/ day IV, D1-4], Solumedrol [250 mg/day IV, D1-4], high dose Ara-C [2 g/m2 IV, D5] and cisplatinum [25 mg/m2/day IV, D1-4] + BV [1.8 mg/kg IV, D1], every 21 days (3 cycles, q21 days).
Or
- ESHAP (Etoposide [40 mg/m2/ day IV, D1-4], Solumedrol [250 mg/day IV, D1-4], high dose Ara-C [2 g/m2 IV, D5] and cisplatinum [25 mg/m2/day IV, D1-4] (3 cycles, q21 days)
Stem cell collection will be performed in all patients according to institutional guidelines, but preferably after the first / second cycle of ESHAP-BV or ESHAP.
Patients attaining a mCR (Deauville 1, 2) after receiving 3 cycles of ESHAP-BV, will receive up to 13 cycles of BV consolidation (administered every 3 weeks, over 39 weeks).
Patients who were randomized to ESHAP and attained a mCR after receiving 3 cycles will receive up to 16 cycles of BV (same dosage and time intervals).
Patients who attained less than mCR following ESHAP-BV/ESHAP they will be taken out of the trial and will be treated according to their physician's clinical decision. However, they will be followed in order to evaluate their clinical outcome in terms of ORR, CR rate, TTNT2 and OS, that will be analyzed the study separately.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Induction ESHAP | Active comparator | Drug: Induction without Brentuximab Vedotin, Drug: Consolidation with Brentuximab Vedotin3 Cycles ESHAP ( 21 days) : Etoposide [40 mg/m2/ day IV, D1-4], Solumedrol [250 mg/day IV, D1-4], High dose Ara-C [2 g/m2 IV, D5] Cisplatinum [25 mg/m2/day IV, D1-4] |
| Induction BV-ESHAP | Experimental | Drug: Induction with Brentuximab vedotin (BV), Drug: Consolidation with Brentuximab Vedotin3 Cycles of Brentuximab VEedotin + ESHAP ( 21 days) : Etoposide [40 mg/m2/ day IV, D1-4], Solumedrol [250 mg/day IV, D1-4], High dose Ara-C [2 g/m2 IV, D5] Cisplatinum [25 mg/m2/day IV, D1-4] Brentuximab Vedotin [1.8 mg/kg IV, D1] |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Patients with classical HL CD30+ confirmed histologically (either at the time of diagnosis / at the time of first relapse) will be included in the trial
- Male or female patients 18 to 65 years of age
- Voluntary written informed consent must be given before performance of any study-related procedure not part of standard medical care, with the understanding that consent may be withdrawn by the patient at any time without prejudice to future medical care
- Female patient is either post-menopausal for at least 1 year before the screening visit or surgically sterile or if of childbearing potential, agree to practice 2 effective methods of contraception, at the same time, from the time of signing the informed consent through 6 months after the last dose of study drug, or agrees to completely abstain from heterosexual intercourse
- Male patients, even if surgically sterilized, (i.e., status post-vasectomy) agree to practice effective barrier contraception during the entire study period and through 6 months after the last dose of study drug, or agrees to completely abstain from heterosexual intercourse
Key exclusion criteria (17 listed)
- Lymphocyte predominant nodular Hodgkin's lymphoma
- Prior treatment with brentuximab vedotin
- Female patient who are both lactating and breast-feeding or have a positive serum pregnancy test during the screening period or a positive pregnancy test on Day 1 before first dose of study drug
- Any serious medical or psychiatric illness that could, in the investigator's opinion, potentially interfere with the completion of treatment according to the protocol.
- Known cerebral or meningeal disease (HL or any other etiology), including signs or symptoms of progressive multifocal leukoencephalopathy (PML)
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 |
|---|---|---|
| Induction with Brentuximab vedotin (BV)Also: Adcetris treatment + ESHAP as salvage therapy3 cycles ESHAP plus antibody-drug conjugate brentuximab vedotin (BV) at a dose of 1.8 mg/kg IV | Drug | Induction BV-ESHAP |
| Induction without Brentuximab VedotinAlso: ESHAP treatment as salvage therapy3 cycles of ESHAP as a standard of care therapy for those patients with primary refractory cHL and those patients relapsing after first-line therapy | Drug | Induction ESHAP |
| Consolidation with Brentuximab VedotinAlso: Adcetris treatment as consolidationUp to 13 or 16 cycles of antibody-drug conjugate brentuximab vedotin (BV) at doses of 1.8 mg/kg iv every 21 days) | Drug | Induction BV-ESHAP, Induction ESHAP |
Primary outcome
PET-CT result
Time frame: 4-6 weeks after the Cycle 3 started (each cycle is 21 days)
PET-CT negative, Deauville scores 1 and 2
4 secondary outcomes
progression-free survival (PFS)
Time frame: At the end of two years of last dose of consoldation Brentuximab VEdotin treatment
Duration of response
Time frame: At the end of two years of last dose of consoldation Brentuximab VEdotin treatment
Overall Survival (OS)
Time frame: At the end of two years of last dose of consoldation Brentuximab VEdotin treatment
Duration of response (DOR)
Time frame: At the end of two years of last dose of consoldation Brentuximab VEdotin treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Feb 2024.
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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. This study is not recruiting at the moment.
Anna Sureda, PhD principal investigator
Institut Català d'Oncologia, Hospital Duran i Reynals
19 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Induction with Brentuximab vedotin (BV), Induction without Brentuximab Vedotin and Consolidation with Brentuximab Vedotin in people with Hodgkin Lymphoma, Adult, run by Grupo Español de Linfomas y Transplante Autólogo de Médula Ósea at 19 sites in Spain.
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 9 inclusion and 17 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: status not confirmed, as of the sponsor's last update on 26 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 19 sites in Spain. 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 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.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact lucia palacios, MSc (+18599134526, ensayosclinicos01@geltamo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PET-CT result (time frame: 4-6 weeks after the Cycle 3 started (each cycle is 21 days)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 26 Feb 2024.