Hodgkin DiseasePhase 2BREVITYNCT02567851
A Study of Brentuximab Vedotin in Patients With Hodgkin Lymphoma Unsuitable for Chemotherapy Due to Age, Frailty or Co-morbidity
A Phase 2 study testing Brentuximab Vedotin in people with Hodgkin Disease, run by University of Birmingham at 12 sites in United Kingdom.
Trial summary
An early phase II, single arm, two stage study, to investigate the level of activity, duration of response and tolerability of brentuximab vedotin (SGN-35), as a single agent, utilising a response adapted approach, in older, frailer or co-morbid patients with previously untreated Hodgkin lymphoma. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Hodgkin Disease
- What is being tested?
- Brentuximab Vedotin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 12 sitesUnited Kingdom
- Study dates
- Feb 2014to 2 Oct 2017
- 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 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Histologically confirmed CD30 positive classical Hodgkin lymphoma
- No previous treatment for classical Hodgkin lymphoma
- Aged ≥ 16 years
- Stages II (with B symptoms, extranodal disease, bulky disease, ≥3 sites of nodal involvement, fewer than 3 sites of nodal involvement but unsuitable for radiotherapy because of anatomical distribution or ESR ≥50 mm/h), III and IV classical Hodgkin lymphoma
- Any of the following:
- At any age and with ECOG score of 0, 1, 2 or 3, for whom standard chemotherapy considered inappropriate because:
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- Impaired cardiac function defined either by an ejection fraction of < 50% assessed by echocardiogram or nuclear medicine scan (MUGA)
- Left ventricular ejection fraction ≥50% measured by echocardiography or MUGA but in the presence of significant co-morbidities or cardiac risk factors such as diabetes mellitus, hypertension, peripheral vascular disease, ischaemic heart disease, previous myocardial infarction, obesity, stroke or transient ischaemic attacks (TIA) that make anthracycline-containing chemotherapy inadvisable as determined by the investigator.
- Heart failure clinically determined by the presence of New York Heart Association (NYHA) heart failure grade II and III due to a cause other than Hodgkin Lymphoma
- Impaired respiratory function with DLCO and/or FVC/FEV1 ratio <75% of predicted due to a cause other than Hodgkin lymphoma
- For patients aged 60 years or older,
- an ECOG score of 1, 2 or 3 for any reason, before the start of permitted steroids (see section 7.9) and considered unsuitable for treatment with standard chemotherapy by the investigator
- All co-morbidities must be documented on the baseline form and the CIRS-G score (if 60 years or older) recorded.
- FDG avid disease - proven by PET scan
- Measurable disease with at least one lesion measuring >1.5 cm in long axis diameter (for nodal lesions) or >1.0cm in long axis diameter (for extra-nodal lesions)
- Written informed consent
- Able to comply with requirements of the protocol (including PET scans)
- Agree and be able to use adequate contraception if required
Who cannot join
- Nodular lymphocyte predominant Hodgkin lymphoma
- Grade 2 or worse peripheral neuropathy
- Haemoglobin <90 g/L (transfusion allowed)
- Unsupported neutrophil count <1.0 x 109/l and platelet count <100 x 109/l unless due to bone marrow infiltration by Hodgkin lymphoma demonstrated by trephine biopsy
- Serum bilirubin ≥1.5 times upper limit normal unless due to Hodgkin lymphoma or Gilbert's syndrome
- Creatinine clearance <30 ml/min (calculated by the modified Cockroft-Gault formula, see appendix) unless due to Hodgkin lymphoma. Patients with an eGFR <30 ml/min but a measured GFR by another method (e.g. EDTA) of 30ml/min or greater would be eligible.
Show all 20Show fewer
- Pregnant or lactating women
- Any other cancer diagnosis within the last 24 months - except for:
- Appropriately treated superficial melanoma, basal cell carcinoma and squamous cell carcinoma of the skin
- Appropriately treated cervical intra-epithelial neoplasia
- In situ or organ confined prostate cancer not currently requiring therapy
- Previous cancers treated with curative intent and with no evidence of recurrence following a minimum of at least 2 years of follow-up are permitted.
- The use of other investigational or anti-neoplastic agents within the previous 6 weeks or during the trial.
- Known to be HIV, Hep B positive (Hep B Core antibody positive allows inclusion providing surface / core antigen both negative) or Hep C positive (Hep C antibody positive allows inclusion providing PCR for viral RNA is negative).
- Known hypersensitivity to recombinant proteins, murine proteins, or to any excipient contained in the drug formulation of brentuximab vedotin.
- Known cerebral or meningeal involvement by Hodgkin lymphoma
- Symptoms or signs of progressive multifocal leukoencephalopathy (PML)
- Any active systemic viral, bacterial, or fungal infection requiring intravenous antimicrobials within 2 weeks prior to registration
- Evidence of current uncontrolled cardiovascular conditions, including unstable angina and NYHA grade IV heart failure
- ECOG 4 at registration
Trial locations and contacts
12 sites in 1 country.
12 sites in 1 country
United Kingdom12 sites
Queen Elizabeth Hospital
Birmingham
University Hospital of Wales
Cardiff
Beatson West of Scotland Cancer Center
Glasgow
St James University Hospital
Leeds
University Hospital
Leicester
Royal Liverpool Hospital
Liverpool
Guys Hospital
London
The Christie Hospital
Manchester, M20 4BX
The Freeman Hospital
Newcastle
Norfolk and Norwich Hospital
Norwich
The Churchill Hospital
Oxford
Southampton General Hospital
Southampton
About this study
Official title: BREVITY: A Phase II Study of Brentuximab Vedotin Using a Response Adapted Design in Patients With Hodgkin Lymphoma Unsuitable for Chemotherapy Due to Age, Frailty or Co-morbidity
An early phase II, single arm, two stage study, to investigate the level of activity, duration of response and tolerability of brentuximab vedotin (SGN-35), as a single agent, utilising a response adapted approach, in older, frailer or co-morbid patients with previously untreated Hodgkin lymphoma.
Opened Feb 2014 and will recruit over 18 months. Duration of treatment will be dependent on the patients' response (see schema below) with a maximum of 16 cycles over 48 weeks.
At the end of treatment patients will be assessed clinically at 3 months intervals and by CT scan at 15, 18, 24 and 36 months. For those still alive and disease free after 2 years, follow-up will be according to local practice.
Read the detailed description
Stage 1 will recruit 20 patients. If at least patients 8 respond after the initial 4 cycles of SGN-35 a further 10 patients will be recruited to stage 2.
In all cases brentuximab vedotin will be administered at an initial dose of 1.8 mg/kg every 3 weeks as a 30-minute outpatient i.v. infusion.
After baseline staging (including PET and CT scans (PET0 + CT0), performed on PET scanners approved for the purpose by The PET Imaging Centre at St Thomas'/Guy's), all eligible and consenting patients will receive an initial 4 cycles of brentuximab vedotin following which response and continuation of brentuximab vedotin will be assessed by PET (PET4) in the first instance. Patients achieving CMR (Deauville score 1-3) will continue treatment. Patients achieving PMR (Deauville score 4,5 with uptake less than baseline) will also continue treatment. Patients achieving NMR (Deauville score 4,5 with no change in uptake from baseline) or PMD (Deauville score 4,5 with increased intensity of uptake compared to baseline and/or new lesions consistent with lymphoma) will stop brentuximab vedotin and be considered for alternative therapy.
CT4 will be performed for future comparison with CT8, CT12 and CT 16 (to exclude Progressive Disease (PD) and to correlate metabolic and radiological responses) and to inform continued treatment. Patients not achieving Deauville score 1-3 at PET 4 will also have a PET scan at completion of treatment (after 16 cycles or earlier if brentuximab vedotin discontinued for reasons other than PD)
In addition an exploratory PET scan will be performed after 2 cycles of brentuximab vedotin (PET2); investigators will be blinded to the results of PET2 which will not influence patient management in any way. All PET scans will be centrally reviewed for QA purposes by The PET Imaging Centre at St Thomas'/Guy's, under the supervision of Sally Barrington and Mike O'Doherty, using the framework developed for the recently completed RAPID and RATHL trials. CT scans after 4 cycles and at the end of treatment may also be reviewed.
After the initial 4 cycles of brentuximab vedotin, subsequent treatment will be response adapted according to PET scan result the following schedule:
- Those with a Complete Metabolic Response (CMR, Deauville Score 1, 2 or 3) at PET 4 will receive up to 12 additional cycles of brentuximab vedotin (maximum of 16 cycles) depending on no evidence of PD by a CT scan performed after each group of 4 cycles of brentuximab vedotin.
- Patients with a Partial Metabolic Response (PMR) at PET4 will receive up to 12 additional cycles of brentuximab vedotin (maximum of 16 cycles) depending on no evidence of PD on a CT scan performed after each group of 4 cycles of brentuximab vedotin.
- Patients with No Metabolic Response (NMR) will stop brentuximab vedotin and be considered for alternative therapy.
- Patients with progressive disease at any time as determined by either CT or PET scan performed after each group of 4 cycles of brentuximab vedotin or in response to clinical concerns will stop study treatment and receive subsequent therapy at investigator discretion. Clinical concerns over PD should be confirmed by either a CT or PET scan.
- Patients who come off treatment with brentuximab vedotin for any other reason (toxicity, patient decision, investigator advice) should have a CT scan performed for response assessment. In addition patients with Partial Metabolic Response at PET 4 should also have a PET scan performed.
All patients who have not progressed irrespective of how many cycles of brentuximab vedotin received will be clinically assessed every 3 months and have a CT scan at months 3, 6, 9, 12. These scan may take place during therapy. During follow-up CT scans will be performed 15, 18, 24 and 36 months from the start of treatment. For those still alive and disease-free after 3 years following start of treatment, follow-up will be according to local practice but data recorded must include date of progressive disease, type of any subsequent therapies, date and cause of death.
For patients who progress at any time, follow-up will be according to local practice but data must be recorded for 5 years form the start of treatment and must include date of progressive disease, type of any subsequent therapies, date and cause of death.
- Conditions
- Hodgkin Disease
- Being tested
- Brentuximab Vedotin
- Keywords
- Brentuximab Vedotin, PET scans, Lymphoma
- Medical subject headings
- Hodgkin Disease, Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Brentuximab VedotinDrug
Also called Adcetris
Monoclonal antibody drug conjugate
| Study group | Role | What they receive |
|---|---|---|
| Brentuximab Vedotin | Experimental | brentuximab vedotin will be administered at an initial dose of 1.8 mg/kg every 3 weeks as a 30-minute outpatient i.v. infusion. A maximum of 16 cycles Receives: Drug: Brentuximab Vedotin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complete metabolic response rate (CMR) after 4 cycles of brentuximab vedotin defined as Deauville score of 1, 2 or 3 by PET
The number of patients achieving a CR at PET4 (after cycle 4) with confidence intervals (CIs) will be presented and assessed using the Simons 2-stage design criterion.
Measured: 4 cycles (3 months)
Secondary outcomes (11)
Tolerability is defined in terms of absence of toxicities related to BV quantified by the CTCAE v4 criteria and dose intensity.
Numbers of patients in each CTCAE toxicity category will be reported. Dose intensity will be reported as the median dose intensity together with full range. The number of patients with dose interruptions, dose reductions and number discontinuing treatment will also be reported over the treatment period.
Measured: 16 cycles (1 year from start of treatment)
Overall objective response rate (ORR), including complete or partial metabolic response (CMR/PMR), after 4 cycles and 16 cycles of treatment with BV according to The Lugano Classification
ORR based on the Recommendations for Initial Evaluation, Staging, and Response Assessment of Hodgkin and Non-Hodgkin Lymphoma: The Lugano Classification will be presented as the number of patients in each response category (CR/PR), as well as overall.
Measured: 16 cycles (1 year from start of treatment)
Progression Free Survival (PFS) where progression is defined as the time from date of Cycle 1 Day 1 until documented progressive disease or death from any cause
Survival estimates (PFS) will be calculated using the Kaplan-Meier method. Median, 12, 24 and 60 month estimates will be presented with CIs. Causes of death will also be reported.
Measured: 5 years from start of treatment
Overall survival (OS) and cause of death. OS is defined as the time from Cycle 1 Day 1 to the date of death from any cause. Alive patients will be censored at their date of last follow-up
Survival estimates (OS) will be calculated using the Kaplan-Meier method. Median, 12, 24 and 60 month estimates will be presented with CIs. Causes of death will also be reported.
Measured: 5 years from start of treatment
Deauville score after cycle 2 based on blinded PET2 scan
Deauville score after cycle 2 (blinded PET2) will be reported as the number of patients in each score category. Scores will also be categorised into complete response (DS=1, 2 or 3) or not complete response (DS=4,5) and reported as the number and proportion of patients in each category
Measured: 5 years from start of treatment
Correlation of Deauville score after 2 cycles (blinded PET2) with Deauville score after 4 cycles (PET 4)
Correlation coefficients will be reported to assess the association of DS after 2 cycles (at blinded PET2) with DS after 4 cycles (at PET 4) will be assessed by cox-regression modelling
Measured: 5 years from start of treatment
Correlation of Deauville score after 2 cycles (blinded PET2) with response after 16 cycles
Correlation coefficients will be reported to assess the association of DS after 2 cycles (at blinded PET2) with end of treatment response. The relationship will also be assessed by cox-regression modelling
Measured: 5 years from start of treatment
Correlation of Deauville score after 2 cycles (blinded PET2) with overall survival
Correlation coefficients will be reported to assess the association of DS after 2 cycles (at blinded PET2) with OS and also will be assessed by cox-regression modelling
Measured: 5 years from start of treatment
Correlation of Deauville score after 2 cycles (blinded PET2) with progression-free survival
Correlation coefficients will be reported to assess the association of DS after 2 cycles (at blinded PET2) with PFS and assessed by cox-regression modelling
Measured: 5 years from start of treatment
CIRS-G profile in the study population assessed at baseline
Numbers of patients in each CIRS-G score at baseline will be reported.
Measured: 5 years from start of treatment
Co-morbidities satisfying eligibility criteria in the study population and documented throughout the study
Numbers of patients will be presented for common co-morbidities (ECOG and IPS) and any additional treatments administered following treatment with brentuximab vedotin
Measured: 5 years from start of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2015 (estimated)
- Study startFeb 2014
- Primary completion14 Jan 2016
- Study completion2 Oct 2017
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 DiseaseStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Birmingham
- Sponsor type
- University, hospital or other
- Collaborators
- Leukaemia Lymphoma Research, Millennium Pharmaceuticals, Inc.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02567851
- Sponsor's protocol ID
- RG_11-225
- Other IDs
- 2012-000214-11
- Acronym
- BREVITY
- Status last verified
- Nov 2017
- First submitted
- 29 Sep 2015
- Last updated
- 11 May 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
Gibb A, Pirrie SJ, Linton K, Warbey V, Paterson K, Davies AJ, Collins GP, Menne T, McKay P, Fields PA, Miall FM, Nagy E, Wheatley K, Reed R, Baricevic-Jones I, Barrington S, Radford J. Results of a UK National Cancer Research Institute Phase II study of brentuximab vedotin using a response-adapted design in the first-line treatment of patients with classical Hodgkin lymphoma unsuitable for chemotherapy due to age, frailty or comorbidity (BREVITY). Br J Haematol. 2021 Apr;193(1):63-71. doi: 10.1111/bjh.17073. Epub 2020 Sep 14.
PubMed 32926420
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- BREVITY: A Phase II Study of Brentuximab Vedotin Using a Response Adapted Design in Patients With Hodgkin Lymphoma Unsuitable for Chemotherapy Due to Age, Frailty or Co-morbidity
- ClinicalTrials.gov ID
- NCT02567851
- Acronym / sponsor ID
- BREVITY / RG_11-225
- Conditions
- Hodgkin Disease
- Keywords
- Brentuximab Vedotin, PET scans, Lymphoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- University of BirminghamUniversity, hospital or other
- Collaborators
- Leukaemia Lymphoma Research, Millennium Pharmaceuticals, Inc.
- Study start
- Feb 2014
- Primary completion
- 14 Jan 2016 (actual)
- Study completion
- 2 Oct 2017 (actual)
- First posted
- 5 Oct 2015 (estimated)
- 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.
An early phase II, single arm, two stage study, to investigate the level of activity, duration of response and tolerability of brentuximab vedotin (SGN-35), as a single agent, utilising a response adapted approach, in older, frailer or co-morbid patients with previously untreated Hodgkin lymphoma.
Opened Feb 2014 and will recruit over 18 months. Duration of treatment will be dependent on the patients' response (see schema below) with a maximum of 16 cycles over 48 weeks.
At the end of treatment patients will be assessed clinically at 3 months intervals and by CT scan at 15, 18, 24 and 36 months. For those still alive and disease free after 2 years, follow-up will be according to local practice.
Detailed description
Stage 1 will recruit 20 patients. If at least patients 8 respond after the initial 4 cycles of SGN-35 a further 10 patients will be recruited to stage 2.
In all cases brentuximab vedotin will be administered at an initial dose of 1.8 mg/kg every 3 weeks as a 30-minute outpatient i.v. infusion.
After baseline staging (including PET and CT scans (PET0 + CT0), performed on PET scanners approved for the purpose by The PET Imaging Centre at St Thomas'/Guy's), all eligible and consenting patients will receive an initial 4 cycles of brentuximab vedotin following which response and continuation of brentuximab vedotin will be assessed by PET (PET4) in the first instance. Patients achieving CMR (Deauville score 1-3) will continue treatment. Patients achieving PMR (Deauville score 4,5 with uptake less than baseline) will also continue treatment. Patients achieving NMR (Deauville score 4,5 with no change in uptake from baseline) or PMD (Deauville score 4,5 with increased intensity of uptake compared to baseline and/or new lesions consistent with lymphoma) will stop brentuximab vedotin and be considered for alternative therapy.
CT4 will be performed for future comparison with CT8, CT12 and CT 16 (to exclude Progressive Disease (PD) and to correlate metabolic and radiological responses) and to inform continued treatment. Patients not achieving Deauville score 1-3 at PET 4 will also have a PET scan at completion of treatment (after 16 cycles or earlier if brentuximab vedotin discontinued for reasons other than PD)
In addition an exploratory PET scan will be performed after 2 cycles of brentuximab vedotin (PET2); investigators will be blinded to the results of PET2 which will not influence patient management in any way. All PET scans will be centrally reviewed for QA purposes by The PET Imaging Centre at St Thomas'/Guy's, under the supervision of Sally Barrington and Mike O'Doherty, using the framework developed for the recently completed RAPID and RATHL trials. CT scans after 4 cycles and at the end of treatment may also be reviewed.
After the initial 4 cycles of brentuximab vedotin, subsequent treatment will be response adapted according to PET scan result the following schedule:
- Those with a Complete Metabolic Response (CMR, Deauville Score 1, 2 or 3) at PET 4 will receive up to 12 additional cycles of brentuximab vedotin (maximum of 16 cycles) depending on no evidence of PD by a CT scan performed after each group of 4 cycles of brentuximab vedotin.
- Patients with a Partial Metabolic Response (PMR) at PET4 will receive up to 12 additional cycles of brentuximab vedotin (maximum of 16 cycles) depending on no evidence of PD on a CT scan performed after each group of 4 cycles of brentuximab vedotin.
- Patients with No Metabolic Response (NMR) will stop brentuximab vedotin and be considered for alternative therapy.
- Patients with progressive disease at any time as determined by either CT or PET scan performed after each group of 4 cycles of brentuximab vedotin or in response to clinical concerns will stop study treatment and receive subsequent therapy at investigator discretion. Clinical concerns over PD should be confirmed by either a CT or PET scan.
- Patients who come off treatment with brentuximab vedotin for any other reason (toxicity, patient decision, investigator advice) should have a CT scan performed for response assessment. In addition patients with Partial Metabolic Response at PET 4 should also have a PET scan performed.
All patients who have not progressed irrespective of how many cycles of brentuximab vedotin received will be clinically assessed every 3 months and have a CT scan at months 3, 6, 9, 12. These scan may take place during therapy. During follow-up CT scans will be performed 15, 18, 24 and 36 months from the start of treatment. For those still alive and disease-free after 3 years following start of treatment, follow-up will be according to local practice but data recorded must include date of progressive disease, type of any subsequent therapies, date and cause of death.
For patients who progress at any time, follow-up will be according to local practice but data must be recorded for 5 years form the start of treatment and must include date of progressive disease, type of any subsequent therapies, date and cause of death.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Brentuximab Vedotin | Experimental | Drug: Brentuximab Vedotinbrentuximab vedotin will be administered at an initial dose of 1.8 mg/kg every 3 weeks as a 30-minute outpatient i.v. infusion. A maximum of 16 cycles |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (18 listed)
- Histologically confirmed CD30 positive classical Hodgkin lymphoma
- No previous treatment for classical Hodgkin lymphoma
- Aged ≥ 16 years
- Stages II (with B symptoms, extranodal disease, bulky disease, ≥3 sites of nodal involvement, fewer than 3 sites of nodal involvement but unsuitable for radiotherapy because of anatomical distribution or ESR ≥50 mm/h), III and IV classical Hodgkin lymphoma
- Any of the following:
Key exclusion criteria (20 listed)
- Nodular lymphocyte predominant Hodgkin lymphoma
- Grade 2 or worse peripheral neuropathy
- Haemoglobin <90 g/L (transfusion allowed)
- Unsupported neutrophil count <1.0 x 109/l and platelet count <100 x 109/l unless due to bone marrow infiltration by Hodgkin lymphoma demonstrated by trephine biopsy
- Serum bilirubin ≥1.5 times upper limit normal unless due to Hodgkin lymphoma or Gilbert's syndrome
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 VedotinAlso: AdcetrisMonoclonal antibody drug conjugate | Drug | Brentuximab Vedotin |
Primary outcome
Complete metabolic response rate (CMR) after 4 cycles of brentuximab vedotin defined as Deauville score of 1, 2 or 3 by PET
Time frame: 4 cycles (3 months)
The number of patients achieving a CR at PET4 (after cycle 4) with confidence intervals (CIs) will be presented and assessed using the Simons 2-stage design criterion.
11 secondary outcomes
Tolerability is defined in terms of absence of toxicities related to BV quantified by the CTCAE v4 criteria and dose intensity.
Time frame: 16 cycles (1 year from start of treatment)
Overall objective response rate (ORR), including complete or partial metabolic response (CMR/PMR), after 4 cycles and 16 cycles of treatment with BV according to The Lugano Classification
Time frame: 16 cycles (1 year from start of treatment)
Progression Free Survival (PFS) where progression is defined as the time from date of Cycle 1 Day 1 until documented progressive disease or death from any cause
Time frame: 5 years from start of treatment
Overall survival (OS) and cause of death. OS is defined as the time from Cycle 1 Day 1 to the date of death from any cause. Alive patients will be censored at their date of last follow-up
Time frame: 5 years from start of treatment
Deauville score after cycle 2 based on blinded PET2 scan
Time frame: 5 years from start of treatment
Correlation of Deauville score after 2 cycles (blinded PET2) with Deauville score after 4 cycles (PET 4)
Time frame: 5 years from start of treatment
Correlation of Deauville score after 2 cycles (blinded PET2) with response after 16 cycles
Time frame: 5 years from start of treatment
Correlation of Deauville score after 2 cycles (blinded PET2) with overall survival
Time frame: 5 years from start of treatment
Correlation of Deauville score after 2 cycles (blinded PET2) with progression-free survival
Time frame: 5 years from start of treatment
CIRS-G profile in the study population assessed at baseline
Time frame: 5 years from start of treatment
Co-morbidities satisfying eligibility criteria in the study population and documented throughout the study
Time frame: 5 years from start of treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2018.
- Derived from this study: PubMed 32926420Gibb A, Pirrie SJ, Linton K, Warbey V, Paterson K, Davies AJ, Collins GP, Menne T, McKay P, Fields PA, Miall FM, Nagy E, Wheatley K, Reed R, Baricevic-Jones I, Barrington S, Radford J. Results of a UK National Cancer Research Institute Phase II study of brentuximab vedotin using a response-adapted design in the first-line treatment of patients with classical Hodgkin lymphoma unsuitable for chemotherapy due to age, frailty or comorbidity (BREVITY). Br J Haematol. 2021 Apr;193(1):63-71. doi: 10.1111/bjh.17073. Epub 2020 Sep 14.
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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.
The record lists no contact. Use the official record to reach the sponsor.
12 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 Brentuximab Vedotin in people with Hodgkin Disease, run by University of Birmingham at 12 sites in United Kingdom.
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 18 inclusion and 20 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: finished, as of the sponsor's last update on 11 May 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in United Kingdom. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Complete metabolic response rate (CMR) after 4 cycles of brentuximab vedotin defined as Deauville score of 1, 2 or 3 by PET (time frame: 4 cycles (3 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 NCT02567851, 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 11 May 2018.