Hodgkin LymphomaPhase 2FIL_BVHD01NCT02227433
Brentuximab Vedotin in the Elderly Hodgkin Lymphoma Patients at First Relapse or With Primary Refractory Disease.
A Phase 2 study testing Brentuximab Vedotin in people with Hodgkin Lymphoma, run by Fondazione Italiana Linfomi - ETS at 6 sites in Italy.
Trial summary
This is a single-arm, open-label, multicenter, clinical trial to evaluate the efficacy and safety of BV as a single agent in elderly patients at first relapse or with primary refractory HL. BV will be administered as a single IV infusion on Day 1 of each 21-day cycle. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Hodgkin Lymphoma
- What is being tested?
- Brentuximab Vedotin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 6 sitesItaly
- Study dates
- 4 Feb 2013to Apr 2020
- 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 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically confirmed CD30-positive disease
- Elderly patients at first relapse or with primary refractory HL (i.e. patients who have previously received only 1 line of treatment.
- Patients must have completed any prior treatment with radiation, chemotherapy, biologics, immunotherapy and/or other investigational agents greater than 5 half-lives of the last dose of that prior treatment prior to the first dose of BV and must have fully recovered from the acute toxic effects prior to entering this study.
- Age greater than or equal to 60 years.
- Fluorodeoxyglucose (FDG)-avid and measurable disease of at least 1.5 cm as documented by both PET and spiral CT.
- An Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
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- The following required baseline laboratory data: absolute neutrophil count (ANC) ≥1500/µL, unless known marrow involvement due to disease, platelets ≥75,000/µL, unless known marrow involvement due to disease, bilirubin ≤1.5X upper limit of normal (ULN) or ≤3X ULN for patients with Gilbert's disease, serum creatinine ≤1.5X ULN, alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤2.5X ULN.
- Females of childbearing potential must have a negative serum or urine β-hCG pregnancy test result prior to the first dose of brentuximab vedotin. Females of non-childbearing potential are those who are postmenopausal greater than 1 year or who have had a bilateral tubal ligation or hysterectomy.
- Females of childbearing potential must agree to use two effective contraceptive methods during the study and for 6 months following the last dose of study drug or agree to completely abstain from heterosexual intercourse.
- Males, even if surgically sterilized, (i.e., status post vasectomy) must agree to practice effective barrier contraception during the entire study period and through 6 months after the last dose of study drug or agree to completely abstain from heterosexual intercourse.
- Patients must provide written informed consent.
Who cannot join
- Previous treatment with BV
- Peripheral neuropathy > grade 1.
- Known history of any of the following cardiovascular conditions:
- Myocardial infarction within 2 years of study entry.
- Congestive heart failure, Class III or IV, by the NYHA criteria.
- Evidence of current uncontrolled cardiac arrhythmias, angina, or electrocardiographic evidence of acute ischemia or active conduction system abnormalities.
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- Recent evidence (within 6 months of study entry) of a left ventricular ejection fraction <50%4) History of another primary malignancy for within 3 years of study entry. (The following are exempt from the 3-year limit: nonmelanoma skin cancer, curatively treated localized prostate cancer, and cervical carcinoma in situ on biopsy or a squamous intraepithelial lesion on PAP smear.)
- 5) Known cerebral/meningeal disease. 6) Signs or symptoms of progressive multifocal leukoencephalopathy (PML). 7) Any active systemic viral, bacterial, or fungal infection requiring treatment with antimicrobial therapy within 2 weeks prior to the first dose of BV. 8) Current therapy with other systemic anti-neoplastic or investigational agents.
- 9) Therapy with corticosteroids at greater than or equal to 20 mg/day prednisone equivalent within 1 week prior to the first dose of BV. 10) Women who are pregnant or lactating and breastfeeding. 11) Patients with a known hypersensitivity to recombinant proteins, murine proteins, or any excipient contained in the drug formulation of brentuximab vedotin. 12) Known human immunodeficiency virus (HIV) positive. 13) Known hepatitis B surface antigen positive, or known or suspected active hepatitis C infection.
- 14) Patients with dementia or an altered mental state that would preclude the understanding and rendering of informed consent.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
Italy6 sites
Irccs Centro Di Riferimento Oncologico Di Aviano (Pn)
Aviano, Italia, 33081
Policlinico S.Orsola Malpighi
Bologna
ASST Spedali Civili di Brescia
Brescia, BS, 25123
Irccs Istituto Nazionale Per Lo Studio E La Cura Dei Tumori Fondazione Giovanni Pascale Di Napoli
Naples
IRCCS Policlinico S. Matteo di Pavia - Div. di Ematologia
Pavia, 27100
Policlinico Umberto I - Università "La Sapienza" - Istituto Ematologia -Dipartimento di Medicina Traslazionale e di Precisione
Rome, 00161
About this study
Official title: A Phase II Study of Brentuximab Vedotin (BV) in the Treatment of Elderly Hodgkin Lymphoma (HL) Patients at First Relapse or With Primary Refractory Disease.
This is a single-arm, open-label, multicenter, clinical trial to evaluate the efficacy and safety of BV as a single agent in elderly patients at first relapse or with primary refractory HL.
BV will be administered as a single IV infusion on Day 1 of each 21-day cycle. Measures of anti-cancer activity will be assessed using the revised response criteria for malignant lymphoma (Cheson et al. 2007).
Read more
Computed tomography (CT) scans (chest, neck, abdomen, and pelvis) will be performed at baseline and Cycles 4, 8, 12, and 16 and positron emission tomography (PET) scans will be done at baseline and Cycles 4, 8, 12 and 16. Patients will have an End of Treatment (EOT) assessment 30 ± 7 days after receiving their final dose of study drug. Long-term follow-up assessments (including survival and disease status information) will be performed every 12 weeks until either patient death or study closure, whichever occurs first. Patients who discontinue study treatment with stable disease or better will have CT scans done every 12 weeks until disease progression.
Study Objectives
Primary:
- To determine the antitumor efficacy of single-agent brentuximab vedotin (BV) (1.8 mg/kg administered intravenously every 3 weeks) as measured by the overall objective response rate in elderly patients at first relapse or with primary refractory Hodgkin lymphoma (HL).
Secondary:
- To assess duration of tumor control, including duration of response and progression-free survival
- To assess survival
- To assess the safety and tolerability of BV
Additional:
- To assess disease-related symptoms Study Population Eligible patients are those with first relapsed or primary refractory elderly HL. Patients must also have histologically-confirmed CD30-positive disease, fluorodeoxyglucose (FDG)-avid and measurable disease of at least 1.5 cm, an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1, and adequate hematologic, kidney, and liver function. Eligible patients must not previously have been treated with BV, patients must not have congestive heart failure, known cerebral/meningeal disease, or any active viral, bacterial, or fungal infection requiring treatment with antimicrobial therapy within 2 weeks prior to first study dose.
- Conditions
- Hodgkin Lymphoma
- Being tested
- Brentuximab Vedotin
- Keywords
- Hodgkin Lymphoma, Elderly Patients, brentuximab vedotin (BV)
- Medical subject headings
- Hodgkin Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Brentuximab VedotinDrug
Also called SGN
| Study group | Role | What they receive |
|---|---|---|
| brentuximab vedotin (BV) | Experimental | Not described Receives: Drug: Brentuximab Vedotin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Antitumor Efficacy
- The antitumor efficacy of single-agent brentuximab vedotin (BV) (1.8 mg/kg administered intravenously every 3 weeks) as measured by the overall objective response rate in elderly patients at first relapse or with primary refractory Hodgkin lymphoma (HL).
Measured: two years
Secondary outcomes (4)
Survival, safety and tolerability
- The duration of tumor control, including duration of response and progression-free survival
Measured: two years
Survival
- The survival
Measured: Two years
Safety and tolerability of Brentuximab Vedotin
- The safety and tolerability of BV
Measured: Two years
Disease related symptoms
Additional:
- The disease-related symptoms
Measured: Two years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2014 (estimated)
- Study start4 Feb 2013
- Primary completion3 Apr 2018
- Study completionApr 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fondazione Italiana Linfomi - ETS
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Vittorio Stefoni, Principal investigator, AO S. Orsola Malpighi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02227433
- Sponsor's protocol ID
- FIL_BVHD01
- Acronym
- FIL_BVHD01
- Status last verified
- Nov 2019
- First submitted
- 11 Aug 2014
- Last updated
- 22 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study of Brentuximab Vedotin (BV) in the Treatment of Elderly Hodgkin Lymphoma (HL) Patients at First Relapse or With Primary Refractory Disease.
- ClinicalTrials.gov ID
- NCT02227433
- Acronym / sponsor ID
- FIL_BVHD01 / FIL_BVHD01
- Conditions
- Hodgkin Lymphoma
- Keywords
- Hodgkin Lymphoma, Elderly Patients, brentuximab vedotin (BV)
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Fondazione Italiana Linfomi - ETSUniversity, hospital or other
- Study start
- 4 Feb 2013 (actual)
- Primary completion
- 3 Apr 2018 (actual)
- Study completion
- Apr 2020 (actual)
- First posted
- 28 Aug 2014 (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.
This is a single-arm, open-label, multicenter, clinical trial to evaluate the efficacy and safety of BV as a single agent in elderly patients at first relapse or with primary refractory HL.
BV will be administered as a single IV infusion on Day 1 of each 21-day cycle. Measures of anti-cancer activity will be assessed using the revised response criteria for malignant lymphoma (Cheson et al. 2007).
Computed tomography (CT) scans (chest, neck, abdomen, and pelvis) will be performed at baseline and Cycles 4, 8, 12, and 16 and positron emission tomography (PET) scans will be done at baseline and Cycles 4, 8, 12 and 16. Patients will have an End of Treatment (EOT) assessment 30 ± 7 days after receiving their final dose of study drug. Long-term follow-up assessments (including survival and disease status information) will be performed every 12 weeks until either patient death or study closure, whichever occurs first. Patients who discontinue study treatment with stable disease or better will have CT scans done every 12 weeks until disease progression.
Study Objectives
Primary:
- To determine the antitumor efficacy of single-agent brentuximab vedotin (BV) (1.8 mg/kg administered intravenously every 3 weeks) as measured by the overall objective response rate in elderly patients at first relapse or with primary refractory Hodgkin lymphoma (HL).
Secondary:
- To assess duration of tumor control, including duration of response and progression-free survival
- To assess survival
- To assess the safety and tolerability of BV
Additional:
- To assess disease-related symptoms Study Population Eligible patients are those with first relapsed or primary refractory elderly HL. Patients must also have histologically-confirmed CD30-positive disease, fluorodeoxyglucose (FDG)-avid and measurable disease of at least 1.5 cm, an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1, and adequate hematologic, kidney, and liver function. Eligible patients must not previously have been treated with BV, patients must not have congestive heart failure, known cerebral/meningeal disease, or any active viral, bacterial, or fungal infection requiring treatment with antimicrobial therapy within 2 weeks prior to first study dose.
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 (BV) | Experimental | Drug: Brentuximab Vedotin |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Histologically confirmed CD30-positive disease
- Elderly patients at first relapse or with primary refractory HL (i.e. patients who have previously received only 1 line of treatment.
- Patients must have completed any prior treatment with radiation, chemotherapy, biologics, immunotherapy and/or other investigational agents greater than 5 half-lives of the last dose of that prior treatment prior to the first dose of BV and must have fully recovered from the acute toxic effects prior to entering this study.
- Age greater than or equal to 60 years.
- Fluorodeoxyglucose (FDG)-avid and measurable disease of at least 1.5 cm as documented by both PET and spiral CT.
Key exclusion criteria (10 listed)
- Previous treatment with BV
- Peripheral neuropathy > grade 1.
- Known history of any of the following cardiovascular conditions:
- 5) Known cerebral/meningeal disease. 6) Signs or symptoms of progressive multifocal leukoencephalopathy (PML). 7) Any active systemic viral, bacterial, or fungal infection requiring treatment with antimicrobial therapy within 2 weeks prior to the first dose of BV. 8) Current therapy with other systemic anti-neoplastic or investigational agents.
- 9) Therapy with corticosteroids at greater than or equal to 20 mg/day prednisone equivalent within 1 week prior to the first dose of BV. 10) Women who are pregnant or lactating and breastfeeding. 11) Patients with a known hypersensitivity to recombinant proteins, murine proteins, or any excipient contained in the drug formulation of brentuximab vedotin. 12) Known human immunodeficiency virus (HIV) positive. 13) Known hepatitis B surface antigen positive, or known or suspected active hepatitis C infection.
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: SGN | Drug | brentuximab vedotin (BV) |
Primary outcome
Antitumor Efficacy
Time frame: two years
• The antitumor efficacy of single-agent brentuximab vedotin (BV) (1.8 mg/kg administered intravenously every 3 weeks) as measured by the overall objective response rate in elderly patients at first relapse or with primary refractory Hodgkin lymphoma (HL).
4 secondary outcomes
Survival, safety and tolerability
Time frame: two years
Survival
Time frame: Two years
Safety and tolerability of Brentuximab Vedotin
Time frame: Two years
Disease related symptoms
Time frame: Two years
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 22 Dec 2020.
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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.
Vittorio Stefoni principal investigator
AO S. Orsola Malpighi
6 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 Lymphoma, run by Fondazione Italiana Linfomi - ETS at 6 sites in Italy.
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 10 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 22 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Italy. 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?
Antitumor Efficacy (time frame: two years). 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 22 Dec 2020; AzTrials last refreshed its copy on 8 Nov 2026.