Primary Mediastinal Large B Cell LymphomaPhase 2FIL_SGN01NCT02423291
A Study of SGN-35 (Brentuximab Vedotin) of Patients With Relapsed or Refractory PMLBCL
A Phase 2 study testing Brentuximab Vedotin in people with Primary Mediastinal Large B Cell Lymphoma, run by Fondazione Italiana Linfomi - ETS at 9 sites in Italy.
Trial summary
Study Objectives Primary: To determine the antitumor efficacy of single-agent Brentuximab vedotin (1.8 mg/kg administered intravenously every 3 weeks) as measured by the overall objective response rate in patients with relapsed or refractory primary mediastinal large B-cell lymphoma. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Primary Mediastinal Large B Cell Lymphoma
- 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
- 15 participants
- Where
- 9 sitesItaly
- Study dates
- Oct 2013to Jul 2016
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients must meet all of the following inclusion criteria to be eligible for this study:
- Patients with relapsed or refractory PMLBCL who have previously received at least 1 line of treatment. Patients must have completed any prior treatment with radiation, chemotherapy, biologics, immunotherapy and/or other investigational agents at least 4 weeks prior to the first dose of Brentuximab vedotin.
- Histologically-confirmed CD30-positive disease.
- Age greater than or equal to 18 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.
- Serum Albumin ≥3 gr/dL;
- Females of childbearing potential must have a negative serum or urine β-hCG pregnancy test result within 7 days 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.
- Both females of childbearing potential and males who have partners of childbearing potential must agree to use two effective contraceptive methods during the study and for 30 days following the last dose of study drug.
- Male patients, even if surgically sterilized (i.e., post vasectomy), who:
- Agree to practice effective barrier contraception during the entire study treatment period and through 6 months after the last dose of the study drug, or
- Agree to completely abstain from heterosexual intercourse
- Patients or their legally authorized representative must provide written informed consent.
Who cannot join
- Previous treatment with Brentuximab vedotin.
- Previously received an allogeneic transplant.
- Congestive heart failure, Class III or IV, by the NYHA criteria.
- History of another primary malignancy for at least 3 years. (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.)
- Known cerebral/meningeal disease.
- Signs or symptoms of progressive multifocal leukoencephalopathy (PML).
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- Pre-existing Peripheral Neuropathy ≥ 2;
- Any active systemic viral, bacterial, or fungal infection requiring treatment with antimicrobial therapy within 2 weeks prior to the first dose of Brentuximab vedotin.
- Current therapy with other systemic anti-neoplastic or investigational agents.
- Therapy with corticosteroids at greater than or equal to 20 mg/day prednisone equivalent within 1 week prior to the first dose of Brentuximab vedotin.
- Women who are pregnant or lactating and breastfeeding.
- Patients with a known hypersensitivity to recombinant proteins, murine proteins, or any excipient contained in the drug formulation.
- Known human immunodeficiency virus (HIV) positive.
- Known hepatitis B surface antigen-positive, or known or suspected active hepatitis C infection.
- Patients with dementia or an altered mental state that would preclude the understanding and rendering of informed consent.
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
Italy9 sites
S.C. Ematologia A.O. SS. Antonio e Biagio e C. Arrigo
Alessandria, AL, 15121
Istituto di Ematologia L. & A. Seragnoli
Bologna, 40138
Ematologia Ospedale Businco
Cagliari, 09121
Unità funzionale di Ematologia A.O.U. Careggi
Florence, FI, 50134
Dip. Oncologia, Ematologia e Patologie dell'apparato respiratorio A.O.U. Policlinico di Modena
Modena, MO, 41100
Divisione di Ematologia Azienda Ospedaliera "Bianchi Melacrino Morelli"
Reggio Calabria, RC, 89125
S. C. Ematologia IRCCS Azienda Ospedaliera Arcispedale "S.Maria Nuova"
Reggio Emilia, RE, 4210
Dipartimento di Biotecnologie Cellulari ed Ematologia Università "La Sapienza"
Roma, Roma, 0016
S.C.D.O. Ematologia 2 A.O. Città della Salute e della Scienza
Torino, TO, 1012
About this study
Official title: A Phase II Study of SGN-35 (Brentuximab Vedotin) of Patients With Relapsed or Refractory Primary Mediastinal Large B-cell Lymphoma (PMLBCL)
Study Objectives Primary:
- To determine the antitumor efficacy of single-agent Brentuximab vedotin (1.8 mg/kg administered intravenously every 3 weeks) as measured by the overall objective response rate in patients with relapsed or refractory primary mediastinal large B-cell lymphoma.
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 Brentuximab vedotin
Additional:
- To assess disease-related symptoms
Number of Planned Patients 20 patients will be enrolled in this study. Duration of the study The study duration is 18 months for enrollment and 2 years for the follow-up.
Read the detailed description
Study Population Eligible patients are those with relapsed or refractory primary mediastinal large B-cell lymphoma. 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 Brentuximab vedotin or previously received an allotransplant. In addition, 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 This is a single-arm, open-label, multicenter, clinical trial to evaluate the efficacy and safety of Brentuximab vedotin as a single agent in patients with relapsed or refractory primary mediastinal large B-cell lymphoma.
Brentuximab vedotin 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. CT scans (chest, neck, abdomen, and pelvis) will be performed at baseline and Cycles 2, 4, 7, 10, 13, and 16 and PET scans will be done at baseline and Cycles 4 and 7. Patients will have an 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.
Test Product, Dose, and Mode of Administration Brentuximab vedotin, 1.8 mg/kg, administered via outpatient IV infusion on Day 1 of each 21-day cycle.
Number of Planned Patients 20 patients will be enrolled in this study. Duration of Treatment Brentuximab vedotin will be administered as a single IV infusion on Day 1 of each 21-day cycle. Patients may continue on study treatment until disease progression or unacceptable toxicity. Patients who achieve stable disease or better should receive a minimum of 8, but no more than 16 cycles of study treatment.
Duration of the study The study duration is 18 months for enrollment and 2 years for the follow-up. Efficacy Assessments Treatment response will be assessed by tumor imaging (spiral CT of neck, chest, abdomen, pelvis and PET scans) performed at protocol-specified timepoints. Determination of antitumor efficacy will be based on objective response assessments made according to the Revised Response Criteria for Malignant Lymphoma. Clinical response of progressive disease (PD), stable disease (SD), partial remission (PR), or complete remission (CR) will be determined at each assessment. Responses will be determined by investigator.
Safety Assessments Assessment of safety during the course of this study will consist of the surveillance and recording of adverse events (AEs), recording of concomitant medication and measurements of protocol-specified physical examination findings and laboratory tests.
- Being tested
- Brentuximab Vedotin
- Keywords
- PMLBCL, Brentuximab Vedotin, CD30-positive, Mediastinal Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Brentuximab VedotinDrug
Also called SGN-35; Adcetris
Brentuximab vedotin, 1.8 mg/kg, administered via outpatient IV infusion on Day 1 of each 21-day cycle.
| Study group | Role | What they receive |
|---|---|---|
| Vial for IV infusion | Experimental | This is a single-arm, open-label, multicenter, Phase 2 clinical trial to evaluate the efficacy and safety of Brentuximab vedotin as a single agent in patients with relapsed or refractory PMLBCL who have previously received a first line of treatment with chemotherapy or immunotherapy.20 patients will be treated in this study and All patients will receive 1.8 mg/kg Brentuximab vedotin administered as a single outpatient IV infusion on Day 1 of each 21-day treatment cycle. Patients may continue on study treatment until disease progression or unacceptable toxicity. Patients who achieve stable disease or better as assessed by investigator should receive a minimum of 8, but no more than 16 cycles of study treatment. Receives: Drug: Brentuximab Vedotin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Objective Response Rate in Patients With Relapsed or Refractory PMLBCL
The antitumor efficacy of single-agent Brentuximab vedotin (1.8 mg/kg administered intravenously every 3 weeks) as measured by the overall objective response rate in patients with relapsed or refractory primary mediastinal large B-cell lymphoma was determined using Cheson BD, Pfistner B, Juweid ME, et al. "Revised response criteria for malignant lymphoma". J Clin Oncol. 2007 Feb 10;25(5):579-586.Treatment response was assessed by dedicated spiral CT scan of neck, chest, neck, abdomen, and pelvis and PET scans performed at protocol-specified time points. Clinical response of progressive disease (PD), stable disease (SD), partial remission (PR), or complete remission (CR) will be determined at each assessment.
Measured: 42 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2015 (estimated)
- Study startOct 2013
- Primary completionJul 2016
- Study completionJul 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Primary Mediastinal Large B Cell 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
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fondazione Italiana Linfomi - ETS
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Pier Luigi Zinzani, Prof., Principal investigator, Istituto di Ematologia L. e A. Seragnoli - Bologna - Italy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02423291
- Sponsor's protocol ID
- FIL_SGN01
- Acronym
- FIL_SGN01
- Status last verified
- Apr 2017
- First submitted
- 30 Sep 2013
- Last updated
- 26 Jun 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study of SGN-35 (Brentuximab Vedotin) of Patients With Relapsed or Refractory Primary Mediastinal Large B-cell Lymphoma (PMLBCL)
- ClinicalTrials.gov ID
- NCT02423291
- Acronym / sponsor ID
- FIL_SGN01 / FIL_SGN01
- Keywords
- PMLBCL, Brentuximab Vedotin, CD30-positive, Mediastinal Lymphoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Fondazione Italiana Linfomi - ETSUniversity, hospital or other
- Study start
- Oct 2013
- Primary completion
- Jul 2016 (actual)
- Study completion
- Jul 2016 (actual)
- First posted
- 22 Apr 2015 (estimated)
- Results
- Posted 26 Jun 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Study Objectives Primary:
- To determine the antitumor efficacy of single-agent Brentuximab vedotin (1.8 mg/kg administered intravenously every 3 weeks) as measured by the overall objective response rate in patients with relapsed or refractory primary mediastinal large B-cell lymphoma.
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 Brentuximab vedotin
Additional:
- To assess disease-related symptoms
Number of Planned Patients 20 patients will be enrolled in this study. Duration of the study The study duration is 18 months for enrollment and 2 years for the follow-up.
Detailed description
Study Population Eligible patients are those with relapsed or refractory primary mediastinal large B-cell lymphoma. 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 Brentuximab vedotin or previously received an allotransplant. In addition, 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 This is a single-arm, open-label, multicenter, clinical trial to evaluate the efficacy and safety of Brentuximab vedotin as a single agent in patients with relapsed or refractory primary mediastinal large B-cell lymphoma.
Brentuximab vedotin 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. CT scans (chest, neck, abdomen, and pelvis) will be performed at baseline and Cycles 2, 4, 7, 10, 13, and 16 and PET scans will be done at baseline and Cycles 4 and 7. Patients will have an 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.
Test Product, Dose, and Mode of Administration Brentuximab vedotin, 1.8 mg/kg, administered via outpatient IV infusion on Day 1 of each 21-day cycle.
Number of Planned Patients 20 patients will be enrolled in this study. Duration of Treatment Brentuximab vedotin will be administered as a single IV infusion on Day 1 of each 21-day cycle. Patients may continue on study treatment until disease progression or unacceptable toxicity. Patients who achieve stable disease or better should receive a minimum of 8, but no more than 16 cycles of study treatment.
Duration of the study The study duration is 18 months for enrollment and 2 years for the follow-up. Efficacy Assessments Treatment response will be assessed by tumor imaging (spiral CT of neck, chest, abdomen, pelvis and PET scans) performed at protocol-specified timepoints. Determination of antitumor efficacy will be based on objective response assessments made according to the Revised Response Criteria for Malignant Lymphoma. Clinical response of progressive disease (PD), stable disease (SD), partial remission (PR), or complete remission (CR) will be determined at each assessment. Responses will be determined by investigator.
Safety Assessments Assessment of safety during the course of this study will consist of the surveillance and recording of adverse events (AEs), recording of concomitant medication and measurements of protocol-specified physical examination findings and laboratory tests.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Vial for IV infusion | Experimental | Drug: Brentuximab VedotinThis is a single-arm, open-label, multicenter, Phase 2 clinical trial to evaluate the efficacy and safety of Brentuximab vedotin as a single agent in patients with relapsed or refractory PMLBCL who have previously received a first line of treatment with chemotherapy or immunotherapy.20 patients will be treated in this study and All patients will receive 1.8 mg/kg Brentuximab vedotin administered as a single outpatient IV infusion on Day 1 of each 21-day treatment cycle. Patients may continue on study treatment until disease progression or unacceptable toxicity. Patients who achieve stable disease or better as assessed by investigator should receive a minimum of 8, but no more than 16 cycles of study treatment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Patients with relapsed or refractory PMLBCL who have previously received at least 1 line of treatment. Patients must have completed any prior treatment with radiation, chemotherapy, biologics, immunotherapy and/or other investigational agents at least 4 weeks prior to the first dose of Brentuximab vedotin.
- Histologically-confirmed CD30-positive disease.
- Age greater than or equal to 18 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.
Key exclusion criteria (15 listed)
- Previous treatment with Brentuximab vedotin.
- Previously received an allogeneic transplant.
- Congestive heart failure, Class III or IV, by the NYHA criteria.
- History of another primary malignancy for at least 3 years. (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.)
- Known cerebral/meningeal disease.
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-35; AdcetrisBrentuximab vedotin, 1.8 mg/kg, administered via outpatient IV infusion on Day 1 of each 21-day cycle. | Drug | Vial for IV infusion |
Primary outcome
Overall Objective Response Rate in Patients With Relapsed or Refractory PMLBCL
Time frame: 42 months
The antitumor efficacy of single-agent Brentuximab vedotin (1.8 mg/kg administered intravenously every 3 weeks) as measured by the overall objective response rate in patients with relapsed or refractory primary mediastinal large B-cell lymphoma was determined using Cheson BD, Pfistner B, Juweid ME, et al. "Revised response criteria for malignant lymphoma". J Clin Oncol. 2007 Feb 10;25(5):579-586.Treatment response was assessed by dedicated spiral CT scan of neck, chest, neck, abdomen, and pelvis and PET scans performed at protocol-specified time points. Clinical response of progressive disease (PD), stable disease (SD), partial remission (PR), or complete remission (CR) will be determined at each assessment.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Pier Luigi Zinzani, Prof. principal investigator
Istituto di Ematologia L. e A. Seragnoli - Bologna - Italy
9 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 Primary Mediastinal Large B Cell Lymphoma, run by Fondazione Italiana Linfomi - ETS at 9 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 14 inclusion and 15 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 26 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 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?
Yes. Results are posted in the registry (first posted 26 Jun 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Overall Objective Response Rate in Patients With Relapsed or Refractory PMLBCL (time frame: 42 months). 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 Jun 2017.