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LymphomaNCT01671813

Brentuximab Vedotin in CD30 Positive Epstein Barr Virus (EBV) Positive DLBCL of Elderly

A study testing brentuximab vedotin in people with Lymphoma, run by H. Lee Moffitt Cancer Center and Research Institute.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial summary

The main purpose of this study is to test if brentuximab vedotin has an effect on cancer in patients with a certain type of large B-Cell Lymphoma. The side effects (unwanted effects) of SGN-35 in patients with this certain type of large B-Cell Lymphoma will also be studied. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
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
0 participants
Where
No sites listed yet
Study dates
Mar 2013to Jul 2013
Phase
Interventional
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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Confirmed diagnosis of CD30+EBV+DLBCLE (EDLBCLE). Diagnosis will be based on identification of diffuse large cell lymphoma (DLBCL) in biopsy specimens characterized by positivity in the malignant cell population of 2 principal markers:
  • CD30 by immunohistochemistry (IHC) and
  • Epstein-Barr virus (EBV) by EBER in situ hybridization (ISH)
  • Histology slides and pathology material must be available at the site for each patient before enrollment in order to be sent to the Leading Institution of the study for central pathology review and pharmacodynamic studies.
  • Patients must have progressive, relapsed or refractory disease after:
  • At least one prior systemic anti-lymphoma regimen (chemotherapy or immunotherapy)
Show all 21Show fewer
  • Relapsed or failed autologous or allogeneic stem cell transplant.
  • Understand and voluntarily sign an Institutional Review Board (IRB) approved informed consent form
  • Must have at least one site of disease (index lesion) measurable in two dimensions by computed tomography (CT)
  • At least 4 weeks since the last chemotherapy, radiation therapy, immunotherapy or any investigational non-immunotherapy products with clinical evidence of recovery from any toxicity associated with such treatment
  • Must meet the following criteria within 4 days before the first dose of study drug:
  • Neutrophils ≥1,000/ul
  • Hemoglobin ≥ 8 g/dL
  • Platelets≥ 50.0x10^9 /L
  • Total bilirubin ≤ 1.5 x upper normal limit, or ≤ 5 x upper normal limit if documented hepatic involvement with lymphoma or history of Gilbert's Syndrome
  • Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 3 x upper normal limit (≤ 5 x upper normal limit if documented hepatic involvement with lymphoma)
  • Calculated creatinine clearance ≥ 40 mL/min/1.73 m^2 based on Cockcroft and Gault method
  • Prothrombin time (PT) or international normalization ratio (INR), and activated partial thromboplastin time (APTT) ≤ 1.5 x upper limit of normal (ULN) unless patient is receiving anticoagulants. If patient is on anticoagulation therapy, levels should be within therapeutic range.
  • Eastern Cooperative Oncology Group (ECOG) performance status 0-2
  • Negative pregnancy test for women of childbearing potential
  • Recovered (≤ Grade 1 toxicity) from the reversible effects of prior antineoplastic therapy

Who cannot join

  • Any of the following cardiovascular conditions or values within 6 months before the first dose of study drug: Myocardial infarction and the New York Heart Association (NYHA) Class III or IV heart failure.
  • History of another primary malignancy not in remission for at least 3 years; except adequately treated patients with completely resected in situ carcinoma, such as nonmelanoma skin cancer and cervical carcinoma in situ on biopsy or a squamous intraepithelial lesion on Pap smear
  • Known active cerebral/meningeal involvement with lymphoma. Asymptomatic patients with previously treated and resolved central nervous system (CNS) lymphoma involvement are permitted.
  • Prior administration of Brentuximab vedotin
  • Corticosteroid monotherapy for lymphoma within 2 weeks of the first dose of study drug
  • Radioimmunotherapy administration within 8 weeks before the first dose of study drug
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  • Any serious underlying medical condition that, in the opinion of the investigator or medical monitor, would impair the ability to receive or tolerate the planned treatment
  • Known hypersensitivity to recombinant proteins, or any component contained in the drug formulation
  • Female patients who are lactating or have a positive serum pregnancy test during the screening period or a positive urine pregnancy test on Day 1 before first dose of study drug

About this study

Official title: Pilot Study of Brentuximab Vedotin in CD30 Positive EBV Positive Diffuse Large B-Cell Lymphomas of the Elderly

The main purpose of this study is to test if brentuximab vedotin has an effect on cancer in patients with a certain type of large B-Cell Lymphoma. The side effects (unwanted effects) of SGN-35 in patients with this certain type of large B-Cell Lymphoma will also be studied. It is not known if brentuximab vedotin is better or worse than other treatment that might be given.

Read the detailed description

Brentuximab vedotin is a type of drug called an antibody drug conjugate (ADC). ADCs usually have 2 parts; a part that targets cancer cells (the antibody) and a cell killing part (the chemotherapy). Antibodies are proteins that are part of the immune system. They can stick to and attack specific targets on cells. The antibody part of brentuximab vedotin sticks to a target called CD30. CD30 is an important molecule on some cancer cells (including non-Hodgkin lymphoma) and some normal cells of the immune system. The cell killing part of brentuximab vedotin is a chemotherapy called monomethyl auristatin E (MMAE). After the brentuximab vedotin attaches to the CD30 part of the cell, the MMAE enters the cell and kills it.

More than 350 people with cancer have already been given brentuximab vedotin in research studies. These research studies were done to test the safety of different doses of brentuximab vedotin and to find out if brentuximab vedotin is active against cancer.

Conditions
Lymphoma
Being tested
brentuximab vedotin
Keywords
positive, diffuse, B-Cell, elderly, EBV, DLBCL, malignant, pilot
Medical subject headings
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™, antibody drug conjugate, ADC

    Brentuximab vedotin will be given intravenously as outlined in treatment arm.

Study groups in NCT01671813
Study groupRoleWhat they receive
Brentuximab vedotin TreatmentExperimentalParticipants will have screening tests up to 4 weeks before study treatment and dosing for up to 48 weeks. Brentuximab vedotin will be given with a dose of 1.8 mg (per kilogram of participant's body weight) intravenously (an IV through their vein) every 21 days, over 30 minutes for 16 cycles. Follow-up assessments will be performed up to 104 weeks (2 years).
Receives: Drug: brentuximab vedotin

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Objective Response Rate (ORR)

    The primary efficacy parameter is objective response rate, defined as the proportion of patients with complete response (CR) and partial response (PR). To evaluate the activity of Brentuximab vedotin in patients with refractory/relapsed EDLBCLE using modified International Working Group (IWG) response criteria for malignant lymphoma. Measurable lesions: Lesions that can be measured accurately in at least one dimension (longest diameter to be recorded) as ≥20 mm with conventional techniques, or as ≥10 mm with spiral CT scan. Nonmeasurable lesions: Lesions not classified as measurable lesions (longest diameter ≤20 mm with conventional techniques or ≤10 mm with spiral CT scan. Frequencies and percentages will be used to summarize for all response categories. The ORR, our primary endpoint, and its 95 confidence interval will be calculated using the exact binominal method.

    Measured: 36 months

Secondary outcomes (5)

  1. Time to Response (TTR)

    Evaluate time to response. Time to Response (TTR) will be measured as the time from the start of treatment to the first time when the measurement criteria for CR or PR are met. Patients who did not have a confirmed response will be censored at the date of the last tumor assessment. For time to response, the median time and its 95% confidence intervals will be estimated using the Kaplan-Meier method.

    Measured: 36 months

  2. Duration of Response (DOR)

    Assess duration of response. DOR will be defined as the number of days between the first tumor response assessment of objective response (complete response and partial response) to the time of the first tumor response assessment of progressive disease (PD) or death if due to disease progression (date of first PD assessment or death due to disease progression-date of first objective response assessment +1). Participants who respond and have not progressed while on study or died for reasons other than disease progression will be censored at the date of the last disease assessment. The corresponding Kaplan-Meier curves will also be generated. For the treatment responders, descriptive statistics (mean, median, standard deviation and range) of will be used to summarize duration of response.

    Measured: 36 months

  3. Time to Disease Progression

    Estimate time to disease progression. For those with disease progression, time to disease progression will be reported. Time to Progression (TTP) will be defined as the number of days from the start of treatment to the date of disease progression based on tumor assessments made according to the 2007 IWG criteria.

    Measured: 36 months

  4. Progression Free Survival (PFS) Rate

    Evaluate progression-free survival. PFS will be calculated as the number of days between first administration of Brentuximab vedotin to the date of evidence of disease progression (date of positive test, e.g. Bone marrow biopsy or CT or PET scan), or death, regardless of cause, date of progressive disease or death-date of first administration of Brentuximab vedotin. Participants who are alive without a disease response assessment of progressive disease will be censored at the disease assessment date. Participants with missing tumor assessment(s) during treatment will be considered as having disease progression on the date of the actual assessment of disease progression. For PFS, the median time and its 95% confidence intervals will be estimated using the Kaplan-Meier method.

    Measured: 36 months

  5. Overall Survival (OS) Rate

    Estimate overall survival. OS will be defined as the time from the date of start of treatment until death as a result of any cause. For OS, the median time and its 95% confidence intervals will be estimated using the Kaplan-Meier method.

    Measured: 36 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Aug 2012 (estimated)
  2. Study startMar 2013
  3. Primary completionJul 2013
  4. Study completionJul 2013

Why it stopped: Terminated by pharmaceutical sponsor - no accrual

Resources

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 N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01671813
Sponsor's protocol ID
MCC-17024
Other IDs
SGN 35-IST-006
Status last verified
Jul 2013
First submitted
21 Aug 2012
Last updated
25 Jul 2013
Results posted
No
Data monitoring committee
No

Publications

  • Ryder CB, Saeed H, Hussaini M. Composite Lymphoma with Follicular Lymphoma Transformation to Clonally Related Epstein-Barr Virus (EBV) Positive Diffuse Large B-Cell Lymphoma and EBV-PositiveClassic Hodgkin Lymphoma. Case Rep Hematol. 2023 Nov 8;2023:8833273. doi: 10.1155/2023/8833273. eCollection 2023.

    PubMed 38028985

Questions about this trial

What is this clinical trial studying?

A study testing brentuximab vedotin in people with Lymphoma, run by H. Lee Moffitt Cancer Center and Research Institute.

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 21 inclusion and 9 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: withdrawn, as of the sponsor's last update on 25 Jul 2013. Status can change between updates, so confirm with the study contact before making plans.

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.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

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?

Objective Response Rate (ORR) (time frame: 36 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 NCT01671813, 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 25 Jul 2013.

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