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Lymphatic DiseasesPhase 2NCT02497131

Study on the Role of Brentuximab Vedotin as Single Agent in the Treatment of Relapsed/Refractory CD30+ PTCL Patients

A Phase 2 study testing Brentuximab Vedotin in people with Lymphatic Diseases, run by Fondazione Italiana Linfomi - ETS at 4 sites in Italy.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This is a single-arm, open-label, multicenter, clinical trial to evaluate the efficacy and safety of Brentuximab Vedotin (BV) as a single agent in relapsed/refractory CD30+ PTCL patients. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Lymphatic Diseases
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
25 participants
Where
4 sitesItaly
Study dates
21 Sep 2015to Mar 2022
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Signed written informed consent.
  • Males and females ≥18 and ≤75 years at the time of enrolment.
  • Histologically confirmed diagnosis of PTCL (PTCL-not otherwise specified [PTCL-NOS], angioimmunoblastic T cell lymphoma [AILT] and transformed mycosis fungoides) according to World Health Organization (2008) classification.
  • Histologically confirmed CD30+ PTCL.
  • Availability of histological material for central review and pathobiological studies.
  • Failed at least one prior systemic antilymphoma therapy.
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  • Eastern Cooperative Oncology Group (ECOG) performance status score of ≤ 1 at study entry.
  • At least one site of disease measurable in two dimensions by computed tomography. Both nodal and extranodal disease will be considered (lymphnodes must have long axis of 1.5 cm regardless of short axis or long axis 1.1 to 1.5 cm and short axis >1.0 cm).
  • Hematology values within the following limits:
  • Absolute neutrophil count (ANC) ≥ 1500/mm3 independent of growth factor support.
  • Platelets ≥75,000/mm3 or ≥50,000/mm3 if bone marrow involvement is independent of transfusion support.
  • Hemoglobin level ≥8 g/dL.
  • Biochemical values within the following limits:
  • Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) < 3 x upper limit of normal (ULN).
  • Total bilirubin < 1.5 x ULN (unless bilirubin rise is due to Gilbert's syndrome or of nonhepatic origin).
  • Serum creatinine ≤ 2 x ULN.
  • Serum albumin ≥ 3 g/dL.
  • Women of childbearing potential (WOCBP) must have a negative pregnancy test within 7 days of receiving study medication.
  • WOCBP must agree to use effective contraception, defined as oral contraceptives, double barrier method or practice true abstinence from sexual intercourse during the study and for 6 months after the last dose of study drug.
  • Male subjects and their female partners of childbearing potential must be willing to use an appropriate method of contraception or practice true abstinence from sexual intercourse during the study and for 6 months after the last dose of study drug.

Who cannot join

  • Diagnosis of CTCL, ALCL, mycosis fungoides or Sezary Syndrome.
  • CD30 expression < 10 %.
  • Patients that have not completed any prior treatment chemotherapy and/or other investigational agents within at least 5 half-lives of last dose of that prior treatment.
  • Patients underwent major surgery without complete recovery
  • Known hypersensitivity to recombinant proteins, murine proteins, or to any excipient contained in the drug formulation of brentuximab vedotin.
  • Any serious active disease or co-morbid medical condition (according to investigator's decision).
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  • Prior history of malignancies other than lymphoma (except for a history of a complete resection for basal cell or squamous cell carcinoma of the skin or carcinoma in situ of the cervix or breast) unless the subject has been free of the disease for ≥ 3 years.
  • Patients with peripheral neuropathy of grade 3-4 (also grade 2 with persistent pain, unresponsive to treatment).
  • Signs or symptoms of progressive multifocal leukoencephalopathy (PML).
  • Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the informed consent form.
  • Pregnant or lactating females or men or women of childbearing potential not willing to use an adequate method of birth control for the duration of the study.
  • CNS disease (meningeal and/or brain involvement by lymphoma) or testicular involvement.
  • History of clinically relevant liver or renal insufficiency; significant cardiac, vascular pulmonary, gastrointestinal, endocrine, neurologic, rheumatologic, hematologic, psychiatric, or metabolic disturbances.
  • Known history of any of the following cardiovascular conditions:
  • Myocardial infarction within 2 years from enrollment
  • New York Heart Association (NYHA) Class III or IV heart failure
  • Evidence of current uncontrolled cardiovascular conditions, including cardiac arrhythmias, congestive heart failure (CHF), angina, or electrocardiographic evidence of acute ischemia or active conduction system abnormalities
  • Recent evidence (within 6 months before first dose of study drug) of a left-ventricular ejection fraction <50%
  • Active opportunistic infection.
  • Known history of Human Immunodeficiency Virus (HIV) or Hepatitis C or active infection with Hepatitis B.
  • Prior allogeneic stem cell transplant.

Trial locations and contacts

4 sites in 1 country.

Italy4 sites

  • Ematologia "L. & A. Seragnoli" - Policlinico S. Orsola Malpighi

    Bologna, 40138

  • Ematologia e Trapianto IRCCS, Istituto Nazionale dei Tumori

    Milan

  • SC Ematologia - Città della Salute e della Scienza

    Torino, 10126

  • A.O. Universitaria S. Maria Della Misericordia Di Udine

    Udine, 33100

Other trials in Italy

About this study

Official title: Phase II Study on the Role of Brentuximab Vedotin as Single Agent in the Treatment of Relapsed/Refractory CD30 Positive Peripheral T Cell Lymphoma (PTCL) Patients

This is a single-arm, open-label, multicenter, clinical trial to evaluate the efficacy and safety of Brentuximab Vedotin (BV) as a single agent in relapsed/refractory CD30+ PTCL patients.

Read the detailed description

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) and PET scan will be performed at baseline and Cycles 3, 8, 12, and 16. Patients will have an End of Treatment (EOT) assessment 30 ± 7 days after receiving their final dose of study drug. Patients with at least stable disease will enter short follow up phase till month 24 with radiology assessment every 6 months and visit every 12 weeks. After month 24 and for all patients with progressive disease, long-term follow-up assessments (including survival, disease status and next therapy information) will be performed every 12 weeks until either patient death or study closure, whichever occurs first.

Being tested
Brentuximab Vedotin
Keywords
PTCL, CD30+
Medical subject headings
Lymphatic Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Brentuximab VedotinDrug

    Also called SGN35

    Brentuximab vedotin will be administered on Day 1 of each 21-day cycle. The dose of brentuximab vedotin is 1.8 mg/kg and is administered by outpatient IV infusion given over approximately 30 minutes

Study groups in NCT02497131
Study groupRoleWhat they receive
Brentuximab Vedotin 16 cyclesExperimentalSubjects will receive 1.8 mg/kg of brentuximab vedotin as an iv infusion administered on Day 1 of each 21-day cycle for 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.

  1. overall objective response rate (ORR)

    Overall objective response rate (ORR) is defined as the proportion of patients with complete remission (CR) or partial remission (PR) according to the Revised Response Criteria for Malignant Lymphoma

    Measured: 1 year

Secondary outcomes (5)

  1. Duration of response

    Duration of response is defined as the time from start of the first documentation of objective tumor response (CR or PR) to the first documentation of objective tumor progression or to death due to lymphoma

    Measured: 1 year

  2. Complete remission rate (CR)

    The proportion of patients with complete remission (CR) according to the Revised Response Criteria for Malignant Lymphoma

    Measured: 1 year

  3. Progression-free survival (PSF)

    Progression-free survival (PFS) is defined as the time from start of study treatment to first documentation of objective tumor progression or to death due to any cause

    Measured: 1 year

  4. Overall survival (OS)

    Overall survival (OS) is defined as the time from start of study treatment to date of death due to any cause.

    Measured: 1 year

  5. Adverse Events

    Type, incidence, severity, seriousness, and relatedness of adverse events, and laboratory abnormalities

    Measured: 1 year

Timeline

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

  1. First posted14 Jul 2015 (estimated)
  2. Study start21 Sep 2015
  3. Primary completion24 Sep 2019
  4. Study completionMar 2022

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 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
Subjects will receive 1.8 mg/kg of brentuximab vedotin as an iv infusion administered on Day 1 of each 21-day cycle for a maximum of 16 cycles.
Masking
None (open label)
Enrolment
25 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02497131
Sponsor's protocol ID
FIL_PTCL_BV
Status last verified
Mar 2022
First submitted
8 Jul 2015
Last updated
22 Mar 2022
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Brentuximab Vedotin in people with Lymphatic Diseases, run by Fondazione Italiana Linfomi - ETS at 4 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 20 inclusion and 21 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 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 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?

overall objective response rate (ORR) (time frame: 1 year). 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 NCT02497131.

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 Mar 2022.

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