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

NCT02497131 | Completed Phase 2

• 1 other identifier: FIL_PTCL_BV
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 4

Brief 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.

Conditions

Lymphatic Diseases

Keywords

PTCL; CD30+

Outcome Measures

Primary Outcomes (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

  1 year

Secondary Outcomes (5)

• Duration of response

  1 year

• Complete remission rate (CR)

  1 year

• Progression-free survival (PSF)

  1 year

• Overall survival (OS)

  1 year

• Adverse Events

  1 year

Other Outcomes (3)

• Event-Free survival (EFS)

  1 year

• B symptom resolution rate

  1 year

• CD30 expression

  1 year

Study Arms (1)

Brentuximab Vedotin 16 cycles

EXPERIMENTAL

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.

Drug: Brentuximab Vedotin

Interventions

Brentuximab Vedotin DRUG

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

Also known as: SGN35

Brentuximab Vedotin 16 cycles

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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).

You may not qualify if:

• 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).
• 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

Sponsors & Collaborators

• Fondazione Italiana Linfomi - ETS: lead

Study Sites (4)

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

Bologna, 40138, Italy

Location

Ematologia e Trapianto IRCCS, Istituto Nazionale dei Tumori

Milan, Italy

Location

SC Ematologia - Città della Salute e della Scienza

Torino, 10126, Italy

Location

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

Udine, 33100, Italy

Location

MeSH Terms

Conditions

Lymphatic Diseases

Interventions

Brentuximab Vedotin

Condition Hierarchy (Ancestors)

Hemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Oligopeptides; Peptides; Amino Acids, Peptides, and Proteins; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Serum Globulins; Globulins

Study Officials

• Vittorio Stefoni, MD

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: July 8, 2015
• First Posted: July 14, 2015
• Study Start: September 21, 2015
• Primary Completion: September 24, 2019
• Study Completion: March 1, 2022
• Last Updated: March 22, 2022

Record last verified: 2022-03

Locations

IT (4)