A Study of SGN-35 (Brentuximab Vedotin) of Patients With Relapsed or Refractory PMLBCL

NCT02423291 | Completed Phase 2 Results DMC

• 1 other identifier: FIL_SGN01
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 9

Brief 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. 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.

Conditions

Primary Mediastinal Large B Cell Lymphoma

Keywords

PMLBCL; Brentuximab Vedotin; CD30-positive; Mediastinal Lymphoma

Outcome Measures

Primary Outcomes (1)

• 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.

  42 months

Study Arms (1)

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.

Drug: Brentuximab Vedotin

Interventions

Brentuximab Vedotin DRUG

Brentuximab vedotin, 1.8 mg/kg, administered via outpatient IV infusion on Day 1 of each 21-day cycle.

Also known as: SGN-35; Adcetris

Vial for IV infusion

Eligibility Criteria

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

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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).
• 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.

Sponsors & Collaborators

• Fondazione Italiana Linfomi - ETS: lead

Study Sites (9)

S.C. Ematologia A.O. SS. Antonio e Biagio e C. Arrigo

Alessandria, AL, 15121, Italy

Location

Unità funzionale di Ematologia A.O.U. Careggi

Florence, FI, 50134, Italy

Location

Dip. Oncologia, Ematologia e Patologie dell'apparato respiratorio A.O.U. Policlinico di Modena

Modena, MO, 41100, Italy

Location

Divisione di Ematologia Azienda Ospedaliera "Bianchi Melacrino Morelli"

Reggio Calabria, RC, 89125, Italy

Location

S. C. Ematologia IRCCS Azienda Ospedaliera Arcispedale "S.Maria Nuova"

Reggio Emilia, RE, 4210, Italy

Location

Dipartimento di Biotecnologie Cellulari ed Ematologia Università "La Sapienza"

Roma, Roma, 0016, Italy

Location

S.C.D.O. Ematologia 2 A.O. Città della Salute e della Scienza

Torino, TO, 1012, Italy

Location

Istituto di Ematologia L. & A. Seragnoli

Bologna, 40138, Italy

Location

Ematologia Ospedale Businco

Cagliari, 09121, Italy

Location

MeSH Terms

Interventions

Brentuximab Vedotin

Intervention Hierarchy (Ancestors)

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

Results Point of Contact

• Title: MD Vittorio Stefoni
• Organization: Institute of Hematology "L. e A. Seràgnoli", AOU Policlinico S.Orsola-Malpighi Via Massarenti, 9 - 40138 Bologna Italy

vittorio.stefoni2@unibo.it

+39 0512143680

Study Officials

• Pier Luigi Zinzani, Prof.

  Istituto di Ematologia L. e A. Seragnoli - Bologna - Italy

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

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

Study Record Dates

• First Submitted: September 30, 2013
• First Posted: April 22, 2015
• Study Start: October 1, 2013
• Primary Completion: July 1, 2016
• Study Completion: July 1, 2016
• Last Updated: June 26, 2017
• Results First Posted: June 26, 2017

Record last verified: 2017-04

Locations

IT (9)