BRENTUXIMAB VEDOTIN as Pre-ASCT Induction Therapy in R/R HL Patients Non Responding to IGEV

NCT02244021 | Completed Phase 2

• 1 other identifier: FIL_BRidge
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 7

Brief Summary

A pilot phase II study with brentuximab vedotin as pre-ASCT induction therapy in relapsed/refractory Hodgkin's lymphoma patients non-responding to IGEV salvage treatment.

Conditions

Relapsed/Refractory Hodgkin's Lymphoma

Keywords

HD; Hodgkin's Lymphoma; RELAPSED-REFRACTORY

Outcome Measures

Primary Outcomes (1)

• Complete response (CR rate)

  Complete response will be defined according to recently updated international criteria (Cheson 2007), assuming that a negative PET is defined by DEAUVILLE scores 1 and 2.

  1 year and half from the beginning of the study

Secondary Outcomes (3)

• PFS

  2 years and half from the beginning of the study

• Neurotoxicity rate

  1 year half from the beginning of the study

• Duration of remission (DR)

  2 years and half from the beginning of the study

Study Arms (1)

BRENTUXIMAB VEDOTIN

EXPERIMENTAL

1 arm for all patients

Drug: BRENTUXIMAB VEDOTIN

Interventions

BRENTUXIMAB VEDOTIN DRUG

Patients with FDG-PET positive after IGEV will be treated with brentuximab vedotin as followed: 1.8 mg/kg every 3 weeks as a 30-minute outpatient IV infusion for a total of 4 cycles of treatment Growth factors may be used at the discretion of investigators but are not routinely advised. Patients with FDG-PET negative after brentuximab vedotin treatment will be addressed to high dose chemotherapy followed by ASCT.

Also known as: SGN-35

BRENTUXIMAB VEDOTIN

Eligibility Criteria

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

You may qualify if:

• Classical Hodgkin Lymphoma according to the WHO classification
• Histologically confirmed CD30+ HL at diagnosis
• Patients at the first line salvage therapy
• FDG-PET positivity after two cycles of IGEV treatment
• PBPCs should have been collected after the first or the second IGEV cycle
• Age≥ 18 years
• ECOG PS of 0-2
• Life expectancy \> 6 months.
• Written informed consent
• Patients available for periodic blood sampling, study-related assessments and management of toxicity
• Females of childbearing potential must have a negative β-HCG pregnancy test result (pregnancy test should be performed at screening an on day 1 of cycle 1 prior to brentuximab vedotin treatment).
• Female patient is either post-menopausal for at least 1 year before the screening visit or surgically sterile or if of childbearing potential, agree to practice 2 effective methods of contraception, at the same time, from the time of signing the informed consent through 6 months after the last dose of study drug, or agrees to completely abstain from heterosexual intercourse.
• Male patients, even if surgically sterilized, (i.e., status post vasectomy) agree to practice effective barrier contraception during the entire study period and through 6 months after the last dose of study drug, or agrees to completely abstain from heterosexual intercourse.
• Required baseline laboratory data: Absolute neutrophil count ≥ 1500/µl, Platelet count ≥ 75.000/ µl, Haemoglobin must be ≥ 8 g/dL, Serum bilirubin ≤ 1.5 times ULN, Serum creatinine \< 2.0 mg/dL and/or creatinine clearance or calculated creatinine clearance \> 40 mL/minute, Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 times ULN

You may not qualify if:

• Peripheral neuropathy \> Grade 1
• Histologic diagnosis different from Hodgkin Lymphoma
• First line treatment with BEACOPP
• Compressive symptoms caused by the presence of Lymphoma
• Patients treated previously with any anti-CD30 antibody.
• Known hypersensitivity to any recombinant proteins, murine proteins, or excipients contained in the brentuximab vedotin formulation.
• Known human immunodeficiency virus (HIV) positive
• Known hepatitis B surface antigen-positive, or known or suspected active hepatitis C infection
• Diagnosed or treated for another malignancy within 3 years before the first dose or previously diagnosed with another malignancy and have evidence of residual disease. Patients with nonmelanoma skin cancer or carcinoma in situ of any type are not excluded if they have undergone complete resection.
• Patients with known history of any of the following cardiovascular conditions:Myocardial infarction within 2 years of randomization, 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%
• Patients with known active viral, bacterial, or fungal infection requiring treatment with antimicrobial therapy within 2 weeks prior to the first dose of brentuximab vedotin.
• Patients with known active Grade 3 or higher viral, bacterial, or fungal infection within 2 weeks prior to the first dose of brentuximab vedotin.
• Patients with known cerebral/meningeal disease (HL or any other etiology), including signs or symptoms of Progressive Multifocal Leukoencephalopathy
• Any serious medical or psychiatric illness that could, in the investigator's opinion, potentially interfere with the completion of treatment according to protocol.
• Symptomatic neurologic disease compromising normal activities of daily living or requiring medications.

Sponsors & Collaborators

• Fondazione Italiana Linfomi - ETS: lead

Study Sites (7)

Istituto di Ematologia "L. & A. Seragnoli" , Policlinico S. Orsola Malpighi

Bologna, Italy

Location

Ematologia, IRCCS AOU San Martino-IST

Genova, Italy

Location

Ematologia Ospedale Vito Fazzi

Lecce, Italy

Location

Ematologia e Unità BMT IRCCS Istituto Nazionale dei Tumori

Milan, Italy

Location

Università degli Studi di Modena e Reggio Emilia, D.A.I di Medicina diagnostica clinica e sanità pubblica, AOU Policlinico

Modena, Italy

Location

Dipartimento di Oncologia Medica ed Ematologia, Istituto Humanitas

Rozzano, Italy

Location

SC Ematologia - Azienda Ospedaliera AO Città della Salute e della Scienza

Torino, Italy

Location

MeSH Terms

Conditions

Hodgkin Disease

Interventions

Brentuximab Vedotin

Condition Hierarchy (Ancestors)

Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System 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

• Angelo Michele Carella, Prof.

  Hematology Division, IRCCS AOU San Martino, Genova, Italy

  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

Study Record Dates

• First Submitted: September 10, 2014
• First Posted: September 18, 2014
• Study Start: December 1, 2014
• Primary Completion: July 1, 2016
• Study Completion: October 1, 2017
• Last Updated: February 9, 2018

Record last verified: 2018-02

Locations

IT (7)