A Study of Brentuximab Vedotin in Patients With Relapsed or Refractory Hodgkin Lymphoma

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2014 by Millennium Pharmaceuticals, Inc.
Sponsor:
Information provided by (Responsible Party):
Millennium Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:
NCT01990534
First received: November 15, 2013
Last updated: September 18, 2014
Last verified: September 2014
  Purpose

This phase 4, single-arm, open-label, multicenter study is designed to evaluate the efficacy and safety of brentuximab vedotin as a single agent in adult patients with histologically confirmed CD30+ relapsed or refractory classical HL who have not received a prior stem cell transplantation (SCT) and are considered to be not suitable for SCT or multiagent chemotherapy at the time of study entry.


Condition Intervention Phase
Hodgkin Lymphoma
Drug: Brentuximab vedotin
Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Single-arm Study of Brentuximab Vedotin in Patients With Relapsed or Refractory Hodgkin Lymphoma Who Are Not Suitable for Stem Cell Transplantation or Multiagent Chemotherapy

Resource links provided by NLM:


Further study details as provided by Millennium Pharmaceuticals, Inc.:

Primary Outcome Measures:
  • Objective response rate (ORR, complete remission (CR) + partial remission (PR)) as assessed by an independent review facility (IRF) according to the International Working Group (IWG) Revised Response Criteria for Malignant Lymphoma [ Time Frame: Until disease progression, death or study closure (up to 5 years after the enrollment of the last patient) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Duration of response, PFS, CR rate, and duration of CR, by IRF assessment [ Time Frame: Until disease progression, death or study closure (up to 5 years after the enrollment of the last patient) ] [ Designated as safety issue: No ]
  • Proportion of patients who receive SCT after treatment with brentuximab vedotin [ Time Frame: Until disease progression, death or study closure (up to 5 years after the enrollment of the last patient) ] [ Designated as safety issue: No ]
  • Overall survival [ Time Frame: Every 3 months for 18 months after end of treatment (EOT), thereafter, every 6 months until the sooner of death, study closure, or 5 years after enrollment of the last patient ] [ Designated as safety issue: No ]

Estimated Enrollment: 60
Study Start Date: March 2014
Estimated Study Completion Date: December 2019
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Brentuximab vedotin
Brentuximab vedotin will be administered every 3 weeks at a dose of 1.8 mg/kg.
Drug: Brentuximab vedotin
Brentuximab vedotin will be administered every 3 weeks at a dose of 1.8 mg/kg.
Other Names:
  • SGN-35
  • ADCETRIS

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria

Each patient must meet all of the following inclusion criteria to be enrolled in the study:

  1. Male or female patients 18 years or older, with relapsed or refractory classical HL, who have previously received at least 1 prior systemic chemotherapeutic regimen
  2. Not suitable for SCT or multiagent chemotherapy, according to 1 of the following criteria:

    • Disease progression within 90 days of the earliest date of complete remission (CR) or complete remission unconfirmed (CRu) after the end of treatment with multiagent chemotherapeutic regimens and/or radiotherapy
    • Progressive disease during frontline multiagent chemotherapy
    • Disease relapse after treatment with at least 2 chemotherapeutic regimens, including any salvage treatments
  3. Bidimensional measurable disease
  4. An Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1
  5. Female patients who are postmenopausal for at least 1 year before the screening visit, surgically sterile, or agree to practice 2 effective methods of contraception at the same time, or agree to practice true abstinence.
  6. Male patients who agree to practice effective barrier contraception during the entire study treatment period through 6 months after the last dose of study drug or agree to practice true abstinence.
  7. Clinical laboratory values as specified in the study protocol.

Exclusion Criteria

Patients who meet any of the following exclusion criteria are not to be enrolled in the study:

  1. Previous treatment with brentuximab vedotin
  2. Previously received an ASCT or alloSCT
  3. Known cerebral/meningeal disease, including signs or symptoms suggestive of progressive multifocal leukoencephalopathy (PML), or any history of PML.
  4. Female patients who are lactating and breastfeeding or pregnant.
  5. Known human immunodeficiency virus (HIV).
  6. Known hepatitis B surface antigen positive, or known or suspected active hepatitis C infection.
  7. Grade 2 or higher peripheral neuropathy.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01990534

Contacts
Contact: For an updated listing of recruitment sites contact: Millennium Medical and Drug Information Center 1-877-674-3784 medical@mlnm.com

Locations
Czech Republic
First Faculty of Medicine, Charles University in Prague Recruiting
Praha, Prague, Czech Republic
Fakultni nemocnice Kralovske Vinohrady Recruiting
Praha 10, Vinohrady, Czech Republic
University Hospital Recruiting
Brno, Czech Republic
Germany
University Hospital of Heidelberg Not yet recruiting
Heidelberg, Germany
Klinikum Der Universitaet Zu Koeln Not yet recruiting
Koeln, Germany
Malaysia
Hospital Ampang Recruiting
Ampang, Selangor, Malaysia
University Malaya Medical Centre Recruiting
Kuala Lumpur, Malaysia
Penang Hospital Recruiting
Penang, Malaysia
Poland
Klinika Hematologii i Transplantologii, Recruiting
Gdansk, Poland
Klinika Hematologii i Transplantologii, Uniwersyteckie Centrum Kliniczne Recruiting
Gdansk, Poland
Malopolskie Centrum Medyczne S.C. Recruiting
Krakow, Poland
Centrum Onkologii - Instytut im. Marii Sklodowskiej-Curie Recruiting
Warszawa, Poland
Spain
Hospital Clinic Barcelona Recruiting
Barcelona, Spain
Hospital Universitario 12 de Octubre Recruiting
Madrid, Spain
Complejo Hospitalario de Navarra Recruiting
Pamplona, Spain
Thailand
Ramathibodi hospital Recruiting
Bangkok, Thailand
Siriraj Hospital Recruiting
Bangkok, Thailand
Chulalongkorn University Recruiting
Bangkok, Thailand
Turkey
Ege University Recruiting
Izmir, Bornova, Turkey
Hacettepe Universitesi Tip Fakultesi Onkoloji Hastanesi Recruiting
Ankara, Turkey
Dokuz Eylul University Hospital Recruiting
Izmir, Turkey
Sponsors and Collaborators
Millennium Pharmaceuticals, Inc.
Investigators
Study Director: Medical Monitor Millennium Pharmaceuticals, Inc.
  More Information

No publications provided

Responsible Party: Millennium Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT01990534     History of Changes
Other Study ID Numbers: C25007, 2013-000232-10, U1111-1154-2250, NMRR-13-1246-18099, REec-2014-0619
Study First Received: November 15, 2013
Last Updated: September 18, 2014
Health Authority: European Union: European Medicines Agency

Keywords provided by Millennium Pharmaceuticals, Inc.:
Lymphatic Diseases
Lymphoma
Hodgkin
Relapsed
Refractory
Antigens, CD30
Antibody-Drug Conjugate
Antibodies, Monoclonal
Monomethyl auristatin E
Drug Therapy
Immunotherapy
Hematologic Diseases
Additional Relevant MeSH terms:
Lymphoma, Large B-Cell, Diffuse
Lymphoma, Hodgkin
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, B-Cell
Lymphoma, T-Cell
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

Additional relevant MeSH terms:
Lymphatic Diseases
Hodgkin Disease
Lymphoma
Immune System Diseases
Immunoproliferative Disorders
Lymphoproliferative Disorders
Neoplasms
Neoplasms by Histologic Type
Antibodies, Monoclonal
Immunologic Factors
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on October 20, 2014