A Study of Brentuximab Vedotin in Participants With Relapsed or Refractory Hodgkin Lymphoma
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
5 other identifiers
interventional
60
7 countries
18
Brief Summary
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 participants with histologically confirmed CD30+ relapsed or refractory classical Hodgkin Lymphoma 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4
Started Mar 2014
Longer than P75 for phase_4
18 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 15, 2013
CompletedFirst Posted
Study publicly available on registry
November 21, 2013
CompletedStudy Start
First participant enrolled
March 14, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 24, 2016
CompletedResults Posted
Study results publicly available
May 5, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
March 12, 2020
CompletedApril 9, 2021
March 1, 2021
2 years
November 15, 2013
March 23, 2017
March 10, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Objective Response Rate (ORR)
Objective response rate is defined as the percentage of participants with complete remission (CR) or partial remission (PR) as assessed by an independent review facility (IRF) using International Working Group (IWG) Revised Response Criteria for Malignant Lymphoma. CR is defined as the disappearance of all evidence of disease and PR is defined as regression of measurable disease and no new sites.
Baseline until disease progression, death or end of study (EOS) (Up to 24 months)
Secondary Outcomes (12)
Duration of Response (DOR)
From first documented complete or partial remission until disease progression (Up to 24 months)
Progression Free Survival (PFS)
Baseline until disease progression, death or end of treatment (EOT), and then every 3 months up to approximately 6 years
Complete Remission Rate
Baseline until disease progression, death or EOS (Up to approximately 6 years)
Duration of Complete Remission
From first documented complete remission until disease progression (up to approximately 6 years)
Overall Survival (OS)
Every 3 months for 18 months after EOT, thereafter, every 6 months until the sooner of death, study closure, or 5 years after enrollment of the last participant (up to approximately 6 years)
- +7 more secondary outcomes
Study Arms (1)
Brentuximab Vedotin 1.8 mg/kg
EXPERIMENTALBrentuximab vedotin 1.8 mg/kg, 30-minute intravenous (IV) infusion, Day 1 in every 3-week cycle, until there is evidence of disease progression or unacceptable toxicity occurs (Up to 16 cycles). The dose could be decreased or delayed or discontinued in participants who develop treatment-associated non-hematologic, hematologic toxicity or peripheral neuropathy to brentuximab vedotin.
Interventions
Brentuximab vedotin IV infusion
Eligibility Criteria
You may qualify if:
- Male or female participants 18 years or older, with relapsed or refractory classical Hodgkin lymphoma (HL), who have previously received at least 1 prior systemic chemotherapeutic regimen
- Not suitable for stem cell transplantation (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
- Bidimensional measurable disease
- An Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1
- Female participants 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.
- Male participants 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.
- Clinical laboratory values as specified in the study protocol.
You may not qualify if:
- Previous treatment with brentuximab vedotin
- Previously received an autologous stem cell transplantation (ASCT) or alloSCT
- Known cerebral/meningeal disease, including signs or symptoms suggestive of progressive multifocal leukoencephalopathy (PML), or any history of PML.
- Female participants who are lactating and breastfeeding or pregnant.
- Known human immunodeficiency virus (HIV).
- Known hepatitis B surface antigen positive, or known or suspected active hepatitis C infection.
- Grade 2 or higher peripheral neuropathy.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (18)
Unknown Facility
Prague, Prague, Czechia
Unknown Facility
Brno, Czechia
Unknown Facility
Heidelberg, Baden-Wurttemberg, Germany
Unknown Facility
Cologne, Germany
Unknown Facility
George Town, Pulau Pinang, Malaysia
Unknown Facility
Ampang, Selangor, Malaysia
Unknown Facility
Kuala Lumpur, Malaysia
Unknown Facility
Gdansk, Poland
Unknown Facility
Krakow, Poland
Unknown Facility
Warsaw, Poland
Unknown Facility
Pamplona, Navarre, Spain
Unknown Facility
Madrid, Spain
Unknown Facility
Bangkoknoi, Bangkok, Thailand
Unknown Facility
Patumwan, Bangkok, Thailand
Unknown Facility
Ratchathewi, Bangkok, Thailand
Unknown Facility
Izmir, Bornova, Turkey (Türkiye)
Unknown Facility
Ankara, Turkey (Türkiye)
Unknown Facility
Izmir, Turkey (Türkiye)
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Medical Director
- Organization
- Takeda
Study Officials
- STUDY DIRECTOR
Medical Monitor
Millennium Pharmaceuticals, Inc.
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 15, 2013
First Posted
November 21, 2013
Study Start
March 14, 2014
Primary Completion
March 24, 2016
Study Completion
March 12, 2020
Last Updated
April 9, 2021
Results First Posted
May 5, 2017
Record last verified: 2021-03
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF, CSR
- Access Criteria
- IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/. For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.
Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.