- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02275598
Brentuximab Vedotin Followed by ABVD in Patients With Previously Untreated Hodgkin Lymphoma
October 22, 2014 updated by: Massimo Federico, MD, University of Modena and Reggio Emilia
A Pilot Phase II Study To Assess The Efficacy Of Brentuximab Vedotin Administered Sequentially With ABVD Chemotherapy In Patients With Untreated Hodgkin Lymphoma.
The purpose of this study is to assess the efficacy of two three-weekly 1.8 mg/kg Brentuximab vedotin administrations in untreated patients with Hodgkin Lymphoma (HL).
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Detailed Description
This is a multicenter pilot phase II trial assessing 2 administrations of Brentuximab vedotin followed by PET scan and subsequent standard treatment with ABVD ± Radiotherapy.
12 patients defined by inclusion and exclusion criteria will be enrolled in one year.
All subjects will be followed for disease evaluation every 3 months for one year after end of therapy until disease progression, death, initiation of alternative therapy, withdrawal of consent, or end of study.
For all study procedures patient will be assigned a Unique Subject Identifier (SID) number that will be used to identify the subject during the screening process and throughout study participation.
A master log will be maintained of all consented subjects and will document all screening failures (i.e.
subjects who are consented but do not meet study eligibility criteria).
Study records such as case report forms (CRFs) may be maintained electronically and require the same security and confidentiality as paper.
Clinical information will not be released without written permission of the subject/legal representative, except as specified in the informed consent form
Study Type
Interventional
Enrollment (Actual)
12
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Bologna, Italy, 40138
- Institute of Hematology and Medical Oncology "L. e A. Seràgnoli" at the University of Bologna
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Modena, Italy, 41124
- Department of Diagnostic, Clinical and Public Health Medicine, University of Modena and Reggio Emilia
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Reggio Emilia, Italy, 42100
- Hematology, Azienda Ospedaliera Arcispedale S.Maria Nuova IRCCS
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
8 years to 70 years (ADULT, OLDER_ADULT, CHILD)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Previously-untreated patients with classical Hodgkin Lymphoma according to the World Health Organisation (WHO) classification
- Histologically confirmed CD30+ HL
- Stage IA, IIA, IIIA
- Absence of bulky disease
- FDG-PET at baseline
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-1
- Life expectancy > 6 months.
- Age 18-70 years.
- Patients must be available for periodic blood sampling, study-related assessments, and management of toxicity at the treating institution.
- Females of childbearing potential must have a negative pregnancy test result within three days of enrollment. All patients must agree to use effective contraceptive methods (one for male and two for female) during the course of the study and for 6 months following the end of full treatment (Brentuximab vedotin + ABVD +/- Radiotherapy).
- Written informed consent.
- Required baseline laboratory data:
Absolute neutrophil count ≥ 1000/μl Platelet count ≥ 50.000/ μl Serum bilirubin ≤ 1.5 times ULN Serum creatinine ≤ 1.5 times ULN Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 times ULN
Exclusion Criteria:
- Peripheral neuropathy > Grade 1
- Histologic diagnosis different from Hodgkin Lymphoma
- Compressive symptoms
- Patients previously treated with any anti-CD30 antibody
- Known human immunodeficiency virus (HIV) positive
- Known hepatitis B surface antigen-positive, or known or suspected infection active hepatitis C
- Patients with signs or symptoms of progressive multifocal leukoencephalopathy (PML)
- Patients with known cerebral/meningeal disease.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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EXPERIMENTAL: BV-ABVD
Treatment will consist of two three-weekly doses of Brentuximab vedotin, followed by standard treatment, ABVD (3 o 6 cycles q4w).
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1.8 mg/kg, IV (in the vein) on day 1 of each 28 day cycle.
Number of Cycles: 2
Other Names:
Doxorubicin 25 mg/m2 IV, Bleomycin 10,000 units/m2 IV, Vinblastine 6 mg/m2 IV, Dacarbazine 375 mg/m2 IV on days 1-15 of each 28 day cycle.
Number of Cycles: 3 or 6 according to initial disease stage.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Participants with Complete Metabolic Response by FDG-PET
Time Frame: between day +8 and day +15 from second administration of Brentuximab
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Complete Metabolic Response will be defined by Deauville score 1, 2, 3.
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between day +8 and day +15 from second administration of Brentuximab
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Overall Response Rate (ORR)
Time Frame: Up to 4 weeks from the end of full treatment program.
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Up to 4 weeks from the end of full treatment program.
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Progression Free Survival (PFS)
Time Frame: at 1 year from the end of full treatment program.
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at 1 year from the end of full treatment program.
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Number of Participants with Adverse Events
Time Frame: from C1D1 of Brentuximab vedotin up to 1 year from the end of full treatment program.
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All serious and on-serious adverse events will be assessed
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from C1D1 of Brentuximab vedotin up to 1 year from the end of full treatment program.
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Study Chair: Massimo Federico, MD, Department of Diagnostic, Clinical and Public Health Medicine
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
April 1, 2013
Primary Completion (ACTUAL)
November 1, 2013
Study Completion (ANTICIPATED)
March 1, 2015
Study Registration Dates
First Submitted
October 8, 2014
First Submitted That Met QC Criteria
October 22, 2014
First Posted (ESTIMATE)
October 27, 2014
Study Record Updates
Last Update Posted (ESTIMATE)
October 27, 2014
Last Update Submitted That Met QC Criteria
October 22, 2014
Last Verified
October 1, 2014
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- BV-ABVD
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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National Cancer Institute (NCI)CompletedRecurrent Adult Hodgkin Lymphoma | Stage III Adult Hodgkin Lymphoma | Stage IV Adult Hodgkin Lymphoma | Recurrent/Refractory Childhood Hodgkin Lymphoma | Stage III Childhood Hodgkin Lymphoma | Stage IV Childhood Hodgkin Lymphoma | Stage I Adult Hodgkin Lymphoma | Stage I Childhood Hodgkin Lymphoma | Stage II Adult Hodgkin Lymphoma and other conditionsUnited States
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Academic and Community Cancer Research UnitedNational Cancer Institute (NCI)Active, not recruitingAnn Arbor Stage III Hodgkin Lymphoma | Ann Arbor Stage IIIA Hodgkin Lymphoma | Ann Arbor Stage IIIB Hodgkin Lymphoma | Ann Arbor Stage IV Hodgkin Lymphoma | Ann Arbor Stage IVA Hodgkin Lymphoma | Ann Arbor Stage IVB Hodgkin Lymphoma | Classic Hodgkin Lymphoma | Ann Arbor Stage IB Hodgkin Lymphoma | Ann... and other conditionsUnited States
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Fred Hutchinson Cancer CenterNational Cancer Institute (NCI)TerminatedRecurrent Hodgkin Lymphoma | Refractory Hodgkin Lymphoma | Refractory B-Cell Non-Hodgkin Lymphoma | Refractory T-Cell Non-Hodgkin Lymphoma | Recurrent B-Cell Non-Hodgkin Lymphoma | Recurrent T-Cell Non-Hodgkin LymphomaUnited States
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Fred Hutchinson Cancer CenterNational Cancer Institute (NCI)CompletedRecurrent Hodgkin Lymphoma | Refractory Hodgkin Lymphoma | Recurrent Mantle Cell Lymphoma | Refractory B-Cell Non-Hodgkin Lymphoma | Refractory T-Cell Non-Hodgkin Lymphoma | Recurrent B-Cell Non-Hodgkin Lymphoma | Recurrent T-Cell Non-Hodgkin Lymphoma | Refractory Mantle Cell LymphomaUnited States
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Children's Oncology GroupNational Cancer Institute (NCI)CompletedStage III Childhood Hodgkin Lymphoma | Stage IV Childhood Hodgkin Lymphoma | Stage I Childhood Hodgkin Lymphoma | Stage II Childhood Hodgkin Lymphoma | Childhood Nodular Lymphocyte Predominant Hodgkin Lymphoma | Childhood Lymphocyte-Depleted Classical Hodgkin Lymphoma | Childhood Mixed Cellularity... and other conditionsUnited States, Canada, Australia, New Zealand, Puerto Rico, Switzerland, Israel
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Academic and Community Cancer Research UnitedNational Cancer Institute (NCI)Active, not recruitingClassic Hodgkin Lymphoma | Ann Arbor Stage IB Hodgkin Lymphoma | Ann Arbor Stage II Hodgkin Lymphoma | Ann Arbor Stage IIA Hodgkin Lymphoma | Ann Arbor Stage IIB Hodgkin Lymphoma | Ann Arbor Stage I Hodgkin Lymphoma | Ann Arbor Stage IA Hodgkin LymphomaUnited States
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Northwestern UniversitySeagen Inc.; Robert H. Lurie Cancer CenterUnknownStage III Adult Hodgkin Lymphoma | Stage IV Adult Hodgkin Lymphoma | Stage II Adult Hodgkin Lymphoma | Adult Lymphocyte Depletion Hodgkin Lymphoma | Adult Lymphocyte Predominant Hodgkin Lymphoma | Adult Mixed Cellularity Hodgkin Lymphoma | Adult Nodular Sclerosis Hodgkin LymphomaUnited States
-
National Cancer Institute (NCI)Active, not recruitingAnn Arbor Stage IIIB Hodgkin Lymphoma | Ann Arbor Stage IVA Hodgkin Lymphoma | Ann Arbor Stage IVB Hodgkin Lymphoma | Classic Hodgkin Lymphoma | Ann Arbor Stage IIB Hodgkin Lymphoma | Childhood Hodgkin LymphomaUnited States, Canada, Puerto Rico
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University Hospital, CaenRecruiting
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Seagen Inc.TerminatedSystemic Lupus ErythematosusUnited States
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Seagen Inc.Millennium Pharmaceuticals, Inc.CompletedLymphoma, Non-Hodgkin | Lymphoma, Large-Cell, Anaplastic | Disease, HodgkinUnited States, France
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Seagen Inc.Millennium Pharmaceuticals, Inc.No longer availableLymphoma, Non-Hodgkin | Lymphoma, T-Cell, Cutaneous | Lymphoma, Large-Cell, Anaplastic | Disease, HodgkinUnited States, United Kingdom, Belgium, Serbia, Australia, Bulgaria, France, Germany, Hungary, Italy, Poland, Romania, Russian Federation, Spain, Switzerland
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Seoul National University HospitalSeoul National University Bundang Hospital; SMG-SNU Boramae Medical CenterCompletedRelapsed or Refractory EBV-and CD30-positive LymphomasKorea, Republic of
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Samsung Medical CenterMillennium Pharmaceuticals, Inc.CompletedNon-Hodgkin LymphomaKorea, Republic of
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Seagen Inc.Millennium Pharmaceuticals, Inc.CompletedLymphoma, Non-Hodgkin | Lymphoma, Large-Cell, Anaplastic | Disease, HodgkinUnited States, Germany
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Fondazione Italiana Linfomi ONLUSCompletedRelapsed/Refractory Hodgkin's LymphomaItaly
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Seagen Inc.CompletedLymphoma, Non-Hodgkin | Lymphoma, Large-Cell, Anaplastic | Disease, HodgkinUnited States