Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
Register:
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EUCTR |
Last refreshed on:
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10 September 2018 |
Main ID: |
EUCTR2010-024215-14-AT |
Date of registration:
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05/06/2012 |
Prospective Registration:
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Yes |
Primary sponsor: |
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Public title:
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Study of Bretuximab Vedotin Compared to Physician's Choice in Patients With CD30-Positive Cutaneous T-Cell Lymphoma
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Scientific title:
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A Randomized, Open-Label, Phase 3 Trial of brentuximab vedotin (SGN-35) Versus Physician's Choice (Methotrexate or Bexarotene) in Patients With CD30-Positive Cutaneous T-Cell Lymphoma |
Date of first enrolment:
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26/06/2012 |
Target sample size:
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132 |
Recruitment status: |
Not Recruiting |
URL:
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https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2010-024215-14 |
Study type:
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Interventional clinical trial of medicinal product |
Study design:
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Controlled: yes
Randomised: yes
Open: yes
Single blind: no
Double blind: no
Parallel group: yes
Cross over: no
Other: no
If controlled, specify comparator, Other Medicinial Product: yes
Placebo: no
Other: no
Number of treatment arms in the trial: 2
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Phase:
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Human pharmacology (Phase I): no
Therapeutic exploratory (Phase II): no
Therapeutic confirmatory - (Phase III): yes
Therapeutic use (Phase IV): no
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Countries of recruitment
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Australia
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Austria
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Belgium
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Brazil
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Canada
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Germany
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Italy
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Poland
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Spain
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Switzerland
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United Kingdom
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United States
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Contacts
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Name:
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Drug Information Call Centre
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Address:
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40 Landsdowne Street
MA 02139
Cambridge, Massachusetts
United States |
Telephone:
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+115107402412 |
Email:
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medical@mlnm.com |
Affiliation:
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Millennium, Drug Information Call Centre |
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Name:
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Drug Information Call Centre
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Address:
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40 Landsdowne Street
MA 02139
Cambridge, Massachusetts
United States |
Telephone:
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+115107402412 |
Email:
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medical@mlnm.com |
Affiliation:
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Millennium, Drug Information Call Centre |
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Key inclusion & exclusion criteria
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Inclusion criteria: - Voluntary consent form
- Male or female patients 18 years or older with diagnosis of MF or pcALCL
- Histologically confirmed CD30+ disease by central laboratory
assessment and pathology review
- Patients with pcALCL who have received prior radiation therapy or at least one systemic therapy; patients with MF who have received one prior systemic therapy
- Eastern Cooperative Oncology Group (ECOG) performance status =2
- Female patients who are post menopausal, surgically sterile,
or agree to practice 2 effective methods of contraception or agree to abstain from heterosexual intercourse or practice true abstinence when this is in line with the preferred and usual lifestyle of the subject
- Male patients who agree to practice effective barrier
contraception or agree to abstain from heterosexual intercourse or practice true abstinence when this is in line with the preferred and usual lifestyle of the subject
- Clinical laboratory value as specified in protocol
Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 79 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 53
Exclusion criteria: - A concurrent diagnosis of systemic ALCL, other non Hodgkin
lymphoma (excluding LyP) or Sezary syndrome or B2 disease.
- Patients with cardiovascular conditions specified in protocols
- Patients with history of another primary malignancy not in
remission for at least 3 years
- Known active cerebral/meningeal disease, HIV infection, hepatitis B or Hepatitis C infection
- Oral retinoid therapy for any indication within 3 weeks of
study entry
- Corticosteroid therapy within 3 weeks or antibody-directed or any immunoglobulin-based immune therapy or radiotherapy within 12 weeks of
first dose of study
- Female patients who are lactating and breastfeeding or have a positive serum pregnancy test during the screening period or a positive urine pregnancy test on day 1 of any cycle
- Progressed on prior therapy with both bexarotene and methotrexate
-Systemic therapy with vitamin A as detailed in the protocol
- History of pancreatitis or significant risk factors for developing pancreatitis
- Previous receipt of brentuximab vedotin
Age minimum:
Age maximum:
Gender:
Female: yes Male: yes
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Health Condition(s) or Problem(s) studied
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CD30-Positive Cutaneous T-Cell Lymphoma MedDRA version: 18.1
Level: LLT
Classification code 10011677
Term: Cutaneous T-cell lymphoma
System Organ Class: 100000004864
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Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]
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Intervention(s)
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Product Name: Brentuximab vedotin Product Code: SGN-35 Pharmaceutical Form: Powder for concentrate for solution for infusion INN or Proposed INN: Brentuximab vedotin CAS Number: 914088-09-8 Current Sponsor code: SGN-35 Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 5-
Trade Name: Methotrexate Pharmaceutical Form: Tablet INN or Proposed INN: METHOTREXATE CAS Number: 59-05-2 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 2.5-
Trade Name: Targretin Pharmaceutical Form: Capsule, soft INN or Proposed INN: BEXAROTENE CAS Number: 153559-49-0 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 75-
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Primary Outcome(s)
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Primary end point(s): To determine the proportion of patients achieving an objective response that lasts at least 4 months
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Main Objective: To determine ORR, lasting at least 4 months, with brentuximab vedotin in patients with CD30+ MF or pcALCL compared to that achieved with therapy in the control arm
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Timepoint(s) of evaluation of this end point: At the end of cycles 3,6,9,12, and 15; at EOT; then every 12 weeks for a minimum of 24 months, and then every 6 months until disease progression or study closure
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Secondary Objective: Determine CR rate with brentuximab vedotin compared to that achieved with therapy in the control arm
Determine progression-free survival (PFS) with brentuximab vedotin compared to that achieved with therapy in the control arm
Determine burden of symptoms during treatment with brentuximab vedotin compared to that achieved with therapy in the control arm
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Secondary Outcome(s)
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Timepoint(s) of evaluation of this end point: Does not have a specific timepoint.
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Secondary end point(s): To determine the proportion of patients achieving complete response (CR)
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Secondary ID(s)
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2010-024215-14-BE
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C25001
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Source(s) of Monetary Support
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Millennium Pharmaceuticals, Inc
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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