Study of Bretuximab Vedotin Compared to Physician's Choice in Patients With CD30-Positive Cutaneous T-Cell Lymphoma

• Register: EUCTR
• Last refreshed on: 15 October 2018
• Main ID: EUCTR2010-024215-14-DE
• Date of registration: 02/05/2012
• Prospective Registration: Yes
• Primary sponsor: Millennium Pharmaceuticals, Inc
• Public title: Study of Bretuximab Vedotin Compared to Physician's Choice in Patients With CD30-Positive Cutaneous T-Cell Lymphoma
• Scientific title: 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: 10/09/2012
• Target sample size: 124
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2010-024215-14
• Study type: Interventional clinical trial of medicinal product
• Study design: 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
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): yes Therapeutic use (Phase IV): no

Countries of recruitment

Australia, Austria, Belgium, Brazil, Canada, Czech Republic, France, Germany, Italy, Poland, Spain, Switzerland, United Kingdom, United States

Contacts

• Name: Drug Information Call Centre
• Affiliation: Millennium, Drug Information Call Centre

• Name: Drug Information Call Centre
• Affiliation: Millennium, Drug Information Call Centre

Key inclusion & exclusion criteria

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
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

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
- 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

Health Condition(s) or Problem(s) studied

CD30-Positive Cutaneous T-Cell Lymphoma
MedDRA version: 17.0 Level: LLT Classification code 10011677 Term: Cutaneous T-cell lymphoma System Organ Class: 100000004864

Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]

Intervention(s)

Trade Name: Adcetris®
Product Name: Adcetris®
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-

Primary Outcome(s)

Primary end point(s): To determine the proportion of patients achieving an objective response that lasts at least 4 months

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

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

Secondary Objective: 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

Secondary Outcome(s)

Timepoint(s) of evaluation of this end point: Does not have a specific timepoint.

Secondary end point(s): To determine the proportion of patients achieving complete response (CR)

Secondary ID(s)

2010-024215-14-BE

C25001

Source(s) of Monetary Support

Millennium Pharmaceuticals, Inc