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

• Register: EUCTR
• Last refreshed on: 21 December 2021
• Main ID: EUCTR2010-024215-14-IT
• Date of registration: 08/06/2012
• Prospective Registration: Yes
• Primary sponsor: MILLENNIUM PHARMACEUTICALS, INC.
• Public 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
• 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: 11/06/2012
• 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, 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 - 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 - Male patients who agree to practice effective barrier contraception or agree to abstain from heterosexual intercourse - Clinical laboratory value as specified in protocol
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 105
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 19

Exclusion criteria:
- A concurrent diagnosis of systemic ALCL, other non Hodgkin lymphoma(excluding LyP) or Sezary syndrome - 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 12 weeks of study entry - Corticosteroid therapy within 4 weeks or immunosuppressive chemotherapy or any immunotherapy within 12 weeks of first dose of study drug - Female patients who are lactating or have a positive serum pregnancy test during the screening period


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

CD30-Positive Cutaneous T-Cell Lymphoma
MedDRA version: 14.1 Level: LLT Classification code 10011677 Term: Cutaneous T-cell lymphoma System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)

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

Intervention(s)

Product Name: Brentuximab vedotin
Product Code: SGN-35
Pharmaceutical Form: 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: metotressato
CAS Number: 59-05-02
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)

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

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

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

Secondary Objective: CR rate with brentuximab vedotin compared to that achieved with therapy in the control arm

Secondary Outcome(s)

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

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

Secondary ID(s)

2010-024215-14-BE

C25001

Source(s) of Monetary Support

Millennium Pharmaceuticals, Inc

Ethics review

Status: Approved
Approval date: 15/05/2012
Contact:

Results

• Results available: Yes
• Date Posted: 07/01/2018
• URL: https://www.clinicaltrialsregister.eu/ctr-search/trial/2010-024215-14/results