CD30-Positive Cutaneous T-Cell Lymphoma MedDRA version: 19.1 Level: LLT Classification code 10011677 Term: Cutaneous T-cell lymphoma System Organ Class: 100000004864
Conditions
Interventions
Trade Name: Adcetris®
Product Name: Adcteris®
Product Code: SGN-35
Pharmaceutical Form: Powder for concentrate for solution for infusion
Sponsors
Millennium Pharmaceuticals, Inc
Eligibility
Sex/Gender
All
Inclusion 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 79 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 53
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 ; 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 ;Primary end point(s): To determine the proportion of patients achieving an objective response that lasts at least 4 months; 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
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
Australia, Austria, Belgium, Brazil, Canada, France, Germany, Italy, Poland, Spain, Switzerland, United Kingdom, United States
Contacts
Public ContactDrug Information Call Centre
Millennium, Drug Information Call Centre
Outcome results
None listed