A comparison of brentuximab vedotin and CHP with standard-of-care CHOP in the treatment of patients with CD30-positive mature T-cell lymphomas
- Conditions
- CD30-positive mature T-cell lymphomasMedDRA version: 20.0Level: HLGTClassification code 10025321Term: Lymphomas non-Hodgkin's T-cellSystem Organ Class: 10005329 - Blood and lymphatic system disordersTherapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2012-002751-42-HU
- Lead Sponsor
- Seattle Genetics, Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 450
- ECOG performance less than or equal to 2
- Fluorodeoxyglucose (FDG)-avid disease by PET and measurable disease of at least 1.5 cm by CT
- Patients with newly diagnosed, CD-30-positive mature T-cell lymphomas
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 270
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 180
- Cerebral/meningeal disease related to the underlying malignancy
- Current diagnosis of primary cutaneous CD30-positive T-cell lymphoproliferative disorders and lymphomas or mycosis funoides
- History of another primary invasive malignancy that has not been in remission for at least 3 years
- History of progressive multifocal leukoencephalopathy (PML)
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: - To compare the progression-free survival (PFS) as determined by an independent review facility (IRF) between the 2 treatment arms;Secondary Objective: - To compare the PFS per IRF between the 2 treatment arms for patients with sALCL<br>- To compare the remission rates per IRF following the completion of study treatment between the 2 treatment arms<br>- To compare overall survival (OS) between the 2 treatment arms<br>- To evaluate the safety and tolerability of the 2 treatment arms<br>;Primary end point(s): Progression-free survival per independent review facility (IRF);Timepoint(s) of evaluation of this end point: Until disease progression, subsequent anticancer chemotherapy, death, or study closure, up to 5 years post-treatment
- Secondary Outcome Measures
Name Time Method Secondary end point(s): 1. Progression-free survival per IRF in patients with sALCL<br>2. Complete remission rate per IRF at end of treatment<br>3. Overall survival<br>4. Objective response rate per IRF following the completion of study treatment<br>5. Type, incidence, severity, seriousness, and relatedness of adverse events<br>6. Incidence of laboratory abnormalities;Timepoint(s) of evaluation of this end point: 1. Until disease progression, subsequent anticancer chemotherapy, death, or study closure, up to 5 years post treatment<br>2. Through 1 month following last dose<br>3. Until death or study closure, up to 7-years post treatment<br>4. Through 1 month following last dose<br>5. Through 1 month following last dose<br>6. Through 1 month following last dose