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A Phase II Open Label Study of Brentuximab Vedotin in Combination with CHEP in Patients with Previously Untreated CD30-expressing Peripheral T-cell Lymphomas (PTCL)

Status
Not yet recruiting
Phases
Phase 2
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2024-511567-28-01
Acronym
CLSG-PTCL-CHEPA
Enrollment
33
Registered
2024-08-27
Start date
Unknown
Completion date
Unknown
Last updated
2024-08-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cancer

Brief summary

Primary Endpoint 1. PET-negative complete response (CR) rate at the end of treatment

Detailed description

Key Secondary Endpoints 2. Type, incidence, severity, seriousness, and relatedness of treatment emergent adverse events. 3. Type, incidence, severity, seriousness, and relatedness of adverse events in the follow-up period. Secondary Endpoints 1. Progression-free survival (PFS) 2. Overall survival (OS) 3. Event-free survival (EFS) 4. Objective Response Rate (ORR) at the end of treatment 5. Rate of pre-planned upfront HDT/ASCT 6. Duration of response (DoR) Exploratory Endpoints 1. Descript

Interventions

DRUGETOPOSIDE
DRUGDOXORUBICIN
DRUGCYCLOPHOSPHAMIDE
DRUGPREDNISONE
DRUGADCETRIS 50 mg powder for concentrate for solution for infusion

Sponsors

Kooperativni Lymfomova Skupina z.s.
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Secondary

MeasureTime frame
Key Secondary Endpoints 2. Type, incidence, severity, seriousness, and relatedness of treatment emergent adverse events. 3. Type, incidence, severity, seriousness, and relatedness of adverse events in the follow-up period. Secondary Endpoints 1. Progression-free survival (PFS) 2. Overall survival (OS) 3. Event-free survival (EFS) 4. Objective Response Rate (ORR) at the end of treatment 5. Rate of pre-planned upfront HDT/ASCT 6. Duration of response (DoR) Exploratory Endpoints 1. Descript—

Primary

MeasureTime frame
Primary Endpoint 1. PET-negative complete response (CR) rate at the end of treatment—

Countries

Czechia

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026