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)
Efficacy assessments will be made according to the revised response criteria for malignant lymphoma based on the guidelines of the Lugano Classification (as reported by Cheson B et al. 2014) and will be based on investigator assessment Efficacy will be evaluated in terms of CR rate, ORR, PFS, EFS, OS. The safety and tolerability of study treatment will be evaluated by means of AE reports (nature, severity, frequency, causality), performance status, physical examinations, ECG and laboratory safety evaluations.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
33
Treatment by study drug Brentuximab Vedotin (Adcetris) in combination with CHEP.
Treatment by study drug Cyclophosphamide (Endoxan) in combination.
Treatment by study drug Doxorubicin in combination.
University Hospital Brno
Brno, Czechia
University Hospital Hradec Králové
Hradec Králové, Czechia
University Hospital Olomouc
Olomouc, Czechia
University Hospital Ostrava
Ostrava, Czechia
PET-negative complete response (CR) rate at the end of treatment
Complete response
Time frame: 6m months
Type, incidence, severity, seriousness, and relatedness of treatment emergent adverse events.
Type, incidence, severity, seriousness, and relatedness of treatment emergent adverse events.
Time frame: 38 months
Type, incidence, severity, seriousness, and relatedness of adverse events in the follow-up period.
ype, incidence, severity, seriousness, and relatedness of adverse events in the follow-up period.
Time frame: 38 months
Progression-free survival (PFS)
PFS is defined as the time from C1D1 to the date of the first clinically or radiologically or histologically/cytologically documented disease progression or death due to any cause. If a patient has not progressed, relapsed, or died as of the clinical cut-off date for final analysis, PFS will be censored on the date of last disease assessment when the patient is known to be alive and progression-free. If no tumour assessments are performed after the baseline visit or all post-baseline tumour assessment results have overall responses of "not evaluable", PFS will be censored on the date of study entry. Kaplan Meier plots will be used to estimate the distribution of PFS. The PFS probabilities at 12 and 24 months, and the associate 95% CI will be summarized.
Time frame: 12 months, 24 months
Overall survival (OS)
Overall survival (OS) is defined as the time from C1D1 until death from any cause and documented by the date of death. Kaplan Meier plots will be used to estimate the distribution of OS. The OS probabilities at 12 and 24 months, and the associate 95% CI will be summarized for each treatment arm.
Time frame: 12months, 24 months,
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Treatment by study drug Etoposide in combination.
Treatment by study drug Prednisone in combination.
University Hospital Plzeň
Pilsen, Czechia
University Hospital Kralovske Vinohrady
Prague, Czechia
Charles University General Hospital
Prague, Czechia
Event-free survival (EFS)
EFS is defined as the time from C1D1 to the date of the first clinically or radiologically documented disease progression or death due to any cause or start of new anti-lymphoma treatment (pre-planned radiotherapy or pre-planned HDT with ASCT are not counted as an event). If a patient has not progressed, relapsed, or died or started a new anti-lymphoma treatment at the analysis cut-off date, EFS will be censored on the date of last contact. Kaplan Meier plots will be used to estimate the distribution of EFS. The EFS probabilities at 12 and 24 months, and the associate 95% CI will be summarized.
Time frame: 12months, 24 months,
Objective Response Rate (ORR) at the end of treatment
The ORR is defined as the proportion of patients with CR or PR based on the response achieved at the end of treatment. The ORR along with 95% CI will be presented. The number and percentage of patients with CR and the number of patients with PR will also be presented.
Time frame: 38 months
Rate of pre-planned upfront HDT/ASCT
The rate of pre-planned upfront HDT/ASCT is defined as the proportion of patients who underwent the pre-planned HDT/ASCT after end of treatment. The rate of pre-planned upfront HDT/ASCT along with 95% CI will be presented.
Time frame: 38 months
Duration of response (DoR)
Duration of response (DoR) is defined as the time from the date of the first occurrence of a documented CR or PR to the date of disease progression, relapse or death from any cause (PFS), as assessed by the investigator for the subgroup of patients with the CR or PR assessment at EoT evaluation. For patients achieving a response who have not experienced disease progression, relapse, or died prior to the time of the analysis, the duration of response will be censored on the date of last disease assessment. Kaplan Meier plots will be used to estimate the distribution of DoR.
Time frame: 38 months