This study evaluate possibility of brentuximab vedotin, administered after first treatment failure (no response or relapse after I line therapy) of Hodgkin's lymphoma, to induce durable response or cure without autologous stem cell transplantation.
Brentuximab vedotin (BV) can induce durable response or cure in some patients with relapsed or refractory Hodgkin's lymphoma (RR HL) after autologous stem cell transplantation (ASCT) failure. It is expecting that BV alone administered earlier (after first treatment failure, without any additional treatment) can cure some RR HL patients and spare them from ASCT-associated risks and toxicity. Therefore in this study full course of BV which confirmed its curative potential in post-ASCT setting will be applicated to the potentially transplant-eligible RR HL patients immediately after first treatment failure, with a aim to assess curative potential of BV in this setting.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
80
brentuximab vedotin 1,8 mg/kg, intravenous infusion every 21 days, up to 16 infusions per patient during study period
City clinical hospital №40
Moscow, Russia
RECRUITINGR. Gorbacheva Research Institute of Pediatric Hematology and Transfusiology; Pavlov State Medical University of Saint-Petersburg
Saint Petersburg, Russia
RECRUITINGContinuous complete response (CCR) rate
Rate of complete responses lasting without further treatment at least 3 years after initiation of BV therapy
Time frame: 3 years
Additional therapy-free survival (ATFS)
time from the first dose of study medication to one of the following events: unsatisfactory investigational treatment effect (as defined as Deauville score \>3 on first positron emission computed tomography/ computer tomography (PET/CT) and \>2 on second), progression or relapse, death of any cause or initiation of any additional anti-lymphoma therapy (except consolidation radiotherapy) without confirmed unsatisfactory investigational treatment effect, progression or relapse
Time frame: 3 years
Overall survival
time from the first dose of BV to the death of any cause
Time frame: 3 year
Incidence AE according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 [Safety]
incidence AE according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03
Time frame: 1 year
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