Bendamustine Plus Brentuximab Vedotin in HL and CD30+ PTCL in First Salvage Setting (FIL-BBV)
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|ClinicalTrials.gov Identifier: NCT02499627|
Recruitment Status : Terminated (expected accrual not reached)
First Posted : July 16, 2015
Last Update Posted : September 11, 2020
This is a single-arm, open-label, multicenter, phase 2 clinical trial aimed at evaluating the efficacy and safety of the combination of bendamustine and brentuximab vedotin as a first salvage therapy in patients with relapsed or refractory Hodgkin's lymphoma or PTCL.
A total of 25 patients with PTCL, and 40 with Hodgkin's lymphoma are expected to be treated according to this treatment protocol.
|Condition or disease||Intervention/treatment||Phase|
|Lymphatic Diseases||Drug: Brentuximab Vedotin Drug: Bendamustine||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||43 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase II Study With Bendamustine Plus Brentuximab Vedotin in Hodgkin's Lymphoma and CD30+ Peripheral T-cell Lymphoma in First Salvage Setting: the BBV Regimen.|
|Actual Study Start Date :||December 23, 2015|
|Actual Primary Completion Date :||September 13, 2019|
|Actual Study Completion Date :||June 30, 2020|
Experimental: Bendamustine + Brentuximab for 6 cycles
Bendamustine 90 mg/m2 d1-2. Brentuximab vedotin 1.8 mg/kg d1.Every 21 days for 6 cycles.
Drug: Brentuximab Vedotin
Brentuximab will be given intravenously at a total dose of 1.8 mg/kg on day 1 of each 21 days-based cycle, for 6 cycles.
Other Name: SGN35
Bendamustine will be administered at a dose of 90 mg/m2 on day 1 and 2 of each 21 days-based cycle, for 6 cycles.
Other Name: Levact
- Overall objective response rate (ORR). [ Time Frame: 1 year ]Proportion of patients in CR or PR
- Duration of the response (DOR) [ Time Frame: 1 year ]Time from documentation of tumor response to disease progression
- Complete remission (CR) rate [ Time Frame: 1 year ]Proportion of patients in CR
- Progression-free survival (PFS) [ Time Frame: 1 year ]Time from study enrollment until disease progression or death
- Adverse Events [ Time Frame: 1 year ]The type, incidence, severity, seriousness, of adverse events and laboratory abnormalities observed during treatment and the assessment of any potential relationship to the study drugs.
- Overall survival (OS) [ Time Frame: 1 year ]Time from study enrollment until death from any cause
- One-year event-free survival (EFS) [ Time Frame: 1 year ]Time from study enrollment to disease progression, death, or discontinuation of treatment for any reason (eg, toxicity, patient preference, or initiation of a new treatment without documented progression)
- B symptoms resolution rate (when documented at presentation) [ Time Frame: 1 year ]Proportion of patients with B symptoms at the end of study
- CD30 expression and the objective response [ Time Frame: 1 year ]Correlation between the CD30 expression and the objective response obtained
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02499627
|Bologna, BO, Italy, 40138|
|Brescia, BS, Italy, 25123|
|Fondazione IRCCS Milano INT|
|Milano, MI, Italy, 20133|
|AO Niguarda Ca' Granda|
|Milano, MI, Italy, 20162|
|Istituto Clinico Humanitas|
|Rozzano, MI, Italy, 20089|
|AOU Città della Salute e della Scienza|
|Torino, TO, Italy, 10126|
|IRCCS Fondazione Pascale|
|Napoli, Italy, 80131|
|Principal Investigator:||Vittorio Stefoni, MD||Ematologia "L. & A. Seragnoli" - Policlinico S. Orsola Malpighi|