Bendamustine Plus Brentuximab Vedotin in HL and CD30+ PTCL in First Salvage Setting

Phase 2

Terminated

• Conditions: Lymphatic Diseases
• Interventions: Drug: Brentuximab Vedotin; Drug: Bendamustine

• Registration Number: NCT02499627
• Lead Sponsor: Fondazione Italiana Linfomi - ETS

Brief Summary

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.

Detailed Description

In the study, intravenous bendamustine will be administered at a dose of 90 mg/m2 on day 1 and 2 and 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. All patients achieving a CR can be considered eligible to peripheral blood stem cell mobilization (to be performed with granulocytecolony stimulating factor alone) and may proceed to an ASCT at any time after cycle 4.

Study Timeline

• Study First Submitted: 2015-07-14
• Study First Submitted QC: 2015-07-14
• Study First Posted: 2015-07-16
• Study Start: 2015-12-23
• Primary Completion: 2019-09-13
• Study Completion: 2020-06-30
• Status Verified: 2020-09
• Last Update Submitted: 2021-05-26
• Last Update Posted: 2021-05-27

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 43

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Bendamustine + Brentuximab for 6 cycles	Brentuximab Vedotin	Bendamustine 90 mg/m2 d1-2. Brentuximab vedotin 1.8 mg/kg d1.Every 21 days for 6 cycles.
Bendamustine + Brentuximab for 6 cycles	Bendamustine	Bendamustine 90 mg/m2 d1-2. Brentuximab vedotin 1.8 mg/kg d1.Every 21 days for 6 cycles.

Primary Outcome Measures

Name	Time	Method
Overall objective response rate (ORR).	1 year	Proportion of patients in CR or PR

Secondary Outcome Measures

Name	Time	Method
Complete remission (CR) rate	1 year	Proportion of patients in CR
Adverse Events	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.
Duration of the response (DOR)	1 year	Time from documentation of tumor response to disease progression
Progression-free survival (PFS)	1 year	Time from study enrollment until disease progression or death
Overall survival (OS)	1 year	Time from study enrollment until death from any cause

Trial Locations

Locations (5)

Spedali Civili; 🇮🇹 Brescia, BS, Italy

AOU Città della Salute e della Scienza; 🇮🇹 Torino, TO, Italy

IRCCS Fondazione Pascale; 🇮🇹 Napoli, Italy

Fondazione IRCCS Milano INT; 🇮🇹 Milano, MI, Italy

A.O S.Orsola-Malpighi; 🇮🇹 Bologna, BO, Italy