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

NCT02499627 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 43

Last updated 2021-05-27

No results posted yet for this study

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.

Conditions

  • Lymphatic Diseases

Interventions

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.

DRUG

Bendamustine

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.

Sponsors & Collaborators

  • Fondazione Italiana Linfomi - ETS

    lead OTHER

Principal Investigators

  • Vittorio Stefoni, MD · Ematologia "L. & A. Seragnoli" - Policlinico S. Orsola Malpighi

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-12-23
Primary Completion
2019-09-13
Completion
2020-06-30

Countries

  • Italy

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02499627 on ClinicalTrials.gov