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BRENTUXIMAB VEDOTIN as Pre-ASCT Induction Therapy in R/R HL Patients Non Responding to IGEV

NCT02244021 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 13

Last updated 2018-02-09

No results posted yet for this study

Summary

A pilot phase II study with brentuximab vedotin as pre-ASCT induction therapy in relapsed/refractory Hodgkin's lymphoma patients non-responding to IGEV salvage treatment.

Conditions

  • Relapsed/Refractory Hodgkin's Lymphoma

Interventions

DRUG

BRENTUXIMAB VEDOTIN

Patients with FDG-PET positive after IGEV will be treated with brentuximab vedotin as followed: 1.8 mg/kg every 3 weeks as a 30-minute outpatient IV infusion for a total of 4 cycles of treatment Growth factors may be used at the discretion of investigators but are not routinely advised. Patients with FDG-PET negative after brentuximab vedotin treatment will be addressed to high dose chemotherapy followed by ASCT.

Sponsors & Collaborators

  • Fondazione Italiana Linfomi - ETS

    lead OTHER

Principal Investigators

  • Angelo Michele Carella, Prof. · Hematology Division, IRCCS AOU San Martino, Genova, Italy

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-12-31
Primary Completion
2016-07-31
Completion
2017-10-31

Countries

  • Italy

Study Locations

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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 NCT02244021 on ClinicalTrials.gov