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Brentuximab Vedotin in Refractory/Relapsed Hodgkin Lymphoma Treated by ICE

NCT02686346 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 53

Last updated 2021-12-07

No results posted yet for this study

Summary

This study is designed as a phase Ib/II trial. The first part (phase Ib) is a dose escalation design to explore the safety and assess the recommended phase 2 dose of Brentuximab Vedotin in Hodgkin lymphoma patients treated with ICE regimen.

The second part, depending on the selected dose after the completion of phase Ib part of the study, will further explore safety in addition to efficacy of the recommended dose of Brentuximab Vedotin in a selected population of patients treated with ICE with Hodgkin lymphoma.

Conditions

  • Hodgkin Disease

Interventions

DRUG

Brentuximab Vedotin

Phase I: Cohort K: BV on Day 1: 1.2 mg/kg (cycle 1-3) and 1.8 mg/kg (cycle 4) Cohort K+1: BV on Day 1: 1.8 mg/kg (cycle 1-3) and 1.8 mg/kg (cycle 4) Cohort K-1: BV on Day 1: 0.8 mg/kg (cycle 1-3) and 1.8 mg/kg (cycle 4) Phase II: BV on Day 1: at the Maximal Tolerated Dose (MTD) defined at Phase I

DRUG

Etoposide

100 mg/m² Days 1-2-3 of Cycles 1-2-3

DRUG

Carboplatine

max 800mg Day 2 of Cycles 1-2-3

DRUG

Ifosfamide

5 g/m² Day 2 of Cycles 1-2-3

Sponsors & Collaborators

  • Millennium Pharmaceuticals, Inc.

    collaborator INDUSTRY

  • The Lymphoma Academic Research Organisation

    lead OTHER

Principal Investigators

  • Pauline Brice, MD · Lymphoma Study Association

  • Aspasia Stamatoullas Bastard, MD · Lymphoma Study Association

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2016-03-31
Primary Completion
2018-10-31
Completion
2021-07-12

Countries

  • Belgium
  • France

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 NCT02686346 on ClinicalTrials.gov