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Brentuximab Vedotin in Pre-transplant Induction and Consolidation for Relapsed or Refractory Hodgkin Lymphoma

NCT02243436 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 67

Last updated 2019-04-24

No results posted yet for this study

Summary

Phase I trial aimed to determine the Maximum Tolerable Dose of the BV in combination with ESHAP in relapsed/resistant Hodgkin Lymphona patients and to evaluate response to treatment with BV-ESHAP as salvage regimen prior to autologous stem cell transplantation.

Conditions

  • CLASSICAL HODGKIN LYMPHOMA

Interventions

DRUG

Brentuximab Vedotin

Brentuximab Vedotin, 0.9mg/kg, 1.2mg/kg, 1.8mg/kg, day 1

DRUG

Etoposide

Intravenose use, 40mg/m2/day, on days 1 to 4

DRUG

Soludomerin

Intravenous use, 250mg/day, on days 1 to 4

DRUG

Cisplatin

Intravenous use, 25mg/m2/day, on days 1 to 4

DRUG

Ara C

Intravenous use, 2g/m2, day 5

Sponsors & Collaborators

  • Millennium Pharmaceuticals, Inc.

    collaborator INDUSTRY

  • Grupo Español de Linfomas y Transplante Autólogo de Médula Ósea

    lead OTHER

Principal Investigators

  • Ramón García-Sanz, MD · University of Salamanca

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-11-11
Primary Completion
2019-01-31
Completion
2019-01-14

Countries

  • Spain

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 NCT02243436 on ClinicalTrials.gov