Study of Ofatumumab and ESHAP for the Treatment of Hodgkin's Lymphoma

February 23, 2016 updated by: Grupo Español de Linfomas y Transplante Autólogo de Médula Ósea

Phase II-study Using Ofatumumab and ESHAP Followed by Autologous Trasplant of Hemopoietic Precursors for the Treatment of Classic Hodgkin's Lymphoma on Relapse, Partial Response or Refractory to First Line Treatment

The aim of this study is to analyze the efficacy of O-ESHAP treatment for Hodgkin's lymphome patients that have a first line chemotherapy treatment failure due to refractoriness, partial response or relapsed.

In the same way, mortality, global survival and free-progression survival after O-ESHAP treatment and TAPH will also analyzed.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

In addition to the above:

  • To asses the complete response rate after O-ESHAP.
  • To asses the toxicity of O-ESHAP regimen
  • To asses the stem cells mobilization capacity of O-ESHAP regimen
  • To evaluate the final results of the whole procedure (O-ESHAP followed by high-dose chemotherapy and ASCT): transplant-related mortality (TRM), overall survival (OS), and progression free survival (PFS)
  • To investigate the correlation between the overall response and CD20 expression by tumoral cells.

Study Type

Interventional

Enrollment (Actual)

64

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Barcelona, Spain, 08036
        • Hospital Clínic
      • Barcelona, Spain, 08025
        • Hospital Sant Pau
      • Madrid, Spain
        • Hospital Ramón y Cajal
      • Madrid, Spain, 28040
        • Hospital Clinico San Carlos
      • Malaga, Spain, 29010
        • Hospital Carlos Haya
      • Murcia, Spain, 30008
        • Hospital Morales Messeguer
      • Salamanca, Spain, 37007
        • Hospital Clinico De Salamanca
      • Tenerife, Spain, 38320
        • Hospital Universitario de Canarias
      • Valencia, Spain, 46010
        • Hospital Clinico de Valencia
      • Valladolid, Spain, 47012
        • Hospital Rio Hortega
    • Barcelona
      • Badalona, Barcelona, Spain, 08916
        • Hospital Germans Trias i Pujol
      • L'Hospitalet, Barcelona, Spain, 08907
        • Instituto Catalan de Oncologia
    • Mallorca
      • Palma de Mallorca, Mallorca, Spain, 07010
        • Hospital Son Espases
    • Navarra
      • Pamplona, Navarra, Spain, 31008
        • Hospital de Navarra

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients with histologically confirmed relapsed, partial response or refractory classical HL after first line chemotherapy. They will be included irrespective of CD20 expression on HRS cells. CD20 expression will be analyzed on all available biopsies and this data will be recorded for further evaluation.
  • Age 18 to 65 years. Patient >65 and <70 years old with ECOG < 2 and absence of comorbidities will be included in the study if considered adequate by the investigator.
  • Leucocytes > 3,0 x 109/L and platelets > 100 x 109/L.
  • ECOG < 2.
  • No major organ dysfunction.
  • Written informed consent.
  • HIV negative.
  • No active hepatitis B or C infection.
  • Availability of histological report of biopsy at diagnosis or at relapse and availability of biopsy to be revised by reference pathologists.
  • Absence of other neoplasia, except basocellular tumor or carcinoma of the uterine cervix in situ.
  • Contraception measures in fertile females.

Exclusion Criteria:

  • Subjects who have current active hepatic or biliary disease
  • presence of pathology that would contraindicate the administration of chemotherapy
  • HIV positive
  • Hepatitis B or C infection
  • history of other malignancies in addition to those specified in the inclusion criteria
  • informed consent not signed
  • Pregnant and / or breast-feeding or reproductive capacity adults who do not use an effective method of birth control during study treatment and at least six months later. An effective method is that used at least one barrier mechanism.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Ofatumumab
Ofatumumab in addition to ESHAP therapy
Drug: Ofatumumab
Ofatumumab in addition with ESHAP therapy
Other Names:
  • ARZERRA

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Analysis of the global response rate (complete responses + partial responses) after O-ESHAP treatment
Time Frame: 4 years follow-up
4 years follow-up

Secondary Outcome Measures

Outcome Measure
Time Frame
To analyze the complete response rate after O-ESHAP treatment. Further secondary outcomes as described in study summary
Time Frame: 4 years follow-up
4 years follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Grupo Español de Linfomas y Transplante Autólogo de Médula Ósea

Investigators

  • Study Director: Carmen Martínez, MD, Hospital Clinic i Provincial de Barcelona

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2010

Primary Completion (ACTUAL)

September 1, 2013

Study Completion (ACTUAL)

May 1, 2015

Study Registration Dates

First Submitted

September 3, 2010

First Submitted That Met QC Criteria

September 3, 2010

First Posted (ESTIMATE)

September 6, 2010

Study Record Updates

Last Update Posted (ESTIMATE)

February 24, 2016

Last Update Submitted That Met QC Criteria

February 23, 2016

Last Verified

February 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • O-ESHAP-LH-2009
  • 2009-016026-13 (EUDRACT_NUMBER)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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