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

This study has been completed.
Information provided by (Responsible Party):
Grupo Español de Linfomas y Transplante Autólogo de Médula Ósea Identifier:
First received: September 3, 2010
Last updated: February 23, 2016
Last verified: February 2016

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.

Condition Intervention Phase
Hodgkin Disease
Drug: Ofatumumab
Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:

Further study details as provided by Grupo Español de Linfomas y Transplante Autólogo de Médula Ósea:

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

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

Enrollment: 64
Study Start Date: July 2010
Study Completion Date: May 2015
Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Ofatumumab
Ofatumumab in addition to ESHAP therapy
Drug: Ofatumumab
Ofatumumab in addition with ESHAP therapy
Other Name: ARZERRA

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.

Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.
  Contacts and Locations
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Please refer to this study by its identifier: NCT01195766

Hospital Germans Trias i Pujol
Badalona, Barcelona, Spain, 08916
Instituto Catalan de Oncologia
L'Hospitalet, Barcelona, Spain, 08907
Hospital Son Espases
Palma de Mallorca, Mallorca, Spain, 07010
Hospital de Navarra
Pamplona, Navarra, Spain, 31008
Hospital Sant Pau
Barcelona, Spain, 08025
Hospital Clinic
Barcelona, Spain, 08036
Hospital Clinico San Carlos
Madrid, Spain, 28040
Hospital Ramon y Cajal
Madrid, Spain
Hospital Carlos Haya
Malaga, Spain, 29010
Hospital Morales Messeguer
Murcia, Spain, 30008
Hospital Clinico de Salamanca
Salamanca, Spain, 37007
Hospital Universitario de Canarias
Tenerife, Spain, 38320
Hospital Clinico de Valencia
Valencia, Spain, 46010
Hospital Rio Hortega
Valladolid, Spain, 47012
Sponsors and Collaborators
Grupo Español de Linfomas y Transplante Autólogo de Médula Ósea
Study Director: Carmen Martínez, MD Hospital Clinic i Provincial de Barcelona
  More Information

Responsible Party: Grupo Español de Linfomas y Transplante Autólogo de Médula Ósea Identifier: NCT01195766     History of Changes
Other Study ID Numbers: O-ESHAP-LH-2009
2009-016026-13 ( EudraCT Number )
Study First Received: September 3, 2010
Last Updated: February 23, 2016

Keywords provided by Grupo Español de Linfomas y Transplante Autólogo de Médula Ósea:

Additional relevant MeSH terms:
Hodgkin Disease
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs processed this record on April 25, 2017