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

This study is currently recruiting participants.
Verified September 2010 by Grupo Español de Linfomas y Transplante Autólogo de Médula Ósea
Sponsor:
Information provided by:
Grupo Español de Linfomas y Transplante Autólogo de Médula Ósea
ClinicalTrials.gov Identifier:
NCT01195766
First received: September 3, 2010
Last updated: NA
Last verified: September 2010
History: No changes posted
  Purpose

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: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
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 ] [ Designated as safety issue: Yes ]

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 ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 63
Study Start Date: July 2010
Estimated Study Completion Date: May 2014
Estimated Primary Completion Date: May 2012 (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

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.
  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01195766

Contacts
Contact: Carmen Martinez, MD cmarti@clinic.ub.es
Contact: Anna Sureda, MD asureda@santpau.cat

Locations
Spain
Hospital Germans Trias i Pujol Recruiting
Badalona, Barcelona, Spain, 08916
Contact: Blanca Xicoy, MD         
Principal Investigator: Blanca Xicoy, MD         
Instituto Catalan de Oncologia Recruiting
L'Hospitalet, Barcelona, Spain, 08907
Contact: Eva Gonzalez Barca, MD         
Principal Investigator: Eva Gonzalez Barca, MD         
Hospital Son Dureta Recruiting
Palma de Mallorca, Mallorca, Spain, 07003
Contact: Antonia Sampol, MD         
Principal Investigator: Antonia Sampol, MD         
Hospital de Navarra Recruiting
Pamplona, Navarra, Spain, 31008
Contact: Eduardo Olavarria, MD         
Principal Investigator: Eduardo Olavarria, MD         
Hospital Clinic Recruiting
Barcelona, Spain, 08036
Principal Investigator: Carmen Martinez, MD         
Hospital Sant Pau Recruiting
Barcelona, Spain, 08025
Contact: Anna Sureda, MD         
Principal Investigator: Anna Sureda, MD         
Hospital Ramon y Cajal Recruiting
Madrid, Spain
Contact: Javier Lopez Jimenez, MD         
Principal Investigator: Javier Lopez Jimenez, MD         
Hospital Clinico San Carlos Recruiting
Madrid, Spain, 28040
Contact: Joaquin Diaz, MD         
Principal Investigator: Joaquin Diaz, MD         
Hospital Carlos Haya Recruiting
Malaga, Spain, 29010
Contact: Manuel Espeso de Haro, MD         
Principal Investigator: Manuel Espeso de Haro, MD         
Hospital Morales Messeguer Recruiting
Murcia, Spain, 30008
Contact: Elena Perez Ceballos, MD         
Principal Investigator: Elena Perez Ceballos, MD         
Hospital Clinico de Salamanca Recruiting
Salamanca, Spain, 37007
Contact: Dolores Caballero, MD         
Principal Investigator: Dolores Caballero, MD         
Hospital Universitario de Canarias Recruiting
Tenerife, Spain, 38320
Contact: Miguel Hernandez, MD         
Principal Investigator: Miguel Hernandez, MD         
Hospital Clinico de Valencia Recruiting
Valencia, Spain, 46010
Contact: Mª Jose Terol, MD         
Principal Investigator: Mª Jose Terol, MD         
Hospital Rio Hortega Recruiting
Valladolid, Spain, 47012
Contact: Mª Jesus Peñarrubia, MD         
Principal Investigator: Mª Jesus Peñarrubia, MD         
Sponsors and Collaborators
Grupo Español de Linfomas y Transplante Autólogo de Médula Ósea
  More Information

No publications provided

Responsible Party: Carmen Martínez, Grupo GELTAMO
ClinicalTrials.gov Identifier: NCT01195766     History of Changes
Other Study ID Numbers: O-ESHAP-LH-2009, 2009-016026-13
Study First Received: September 3, 2010
Last Updated: September 3, 2010
Health Authority: Spain: Spanish Agency of Medicines

Additional relevant MeSH terms:
Hodgkin Disease
Lymphoma
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases

ClinicalTrials.gov processed this record on April 17, 2014