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

NCT ID: NCT01195766

Last Updated: 2016-02-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 64 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-07-31
• Study Completion Date: 2015-05-31

Brief Summary

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.

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.

Conditions

Hodgkin Disease

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Ofatumumab

Ofatumumab in addition to ESHAP therapy

Group Type: EXPERIMENTAL

Ofatumumab

Intervention Type: DRUG

Ofatumumab in addition with ESHAP therapy

Interventions

Ofatumumab

Ofatumumab in addition with ESHAP therapy

Intervention Type: DRUG

Other Intervention Names

ARZERRA

Eligibility 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.

• 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.

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Grupo Español de Linfomas y Transplante Autólogo de Médula Ósea

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Carmen Martínez, MD

Role: STUDY_DIRECTOR

Hospital Clinic i provincial de Barcelona

Locations

Hospital Germans Trias i Pujol

Badalona, Barcelona, Spain

Hospital Sant Pau

Barcelona, Barcelona, Spain

Hospital Clinic

Barcelona, Barcelona, Spain

Instituto Catalan de Oncologia

L'Hospitalet de Llobregat, Barcelona, Spain

Hospital Clinico San Carlos

Madrid, Madrid, Spain

Hospital Ramon y Cajal

Madrid, Madrid, Spain

Hospital Carlos Haya

Málaga, Malaga, Spain

Hospital Son Espases

Palma de Mallorca, Mallorca, Spain

Hospital Morales Messeguer

Murcia, Murcia, Spain

Hospital de Navarra

Pamplona, Navarre, Spain

Hospital Clinico de Salamanca

Salamanca, Salamanca, Spain

Hospital Universitario de Canarias

Santa Cruz de Tenerife, Tenerife, Spain

Hospital Clinico de Valencia

Valencia, Valencia, Spain

Hospital Rio Hortega

Valladolid, Valladolid, Spain

Countries

Spain

Other Identifiers

2009-016026-13

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

O-ESHAP-LH-2009

Identifier Type: -

Identifier Source: org_study_id