Status:
COMPLETED
Study of Ofatumumab and ESHAP for the Treatment of Hodgkin's Lymphoma
Lead Sponsor:
Grupo Español de Linfomas y Transplante Autólogo de Médula Ósea
Conditions:
Hodgkin Disease
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
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 r...
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 evalu...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
July 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2015
Estimated Enrollment :
64 Patients enrolled
Trial Details
Trial ID
NCT01195766
Start Date
July 1 2010
End Date
May 1 2015
Last Update
February 24 2016
Active Locations (14)
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1
Hospital Germans Trias i Pujol
Badalona, Barcelona, Spain, 08916
2
Hospital Sant Pau
Barcelona, Barcelona, Spain, 08025
3
Hospital Clinic
Barcelona, Barcelona, Spain, 08036
4
Instituto Catalan de Oncologia
L'Hospitalet de Llobregat, Barcelona, Spain, 08907