Study of Ofatumumab and ESHAP for the Treatment of Hodgkin's Lymphoma
- Registration Number
- NCT01195766
- Lead Sponsor
- Grupo Español de Linfomas y Transplante Autólogo de Médula Ósea
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 64
- 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.
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Ofatumumab Ofatumumab Ofatumumab in addition to ESHAP therapy
- Primary Outcome Measures
Name Time Method Analysis of the global response rate (complete responses + partial responses) after O-ESHAP treatment 4 years follow-up
- Secondary Outcome Measures
Name Time Method To analyze the complete response rate after O-ESHAP treatment. Further secondary outcomes as described in study summary 4 years follow-up
Trial Locations
- Locations (14)
Hospital Rio Hortega
🇪🇸Valladolid, Spain
Hospital Carlos Haya
🇪🇸Malaga, Spain
Hospital Sant Pau
🇪🇸Barcelona, Spain
Hospital Clinic
🇪🇸Barcelona, Spain
Hospital Son Espases
🇪🇸Palma de Mallorca, Mallorca, Spain
Hospital Ramon y Cajal
🇪🇸Madrid, Spain
Hospital Clinico de Valencia
🇪🇸Valencia, Spain
Hospital de Navarra
🇪🇸Pamplona, Navarra, Spain
Hospital Clinico de Salamanca
🇪🇸Salamanca, Spain
Hospital Clinico San Carlos
🇪🇸Madrid, Spain
Instituto Catalan de Oncologia
🇪🇸L'Hospitalet, Barcelona, Spain
Hospital Morales Messeguer
🇪🇸Murcia, Spain
Hospital Germans Trias i Pujol
🇪🇸Badalona, Barcelona, Spain
Hospital Universitario de Canarias
🇪🇸Tenerife, Spain