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

• Status: Completed
• Trial end date: 2015-05-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Grupo Español de Linfomas y Transplante Autólogo de Médula Ósea
• Treatments: Antibodies, Monoclonal; Ofatumumab

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.