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

Grupo Español de Linfomas y Transplante Autólogo de Médula Ósea

Status and phase

Completed

Phase 2

Conditions

Hodgkin Disease

Treatments

Drug: Ofatumumab

Study type

Interventional

Funder types

Other

Identifiers

NCT01195766

O-ESHAP-LH-2009

2009-016026-13 (EudraCT Number)

Details and patient eligibility

About

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.

Full 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.

Enrollment

64 patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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.