Clinical trial NCT01195766: Study of Ofatumumab and ESHAP for the Treatment of Hodgkin's Lymphoma
Official title: Phase II-study Using Ofatumumab and ESHAP Followed by Autologous Trasplant of Hemopoietic Precursors for the Treatment of Classic Hodgkin's Lymphoma on Relapse, Partial Response or Refractory to First Line Treatment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Hodgkin Disease
Keywords: Hodgkin
Ofatumumab
Lymphoma
Lead sponsor: Grupo Español de Linfomas y Transplante Autólogo de Médula Ósea
Sponsor class: OTHER
First posted: 2010-09-06
Enrollment: 64
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

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.

Primary outcomes:
measure: Analysis of the global response rate (complete responses + partial responses) after O-ESHAP treatment
timeFrame: 4 years follow-up
Secondary outcomes:
measure: To analyze the complete response rate after O-ESHAP treatment. Further secondary outcomes as described in study summary
timeFrame: 4 years follow-up
Other outcomes:
Locations:
city: Badalona
country: Spain
facility: Hospital Germans Trias i Pujol
state: Barcelona
city: L'Hospitalet
country: Spain
facility: Instituto Catalan de Oncologia
state: Barcelona
city: Palma de Mallorca
country: Spain
facility: Hospital Son Espases
state: Mallorca
city: Pamplona
country: Spain
facility: Hospital de Navarra
state: Navarra
city: Barcelona
country: Spain
facility: Hospital Sant Pau
city: Barcelona
country: Spain
facility: Hospital Clinic
city: Madrid
country: Spain
facility: Hospital Clinico San Carlos
city: Madrid
country: Spain
facility: Hospital Ramon y Cajal
city: Malaga
country: Spain
facility: Hospital Carlos Haya
city: Murcia
country: Spain
facility: Hospital Morales Messeguer
city: Salamanca
country: Spain
facility: Hospital Clinico de Salamanca
city: Tenerife
country: Spain
facility: Hospital Universitario de Canarias
city: Valencia
country: Spain
facility: Hospital Clinico de Valencia
city: Valladolid
country: Spain
facility: Hospital Rio Hortega
Study officials:
affiliation: Hospital Clinic i provincial de Barcelona
name: Carmen Martínez, MD
role: STUDY_DIRECTOR
References: