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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Hodgkin Disease

Intervention / Treatment
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* Drug: Ofatumumab


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ofatumumab<br>Ofatumumab in addition to ESHAP therapy | Drug: Ofatumumab<br>* Ofatumumab in addition with ESHAP therapy<br>* Other names: ARZERRA;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Analysis of the global response rate (complete responses + partial responses) after O-ESHAP treatment |  | 4 years follow-up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To analyze the complete response rate after O-ESHAP treatment. Further secondary outcomes as described in study summary |  | 4 years follow-up | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hodgkin, Ofatumumab, Lymphoma