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

Hodgkin Disease Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01195766
• Other study ID #: O-ESHAP-LH-2009
• Secondary ID: 2009-016026-13
• Status: Completed
• Phase: Phase 2
• First received: September 3, 2010
• Last updated: February 23, 2016
• Start date: July 2010
• Est. completion date: May 2015

Study information

• Verified date: February 2016
• Source: Grupo Español de Linfomas y Transplante Autólogo de Médula Ósea
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Spanish Agency of Medicines
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 64
• Est. completion date: May 2015
• Est. primary completion date: September 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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.

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hodgkin Disease

Intervention

Drug:
• Ofatumumab
Ofatumumab in addition with ESHAP therapy

Locations

Country	Name	City	State
Spain	Hospital Germans Trias i Pujol	Badalona	Barcelona
Spain	Hospital Clinic	Barcelona
Spain	Hospital Sant Pau	Barcelona
Spain	Instituto Catalan de Oncologia	L'Hospitalet	Barcelona
Spain	Hospital Clinico San Carlos	Madrid
Spain	Hospital Ramon y Cajal	Madrid
Spain	Hospital Carlos Haya	Malaga
Spain	Hospital Morales Messeguer	Murcia
Spain	Hospital Son Espases	Palma de Mallorca	Mallorca
Spain	Hospital de Navarra	Pamplona	Navarra
Spain	Hospital Clinico de Salamanca	Salamanca
Spain	Hospital Universitario de Canarias	Tenerife
Spain	Hospital Clinico de Valencia	Valencia
Spain	Hospital Rio Hortega	Valladolid

Sponsors (1)

Lead Sponsor	Collaborator
Grupo Español de Linfomas y Transplante Autólogo de Médula Ósea

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Analysis of the global response rate (complete responses + partial responses) after O-ESHAP treatment		4 years follow-up	Yes
Secondary	To analyze the complete response rate after O-ESHAP treatment. Further secondary outcomes as described in study summary		4 years follow-up	Yes