NCT01195766

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
64

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Jul 2010

Longer than P75 for phase_2

Geographic Reach
1 country

14 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2010

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

September 3, 2010

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 6, 2010

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2013

Completed
1.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2015

Completed
Last Updated

February 24, 2016

Status Verified

February 1, 2016

Enrollment Period

3.2 years

First QC Date

September 3, 2010

Last Update Submit

February 23, 2016

Conditions

Hodgkin Disease

Keywords

HodgkinOfatumumabLymphoma

Outcome Measures

Primary Outcomes (1)

  • Analysis of the global response rate (complete responses + partial responses) after O-ESHAP treatment

    4 years follow-up

Secondary Outcomes (1)

  • To analyze the complete response rate after O-ESHAP treatment. Further secondary outcomes as described in study summary

    4 years follow-up

Study Arms (1)

Ofatumumab

EXPERIMENTAL

Ofatumumab in addition to ESHAP therapy

Drug: Ofatumumab

Interventions

OfatumumabDRUG

Ofatumumab in addition with ESHAP therapy

Also known as: ARZERRA
Ofatumumab

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (14)

Hospital Germans Trias i Pujol

Badalona, Barcelona, 08916, Spain

Location

Hospital Sant Pau

Barcelona, Barcelona, 08025, Spain

Location

Hospital Clinic

Barcelona, Barcelona, 08036, Spain

Location

Instituto Catalan de Oncologia

L'Hospitalet de Llobregat, Barcelona, 08907, Spain

Location

Hospital Clinico San Carlos

Madrid, Madrid, 28040, Spain

Location

Hospital Ramon y Cajal

Madrid, Madrid, Spain

Location

Hospital Carlos Haya

Málaga, Malaga, 29010, Spain

Location

Hospital Son Espases

Palma de Mallorca, Mallorca, 07010, Spain

Location

Hospital Morales Messeguer

Murcia, Murcia, 30008, Spain

Location

Hospital de Navarra

Pamplona, Navarre, 31008, Spain

Location

Hospital Clinico de Salamanca

Salamanca, Salamanca, 37007, Spain

Location

Hospital Universitario de Canarias

Santa Cruz de Tenerife, Tenerife, 38320, Spain

Location

Hospital Clinico de Valencia

Valencia, Valencia, 46010, Spain

Location

Hospital Rio Hortega

Valladolid, Valladolid, 47012, Spain

Location

MeSH Terms

Conditions

Hodgkin DiseaseLymphoma

Interventions

ofatumumab

Condition Hierarchy (Ancestors)

Neoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Study Officials

  • Carmen Martínez, MD

    Hospital Clinic i provincial de Barcelona

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 3, 2010

First Posted

September 6, 2010

Study Start

July 1, 2010

Primary Completion

September 1, 2013

Study Completion

May 1, 2015

Last Updated

February 24, 2016

Record last verified: 2016-02

Locations

ES(14)