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

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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01195766

Enrollment

Registered

2010-09-06

Start date

2010-07-31

Completion date

2015-05-31

Last updated

2016-02-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hodgkin Disease

Keywords

Hodgkin, Ofatumumab, Lymphoma

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.

Interventions

DRUGOfatumumab

Ofatumumab in addition with ESHAP therapy

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

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.

Design outcomes

Primary

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

Secondary

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

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026