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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


Phase 2
18 Years
75 Years
Open (Enrolling)
Both
Hodgkin Disease

Thank you

Trial Information

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


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.


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.

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

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

Outcome Time Frame:

4 years follow-up

Safety Issue:

Yes

Authority:

Spain: Spanish Agency of Medicines

Study ID:

O-ESHAP-LH-2009

NCT ID:

NCT01195766

Start Date:

July 2010

Completion Date:

May 2014

Related Keywords:

  • Hodgkin Disease
  • Hodgkin Disease
  • Lymphoma

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