Ibritumomab followed by a reduced intensity, partial T cell-depleted allogeneic stem cell transplantation and immunomodulation with lenalidomide and DLI in patients with relapsed diffuse large B-cell Non-Hodgkins lymphoma

Phase 2

Withdrawn

Conditions: Diffuse large B cell lymphoma
Non Hodgkins lymphoma
10025320

Registration Number: NL-OMON36669

Lead Sponsor: niversitair Medisch Centrum Utrecht

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Withdrawn

Sex: Not specified

Target Recruitment: 10

Inclusion Criteria

By histology confirmed CD20+ DLBCL de novo, relapsed after autologous stem cell transplantation
At least partial response according to the Cheson criteria, before entering the protocol, by the use of a salvage chemotherapy regimen
age 18-65 years

Exclusion Criteria

previous diagnosis of follicular lymphoma
primary cerebral lymphoma or cerebral localisation

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Primary objective<br /><br>* To determine the feasibility (as measured by non-relapse mortality after 7<br /><br>months) of the regimen of Ibritumomab, followed by a reduced intensity, partial<br /><br>T cell-depleted allogeneic stem cell transplantation and immunomodulation with<br /><br>lenalidomide and DLI in patients with relapsed diffuse large B-cell<br /><br>Non-Hodgkin*s lymphoma </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary Objectives<br /><br>* To determine the feasibility of the proposed regimen by measurement of GvHD<br /><br>* To determine the feasibility of the proposed regimen by measurement of<br /><br>infections * grade 3 according to CTCAE 4.0.<br /><br>* To determine the percentage of patient with graft failure<br /><br>* To describe the progression free and overall survival of patients<br /><br>* To explore the effect of lenalidomide and DLI after T cell depleted stem cell<br /><br>transplantation on the T and NK cells<br /><br>* To explore relationships between different subtypes of DLBCL /<br /><br>immunohistochemical markers and progression free survival/ GvHD</p><br>