A phase IV study to evaluate the treatment response (Complete Response [CR]and Partial Response [PR] of out-patient Ifosfamide, Etoposide plus Rituximab (R-IE) for salvage in patients >60 years with relapsed or refractory CD20 positive diffuse large B-cell lymphoma who are not candidates for stem cell transplant

Roche0 sites40 target enrollmentAugust 25, 2006

Overview

Phase: Phase 3
Intervention: Not specified
Conditions: Relapsed or refractory CD20 positive diffuse large B-cell lymphoma
Sponsor: Roche
Enrollment: 40
Status: Recruiting
Last Updated: 6 years ago

No summary available.

Registry

who.int

Start Date

August 25, 2006

End Date

TBD

Last Updated

6 years ago

Study Type

Interventional

Sex

All

Sponsor

•1\. Eastern Oncology Co\-operative Group (ECOG) performance status 0 to 2\. 2\. Relapsed or progressive Cluster Designation 20 (CD20\) positive diffuse large B\-cell lymphoma including induction failures to first\-line anthracycline\-containing regimens and not usually considered eligible for high dose chemotherapy and stem cell transplantation. 3\. Able to give written informed consent. 4\. Life expectancy ³ 3 months

•1\. History of severe cardiac, hepatic, respiratory, or renal disease. 2\. Poor renal function (serum creatinine \> 150 µmol/L or 1\.5\-2\.0 x Upper Limit Normal (ULN), poor hepatic function (bilirubin \>30 µmol/L or \>1\.5x ULN; transaminases\>2\.5 x ULN) unless these abnormalities are related to lymphoma. 3\. Poor bone marrow reserve as defined by neutrophils \<1\.5 x 109/L or platelets \<100 x 109/L unless related to bone marrow infiltration. 4\. Pregnant women or breast\-feeding mothers. 5\. Known hypersensitivity to E coli proteins, or with known anaphylaxis or IgE\-mediated hypersensitivity to murine proteins, or to any component of the drugs being used. 6\. Unable to provide written informed consent.