Outpatient 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 study

Phase 3

Recruiting

• Conditions: Relapsed or refractory CD20 positive diffuse large B-cell lymphoma; Cancer - Lymphoma (non Hodgkin's lymphoma) - High grade lymphoma

• Registration Number: ACTRN12606000373572
• Lead Sponsor: Roche

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2006-08-25
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

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

Exclusion Criteria

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To evaluate overall treatment response (Complete Response (CR) and Partial Response(PR)) of an outpatient-based fractionated salvage regimen consisting of ifosfamide, etoposide plus rituximab (R-IE) given every three weeks in patients > 60 years with relapsed or refractory CD20 positive diffuse large B-cell lymphoma and who are not considered eligible for stem cell transplantation. [To be assessed after Cycle 3 & 6.]

Secondary Outcome Measures

Name	Time	Method
To evaluate overall survival[Every 3 months following completion of 6 cycles of therapy for 5 years.];To evaluate event free survival[Every 3 months following completion of 6 cycles of therapy for 5 years.];To evaluate the safety profile[After each cycle of therapy];To evaluate the haematological toxicity (grades 3/4 neutropenia and thrombocytopenia).[After each cycle of therapy]