RecruitingPhase 3Phase 4ACTRN12606000373572

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

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


Sponsor

Roche

Enrollment

40 participants

Start Date

May 1, 2006

Study Type

Interventional

Conditions

Summary

Patients with relapsed or refractory lymphoma require initial salvage chemotherapy to control their disease. One type of salvage chemotherapy is Rituximab, Ifosfamide and Etoposide (R-IE) given for six cycles administered every 21 days, followed by two additional doses of Rituximab at intervals of 21 days. Ifosfamide and Etopside are given on days 1 to 3 and Rituximab is given on day 1. On the day following each cycle of the R-IE therapy (day 4) a single injection under the skin of pegfilgrastim is given to prevent the white blood cell count from falling too low and therefore reduce the number of infections the patient may experience.


Eligibility

Sex: Both males and femalesMin Age: 60 Yearss

Plain Language Summary

Simplified for easier understanding

This study is for older patients (60 years and above) with a type of lymphoma (blood cancer) called diffuse large B-cell lymphoma that has come back or stopped responding to treatment, and who are not well enough for an intensive stem cell transplant. The study is testing a chemotherapy combination called R-IE (Rituximab, Ifosfamide, and Etoposide) given every three weeks for six cycles, followed by two additional doses of Rituximab. A single injection of pegfilgrastim is given after each cycle to protect the immune system. The goal is to see if this outpatient treatment can control the lymphoma and improve quality of life. You may be eligible if: - You are 60 years of age or older - You have CD20-positive diffuse large B-cell lymphoma that has relapsed or is not responding to first-line treatment, and you are not suitable for high-dose chemotherapy/stem cell transplant - Your general health is good enough (ECOG performance status 0 to 2) - Your expected survival is at least 3 months - You are able to give written consent You may NOT be eligible if: - You have severe heart, liver, breathing, or kidney problems - You are pregnant or breastfeeding - You have a known allergy to E. coli proteins, or severe allergy to mouse-derived proteins - You are unable to give written consent Talk to your doctor about whether this trial might be right for you.

This is a simplified summary. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

Rituximab 375 mg/m2 iv on day 1 Ifosfamide 5,000 mg/m2 iv in equally divided doses over 3 days (days 1-3) Etoposide 100 mg/m2 iv daily for days 1 to 3 Pegfilgrastim 6 mg subcutaneous (SC) on day 4

Rituximab 375 mg/m2 iv on day 1 Ifosfamide 5,000 mg/m2 iv in equally divided doses over 3 days (days 1-3) Etoposide 100 mg/m2 iv daily for days 1 to 3 Pegfilgrastim 6 mg subcutaneous (SC) on day 4 6 cycles (21 days in each cycle)


Locations(1)

Australia

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ACTRN12606000373572