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

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12606000373572

Acronym

R-IE

Enrollment

Registered

2006-08-25

Start date

2006-05-01

Completion date

Unknown

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief 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.

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 6 cycles (21 days in each cycle)

Study design

Allocation

Non-randomised trial

Intervention model

Single group

Primary purpose

Treatment

Masking

Open (masking not used)

Eligibility

Sex/Gender

All

Age

60 Years to No maximum

Healthy volunteers

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.

Outcome results