Outpatient-based fractionated Ifosfamide, Carboplatin, Etoposide (ICE) chemotherapy supported with pegfilgrastim for salvage and stem cell mobilisation in transplant eligible patients with relapsed or refractory diffuse large B-cell lymphoma and Hodgkin lymphoma

A phase II study to determine the ability of outpatient-based fractionated ICE salvage chemotherapy and 6 mg pegfilgrastim to mobilise sufficient numbers of peripheral blood CD34+ stem cells in transplant-eligible patients with relapsed or refractory diffuse large B-cell lymphoma and Hodgkin lymphoma.

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12606000350527

Acronym

Peg-Auto

Enrollment

Registered

2006-08-15

Start date

2005-07-01

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 resistant lymphoma require initial salvage chemotherapy to control their disease. One type of salvage chemotherapy is called ICE which can be given over 3 consecutive days as an outpatient for 3 cycles. On the day following each cycle of the ICE therapy (day 4) a single injection under the skin of pegfilgrastim is given to prevent the white blood cell count from falling too low. Provided patients respond to the salvage ICE chemotherapy, they then require high-dose chemotherapy as an inpatient. However, since this high dose therapy also kills some of the healthy white blood cells, it is necessary to collect stem cells from the blood before the high dose therapy. This is done by a process called leukapheresis. This study aims to collect stem cells by giving two doses of Pegfilgrastim on a single day, instead of 8-12 daily injections of standard filgrastim, following cycle 2 or 3 of ICE chemotherapy.

Interventions

Ifosfamide 5,000 mg/m2 iv in equally divided doses over 3 days Carboplatin 5 x Area under the Curve on day 1 (max. 800 mg) Etoposide 100 mg/m2 iv daily for days 1 to 3 Pegfilgrastim 6 mg Subcutaneous on day 4 Patients will receive 3 cycles of treatment every 21 days.

Study design

Allocation

Non-randomised trial

Intervention model

Single group

Primary purpose

Prevention

Masking

Open (masking not used)

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

1. Eastern Co-operative Oncology Group performance status 0, 1 or 2. 2. Relapsed or progressive non-Hodgkin lymphoma (WHO diffuse large B-cell) including induction failures to first-line anthracycline-containing regimens; or relapsed or refractory Hodgkin lymphoma. 3. Intended for chemo-responsive patients to proceed to autologous peripheral blood stem cell transplantation 4. Minimum life expectancy of 3 months 5. Able to give written informed consent.

Exclusion criteria

1. More than one regimen of previous chemotherapy treatment2. Past history of severe cardiac, hepatic, respiratory or renal disease. 3. Poor renal function (serum creatinine > 150 µmol/L or 1.5-2.0 x ULN), poor hepatic function (bilirubin >30 µmol/L or >1.5x Upper Limit of Normal (ULN); transaminases>2.5 x ULN) unless these abnormalities are related to lymphoma.4. 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.5. HIV seropositive6. Pregnant women or breast-feeding mothers7. Those in whom high dose chemotherapy as conditioning for autologous stem cell transplantation would be otherwise precluded.8. Previous radiotherapy to >20% bone marrow 9. Previous bone marrow or PBSC transplant10. History of cancer within the previous 5 years except non-melanoma skin tumours or stage 0 (in situ) cervical carcinoma.11. Known hypersensitivity to E coli-derived proteins.

Outcome results