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.
Amgen
40 participants
Jul 1, 2005
Interventional
Conditions
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.
Eligibility
Plain Language Summary
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This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.
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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.
Locations(1)
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ACTRN12606000350527