RecruitingPhase 2ACTRN12606000350527

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.


Sponsor

Amgen

Enrollment

40 participants

Start Date

Jul 1, 2005

Study Type

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

Sex: Both males and femalesMin Age: 18 Yearss

Plain Language Summary

Simplified for easier understanding

This study is for adults with certain types of lymphoma (cancer of the lymphatic system) that have come back or stopped responding to treatment. These include diffuse large B-cell lymphoma and Hodgkin lymphoma. The study is testing a chemotherapy combination called ICE (Ifosfamide, Carboplatin, and Etoposide), given as outpatient treatment over three cycles. Researchers are also studying whether two injections of a drug called pegfilgrastim, given on a single day, can collect enough stem cells from the blood to allow for a stem cell transplant — which is necessary for high-dose curative treatment. You may be eligible if: - You are 18 years of age or older - You have relapsed or refractory diffuse large B-cell non-Hodgkin lymphoma or Hodgkin lymphoma - You are being considered for a stem cell transplant - Your general health status (ECOG performance status) is 0, 1, or 2 - You have a life expectancy of at least 3 months - You are able to give written consent You may NOT be eligible if: - You have already had more than one course of chemotherapy - You have severe heart, liver, breathing, or kidney problems - You are HIV positive - You are pregnant or breastfeeding - You have had a previous stem cell or bone marrow transplant - You have had radiotherapy to more than 20% of your bone marrow - You have had another cancer in the past 5 years (except minor skin cancers or early-stage cervical cancer) Talk to your doctor about whether this trial might be right for you.

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 S

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)

Australia

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ACTRN12606000350527