Australian New Zealand Clinical Trials Registry

Trial Details

indicate updates made to monitored data item(s) since trial registration. These data item(s) are monitored to ensure they comply with the WHO / journal editors standards.

Request Number:

001310

ACTR Number:

ACTRN12606000350527

Trial Status:

Registered

Date Submitted:

4/08/2006

Date Registered:

15/08/2006

Page 1

Public title:

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

ANZCTR registration title:

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.

Secondary ID:

UTN:

Trial acronym:

Peg-Auto

Page 2
Health condition(s) or problem(s) studied:
Relapsed or refractory diffuse large B-cell lymphoma and Hodgkin lymphoma

Cancer	Hodgkin's
Condition category:	Condition code:
Cancer	Lymphoma (non Hodgkin's lymphoma) - High grade lymphoma

Page 3

Description of intervention(s) / exposure:

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.

Intervention code:

Treatment: drugs

Comparator / control treatment:

No comparator.

Control group:

Active

Page 4
Primary outcome:	To determine the ability of fractionated outpatient ICE salvage chemotherapy and 6 mg pegfilgrastim to mobilise sufficient numbers of peripheral blood cluster designation 34+ stem cells in transplant-eligible patients with relapsed or refractory diffuse large B-cell lymphoma and Hodgkin lymphoma.
Timepoint:	During mobilisation cycles, Full Blood Count (FBC) will be performed every second day during weekdays until day 10 and then daily on weekdays together with CD34+ cell counts
Secondary outcome 1:	To determine the feasibility of ICE cycles given every 14 days.
Timepoint:	At end of study
Secondary outcome 2:	To determine the efficacy and toxicity of an outpatient-based fractionated ICE salvage regimen consisting of ifosfamide, carboplatin and etoposide given every three weeks or two weeks and supported by pegfilgrastim 6 mg in non-mobilisation cycles in transplant-eligible patients with relapsed or refractory diffuse large B-cell lymphoma and Hodgkin lymphoma.
Timepoint:	At end of study

Page 5

Key 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.

Minimum Age:

18 Years

Maximum Age:

Not stated

Gender:

Both males and females

Healthy volunteers?

Key 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.

Page 6

Study type:

Interventional

Purpose of the study:

Prevention

Allocation to intervention:

Nonrandomised trial

Describe the procedure for enrolling a subject and allocating the treatment (allocation concealment procedures):

Describe the methods used to generate the sequence in which subjects will be randomised (sequence generation):

Masking / blinding:

Open (masking not used)

Assignment:

Single group

Other design features (specify):

Type of endpoint(s):

Efficacy

Page 7

Phase

Phase 2

Anticipated or actual date of first participant enrolement:

1/07/2005

Target sample size:

Recruitment status:

Open to recruitment

Page 8

Funding source:

Commercial sector/Industry

Name:

Amgen

Address:

Country:

Primary sponsor:

Commercial sector/Industry

Name:

Amgen

Address:

Country:

United States of America

Secondary sponsor:

None

Name:

None

Address:

Country:

Other collaborator:

Page 9

Has the study received approval from at least one ethics committee?

Yes

Ethics Committee name 1:

Westmead Hospital

Address:

Country:

Australia

Date of approval:

HREC Number:

2004/11/4.8(1958)

Ethics Committee name 2:

Prince of Wales Hospital

Address:

Country:

Australia

Date of approval:

1/03/2006

HREC Number:

05/377

Countries of recruitment:

Australia

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.

Trial website:

Presentations / publication list:

Page 10

Contact person for public queries

Name:

Angela Bayley

Address:

Department of Clinical Haematology Westmead Hospital Westmead NSW 2145

Country:

Australia

Tel:

61 2 98457219

Fax:

+61 2 96893700

Email:

Angelab@icpmr.wsahs.nsw.gov.au

Contact person for scientific queries

Name:

Mark Hertzberg

Address:

Department of Clinical Haematology Westmead Hospital Westmead NSW 2145

Country:

Australia

Tel:

+61 2 98457610

Fax:

+61 2 96892331

Email:

mark_hertzberg@wmi.usyd.edu.au

Contact person responsible for updating information

Name:

Address:

Country:

Tel:

Fax:

Email:

Trial Details

Page 1

Page 2

Page 3

Page 4

Page 5

Page 6

Page 7

Page 8

Page 9

Page 10