Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12606000350527
Ethics application status
Approved
Date submitted
4/08/2006
Date registered
15/08/2006
Date last updated
3/10/2013
Type of registration
Retrospectively registered

Titles & IDs
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
Scientific 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.
Universal Trial Number (UTN)
Trial acronym
Peg-Auto
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Relapsed or refractory diffuse large B-cell lymphoma and Hodgkin lymphoma 1320 0
Condition category
Condition code
Cancer 1406 1406 0 0
Hodgkin's
Cancer 1407 1407 0 0
Lymphoma (non Hodgkin's lymphoma) - High grade lymphoma

Intervention/exposure
Study type
Interventional
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 [1] 1065 0
Treatment: Drugs
Comparator / control treatment
No comparator.
Control group
Active

Outcomes
Primary outcome [1] 1928 0
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 [1] 1928 0
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] 3388 0
To determine the feasibility of ICE cycles given every 14 days.
Timepoint [1] 3388 0
At end of study
Secondary outcome [2] 3389 0
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 [2] 3389 0
At end of study

Eligibility
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
Sex
Both males and females
Can healthy volunteers participate?
No
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.

Study design
Purpose of the study
Prevention
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 2
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/07/2005
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
40
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 1540 0
Commercial sector/Industry
Name [1] 1540 0
Amgen
Country [1] 1540 0
Primary sponsor type
Commercial sector/Industry
Name
Amgen
Address
Country
United States of America
Secondary sponsor category [1] 1353 0
None
Name [1] 1353 0
None
Address [1] 1353 0
Country [1] 1353 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 2969 0
Westmead Hospital
Ethics committee address [1] 2969 0
Ethics committee country [1] 2969 0
Australia
Date submitted for ethics approval [1] 2969 0
Approval date [1] 2969 0
Ethics approval number [1] 2969 0
2004/11/4.8(1958)
Ethics committee name [2] 2970 0
Prince of Wales Hospital
Ethics committee address [2] 2970 0
Ethics committee country [2] 2970 0
Australia
Date submitted for ethics approval [2] 2970 0
Approval date [2] 2970 0
01/03/2006
Ethics approval number [2] 2970 0
05/377

Summary
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
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 35106 0
Address 35106 0
Country 35106 0
Phone 35106 0
Fax 35106 0
Email 35106 0
Contact person for public queries
Name 10254 0
Angela Bayley
Address 10254 0
Department of Clinical Haematology
Westmead Hospital
Westmead NSW 2145
Country 10254 0
Australia
Phone 10254 0
61 2 98457219
Fax 10254 0
+61 2 96893700
Email 10254 0
Angelab@icpmr.wsahs.nsw.gov.au
Contact person for scientific queries
Name 1182 0
Mark Hertzberg
Address 1182 0
Department of Clinical Haematology
Westmead Hospital
Westmead NSW 2145
Country 1182 0
Australia
Phone 1182 0
+61 2 98457610
Fax 1182 0
+61 2 96892331
Email 1182 0
mark_hertzberg@wmi.usyd.edu.au

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided


Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.