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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT00163761




Registration number
NCT00163761
Ethics application status
Date submitted
11/09/2005
Date registered
14/09/2005
Date last updated
8/01/2016

Titles & IDs
Public title
Efficacy Study of Outpatient Therapy for Lymphoma
Scientific title
A Multicentre Phase II Study of Risk-adjusted Outpatient-based Salvage Therapy for Patients With Relapsed and Refractory Lymphoma
Secondary ID [1] 0 0
AH226/02
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Non-Hodgkin's Lymphoma 0 0
Hodgkin's Disease 0 0
Condition category
Condition code
Cancer 0 0 0 0
Lymphoma (non Hodgkin's lymphoma) - High grade lymphoma
Cancer 0 0 0 0
Lymphoma (non Hodgkin's lymphoma) - Low grade lymphoma
Cancer 0 0 0 0
Hodgkin's

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - gemcitabine, vinorelbine, ifosfamide, filgastrim
Treatment: Drugs - gemcitabine, vinorelbine, filgastrim

Active Comparator: Commence VGF treatment - Drug. Vinorelbine, gemcitabine and filgrastim 21 day cycle

Active Comparator: Commence F-GIV treatment - Drug. Gemcitabine, ifosfamide, Vinorelbine and filgrastim 21 day cycle


Treatment: Drugs: gemcitabine, vinorelbine, ifosfamide, filgastrim
Drug

Treatment: Drugs: gemcitabine, vinorelbine, filgastrim
Drug
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
To evaluate the efficacy (overall response rate) of a risk-adjusted outpatient-based approach to lymphoma salvage therapy with VGF (vinorelbine, gemcitabine and pegfilgrastim) and/or F-GIV (gemcitabine, Ifosfamide, vinorelbine and pegfilgrastim).
Timepoint [1] 0 0
After two cycles and after four cycles
Secondary outcome [1] 0 0
To evaluate safety,
Timepoint [1] 0 0
Days 1 and 8 for every cycle, days 10,12,14, and 16 for first cycle.
Secondary outcome [2] 0 0
relapse free survival,
Timepoint [2] 0 0
After 2 cycles, 4 cyles and every 3 or 4 months for 12 months. Then every 6 months until disease progression
Secondary outcome [3] 0 0
overall survival,
Timepoint [3] 0 0
every 3 or 4 months for 12 months. Then every 6 months.
Secondary outcome [4] 0 0
and planned dose-on-time.
Timepoint [4] 0 0
After two cycles and after four cycles

Eligibility
Key inclusion criteria
- age > 18 years

- relapsed or primary refractory non-Hodgkin's lymphoma (NHL) or Hodgkin's Disease (HD)

- ECOG 0 - 2

- written informed consent
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria:

- Intention to proceed with any form of transplant therapy following fewer than 2 cycles
of protocol salvage therapy

- bilirubin > 50µmol/litre unless secondary to lymphoma

- creatinine > 2 x upper limit of normal unless secondary to lymphoma, absolute
neutrophil count <0.5 x 109/litre and / or platelets < 50 x 109/litre unless secondary
to lymphoma

- relapse within 6 months of a prior transplant procedure (autologous or allogeneic)

- known sensitivity to E coli derived preparations

Study design
Purpose of the study
Treatment
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
Crossover
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/12/2002
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/02/2008
Sample size
Target
Accrual to date
Final
90
Recruitment in Australia
Recruitment state(s)
ACT,NSW,QLD,TAS,VIC,WA
Recruitment hospital [1] 0 0
Canberra Hospital - Canberra
Recruitment hospital [2] 0 0
Royal North Shore Hospital - Sydney
Recruitment hospital [3] 0 0
Mater Adult Hospital - South Brisbane
Recruitment hospital [4] 0 0
Royal Hobart Hospital - Hobart
Recruitment hospital [5] 0 0
The Alfred Hospital - Melbourne
Recruitment hospital [6] 0 0
The Royal Melbourne Hospital - Melbourne
Recruitment hospital [7] 0 0
Frankston Hospital - Melbourne
Recruitment hospital [8] 0 0
Monash Medical Centre - Melbourne
Recruitment hospital [9] 0 0
Border Medical Oncology - Wodonga
Recruitment hospital [10] 0 0
Fremantle Hospital - Fremantle
Recruitment postcode(s) [1] 0 0
2605 - Canberra
Recruitment postcode(s) [2] 0 0
2065 - Sydney
Recruitment postcode(s) [3] 0 0
4101 - South Brisbane
Recruitment postcode(s) [4] 0 0
7001 - Hobart
Recruitment postcode(s) [5] 0 0
3004 - Melbourne
Recruitment postcode(s) [6] 0 0
3050 - Melbourne
Recruitment postcode(s) [7] 0 0
3199 - Melbourne
Recruitment postcode(s) [8] 0 0
3690 - Wodonga
Recruitment postcode(s) [9] 0 0
6160 - Fremantle

Funding & Sponsors
Primary sponsor type
Other
Name
Bayside Health
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
This is a Phase II trial evaluating the efficacy (overall response rate) of a risk-adjusted
outpatient based approach to lymphoma salvage therapy with vinorelbine, gemcitabine and
pegfilgrastim and/or gemcitabine, ifosfamide, vinorelbine and pegfilgrastim.
Trial website
https://clinicaltrials.gov/ct2/show/NCT00163761
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Andrew Spencer, Assoc. Prof
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT00163761