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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/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
Gender
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
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
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/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
Other publications