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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/NCT00280878
Registration number
NCT00280878
Ethics application status
Date submitted
22/01/2006
Date registered
24/01/2006
Date last updated
15/01/2016
Titles & IDs
Public title
Rituximab in Combination With Outpatient Therapy for CD20+ Lymphoma
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Scientific title
A Pilot Study of Rituximab in Combination With Out-patient Based VGF/F-GIV Salvage Therapies for Relapsed/Refractory CD20+ Lymphomas
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Secondary ID [1]
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AH204/05
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Non-Hodgkin's Lymphoma (CD20+)
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Condition category
Condition code
Cancer
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Lymphoma (non Hodgkin's lymphoma) - High grade lymphoma
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Cancer
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Lymphoma (non Hodgkin's lymphoma) - Low grade lymphoma
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - gemcitabine
Treatment: Drugs - vinorelbine
Treatment: Drugs - ifosfamide
Treatment: Drugs - rituximab
Treatment: Drugs: gemcitabine
Treatment: Drugs: vinorelbine
Treatment: Drugs: ifosfamide
Treatment: Drugs: rituximab
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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To evaluate the safety of a risk-adjusted outpatient-based approach to lymphoma salvage therapy with VGF and/or F-GIV in combination with Rituximab.
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Assessment method [1]
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Timepoint [1]
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Secondary outcome [1]
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To determine point estimates of the response rates achieved with R-VGF or R-F-GIV in previously treated patients with relapsed/refractory CD20+ B-cell NHL.
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Assessment method [1]
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Timepoint [1]
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Eligibility
Key inclusion criteria
- Age >18 years
- Relapsed or primary refractory CD20+ NHL
- ECOG 0 - 2
- Written informed consent
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key 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
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Non-randomised trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Crossover
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Other design features
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Phase
Phase 2
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/01/2006
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
1/09/2007
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Sample size
Target
12
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
VIC
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Recruitment hospital [1]
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The Alfred Hospital - Melbourne
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Recruitment hospital [2]
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Frankston Hospital - Melbourne
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Recruitment postcode(s) [1]
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3004 - Melbourne
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Recruitment postcode(s) [2]
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- Melbourne
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Funding & Sponsors
Primary sponsor type
Other
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Name
Bayside Health
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
This is a Phase II pilot study evaluating the safety 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) in combination with
Rituximab (R-VGF/R-F-GIV).
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Trial website
https://clinicaltrials.gov/ct2/show/NCT00280878
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Andrew Spencer, Assoc.Prof
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Address
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT00280878
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