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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/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
Scientific title
A Pilot Study of Rituximab in Combination With Out-patient Based VGF/F-GIV Salvage Therapies for Relapsed/Refractory CD20+ Lymphomas
Secondary ID [1] 0 0
AH204/05
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Non-Hodgkin's Lymphoma (CD20+) 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

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
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.
Timepoint [1] 0 0
Secondary outcome [1] 0 0
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.
Timepoint [1] 0 0

Eligibility
Key inclusion criteria
* Age >18 years
* Relapsed or primary refractory CD20+ NHL
* 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
* 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
1/01/2006
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/09/2007
Sample size
Target
12
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
The Alfred Hospital - Melbourne
Recruitment hospital [2] 0 0
Frankston Hospital - Melbourne
Recruitment postcode(s) [1] 0 0
3004 - Melbourne
Recruitment postcode(s) [2] 0 0
- Melbourne

Funding & Sponsors
Primary sponsor type
Government body
Name
Bayside Health
Address
Country

Ethics approval
Ethics application status

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).
Trial website
https://clinicaltrials.gov/study/NCT00280878
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/study/NCT00280878