Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12606000386538
Ethics application status
Approved
Date submitted
10/08/2006
Date registered
4/09/2006
Date last updated
12/10/2016
Type of registration
Retrospectively registered

Titles & IDs
Public title
A Pilot Study to Evaluate the Safety and Efficacy of Rituximab in Combination with Out-Patient Based Vinorelbine, Gemcitabine and Pegfilgrastim (VGF)/Pegfilgrastim, Gemcitabine, Ifosfamide and Vinorelbine (F-GIV) Salvage Therapies in the treatment of Relapsed/Refractory CD20+ Lymphomas.
Scientific title
A Pilot Study to Evaluate the Safety and Efficacy of Rituximab in Combination with Out-Patient Based Vinorelbine, Gemcitabine and Pegfilgrastim or Pegfilgrastim, Gemcitabine, Ifosfamide and Vinorelbine Salvage Therapies in the Treatment of Relapsed/Refractory CD20+ Non-Hodgkin Lymphomas to Improve the Outcome of Quality of Life and to Minimise Inpatient Stay.
Secondary ID [1] 303 0
ClinicalTrials.gov: NCT00280878
Universal Trial Number (UTN)
Trial acronym
Rituximab in Combination with Out-Patient Therapy for CD20+ Lymphoma
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Relapsed and refractory CD20+ lymphoma 1352 0
Condition category
Condition code
Cancer 1442 1442 0 0
Lymphoma (non Hodgkin's lymphoma) - High grade lymphoma
Cancer 1443 1443 0 0
Lymphoma (non Hodgkin's lymphoma) - Low grade lymphoma

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This is an open label, Phase II, pilot study of 12 patients using a risk-adjusted outpatient-based approach to non- Hodgkin Lymphoma salvage therapy with R-VGF (Rituximab 375mg/m2 IV, Vinorelbine 25mg/m2 IV, Gemcitabine 1000mg/m2 IV and Pegfilgrastim 6mg subcutaneous) and R-F-GIV (Rituximab 375mg/m2 IV, Gemcitabine 1000mg/m2 IV, Ifosfamide 3g/m2 IV, Vinorelbine 25mg/m2 IV and Pegfilgrastim 6mg subcutaneous. Patients will be stratified at the time of accrual to 1 of 3 groups: Good risk (Group 1), poor risk (Group 2) or post-transplant (Group 3). Patients in Groups 1 and 3 will commence treatment with R-VGF. Patients in Group 2 will commence treatment with R-F-GIV. Patients failing to show an adequate response following 2 cycles of therapy and who do not have progressive disease will escalate to a more intensive regimen for 2 further cycles of therapy (R-VGF to R-F-GIV, R-F-GIV to IVAC). IVAC comprises Etoposide 60mg/m2 IV and Ifosfamide 1.5g/m2 IV given on Day 1 to 5, Cytarabine 2g/m2 IV given on Day 1 and 2 and Pegfilgrastim 6mg subcutaneous given on Day 6 of each 21 Day cycle. The pegylated form of Filgrastim, Pegfilgrastim, will be used once per cycle instead of daily Filgrastim. Patients will receive treatment on Day 1 and 8 of every 3 week cycle.
Intervention code [1] 1274 0
Treatment: Drugs
Comparator / control treatment
not applicable
Control group
Uncontrolled

Outcomes
Primary outcome [1] 1991 0
To evaluate 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).
A 20% rate of Grade 4 non-haematological toxicity would be considered excessive. Treatment with protocol therapy will be terminated if 4 out of the first 10 patients treated experience at least 1 Grade 4 non-haematological toxicity. All patients who receive any study medication will be included in the toxicity analysis.
Timepoint [1] 1991 0
Patients will be assessed after each cycle of treatment.
Secondary outcome [1] 3453 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] 3453 0
An intention to treat analysis of response will be conducted including all patients receiving any protocol medication. Response assessment will be performed post 2 cycles of treatment and again after the completion of 4 cycles of treatment.

Eligibility
Key inclusion criteria
Relapsed or primary refractory CD20+ NHL, ECOG 0 – 2, Written informed consent.
Minimum age
18 Years
Maximum age
Not stated
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
Safety
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/03/2006
Actual
3/03/2006
Date of last participant enrolment
Anticipated
Actual
9/07/2007
Date of last data collection
Anticipated
Actual
1/03/2012
Sample size
Target
12
Accrual to date
Final
12
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 1581 0
Hospital
Name [1] 1581 0
The Alfred Hospital
Country [1] 1581 0
Australia
Primary sponsor type
Individual
Name
Associate Professor Andrew Spencer
Address
Commercial Road, Melbourne 3004
Country
Australia
Secondary sponsor category [1] 1388 0
None
Name [1] 1388 0
None
Address [1] 1388 0
Country [1] 1388 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 3006 0
The Alfred Hospital
Ethics committee address [1] 3006 0
Ethics committee country [1] 3006 0
Australia
Date submitted for ethics approval [1] 3006 0
Approval date [1] 3006 0
03/01/2006
Ethics approval number [1] 3006 0
AH204/05

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 35554 0
Prof Andrew Spencer
Address 35554 0
C/o Malignant Haematology and Stem Cell Transplantation Service, The Alfred Hospital
Country 35554 0
Australia
Phone 35554 0
+61 3 9076 3393
Fax 35554 0
Email 35554 0
aspencer@netspace.net.au
Contact person for public queries
Name 10463 0
Kate Reed
Address 10463 0
Myeloma Research Group and Clinical Haematology
The Alfred Hospital
Ground Floor South Block
Commercial Road
Melbourne VIC 3004
Country 10463 0
Australia
Phone 10463 0
+61 3 92763571
Fax 10463 0
+61 3 92766531
Email 10463 0
K.Reed@alfred.org.au
Contact person for scientific queries
Name 1391 0
Associate Professor Andrew Spencer
Address 1391 0
Myeloma Research Group and Clinical Haematology
The Alfred Hospital
Ground Floor South Block
Commercial Road
Melbourne VIC 3004
Country 1391 0
Australia
Phone 1391 0
+61 3 92763392
Fax 1391 0
+61 3 92762298
Email 1391 0
aspencer@netspace.net.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.