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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/NCT00193973




Registration number
NCT00193973
Ethics application status
Date submitted
13/09/2005
Date registered
19/09/2005
Date last updated
17/02/2017

Titles & IDs
Public title
Idarubicin Based Combined Modality Therapy in Primary CNS Lymphoma
Scientific title
A Phase 2 Study of Idarubicin Based Combined Modality Therapy in Primary Central Nervous System Lymphoma
Secondary ID [1] 0 0
ALLG LY4
Secondary ID [2] 0 0
TROG 01.02
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Primary Central Nervous System Lymphoma 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
Treatment: Drugs - Idarubicin, Methotrexate, Filgrastim, intrathecal Ara-C
Treatment: Other - Radiation Therapy

Active Comparator: 1 -


Treatment: Drugs: Idarubicin, Methotrexate, Filgrastim, intrathecal Ara-C
Idarubicin 15mg/m2 days 1, 22. Filgrastim 5mcg/kg until neutrophil recovery days 2, 23. Methotrexate 1g/m2 days 15, 36 and 50.

Treatment: Other: Radiation Therapy
Whole brain Irradiation, 30Gy in 20 fractions over 4 weeks
Intervention code [1] 0 0
Treatment: Drugs
Intervention code [2] 0 0
Treatment: Other
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
To estimate the median and 2 year overall survival.
Timepoint [1] 0 0
Estimate of survival at 2 years and at 5 years.
Secondary outcome [1] 0 0
Assess acute toxicity.
Timepoint [1] 0 0
Interim actute toxicity analyses will be performed at accrual points: 5, 10, 15, 20 and 25 patients.
Secondary outcome [2] 0 0
Assess functional indices of living in patients with PCNSL.
Timepoint [2] 0 0
Analysis will be at 5 years.
Secondary outcome [3] 0 0
To estimate the risk of late neurotoxicity relative to results achieved in TROG 92.01.
Timepoint [3] 0 0
Analysis at 3 years.

Eligibility
Key inclusion criteria
- Histologically proven primary CNS lymphoma.

- Absence of disease outside the CNS.

- ECOG performance status 0-3

- Negative HIV status.

- Peripheral blood counts with granulocytes >1.5 x 109L and platelets > 100 x 109L.
Serum creatinine <150mmol/L. Serum bilirubin <1.5 times and AST <2 times upper limit
of normal.

- Age >18 and <=70 years.

- Patients must give written informed consent.

- Corticosteroids prior to histological diagnosis are allowed.
Minimum age
18 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Previous history of malignancy (other than non-melanomatous skin carcinoma, or
carcinoma in situ of cervix completely excised).

- Patients who are pregnant or lactating.

- NYHA (New York State Heart Association classification) cardiac failure grade 3

- Macroscopic spinal thecal or spinal cord disease.

Study design
Purpose of the study
Treatment
Allocation to intervention
N/A
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
Single group
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
1/07/2001
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/08/2013
Sample size
Target
Accrual to date
Final
20
Recruitment in Australia
Recruitment state(s)
ACT,NSW,QLD,SA,VIC,WA
Recruitment hospital [1] 0 0
The Canberra Hospital - Garran
Recruitment hospital [2] 0 0
Calvary Mater Newcastle - Newcastle
Recruitment hospital [3] 0 0
Prince of Wales Hospital - Randwick
Recruitment hospital [4] 0 0
Westmead Hospital - Wentworthville
Recruitment hospital [5] 0 0
Illawarra Cancer Care Centre - Wollongong
Recruitment hospital [6] 0 0
Royal Brisbane Hospital - Herston
Recruitment hospital [7] 0 0
Mater QRI - South Brisbane
Recruitment hospital [8] 0 0
Premion - Tugun - Tugun
Recruitment hospital [9] 0 0
Princess Alexandra Hospital - Woolloongabba
Recruitment hospital [10] 0 0
Royal Adelaide Hospital - Adelaide
Recruitment hospital [11] 0 0
Andrew Love Cancer Centre, Geelong Hospital - Geelong
Recruitment hospital [12] 0 0
Peter MacCallum Cancer Centre - Melbourne
Recruitment hospital [13] 0 0
Sir Charles Gairdner Hospital - Nedlands
Recruitment postcode(s) [1] 0 0
2605 - Garran
Recruitment postcode(s) [2] 0 0
2298 - Newcastle
Recruitment postcode(s) [3] 0 0
2031 - Randwick
Recruitment postcode(s) [4] 0 0
2145 - Wentworthville
Recruitment postcode(s) [5] 0 0
- Wollongong
Recruitment postcode(s) [6] 0 0
4029 - Herston
Recruitment postcode(s) [7] 0 0
4101 - South Brisbane
Recruitment postcode(s) [8] 0 0
4224 - Tugun
Recruitment postcode(s) [9] 0 0
4102 - Woolloongabba
Recruitment postcode(s) [10] 0 0
5000 - Adelaide
Recruitment postcode(s) [11] 0 0
3220 - Geelong
Recruitment postcode(s) [12] 0 0
8006 - Melbourne
Recruitment postcode(s) [13] 0 0
6009 - Nedlands
Recruitment outside Australia
Country [1] 0 0
New Zealand
State/province [1] 0 0
Auckland
Country [2] 0 0
New Zealand
State/province [2] 0 0
Christchurch

Funding & Sponsors
Primary sponsor type
Other
Name
Trans Tasman Radiation Oncology Group
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Australasian Leukaemia and Lymphoma Group
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Idarubicin combined with high dose methotrexate and moderate dose radiotherapy will achieve
similar survival outcomes but with reduced neurotoxicity compared to regimens using
methotrexate with high dose radiotherapy.
Trial website
https://clinicaltrials.gov/ct2/show/NCT00193973
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Peter O'Brien, FRANZCR
Address 0 0
Newcastle Mater Misericordiae Hospital
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/NCT00193973