Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12610000748011
Ethics application status
Approved
Date submitted
6/09/2010
Date registered
8/09/2010
Date last updated
8/09/2010
Type of registration
Prospectively registered

Titles & IDs
Public title
Inflammation and treatment tolerance in Non Hodgkin Lymphoma
Scientific title
Data analysis on selected previous clinical trials looking at inflammation and treatment tolerance in Non Hodgkin Lymphoma
Secondary ID [1] 252644 0
nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
non hodgkin lymphoma 258134 0
Condition category
Condition code
Cancer 258316 258316 0 0
Lymphoma (non Hodgkin's lymphoma) - High grade lymphoma

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
No intervention- retrospective data analysis of clinical trial data combined from two previously conducted clincial trials employing chemotherapy in patients with Non Hodgkin's Lymphoma (NHL).

Deidentified data will be collated from existing clincial trial databases and analysed using pred-determined statistical testing. This is expected to take approx. 6 months.

The two previous clincial trials are:
1) NHL7- Phase III randomised trial of high-dose CEOP + filgrastim versus standard dose CEOP in patients with Non-Hodgkin’s Lymphoma. Not registered. Accrual years- 1994-1999
2) NHL11- A phase-II study of a modified “Hyper-CVAD” frontline therapy for patients with poor prognosis diffuse large B-cell and peripheral T-cell non-Hodgkin’s lymphoma - Registered on ANZCTR, ACTRN12605000105640 Accrual years- 2005-2010
Intervention code [1] 257151 0
Not applicable
Comparator / control treatment
N/A
Control group
Uncontrolled

Outcomes
Primary outcome [1] 259164 0
To evaluate the associations of the neutrophil to lymphocyte ratio (NLR) and the presence of B symptoms at baseline with the incidence and grades of haematological and non-haematological toxicity after chemotherapy
Timepoint [1] 259164 0
Originally collected at baseline and after chemotherapy, data analysed at the conclusion of this data mining study
Primary outcome [2] 259165 0
To evaluate the associations of the NLR and presence of B symptoms at baseline with the requirement for dose reduction and delay in chemotherapy
Timepoint [2] 259165 0
Originally collected at baseline and after chemotherapy, data analysed at the conclusion of this data mining study
Primary outcome [3] 259166 0
To evaluate the associations of the NLR and presence of B symptoms at baseline with the requirement and duration of hospitalization for treatment-related toxicities.
Timepoint [3] 259166 0
Originally collected at baseline and after chemotherapy, data analysed at the conclusion of this data mining study
Secondary outcome [1] 265496 0
To evaluate the associations of the presence of NLR and B symptoms at baseline with response rates, progression free and overall survival
Timepoint [1] 265496 0
Originally collected at baseline and at trial closure, data analysed at the conclusion of this data mining study
Secondary outcome [2] 265497 0
To correlate the baseline neutrophil to lymphocyte ratio (NLR) with other baseline prognostic factors in NHL including B symptoms, International Prognostic Index, disease stage, beta 2 microglobulin and others.
Timepoint [2] 265497 0
Originally collected at baseline, data analysed at the conclusion of this data mining study
Secondary outcome [3] 265498 0
To correlate plasma levels of inflammatory proteins with B symptoms, NLR and other prognostic markers.
Timepoint [3] 265498 0
Originally collected at baseline, data analysed at the conclusion of this data mining study

Eligibility
Key inclusion criteria
high grade NHL, participation in either NHL7 or NHL11 Australasian leukaemia and Lymphoma Group trial
Minimum age
15 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
nil

Study design
Purpose
Natural history
Duration
Cross-sectional
Selection
Defined population
Timing
Retrospective
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/12/2010
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
250
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 257604 0
Self funded/Unfunded
Name [1] 257604 0
Country [1] 257604 0
Australia
Primary sponsor type
Other Collaborative groups
Name
Australasian Leukaemia and Lymphoma Group
Address
Level 2/10 St Andrews place,
East Melbourne, Vic, 3002
Country
Australia
Secondary sponsor category [1] 256830 0
None
Name [1] 256830 0
Address [1] 256830 0
Country [1] 256830 0
Other collaborator category [1] 251483 0
Individual
Name [1] 251483 0
Stephen Clarke
Address [1] 251483 0
Concord Hospital
Hospital Road
Concord, NSW, 2139
Country [1] 251483 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 259624 0
CONCORD REPATRIATION GENERAL HOSPITAL
Ethics committee address [1] 259624 0
CONCORD REPATRIATION GENERAL HOSPITAL
HOSPITAL ROAD
CONCORD, NSW, 2139
Ethics committee country [1] 259624 0
Australia
Date submitted for ethics approval [1] 259624 0
21/09/2010
Approval date [1] 259624 0
Ethics approval number [1] 259624 0

Summary
Brief summary
Our research has shown that patients with inflammatory symptoms (fevers, sweats and weight loss) and/or elevated inflammatory markers have slower clearance of chemotherapy and experience worse toxicity, as well as worse response and survival. We recently confirmed that UK based lymphoma patients with inflammatory (also known as B) symptoms experienced worse chemotherapy related leucopenia and thrombocytopenia, however we were not able to explore whether this resulted in more neutropenia, febrile neutropenia, treatment related hospitalisation or deaths, because of gaps in the UK data set. We plan to evaluate these issues in Australian lymphoma patients by re-evaluating stored de-identified data collected as part of several ALLG national lymphoma trials. Using the same data, we will also evaluate the prognostic significance of a new inflammatory marker (the neutrophil/lymphocyte ratio (NLR)) in lymphoma patients. We have shown this marker to be prognostic for survival in mesothelioma and colorectal and lung cancer patients. To our knowledge, it has not been evaluated in patients with NHL.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 31611 0
Address 31611 0
Country 31611 0
Phone 31611 0
Fax 31611 0
Email 31611 0
Contact person for public queries
Name 14858 0
Professor Stephen Clarke
Address 14858 0
Department of Medicine
Concord Hospital
Hospital Road
Concord, NSW, 2139
Country 14858 0
Australia
Phone 14858 0
+61297676587
Fax 14858 0
Email 14858 0
[email protected]
Contact person for scientific queries
Name 5786 0
Professor Stephen Clarke
Address 5786 0
Department of Medicine
Concord Hospital
Hospital Road
Concord, NSW, 2139
Country 5786 0
Australia
Phone 5786 0
+61297676587
Fax 5786 0
Email 5786 0
[email protected]

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
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