Inflammation and treatment tolerance in Non Hodgkin Lymphoma

Data analysis on selected previous clinical trials looking at inflammation and treatment tolerance in Non Hodgkin Lymphoma

Status

Not yet recruiting

Phases

Unknown

Study type

Observational

Source

ANZCTR

Registry ID

ACTRN12610000748011

Enrollment

250

Registered

2010-09-08

Start date

2010-12-01

Completion date

Unknown

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

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.

Interventions

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

Eligibility

Sex/Gender

All

Age

15 Years to No maximum

Healthy volunteers

Inclusion criteria

high grade NHL, participation in either NHL7 or NHL11 Australasian leukaemia and Lymphoma Group trial

Exclusion criteria

nil

Outcome results