Analysis of the Risk Factors for the Neutropenic Fever in the High Risk NHL Patients for Developing Febrile Neutropenia Who Received 3-weekly CHOP-like Chemotherapy With Primary G-CSF Prophylaxis; Prospective Multicenter Observation Study

The domestic standards of G-CSF permit the use of the G-CSF only when the ANC(absolute neutrophil count) drops to 1,000/uL or below. Therefore it is impossible to inject the G-CSF in order to prevent neutropenia. However, 'the 2006 Update of Recommendations for the Use of White Blood Cell Growth Factors: An Evidence-Based Clinical Practice Guideline(J ClinOncol 2006; 24:3187-3205)' and the 'NCCN Guideline' have revealed that as a precaution, it is appropriate to inject the G-CSF to the non-Hodgkin's lymphoma patients with high-risk factors under the anticancer treatment of CHOP-21 Rituximab before the number of neutrophils decreases. Thus, it is intended to analyze the risk factors of febrile neutropenia in a high-risk group of non-Hodgkin's lymphoma patients with a neutropenic fever who receive the CHOP-like regimen and primary G-CSF prophylactic therapy every three weeks. (The definition of neutropenic fever is a fever over 38.3 degrees C or continuous fever lasting longer than 1 hour over 38 degrees C with the number of neutrophil ≤ 500/uL or neutrophil ≤ 1,000/uL in case of expected decline to ≤ 500/uL within 48 hours.)

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Key information

Conditions

Non-Hodgkin's Lymphoma Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Lymphatic Diseases Lymphoma Lymphoma, Non-Hodgkin Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type

Age range

20 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Severance Hospital

Seoul, 120-752, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Histologically diagnosed non-Hodgkin's lymphoma patients treated by CHOP-regimen or R (Rituximab)-CHOP regimen at 21±5 days interval
Age >= 20 years old
The patients with at least one of the following risk factor of neutropenic fever at initiation of anti-cancer treatment

Age >= 65 years old
Progressed stage of disease (Ann Arbor stage III)
History of previous anti-cancer treatment
History of previous radiotherapy (Including bone region includes bone marrow)
Bone marrow involvement
Comorbid neutropenia (neutrophils < 1,500/uL ) before the initiation of anti-cancer treatment
Comorbid anemia (hemoglobin < 12.0 g/dL ) before the initiation of anti-cancer treatment
Evidence of activated inflammation
Existence of open wound
Poor health state (ECOG 2)
Poor nutritional state (Serum albumin < 3.5 g/dL)
Kidney disease or renal insufficiency
Liver disease (chronic hepatitis or cirrhosis) or hepatic insufficiency
Chronic Obstructive Pulmonary Disease (COPD)
Cardiovascular disease
Diabetes mellitus
Increased cardiac output by 50% above the baseline without clinically significant abnormal findings on MUGA or echocardiography
life expectancy >=6 months
Amenorrhea less than 1 year (less than 1 year after menopause) or premenopausal female with negative response to serum or urine pregnancy test before initiation of the treatment
Voluntary participants with written consent agreement for this study

Exclusion criteria

The patients treated by other anti-cancer treatment except CHOP regimen or R (Rituximab)-CHOP regimen at 21 days interval
Pregnant or breast feeding woman, fertile woman without appropriate contraception
Patients with hypersensitivity against study drugs
Patients treated by other study medication or co-treatment with anticancer chemotherapy, hormone therapy, and immunotherapy

Treatment and study plan

Primary outcomes

Hospitalization period

Time frame: 24months

Hospitalization relevant to this during the occurrence of febrile neutropenia under anticancer treatments

Sponsors and collaborators

Lead sponsor

Yonsei University

Other

Collaborators

JW Pharmaceutical

Registry information

Important dates

Study start: 2011
Primary completion: 2015
Study completion: 2015
First posted: Jan 8, 2013
Registry last updated: Nov 1, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

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