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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-09-30

Study Completion Date

2015-08-31

Brief Summary

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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.)

Detailed Description

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Conditions

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Non-Hodgkin's Lymphoma

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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non-Hodgkin's lymphoma

Patients with non-Hodgkin's lymphoma, high risk group for neutropenic fever, treated by CHOP-like regimen and primary G-CSF prophylactic therapy

No interventions assigned to this group

Eligibility Criteria

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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

1. Age \>= 65 years old
2. Progressed stage of disease (Ann Arbor stage III)
3. History of previous anti-cancer treatment
4. History of previous radiotherapy (Including bone region includes bone marrow)
5. Bone marrow involvement
6. Comorbid neutropenia (neutrophils \< 1,500/uL ) before the initiation of anti-cancer treatment
7. Comorbid anemia (hemoglobin \< 12.0 g/dL ) before the initiation of anti-cancer treatment
8. Evidence of activated inflammation
9. Existence of open wound
10. Poor health state (ECOG 2)
11. Poor nutritional state (Serum albumin \< 3.5 g/dL)
12. Kidney disease or renal insufficiency
13. Liver disease (chronic hepatitis or cirrhosis) or hepatic insufficiency
14. Chronic Obstructive Pulmonary Disease (COPD)
15. Cardiovascular disease
16. 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

Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Locations

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Severance Hospital

Seoul, Seoul, South Korea

Site Status

Countries

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South Korea

Other Identifiers

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4-2011-0432

Identifier Type: -

Identifier Source: org_study_id