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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

This study has been completed.
JW Pharmaceutical
Information provided by (Responsible Party):
Yonsei University Identifier:
First received: January 4, 2013
Last updated: October 30, 2016
Last verified: October 2016
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.)

Non-Hodgkin's Lymphoma

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective

Resource links provided by NLM:

Further study details as provided by Yonsei University:

Primary Outcome Measures:
  • Hospitalization period [ Time Frame: 24months ]
    Hospitalization relevant to this during the occurrence of febrile neutropenia under anticancer treatments

Enrollment: 500
Study Start Date: September 2011
Study Completion Date: August 2015
Primary Completion Date: August 2015 (Final data collection date for primary outcome measure)
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


Ages Eligible for Study:   20 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with non-Hodgkin's lymphoma, high risk group for neutropenic fever, treated by CHOP-like regimen and primary G-CSF prophylactic therapy

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
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Please refer to this study by its identifier: NCT01763398

Korea, Republic of
Severance Hospital
Seoul, Korea, Republic of, 120-752
Sponsors and Collaborators
Yonsei University
JW Pharmaceutical
  More Information

Responsible Party: Yonsei University Identifier: NCT01763398     History of Changes
Other Study ID Numbers: 4-2011-0432
Study First Received: January 4, 2013
Last Updated: October 30, 2016

Additional relevant MeSH terms:
Lymphoma, Non-Hodgkin
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases processed this record on August 18, 2017