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.)

Study Overview

• Status: Completed
• Conditions: Non-Hodgkin's Lymphoma

• Study Type: Observational
• Enrollment (Actual): 500

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 120-752
    • Severance Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hospitalization period	Hospitalization relevant to this during the occurrence of febrile neutropenia under anticancer treatments	24months

Collaborators and Investigators

• Sponsor: Yonsei University
• Collaborators: JW Pharmaceutical

Study record dates

Study Major Dates

• Study Start: September 1, 2011
• Primary Completion (ACTUAL): August 1, 2015
• Study Completion (ACTUAL): August 1, 2015

Study Registration Dates

• First Submitted: January 4, 2013
• First Submitted That Met QC Criteria: January 4, 2013
• First Posted (ESTIMATE): January 8, 2013

Study Record Updates

• Last Update Posted (ESTIMATE): November 1, 2016
• Last Update Submitted That Met QC Criteria: October 30, 2016
• Last Verified: October 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Immune System Diseases; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Lymphoma; Lymphoma, Non-Hodgkin
• Other Study ID Numbers: 4-2011-0432