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 is currently recruiting participants. (see Contacts and Locations)
Verified February 2014 by Yonsei University
Sponsor:
Collaborator:
JW Pharmaceutical
Information provided by (Responsible Party):
Yonsei University
ClinicalTrials.gov Identifier:
NCT01763398
First received: January 4, 2013
Last updated: February 17, 2014
Last verified: February 2014
  Purpose

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.)


Condition
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 ] [ Designated as safety issue: No ]
    Hospitalization relevant to this during the occurrence of febrile neutropenia under anticancer treatments


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

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
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

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01763398

Locations
Korea, Republic of
Severance Hospital Recruiting
Seoul, Korea, Republic of, 120-752
Contact: JinSeok Kim, MD, PhD    82-2-2228-1972    hemakim@yuhs.ac   
Sponsors and Collaborators
Yonsei University
JW Pharmaceutical
  More Information

No publications provided

Responsible Party: Yonsei University
ClinicalTrials.gov Identifier: NCT01763398     History of Changes
Other Study ID Numbers: 4-2011-0432
Study First Received: January 4, 2013
Last Updated: February 17, 2014
Health Authority: South Korea: Institutional Review Board

Additional relevant MeSH terms:
Lymphoma, Non-Hodgkin
Lymphoma
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases

ClinicalTrials.gov processed this record on September 18, 2014