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

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Yonsei University

Status

Completed

Conditions

Non-Hodgkin's Lymphoma

Study type

Observational

Funder types

Other
Industry

Identifiers

NCT01763398
4-2011-0432

Details and patient eligibility

About

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.)

Enrollment

500 patients

Sex

All

Ages

20+ years old

Volunteers

No Healthy Volunteers

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

Trial design

500 participants in 1 patient group

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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