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

Non-Hodgkin's Lymphoma Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01763398
• Other study ID #: 4-2011-0432
• Status: Completed
• Phase: N/A
• First received: January 4, 2013
• Last updated: October 30, 2016
• Start date: September 2011
• Est. completion date: August 2015

Study information

• Verified date: October 2016
• Source: Yonsei University
• Contact: n/a
• Is FDA regulated: No
• Health authority: South Korea: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

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.)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 500
• Est. completion date: August 2015
• Est. primary completion date: August 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years and older

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Febrile Neutropenia
• Lymphoma, Non-Hodgkin
• Non-Hodgkin's Lymphoma

Locations

Country	Name	City	State
Korea, Republic of	Severance Hospital	Seoul

Sponsors (2)

Lead Sponsor	Collaborator
Yonsei University	JW Pharmaceutical

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hospitalization period	Hospitalization relevant to this during the occurrence of febrile neutropenia under anticancer treatments	24months	No