Non-Hodgkin's Lymphoma
Conditions
Brief 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.)
Interventions
None listed
Sponsors
JW Pharmaceutical
Yonsei University
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Hospitalization period | 24months | Hospitalization relevant to this during the occurrence of febrile neutropenia under anticancer treatments |
Countries
South Korea
Outcome results
None listed