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Open (Enrolling)
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Non-Hodgkin's Lymphoma

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Trial Information


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

Type of Study:

Observational

Study Design:

Observational Model: Cohort, Time Perspective: Prospective

Outcome Measure:

Hospitalization period

Outcome Description:

Hospitalization relevant to this during the occurrence of febrile neutropenia under anticancer treatments

Outcome Time Frame:

24months

Safety Issue:

No

Authority:

South Korea: Institutional Review Board

Study ID:

4-2011-0432

NCT ID:

NCT01763398

Start Date:

September 2011

Completion Date:

September 2013

Related Keywords:

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

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