Effect of recombinant Granulocyte Colony-Stimulating Factor (G-CSF) on the results of chemotherapy (CHOP) in elderly patients with intermediate-/high-grade Non-Hodgkin's Lymphoma: a prospective phase III study

Completed

• Conditions: on Hogdkin's Lymphoma (NHL); Cancer; Non Hogdkin's Lymphoma

• Registration Number: ISRCTN26340837
• Lead Sponsor: Dutch Haemato-Oncology Association (Stichting Hemato-Oncologie Volwassenen Nederland) (HOVON) (Netherlands)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2005-12-20
• Last Update Posted: 13 January 2015

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 410

Inclusion Criteria

1. Previously untreated Non-Hodgkin?s Lymphoma
2. Ann Arbor stage II, III or IV
3. Intermediate- or high grade malignancy (Working Formulation), confirmed by histology
4. Aged greater than or equal to 65 years
5. Informed consent

Exclusion Criteria

1. Treatment for NHL with chemotherapy or radiotherapy (local irradiation to life-threatening tumor infiltration is allowed)
2. Lymphoblastic lymphoma
3. Other malignant diseases, except localized squamous skin carcinoma
4. Severe heart failure requiring symptomatic treatment or a cardiac ejection fraction of less than 45%
5. Inadequate liver or renal function, ie serum creatinine or serum bilirubin > 15x the upper normal value, except when related to lymphoma organ infiltration
6. HIV positivity

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Complete Remission (CR) rate.

Secondary Outcome Measures

Name	Time	Method
1. Relapse rate<br>2. Event-free survival<br>3. Overall survival<br>4. Treatment-related morbidity<br>5. Therapy-related hospital admissions<br>6. Mortality