Effect of recombinant G-CSF on the results of chemotherapy (CHOP) in elderly patients with intermediate-/high-grade Non-Hodgkin’s Lymphoma. A prospective phase III study.

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON22855

Enrollment

410

Registered

2005-09-09

Start date

1994-08-01

Completion date

Unknown

Last updated

2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Non-Hodgkin’s Lymphoma.

Interventions

Patients will be randomized at entry between: Arm A: CHOP q 3 weeks, 6 or 8 courses

Arm B: CHOP q 3 weeks, 6 or 8 courses + 300 mcg s.c. daily. G-CSF CHOP consists of cyclophosphamide, doxorubicin, vincristine and prednisone.

Eligibility

Inclusion criteria

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. Age >= 65 years; 5. Informed consent.

Exclusion criteria

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, i.e. serum creatinine or serum bilirubin > 1.5x the upper normal value, except when related to lymphoma organ infiltration; 6. HIV positivity.

Design outcomes

Primary

Measure	Time frame
CR rate.	—

Secondary

Measure	Time frame
1. Relapse rate; 2. Event-free survival; 3. Overall survival; 4. Treatment-related morbidity; 5. Therapy-related hospital admissions; 6. Mortality.	—

Contacts

Public ContactP. Sonneveld

P.O. Box 2040

p.sonneveld@erasmusmc.nl+31 (0)10 7033589

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)