Phase III randomised trial of high dose Cyclophosphamide, Epirubicin, Vincristine and Prednisolone (CEOP) chemotherapy regimen & Filgrastim versus standard dose CEOP chemotherapy regimen in patients with non-Hodgkin’s lymphoma

Phase 3

Completed

• Conditions: on-Hodgkin Lymphoma; Non-Hodgkin Lymphoma; Cancer - Lymphoma (non Hodgkin's lymphoma) - High grade lymphoma

• Registration Number: ACTRN12613000909729
• Lead Sponsor: Australasian Leukaemia and Lymphoma Group

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2013-08-14
• Study Completion: 2016-09-27
• Last Update Posted: 4 September 2023

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 250

Inclusion Criteria

1. Patients with non-Hodgkin’s lymphoma of the following histological types:
-Follicular large cell (Group D).
-Diffuse mixed small cleaved and large cell (Group F).
-Diffuse large cell (Group G).
-Large cell immunoblastic (Group H).
2. Ann Arbor Stage I with bulky disease (tumour mass >=10cm in largest diameter), II, III or IV.
3. Age >=16 years.
4. Measurable or evaluable disease.
5. Absolute neutrophil count >1.5 x 109/L, platelet count >75 x 109/L, unless cytopenia is due to bone marrow infiltration.
6. Adequate renal function (creatinine less than twice upper limit of normal); adequate hepatic function (bilirubin less than twice upper limit of normal).
7. ECOG performance status 0-3.
8. Accessible for treatment and follow-up.
9. Informed consent in accordance with institutional ethical guidelines.

Exclusion Criteria

1 Previous chemotherapy or radiation therapy for lymphoma. Use of corticosteroids alone does not make patient ineligible.
2 A known contra-indication to any of the trial drugs.
3 Past or current malignancies at other sites, except adequately treated squamous or basal cell carcinoma of the skin or carcinoma in situ of the cervix.
4 Congestive cardiac failure or symptomatic coronary artery disease. Patients with other pre-existing cardiac disease may be entered at the investigator’s discretion provided cardiac investigations are satisfactory (ECG and LVEF).
5 Patients who are pregnant or breast feeding or women of child bearing age who are not taking adequate contraceptive precautions.
6 Patients with primary CNS lymphoma.
7 Known HIV antibody positive.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The primary endpoint was overall survival (OS) 5 years after randomisation, analysed by intention-to-treat analysis including all eligible randomised patients. The reverse Kaplan-Meier method was used to calculate the estimated median duration of follow-up. OS was measured from the date of randomisation, to the date of death (no matter what the cause). Survival proportions were estimated using the Kaplan-Meier product-limit method. Hazard ratios (HR) were estimated using the Cox proportional hazards model, stratified by the International Prognostic Index (IPI), including a stratum for patients with unknown IPI.[5 years post treatment]