ALLG NHL07
ACTRN12613000909729
Treatment
Phase 3
Commercial sector/Industry,Pharmacia Pty Ltd now Pfizer Australia
A/Prof Max Wolf
This study evaluated the effectiveness of high dose Cyclophosphamide, Epirubicin, Vincristine and Prednisolone ifosfamide (CEOP) chemotherapy regime with Filgrastim, and standard dose CEOP chemotherapy regime in patients with non-Hodgkin's lymphoma (NHL). Who was it for? Patients were eligible to join this study if they were aged 16 years or more, had been diagnosed with NHL (Histological types: Follicular large cell (Group D), Diffuse mixed small cleaved and large cell (Group F), Diffuse large .... Read more
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 infi .... Read more
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 pro .... Read more
No
Sample Size 250
Min. age 16 Years
Max. age 0 No limit
Sex Both males and females
Condition category Non-Hodgkin Lymphoma
Condition code Cancer
Intervention code Treatment: Drugs
HIGH DOSE CEOP. One cycle consisted of: Cyclophosphamide 1500mg/m2 intravenously Day 1 Epirubicin 150mg/m2 intravenously Day 1 Vincristine (max 2.0 mg) 1.4 mg/m2 intravenouslyDay 1 Prednisolone 100mg/D orally Days 1-5 Filgrastim 5 microg/kg/D subcutaneously Days 2 until absolute neutrophil count (ANC) >10X 109/L (max. 14 days) The above regimen was repeated every 3 weeks for 6 to 8 cycles depending on when the patient achieved complete response (CR). Patients were then assessed 3 months followin .... Read more
Control group Active
STANDARD DOSE CEOP. One cycle consisted of Cyclophosphamide 750mg/m2 intravenously Day 1 Epirubicin 75mg/m2 intravenously Day 1 Vincristine (max 2.0 mg) 1.4 mg/m2 intravenously Day 1 Prednisolone 100mg/D orally Days 1-5 The above regimen was repeated every 3 weeks for 6 to 8 cycles depending on when the patient achieved complete response (CR). Patients were then assessed 3 months following completion of treatment and then at the clinician's discretion or upon request from the Trial Centre. All p .... Read more
Outcome: 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 usin .... Read more
yes
De-identified IPD data for all data collected during the trial
Data available 3 months following publication, for an indefinite period
Data are potentially available to: • Researchers from not-for-profit organisations • Commercial organisations • Other Based in: • Any location Further information: All data requests will be considered by the primary sponsor on a case by case basis. Requests must include a methodologically sound proposal. Specific conditions of use may apply and will be specified in a data sharing agreement (or similar) that the requester must agree to before access is granted.
Any type of analysis Proposals will be assessed on a case-by-case basis