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 (NHL07)

Funding

Commercial sector/Industry,Pharmacia Pty Ltd now Pfizer Australia

Scientific enquiries

A/Prof Max Wolf

Brief Summary

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 .... 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 cell (Group G) or Large cell immunoblastic (Group H)), and had not received previous chemotherapy or radiation therapy for NHL. Trial details Participants in this trial were randomly (by chance) allocated to one of two treatment groups. Participants in group 1 received a high dose CEOP chemotherapy regime with Filgrastim which involved 1500mg/m2 of Cyclophosphamide intravenously on day 1, 150 mg/m2 of Epirubicin intravenously on day 1, 1.4 mg/m2 (maximum of 2.0mg) of Vincristine intravenously on day 1, 100 mg/day of Prednisolone orally from days 1 to 5, and 5 micrograms/kg/day of Filgrastim subcutaneously from day 2 until Absolute Neutrophil Count was greater than 10 x 109/L for a maximum of 14 days. This treatment regime was repeated every 3 weeks and was administered to participants 6 times. Participants in group 2 received standard dose CEOP which included 750mg/m2 of Cyclophosphamide intravenously on day 1, 75mg/m2 of Epirubicin intravenously on day 1, 1.4mg/m2 (maximum of 2.0 mg) of Vincristine intravenously on day 1, and 100 mg/day of Prednisolone orally from days 1 to 5. Similarly to group 1, this treatment regime was repeated every 3 weeks and was administered to participants 6 times. All participants were assessed prior to treatment, after 3 courses of the treatment, at completion of the 6 courses of the treatment, at 3 months post treatment, at 6 months post treatment and at 5 years post treatment to assess the effectiveness of the treatment regimes.
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Key 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 infi .... 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.
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Key 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 pro .... 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.
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