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

Australasian Leukaemia and Lymphoma Group0 个研究点目标入组 250 人开始时间: 2013年8月14日最近更新: 2023年9月4日

适应症

试验速览

暂无简介。

•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.

•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.

发起方

Australasian Leukaemia and Lymphoma Group