A randomized controlled trial evaluating the protective effect of a gonadotrophin-releasing hormone agonist on ovarian function in young women with Non-Hodgkin’s Lymphoma receiving a 14 day regimen of rituximab, cyclophosphamide, doxorubicin hydrochloride, vincristine sulfate and prednisone (R-CHOP-14).

Melbourne in vitro fertilization (IVF)0 个研究点目标入组 80 人开始时间: 2010年9月21日最近更新: 2020年1月13日

试验速览

暂无简介。

•women anticipated to receive 6 cycles of R-CHOP-14 with curative intent for Non-Hodgkin's Lymphoma (NHL)
•- resident in Australia for the duration of trial participation
•- a minimum of 12 months post-menarche and be less than or equal to 38 years at the start of treatment
•- premenopausal state, as demonstrated by greater than and equal to 3 spontaneous menstrual cycles in the last 6 months or by non-menopausal levels of FSH or oestradiol at baseline
•- ability to administer the first dose of Zoladex no later than 1 week after commencing chemotherapy
•- consent to utilizing a progesterone-only contraceptive during their chemotherapy and also barrier contraception for 8 weeks prior to each follow up blood test
•- ability to give informed consent. For patients under 18 years parental consent must be given, with patient assent where appropriate

•- known contraindication to the use of a GnRH analogue (e.g. pregnancy or hypersensitivity) or a progesterone-only contraceptive
•- anticipated requirement for pelvic irradiation as part of therapy
•- radiological evidence of ovarian involvement with NHL
•- prior cytotoxic chemotherapy for this or any other diagnosis
•- contraindication to use of a progesterone-only contraceptive pill (e.g. previous history of thromboembolic disease)

发起方

Melbourne in vitro fertilization (IVF)