A Multicenter, randomized, double blind, double dummy, placebo controlled, parallel group, phase II study on the prevention of mucositis by CR3294, orally administered for 5 days in haematological patients receiving high dose chemotherapy followed by autologous stem cell transplantation. - ND

ROTTAPHARM S.P.A.0 个研究点开始时间: 2010年7月22日最近更新: 2012年3月19日

试验速览

暂无简介。

•- Patients with haematological malignancies eligible for conditioning myeloablative high dose chemotherapy that require autologous HSCT; - Age = 18 years; - Conditioning regimens are limited to BEAM or high-dose Melphalan (200 mg/m2) as single agent; - ECOG (Eastern Cooperative Oncology Group) performance status (PS) 0-2; - Eligibility for autologous HSCT according to institutional requirements; - Baseline creatinine level < 2 mg/dl or creatinine clearance > 50 ml/min (calculated); total serum bilirubin < 2 mg/dl; AST, ALT and AP < 2x Upper Limit of Normal-ULN (except patients with active viral hepatitis B or C); - Female patients of child-bearing potential must agree on using a contraceptive method (oral contraceptive, intra uterine device-IUD, transdermal contraceptive patch) and must have a negative pregnancy urine test at screening; - Signed informed consent.
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range

•- Patients who have been treated with radiotherapy within 1 month before the screening visit; - Unhealed mucositis from any previous treatment; - Chronic inflammatory bowel disease; - Active bacterial, fungal or viral infection; - Pregnant or lactating women; - Male of child-bearing potential who do not use appropriate contraception; - Sero-positivity for HIV; - Participation in any other clinical trial within 30 days of randomization or intention to participate in another clinical trial during participation in this study.

发起方