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

• Conditions: assessment of the effect of CR3294 in preventing oral mucositis induced by conditioning myeloablative regimens in patients undergoing high-dose chemotherapy (HDCT) and autologous HSCT.; MedDRA version: 9.1Level: LLTClassification code 10028130; MedDRA version: 9.1Level: LLTClassification code 10017981

• Registration Number: EUCTR2010-020660-37-IT
• Lead Sponsor: ROTTAPHARM S.P.A.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-07-22
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

- 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

Exclusion Criteria

- 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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To assess the effect of CR3294 in preventing oral mucositis induced by conditioning myeloablative regimens.;Primary end point(s): Incidence of oral mucositis grade 3 and 4 according to Common Terminology Criteria for Adverse Events (CTCAE) v 3.0;Secondary Objective: - To assess the effect of CR3294 in reducing the severity and duration of oral mucositis induced by conditioning myeloablative regimens; - To assess the effect of CR3294 in preventing rate and severity of gut MBI (intestinal mucositis) induced by conditioning myeloablative regimens; - To assess the effect of CR3294 on other outcomes of conditioning myeloablative regimens and the following HSCT; - To assess the safety of CR3294 in patients undergoing conditioning myeloablative regimens and HSCT; - To evaluate the plasma concentration of CR3294 and its metabolite(s) and the urine concentration of CR3294 in this patient population; - To identify mucositis biomarkers correlating with the efficacy of treatment.