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: 9.1 Level: LLT Classification code 10028130 MedDRA version: 9.1 Level: LLT Classification code 10017981
Conditions
Interventions
Product Name: CR3294.HCl
Product Code: CR3294.HCl
Pharmaceutical Form: Capsule, hard
CAS Number: 457939-77-4
Current Sponsor code: CR3294.HCl
Concentration unit: mg milligram(s)
Concentration type: eq
Sponsors
ROTTAPHARM S.P.A.
Eligibility
Sex/Gender
All
Inclusion criteria
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 50 ml/min (calculated); total serum bilirubin =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
Italy
Outcome results
None listed