Safety, Tolerability and Efficacy of ATL-104 in Oral Mucositis

Study Overview
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Brief Summary
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This purpose of this study is to investigate whether ATL-104 is safe and well tolerated, and whether it shows evidence of efficacy in mucositis in patients undergoing PBSCT

Detailed Description
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Mucositis is a serious side effect of cancer therapy and Peripheral Blood Stem Cell Transplant (PBSCT) which requires appropriate and effective management. Mucositis is a condition in which there is inflammation and ulceration of the mouth, throat and gut caused by damage to the mucosal barrier induced by chemo- and radiotherapy. Symptoms include pain, nausea, abdominal cramping, and vomiting. This study will investigate whether ATL-104, when administered as a swallowable mouthwash, is safe and well tolerated in patients undergoing PBSCT and to investigate its potential to reduce the level of severity of mucositis associated with PBSCT.

Official Title
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Randomised Double-Blind Placebo-Controlled Study of Orally Administered ATL-104 to Assess Safety, Tolerance and Effect on Oral Mucositis in Patients Following Treatment With Chemotherapy and Peripheral Blood Stem Cell Transplant (PBSCT)

Conditions
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Mucositis

Intervention / Treatment
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* Drug: ATL-104


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with haematological malignancies undergoing chemotherapy in association with PBSCT Exclusion Criteria: Clinically significant conditions that would exclude the patient receiving chemotherapy in association with PBSCT Visible oral disease Significantly reduced platelet and neutrophil count

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>ATL-104 50mg | Drug: ATL-104<br>* Daily does of ATL-104 (50,100 or 150mg) or placebo for 3 days prior to the start of chemotherapy and peripheral blood stem cell transplantation. Following stem cell transplantation patients received 3 further daily doses of ATL-104 (50, 100 or 150mg) or placebo.<br>|
| Experimental: 2<br>ATL-104 100mg | Drug: ATL-104<br>* Daily does of ATL-104 (50,100 or 150mg) or placebo for 3 days prior to the start of chemotherapy and peripheral blood stem cell transplantation. Following stem cell transplantation patients received 3 further daily doses of ATL-104 (50, 100 or 150mg) or placebo.<br>|
| Experimental: 3<br>ATL-104 150mg | Drug: ATL-104<br>* Daily does of ATL-104 (50,100 or 150mg) or placebo for 3 days prior to the start of chemotherapy and peripheral blood stem cell transplantation. Following stem cell transplantation patients received 3 further daily doses of ATL-104 (50, 100 or 150mg) or placebo.<br>|
| Placebo Comparator: 4<br>Placebo | Drug: ATL-104<br>* Daily does of ATL-104 (50,100 or 150mg) or placebo for 3 days prior to the start of chemotherapy and peripheral blood stem cell transplantation. Following stem cell transplantation patients received 3 further daily doses of ATL-104 (50, 100 or 150mg) or placebo.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety: Adverse events |  | 28 days post-treatment | 
| Efficacy: Oral mucositis scale |  | 28 days post-treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety: Laboratory monitoring, vital signs, ECG |  | 28 days post-treatment | 
| Pharmacokinetics of ATL-104 |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Mucositis, Peripheral blood stem cell transplant