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

Alizyme63 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Enrollment

Conditions

Mucositis

Interventions

ATL-104DRUG

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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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

Locations (8)

Research Site

Birmingham, United Kingdom

Research Site

Cambridge, United Kingdom

Research Site

Cardiff, United Kingdom

Research Site

Leeds, United Kingdom

Outcomes

Primary Outcomes

Safety: Adverse events

Time frame: 28 days post-treatment

Efficacy: Oral mucositis scale

Time frame: 28 days post-treatment

Secondary Outcomes

Safety: Laboratory monitoring, vital signs, ECG

Time frame: 28 days post-treatment

Pharmacokinetics of ATL-104

Data from ClinicalTrials.gov

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