Phase II randomised, double-blind, placebo controlled, multicentre study of orally administered ATL-104 (by swallowable mouthwash) to assess safety and tolerance and effect on oral mucositis in patients with haematological malignancies after treatment with chemotherapy associated with peripheral blood stem cell transplant (PBSCT)

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Dr Robert Marcus
Scientific

Addenbrooke's Hospital
Cambridge
CB2 2QQ
United Kingdom

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Scientific title
Study objectives	Is ATL-104 safe and well tolerated and does it show evidence of efficacy in mucositis in patients undergoing PBSCT?
Ethics approval(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	Mucositis in the mouth and gastrointestinal tract
Intervention	ATL-104 (50 mg, 100 mg or 150 mg) or placebo, given as a swallowable mouth wash, as three single daily doses prior to commencement of PBSCT and three single daily doses following PBSCT.
Intervention type	Drug
Phase	Phase II
Drug / device / biological / vaccine name(s)	ALT-104
Primary outcome measure(s)	1. Safety: adverse events 2. Efficacy: oral mucositis scale
Key secondary outcome measure(s)	1. Safety parameters including laboratory monitoring, vital signs, electrocardiogram (ECG) 2. Pharmacokinetics of ATL-104
Completion date	31/12/2005

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	All
Target sample size at registration	60
Key inclusion criteria	1. Aged 18 - 65 years 2. With haematological malignancies 3. Undergoing chemotherapy in association with PBSCT
Key exclusion criteria	1. Clinically significant conditions that would exclude the patient receiving chemotherapy in association with PBSCT 2. Visible oral disease 3. Significantly reduced platelet or neutrophil count
Date of first enrolment	01/07/2004
Date of final enrolment	31/12/2005

Addenbrooke's Hospital

Cambridge
CB2 2QQ
United Kingdom

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/04/2009		Yes	No