Status:
COMPLETED
Safety, Tolerability and Efficacy of ATL-104 in Oral Mucositis
Lead Sponsor:
Alizyme
Conditions:
Mucositis
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
Brief Summary
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
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 i...
Eligibility Criteria
Inclusion
- Patients with haematological malignancies undergoing chemotherapy in association with PBSCT
Exclusion
- Clinically significant conditions that would exclude the patient receiving chemotherapy in association with PBSCT
- Visible oral disease
- Significantly reduced platelet and neutrophil count
Key Trial Info
Start Date :
July 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2005
Estimated Enrollment :
63 Patients enrolled
Trial Details
Trial ID
NCT00163280
Start Date
July 1 2004
End Date
December 1 2005
Last Update
February 12 2008
Active Locations (8)
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1
Research Site
Birmingham, United Kingdom
2
Research Site
Cambridge, United Kingdom
3
Research Site
Cardiff, United Kingdom
4
Research Site
Leeds, United Kingdom