To establish the safety and tolerablity of multiple doses of hLF1-11 given once daily for 10 days.
ID
Source
Brief title
Condition
- Plasma cell neoplasms
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Safety and tolerability as measured by adverse events, laboratory
abnormalities, alterations in vital signs and the elaboration of specific
anti-hLF1-11 antibodies.
Secondary outcome
Not applicable
Background summary
hLF1-11 is an antimicrobial peptide comprising the first 11 amino acids found
in the naturally occurring lactoferrin that plays a role in the innate host
response against bacterial and fungal diseases. Animal infections models have
shown hLF1-11 to be effective in treating infections due to bacteria such as
Staphylococcus aureus and fungi such as Candida albicans and the drug has been
shown to be well tolerated and safe in volunteers. Recipients of stem cell
transplant are at risk of developing infectious complications due to invasive
fungal or bacterial disease. These patients are different from healthy
volunteers because they have received myeloablative treatment, which not only
arrests haematopoiesis resulting in neutropenia but also induces mucosal
barrier injury both of which predispose to infections. It is therefore
essential to know that hLF 1-11 is safe and well tolerated when given during
neutropenia and mucosal barrier injury before infections ensue
Study objective
To establish the safety and tolerablity of multiple doses of hLF1-11 given once
daily for 10 days.
Study design
Open label prospective study of the safety and tolerability of 5 mg hLF1-11
given once daily for 10 days to recipients of an autologous haematopoietic stem
cell transplant.
Intervention
5 mg hLF1-11 given once daily for 10 consecutive days
Study burden and risks
Extra blood will be drawn through the central venous catheter
Rumpsterweg 6
3981AK Bunnik
Nederland
Rumpsterweg 6
3981AK Bunnik
Nederland
Listed location countries
Age
Inclusion criteria
· has been admitted for an autologous HSCT after myeloablative therapy with
high-dose melphalan;
· is being managed with a 3 or 4-lumen central venous catheter;
· is at least 18 years old;
· has a BMI < 30 kg/M2;
· has no medical reason for not participating;
· has adequate renal function (creatinine < 1.5 x ULN) ;
· has adequate liver function (ASAT, ALAT < 2.5 x ULN, bilirubin < 1.5 x ULN);
· if a woman, is functionally post-menopausal;
· has not participated in a study of a new chemical molecular entity in the
previous 3 months;
· is able and willing to participate;
· has provided written informed consent.
Exclusion criteria
Not applicable
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2006-004012-52-NL |
| CCMO | NL16479.091.07 |