Safety and efficacy of human lactoferrin hLF1-11 for the treatment of infectious complications among haematopoietic stem cell transplant recipients.

1. Admitted for an autologous HSCT after myeloablative therapy with high-dose melfalan;

2. Managed with a 4-lumen central venous catheter;

3. 18 to 45 years of age;

4. BMI < 30;

5. Able and willing to participate;

6. Has provided written informed consent;

7. There is no medical reason for exclusion;

8. Has adequate renal function (creatinine <110 µmol/L (man); <90 µmol/L (woman));

9. Has adequate liver function (ASAT <40 U; ALAT <45 U; bilirubin <10µmol/L);

10. Has no known allergy to lactoferrin;

11. Has no history of hepatitis and is not HIV seropositive;

12. If a woman, functionally post-menopausal.

1. A history of, or presence of, significant respiratory, cardiovascular, neurological, haematological, endocrine, gastro intestinal, hepatic or renal disease or other condition known to interfere with the absorption, distribution, metabolism or excretion of drugs (as judged clinically relevant by the investigator);

2. Participation in a study with a new chemical entity or new molecular entity 3 months before or participation in a study with a registered drug less than 5 times of the half life of the registered drug before entering the study;

3. A clinically relevant history of intolerance or hypersensitivity to the study drug, or its additives and excipients in the intravenous formulation;

4. Evidence of having serum hepatitis or carrying the hepatitis B surface antigen or Hepatitis C antibodies or being HIV positive;

5. Subjects, who in the opinion of the investigator should not, for reasons of safety, participate in the study.