Recruiting
Phase 2 / Phase 3
Role of Antibiotic Therapy or Immunoglobulin On iNfections in hAematoLogy Platform Trial (RATIONAL-PT)
About this study
This is an adaptive platform study to find out how safe and effective different strategies are in comparison to each other, for preventing infection in patients with blood cancers. It is a comparison between Immunoglobulin and antibiotics use.
- Condition
- Myeloma, Non-Hodgkin's Lymphoma, Leukemia
- Tested
- Intravenous immunoglobulin, Trimethoprim / Sulfamethoxazole, Amoxicillin clavulanic acid, Intravenous immunoglobulin (IV...
- Sponsor
- Monash University
Who can join
- Age
- 18 years and older
- Sex
- All sexes
- Healthy volunteers
- Not accepted
Inclusion 7
- Minimum age: 18 years
- Study condition: Myeloma, Non-Hodgkin's Lymphoma, Leukemia
- Aged greater than or equal to 18 years of age
- Diagnosis of haematological malignancy, including (CLL) chronic lymphocytic leukemia, (MM) multiple myeloma or (NHL) non-Hodgkin's lymphoma.
- Eligible to receive or currently receiving Ig (IV or subcutaneous - SCIg) replacement for history of recurrent or severe infection(s) and IgG less than the lower limit of the reference range (excluding paraprotein) OR IgG\<4g/L (excluding paraprotein)
- Life expectancy \> 12 months
- Able to give informed consent
Exclusion 1
- \. Treating team deems enrolment in the study is not in the best interests of the patient.
Where
3 sites, 3 recruiting
Royal Adelaide Hospital
Adelaide, South Australia, Australia
Austin Hospital
Melbourne, Victoria, Australia
Northern Health
Melbourne, Victoria, Australia
Potential match only. Final eligibility is determined by the study team.