Role of Antibiotic Therapy or Immunoglobulin On iNfections in hAematoLogy Platform Trial (RATIONAL-PT)
Recruiting
Phase 2Phase 3Interventional Study
MyelomaNon-Hodgkin's LymphomaLeukemia
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 and older
Sex
Any
Trial phase
Phase 2/3
Study type
Interventional
Purpose
Treatment
Participants needed
900 (estimated)
Sponsor
Monash University · Other
Who this trial is looking for
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
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.
Trial Locations
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Status
Eligibility Criteria
Inclusion Criteria:
1. Aged greater than or equal to 18 years of age
2. Diagnosis of haematological malignancy, including (CLL) chronic lymphocytic leukemia, (MM) multiple myeloma or (NHL) non-Hodgkin's lymphoma.
3. Eligible to receive or currently receiving Ig (IV or subcutaneous - SCIg) replaceme…
Inclusion Criteria:
1. Aged greater than or equal to 18 years of age
2. Diagnosis of haematological malignancy, including (CLL) chronic lymphocytic leukemia, (MM) multiple myeloma or (NHL) non-Hodgkin's lymphoma.
3. 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)
4. Life expectancy \> 12 months
5. Able to give informed consent
Exclusion Criteria:
1\. Treating team deems enrolment in the study is not in the best interests of the patient.
Contacts
No contact information available.
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