NCT07202052 Role of Antibiotic Therapy or Immunoglobulin On iNfections in hAematoLogy Platform Trial (RATIONAL-PT)
| NCT ID | NCT07202052 |
| Status | Recruiting |
| Phase | Phase 2, Phase 3 |
| Sponsor | Monash University |
| Condition | Myeloma |
| Study Type | INTERVENTIONAL |
| Enrollment | 900 participants |
| Start Date | 2025-05-06 |
| Primary Completion | 2027-03-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 900 participants in total. It began in 2025-05-06 with a primary completion date of 2027-03-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
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) 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.
Contact & Investigator
Zoe McQuilten, Professor
PRINCIPAL INVESTIGATOR
Monash University
Frequently Asked Questions
Who can join the NCT07202052 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Myeloma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07202052 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT07202052 currently recruiting?
Yes, NCT07202052 is actively recruiting participants. Visit ClinicalTrials.gov or contact Monash University to inquire about joining.
Where is the NCT07202052 trial being conducted?
This trial is being conducted at Adelaide, Australia, Melbourne, Australia, Melbourne, Australia.
Who is sponsoring the NCT07202052 clinical trial?
NCT07202052 is sponsored by Monash University. The principal investigator is Zoe McQuilten, Professor at Monash University. The trial plans to enroll 900 participants.