Overview Study details Eligibility Things to know Research Study plan

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Overview Study details Eligibility Things to know Research Study plan

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Role of Antibiotic Therapy or Immunoglobulin On iNfections in hAematoLogy Dosing Immunoglobulin (Dose Ig)

PHASE2PHASE3RECRUITING

This study is being conducted to find out how safe and effective different strategies of infection prevention are in comparison to each other, for preventing infection in patients with blood cancers. The best way to find out this information is to directly compare the effect of different treatment strategies in patients with blood cancers. We want to know how these different treatments impact on your health and your use of healthcare services.

This research project uses an Adaptive Platform Design. This design allows the researchers to compare multiple infection prevention strategies within the same trial at the same time (rather than running separate trials), to analyse results as the trial occurs and to add new research questions during the course of the trial. The treatments that you may receive as part of the study will be determined by which domain(s) of the platform you participate in.

By combining data collected within each domain as part of the platform, the researchers can investigate and compare treatment strategies and infection outcomes across a broader range of participants.

Study details:

This is a domain within the RATIONAL Platform Trial to test the effectiveness and safety of prophylactic antibiotics as an alternative Ig replacement in patients who have not yet commenced Ig replacement therapy.

Eligibility criteria

Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.

Inclusion criteria

Patients must be receiving IVIg replacement at standard dose for prevention of bacterial infections due to hypogammaglobulinaemia for at least 6 consecutive months.
Patient is not eligible for trial of Ig cessation in the opinion of the treating clinician and local investigator.

Exclusion criteria

Prior or planned allogeneic haematopoietic stem cell transplantation.
Major infection (Grade 3 or higher) in preceding 3 months, and or current active infection requiring systemic antimicrobial treatment.
Previous splenectomy.
Known history of bronchiectasis.
Previous participation in this domain.
Treating team deems enrolment in the domain is not in the best interest of the patient.

Eligibility

Age eligible for study : NA

Healthy volunteers accepted : No

Gender eligible for study: ALL

Things to know

Study dates

Study start:

Primary completion:

Study completion finish:

Study type

TREATMENT

Phase

PHASE2PHASE3

Study ID

NCT07202065

Intervention or treatment

BIOLOGICAL: Immune Globulin Intravenous

Conditions

Myeloma
Non Hodgkin's Lymphoma
Leukemia

Condition: Myeloma, Non Hodgkin's Lymphoma and more
BIOLOGICAL: Immune Globulin Intravenous
Adelaide, South Australia, Australia and more
Sponsor: Monash University

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You may be eligible to participate in this trial based on your search. Check eligibility by answering some questions.

Are you running this trial?

If you're a clinic or sponsor, you can claim this study

Research sites nearby

Closest Location:

Royal Adelaide Hospital

Select from list below to view details:

Royal Adelaide Hospital
Adelaide, South Australia, Australia
Austin Hospital
Melbourne, Victoria, Australia
Northern Health
Melbourne, Victoria, Australia

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Who is running the clinical trial?

Monash University

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Participant Group/Arm	Intervention/Treatment
OTHER: Arm A: Low dose (IgRT) immunoglobulin replacement therapy Participants will be treated with intravenous immunoglobulin monthly (every 4 weeks ± 1 week) at a dose of 0.25g/kg. No dose adjustment for trough serum (IgG) immunoglobulin G levels is required.	Biological: Immune Globulin Intravenous
OTHER: Arm B: Usual dose Participants will be treated with intravenous immunoglobulin monthly (every 4 weeks ± 1 week) at a dose of 0.4g/kg, modified to achieve an IgG trough level of at least lower limit of age-specific serum (IgG) immunoglobulin G reference range.	Biological: Immune Globulin Intravenous

What is the study measuring?

Primary Outcome

Measure	Description	Time Frame
Event-free survival (EFS).	Defined as time from randomisation (or, in domains with a single treatment arm, time from registration) until occurrence of a Grade 3 or higher infection (as defined by CTCAE Version 5), or death from any cause.	12 months following randomisation (or, in domains with a single treatment arm, time from registration)

Secondary Outcome

Measure	Description	Time Frame
Occurrence of at least one Grade 3 or higher infection(s) from randomisation to 12 months.	Occurrence of at least one Grade 3 or higher infection(s) from randomisation to 12 months.	12 months following randomisation (or, in domains with a single treatment arm, time from registration).
Occurrence of one or more clinically documented infections (symptoms/signs of infection requiring antimicrobial treatment) from randomisation to 12 months.	Occurrence of one or more clinically documented infections (symptoms/signs of infection requiring antimicrobial treatment) from randomisation to 12 months.	12 months following randomisation (or, in domains with a single treatment arm, time from registration).
Number of clinically documented infections (symptoms/signs of infection requiring antimicrobial treatment) from randomisation to 12 months.	Number of clinically documented infections (symptoms/signs of infection requiring antimicrobial treatment) from randomisation to 12 months.	12 months following randomisation (or, in domains with a single treatment arm, time from registration).
Occurrence of one or more microbiologically documented infections from randomisation to 12 months.	Occurrence of one or more microbiologically documented infections from randomisation to 12 months.	12 months following randomisation (or, in domains with a single treatment arm, time from registration).
Number of microbiologically documented infections from randomisation to 12 months.	Number of microbiologically documented infections from randomisation to 12 months.	12 months following randomisation (or, in domains with a single treatment arm, time from registration).
All-cause mortality at 12 months.	All-cause mortality at 12 months.	12 months following randomisation (or, in domains with a single treatment arm, time from registration).
Infection-related mortality at 12 months.	Infection-related mortality at 12 months.	12 months following randomisation (or, in domains with a single treatment arm, time from registration).
Time free from hospitalisation with antimicrobial administration with therapeutic intent from randomisation to 12 months.	Time free from hospitalisation with antimicrobial administration with therapeutic intent from randomisation to 12 months.	12 months following randomisation (or, in domains with a single treatment arm, time from registration).
Occurrence of one or more treatment-related adverse events.	Occurrence of one or more treatment-related adverse events.	12 months following randomisation (or, in domains with a single treatment arm, time from registration).
Number of treatment-related adverse events.	Number of treatment-related adverse events.	12 months following randomisation (or, in domains with a single treatment arm, time from registration).
Isolation of fluoroquinolone resistant organisms, co-trimoxazole resistant organisms, extended spectrum beta lactamases or multidrug resistant organisms from randomisation to 12 months.	Isolation of fluoroquinolone resistant organisms, co-trimoxazole resistant organisms, extended spectrum beta lactamases or multidrug resistant organisms from randomisation to 12 months.	12 months following randomisation (or, in domains with a single treatment arm, time from registration).
Number of infections with fluoroquinolone resistant organisms, co-trimoxazole resistant organisms, extended spectrum beta lactamases or multidrug resistant organisms isolated from randomisation to 12 months.	Number of infections with fluoroquinolone resistant organisms, co-trimoxazole resistant organisms, extended spectrum beta lactamases or multidrug resistant organisms isolated from randomisation to 12 months.	12 months following randomisation (or, in domains with a single treatment arm, time from registration).
Quality of Life (QoL) measured at randomisation then 3, 6, 9 and 12 months, using different questionnaire.	Quality of Life (QoL) measured at randomisation then 3, 6, 9 and 12 months, using different questionnaire.	Randomisation, Month 3, Month 6, Month 9 and Month 12
Costs associated with allocated treatment arm and infections during study.	Costs of infections and trial interventions will be estimated based on trial treatment and adverse event data within the hospital medical record, as well as linked data obtained from the Medicare Benefits Scheme (MBS), Pharmaceutical Benefits Scheme (PBS) and Australian Immunisation Register (AIR). Data from the quality of life questionnaires will be used to calculate quality adjusted life years.	12 months following randomisation (or, in domains with a single treatment arm, time from registration).

Are you running this trial?If you're a clinic or sponsor, you can claim this study.

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References

Clinical Trials Gov: Role of Antibiotic Therapy or Immunoglobulin On iNfections in hAematoLogy Dosing Immunoglobulin (Dose Ig)

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