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Role of Antibiotic Therapy or Immunoglobulin On iNfections in hAematoLogy Platform Trial (RATIONAL-PT)

NCT ID: NCT07202052

Last Updated: 2025-10-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE2/PHASE3

Total Enrollment

900 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-05-06

Study Completion Date

2027-03-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Myeloma Non-Hodgkin's Lymphoma Leukemia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Up to 900 participants will be recruited to the RATIONAL-PT, including up to 300 per domain. The aim of the platform is to determine optimal supportive care interventions for patients with haematological malignancies. The primary outcome for the platform is 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. Data from each domain will contribute to the primary analysis.
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

An independent outcome adjudication committee will meet to review and adjudicate infection outcome data. These committee members will be blinded to treatment allocation.

Study Groups

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Start Immunoglobulin

Patients eligible to start immunoglobulin are randomly assigned to:

* receive either prophylactic antibiotic
* or Ig replacement.

Group Type OTHER

Intravenous immunoglobulin

Intervention Type BIOLOGICAL

(IVIg) intravenous immunoglobulin every 4 weeks ± 1 week at a dose of 0.4g/kg, modified to achieve an (IgG) immunoglobulin G trough level of at least lower limit of age-specific serum IgG reference range; or SCIg, weekly, may be used in patients who meet local criteria for home-based self-administration in centres with established SCIg programs. Dosing is usually given at 100mg/kg/week, modified to achieve an IgG steady state level of at least the lower limit of the serum reference range. A loading IVIg dose may be given in the first month if required.

Trimethoprim / Sulfamethoxazole

Intervention Type DRUG

Once daily trimethoprim-sulfamethoxazole (co-trimoxazole) 160mg/800mg. Doxycycline 100mg daily as an alternative for patients with hypersensitivity to co-trimoxazole.

Stop Immunoglobulin

Patients eligible to stop immunoglobulin are randomly assigned to:

* Stop Ig and take daily antibiotics
* Stop Ig and take antibiotics only when infections occur
* Continue Ig therapy

Group Type OTHER

Intravenous immunoglobulin

Intervention Type BIOLOGICAL

(IVIg) intravenous immunoglobulin every 4 weeks ± 1 week at a dose of 0.4g/kg, modified to achieve an (IgG) immunoglobulin G trough level of at least lower limit of age-specific serum IgG reference range; or SCIg, weekly, may be used in patients who meet local criteria for home-based self-administration in centres with established SCIg programs. Dosing is usually given at 100mg/kg/week, modified to achieve an IgG steady state level of at least the lower limit of the serum reference range. A loading IVIg dose may be given in the first month if required.

Trimethoprim / Sulfamethoxazole

Intervention Type DRUG

Once daily trimethoprim-sulfamethoxazole (co-trimoxazole) 160mg/800mg. Doxycycline 100mg daily as an alternative for patients with hypersensitivity to co-trimoxazole.

Amoxicillin clavulanic acid

Intervention Type DRUG

Patients will be provided with amoxycillin/clavulanic acid 1750-2000mg/250mg and ciprofloxacin 750 mg to keep at home for initial use if symptoms of infection develop, with immediate review by their treating clinical team, or nearest emergency department or medical practitioner with phone contact to treating team if most practical. Clindamycin 600 mg is permitted as an alternative to amoxycillin/clavulanic acid for patients with hypersensitivity to penicillin. Ciprofloxacin is omitted for participants with hypersensitivity.

Dose Immunoglobulin

Patients receiving IVIg are randomly assigned to:

* Continue with standard dose (0.4 g/kg)
* Switch to a lower dose (0.25 g/kg)

Group Type OTHER

Intravenous immunoglobulin (IVIG)

Intervention Type BIOLOGICAL

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 levels is required.

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 reference range.

Interventions

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Intravenous immunoglobulin

(IVIg) intravenous immunoglobulin every 4 weeks ± 1 week at a dose of 0.4g/kg, modified to achieve an (IgG) immunoglobulin G trough level of at least lower limit of age-specific serum IgG reference range; or SCIg, weekly, may be used in patients who meet local criteria for home-based self-administration in centres with established SCIg programs. Dosing is usually given at 100mg/kg/week, modified to achieve an IgG steady state level of at least the lower limit of the serum reference range. A loading IVIg dose may be given in the first month if required.

Intervention Type BIOLOGICAL

Trimethoprim / Sulfamethoxazole

Once daily trimethoprim-sulfamethoxazole (co-trimoxazole) 160mg/800mg. Doxycycline 100mg daily as an alternative for patients with hypersensitivity to co-trimoxazole.

Intervention Type DRUG

Amoxicillin clavulanic acid

Patients will be provided with amoxycillin/clavulanic acid 1750-2000mg/250mg and ciprofloxacin 750 mg to keep at home for initial use if symptoms of infection develop, with immediate review by their treating clinical team, or nearest emergency department or medical practitioner with phone contact to treating team if most practical. Clindamycin 600 mg is permitted as an alternative to amoxycillin/clavulanic acid for patients with hypersensitivity to penicillin. Ciprofloxacin is omitted for participants with hypersensitivity.

Intervention Type DRUG

Intravenous immunoglobulin (IVIG)

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 levels is required.

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 reference range.

Intervention Type BIOLOGICAL

Other Intervention Names

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Subcutaneous immunoglobulin co-trimoxazole Ciprofloxacin

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Monash University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Zoe McQuilten, Professor

Role: PRINCIPAL_INVESTIGATOR

Monash University

Locations

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Royal Adelaide Hospital

Adelaide, South Australia, Australia

Site Status RECRUITING

Austin Hospital

Melbourne, Victoria, Australia

Site Status RECRUITING

Northern Health

Melbourne, Victoria, Australia

Site Status RECRUITING

Countries

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Australia

Facility Contacts

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Peter Bardy

Role: primary

[email protected]
+61 (8) 7074 5898

Chris Hoare

Role: backup

[email protected]
+61 08 7074 3290

Andrew Lim, Dr

Role: primary

[email protected]
+61 (03) 9070 5741

Selena Squillaciotti

Role: backup

[email protected]

Rachel Cooke, PhD

Role: primary

[email protected]
+61 (03) 8408 6000

Rhiannon Davidson

Role: backup

[email protected]

Provided Documents

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Document Type: Study Protocol

View Document

Related Links

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https://rationaltrial.com

Study Website

Other Identifiers

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TRU-RPT-22

Identifier Type: OTHER

Identifier Source: secondary_id

TRU-RPT-22

Identifier Type: -

Identifier Source: org_study_id

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