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

Monash University

Status and phase: Enrolling; Phase 3; Phase 2

Conditions: Non-Hodgkin's Lymphoma; Myeloma; Leukemia

Treatments: Biological: Intravenous immunoglobulin; Drug: Trimethoprim / Sulfamethoxazole; Drug: Amoxicillin clavulanic acid; Biological: Intravenous immunoglobulin (IVIG)

Study type: Interventional

Funder types: Other

Identifiers

NCT07202052

TRU-RPT-22 (Other Identifier)

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 900 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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900 participants in 3 patient groups

Start Immunoglobulin

Other group

Description:

Patients eligible to start immunoglobulin are randomly assigned to: * receive either prophylactic antibiotic * or Ig replacement.

Treatment:

Drug: Trimethoprim / Sulfamethoxazole

Biological: Intravenous immunoglobulin

Stop Immunoglobulin

Other group

Description:

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

Treatment:

Drug: Amoxicillin clavulanic acid

Drug: Trimethoprim / Sulfamethoxazole

Biological: Intravenous immunoglobulin

Dose Immunoglobulin

Other group

Description:

Patients receiving IVIg are randomly assigned to: * Continue with standard dose (0.4 g/kg) * Switch to a lower dose (0.25 g/kg)

Treatment:

Biological: Intravenous immunoglobulin (IVIG)