ClinTrial Refer

Trial Acronym
RATIONALISE

Registration Number
ACTRN12622000359730

Scientific Title
A randomised controlled trial of continuing immunoglobulin therapy, or stopping with or without prophylactic antibiotics, on infection rate in patients with acquired hypogammaglobulinemia secondary to haematological malignancies.

The aim of the study is to find out if oral antibiotics can be used instead of immunoglobulin (Ig) for preventing infections in patients with blood cancers, and if the oral antibiotics should be taken every day or only once symptoms of infection occur.

Who is it for?
You may be eligible to join this study if you are aged 18 years or above, have an acquired hypogammaglobulinaemia secondary to a haematological malignancy, and have received Ig treatment for over 6 months.

Study details
Participants will be randomised (allocated by chance) to one of three treatment groups, as follows:
- stop Ig, and be given oral antiobiotics (such as co-trimoxazole (Trimethoprim-sulfamethoxazole) 160mg/800mg) to take every day
- stop Ig, and be given oral antibiotics (amoxycillin/clavulanic acid 1750-2000mg/250mg and ciprofloxacin 750 mg) to keep at home, and used only if infection symptoms occur
- continue receiving their usual Ig treatment
The duration of each treatment is for 12 months.

Over the course of the 13 month study participation period, participants will be asked to return to the hospital for a study visit every 3 months, with monthly telephone visits to check-in on your progress between each in-person visit. Participants will also be asked to complete a study diary, recording treatment compliance and signs/symptoms of infection experienced throughout the study period.

Types of assessments and data collected will include: medical history, demographics, physical examination, blood tests, stool sample, quality of life questionnaires, information about your general health, hospitalisations, medications and procedures. In order to assess and compare the cost-effectiveness of the treatment groups, the study team will also request authorisation from participants to access their Medicare Benefits Schedule (MBS), Pharmaceutical Benefits Scheme (PBS), and Australian Immunisation Register (AIR) data.

It is hoped that this study will confirm if Ig used to prevent infections can be safely stopped, and if oral antibiotics should be given as an alternative, thus improving treatment for people with blood cancer.

1. Aged greater than or equal to 18 years of age
2. Diagnosis of chronic lymphocytic leukaemia (CLL), multiple myeloma (MM) or non-Hodgkin lymphoma (NHL). 
3. Patients must be receiving Ig (IV or subcutaneous - SCIg) replacement for prevention of bacterial infections due to hypogammaglobulinaemia for longer than 6 consecutive months. 
4. Patient is eligible for trial of Ig cessation in the opinion of the treating clinician and local investigator. 
5. Life expectancy greater than 12 months. 
6. Able to give informed consent, and willing and able to comply with each of the treatment arms.

1. Prior or planned allogeneic haematopoietic stem cell transplantation. 
2. Major infection (Grade 3 or higher) in preceding 3 months, and/or current active infection requiring antimicrobial treatment. 
3. Already receiving daily antibiotic prophylaxis for the purpose of preventing bacterial infection (Note: patients may receive antiviral, antifungal and PJP prophylaxis). 
4. Intolerance of all trial antibiotic options in either arm A or arm B.
5. Communication, compliance or logistical issues that are likely to limit patient’s ability to take prophylactic or emergency antibiotics, or to obtain urgent medical attention for symptoms of infection.
6. Pregnant or breastfeeding.
7. Severe renal impairment (estimated or measured creatinine clearance of less than 30 mL/min).
8. Previous splenectomy.
9. Previous participation in this trial.
10. Treating team deems enrolment in the study is not in the best interests of the patient.

Trial Location Name

Address

Status

Concord Repatriation General Hospital (Haematology)

Hospital Rd, Concord NSW 2139, Australia

Recruiting

Primary Contact : Jennifer Harman, SLHD-ConcordHaematologyClinicalResearch@health.nsw.gov.au , 02 9767 6348

Monash University

Website URL

Link Name

Link URL

ANZCTR

http://www.anzctr.org.au/TrialSearch.aspx?searchTxt=ACTRN12622000359730

Secondary IDs
TRU-RLS-21

Study Type
Interventional

Intervention Code
Treatment - Drugs

Phase
Phase 2/Phase 3

Minimum Age
18

Maximum Age
100

Date Registered
06/08/2024

Date Closed
N/A

Status
Pending

Enrolment Type
By Specialist and/or Surgeon Referral

Mutation Status and Biomarker
Any or not stated

Is it a Cohort Trial?
No

Is this a Tele-Trial?
No

Can healthy volunteer participate?
No

Discipline

Health Condition

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