Role of Antibiotic Therapy or Immunoglobulin On iNfections in hAematoLogy: Immunoglobulin Stopping or Extension

Trial Title: Role of Antibiotic Therapy or Immunoglobulin On iNfections in hAematoLogy: Immunoglobulin Stopping or Extension

NCT ID: NCT05678621

Condition: Haematological Malignancy
Hypogammaglobulinemia

Conditions: Official terms:
Infections
Neoplasms
Hematologic Neoplasms
Agammaglobulinemia
Amoxicillin
Ciprofloxacin
Clavulanic Acids
Clavulanic Acid
Trimethoprim, Sulfamethoxazole Drug Combination
Trimethoprim
Sulfamethoxazole
Immunoglobulins

Conditions: Keywords:
Myeloma
Lymphoma
Leukaemia
Blood cancer
Malignancy
Infection
Antibiotic
Anti-infective agent
Immunoglobulin

Study type: Interventional

Study phase: Phase 2/Phase 3

Overall status: Recruiting

Study design:

Allocation: Randomized

Intervention model: Parallel Assignment

Primary purpose: Treatment

Masking: Single (Outcomes Assessor)

Masking description: Infectious outcomes and adverse events will be adjudicated by an independent, blinded outcome adjudication committee.

Intervention:

Intervention type: Drug
Intervention name: trimethoprim-sulfamethoxazole (co-trimoxazole)
Description: Doxycycline is an alternative for participants with hypersensitivity to co-trimoxazole.
Arm group label: ARM A: Stop immunoglobulin (Ig) and commence prophylactic oral antibiotics

Intervention type: Drug
Intervention name: amoxycillin/clavulanic acid and ciprofloxacin
Description: clindamycin is an alternative to amoxycillin/clavulanic acid for participants with hypersensitivity to penicillin.
Arm group label: ARM B: Stop immunoglobulin (without prophylactic antibiotics)

Intervention type: Drug
Intervention name: Immunoglobulins
Description: Intravenous monthly immunoglobulin or subcutaneous weekly immunoglobulin
Arm group label: ARM C: Continue immunoglobulin

Summary: The aim of the study is to find out if patients with blood cancers receiving immunoglobulin (Ig) for the purpose of preventing infections can safety stop immunoglobulin after six months of therapy, and take oral antibiotics instead to prevent serious infections. Patients may be eligible to join this study if they are aged 18 years or above, have an acquired hypogammaglobulinaemia secondary to a haematological malignancy, and have been receiving intravenous or subcutaneous Ig for longer than 6 consecutive months. Participants will be randomised (allocated by chance) to one of three treatment groups, as follows: - Stop immunoglobulin (IVIg or SCIg) and be given oral antibiotics to take every day (ARM A) - Stop immunoglobulin (IVIg or SCIg) and be given oral antibiotics to keep at home to use as soon as symptoms of an infection develop (ARM B) - Continue receiving immunoglobulin (IVIg or SCIg) - this is the usual care group (ARM C) The duration of each treatment is for 12 months from study entry. Participants will be asked to attend a screening/baseline visit so that their treating clinician can assess their eligibility for the trial and collect baseline data. If eligible for the trial, participants will then be randomly allocated to one of the three treatment groups. Once randomised, active participation in the study will last for 13 months. During this 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.

Criteria for eligibility:
Criteria:
Inclusion Criteria: 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. Exclusion Criteria: 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 Pneumocystis jirovecii pneumonia (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.

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Locations:

Facility:
Name: Canberra Hospital

Address:
City: Garran
Zip: 2605
Country: Australia

Status: Not yet recruiting

Facility:
Name: Concord Hospital

Address:
City: Concord
Zip: 2139
Country: Australia

Status: Recruiting

Facility:
Name: Royal North Shore

Address:
City: St Leonards
Zip: 2065
Country: Australia

Status: Not yet recruiting

Facility:
Name: Monash Medical Centre

Address:
City: Clayton
Zip: 3168
Country: Australia

Status: Recruiting

Facility:
Name: Austin Hospital

Address:
City: Heidelberg
Zip: 3084
Country: Australia

Status: Recruiting

Facility:
Name: The Alfred Hospital

Address:
City: Melbourne
Zip: 3004
Country: Australia

Status: Recruiting

Facility:
Name: Sunshine Hospital

Address:
City: St Albans
Zip: 3021
Country: Australia

Status: Recruiting

Start date: November 30, 2022

Completion date: April 2027

Lead sponsor:
Agency: Monash University
Agency class: Other

Source: Monash University

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT05678621