Testing if stopping immunoglobulin therapy and using antibiotics can prevent infections in blood cancer patients

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study aims to determine whether patients with blood cancers, who have been receiving immunoglobulin therapy to prevent infections, can safely stop this therapy after six months and instead take oral antibiotics. Participants will be randomly assigned to one of three groups: one group will stop immunoglobulin and take daily antibiotics, another will stop immunoglobulin and take antibiotics only when symptoms arise, and the third group will continue with immunoglobulin therapy as usual. The study will last for 12 months and focuses on patients with acquired hypogammaglobulinaemia due to haematological malignancies.

Why it matters

Who can join: the full rules

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.

Where it's running

• Concord Hospital
  Concord, New South Wales, Australia Recruiting
• Monash Medical Centre
  Clayton, Victoria, Australia Recruiting
• Austin Hospital
  Heidelberg, Victoria, Australia Recruiting
• The Alfred Hospital
  Melbourne, Victoria, Australia Recruiting
• Sunshine Hospital
  St Albans, Victoria, Australia Recruiting
• Canberra Hospital
  Garran, Australian Capital Territory, Australia Not yet recruiting

Study contacts

• Principal investigator: Prof Erica Wood — Monash University
• Study coordinator: Prof Zoe McQuilten
• Email: zoe.mcquilten@monash.edu
• Phone: +61 3 9903 0379

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Dabrafenib and trametinib for rare cancers with BRAF V600 mutations

  This arm tests whether dabrafenib and trametinib can help adults, children, and teens with cancers that have a BRAF V600 mutation.

  Recruiting at 15 sites Phase 2/3 Cancer Research UK · Belfast and 26 other locations · NCT07440290

• Panzyga to prevent major infections during autoimmune therapy

  This Phase 3 trial tests whether Panzyga can help prevent serious infections in adults with hypogammaglobulinemia who are receiving B-cell depletion therapy for autoimmune or rheumatic conditions.

  Recruiting at 11 sites Phase 3 Octapharma · Glendale, Arizona and 24 other locations · NCT07220915

• Capmatinib treatment for adults with cancers having MET gene changes

  This study is testing if capmatinib, a drug for lung cancer, can help adults with different types of cancers that have changes in the MET gene.

  Recruiting at 16 sites Phase 2/3 Cancer Research UK · Belfast and 16 other locations · NCT06988475

• Using IgPro20 to prevent infections in patients with multiple myeloma and low immunoglobulin levels

  This study is testing if IgPro20 can help prevent infections in people with multiple myeloma and low immune levels who are receiving certain treatments.

  Recruiting at 8 sites Phase 2 Memorial Sloan Kettering Cancer Center · Atlanta, Georgia and 8 other locations · NCT06976476

• Home management program for patients with blood cancers after chemotherapy

  This study tests a new home care program for patients with blood cancers after high-dose chemotherapy to see if it helps them recover better while allowing them to leave the hospital sooner.

  Recruiting IRCCS Azienda Ospedaliero-Universitaria di Bologna · Bologna, Bologna · NCT06814405

• Pharmacogenomics to improve voriconazole dosing for fungal infections

  This trial will test whether using a patient's CYP2C19 genotype with Bayesian dosing software helps get voriconazole levels into the therapeutic range by Day 8 for people with fungal infections, including those with blood cancers.

  Recruiting at 7 sites Phase 2 The University of Queensland · Seattle, Washington and 6 other locations · NCT06510699

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.