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New treatment option for Haematological Malignancy
Official title Role of Antibiotic Therapy or Immunoglobulin On iNfections in hAematoLogy: Immunoglobulin Stopping or Extension
ClinicalTrials.gov ID: NCT05678621
What this study is testing
What is trimethoprim-sulfamethoxazole (co-trimoxazole)?
trimethoprim-sulfamethoxazole (co-trimoxazole) is an investigational medicine, given as a monthly injection under the skin, being studied as a potential treatment for haematological malignancy.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 3: a large, late-stage study
- Time commitment: about 13 months
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Aged greater than or equal to 18 years of age
- Diagnosis of chronic lymphocytic leukaemia (CLL), multiple myeloma (MM) or non-Hodgkin lymphoma (NHL).
- Patients must be receiving Ig (IV or subcutaneous - SCIg) replacement for prevention of bacterial infections due to hypogammaglobulinaemia for longer...
- Patient is eligible for trial of Ig cessation in the opinion of the treating clinician and local investigator.
- Life expectancy greater than 12 months.
You likely can't join if
- Prior or planned allogeneic haematopoietic stem cell transplantation.
- Major infection (Grade 3 or higher) in preceding 3 months, and/or current active infection requiring antimicrobial treatment.
- Already receiving daily antibiotic prophylaxis for the purpose of preventing bacterial infection (Note: patients may receive antiviral, antifungal...
- Intolerance of all trial antibiotic options in either arm A or arm B.
- Communication, compliance or logistical issues that are likely to limit patient's ability to take prophylactic or emergency antibiotics, or to obtain...
- Pregnant or breastfeeding.
See the full eligibility criteria
- Aged greater than or equal to 18 years of age
- Diagnosis of chronic lymphocytic leukaemia (CLL), multiple myeloma (MM) or non-Hodgkin lymphoma (NHL).
- Patients must be receiving Ig (IV or subcutaneous - SCIg) replacement for prevention of bacterial infections due to hypogammaglobulinaemia for longer than 6 consecutive months.
- Patient is eligible for trial of Ig cessation in the opinion of the treating clinician and local investigator.
- Life expectancy greater than 12 months.
- Able to give informed consent, and willing and able to comply with each of the treatment arms.
- Prior or planned allogeneic haematopoietic stem cell transplantation.
- Major infection (Grade 3 or higher) in preceding 3 months, and/or current active infection requiring antimicrobial treatment.
- Already receiving daily antibiotic prophylaxis for the purpose of preventing bacterial infection (Note: patients may receive antiviral, antifungal and Pneumocystis jirovecii pneumonia (PJP) prophylaxis).
- Intolerance of all trial antibiotic options in either arm A or arm B.
- 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.
- Pregnant or breastfeeding.
- Severe renal impairment (estimated or measured creatinine clearance of less than 30 mL/min).
- Previous splenectomy.
- Previous participation in this trial.
- Treating team deems enrolment in the study is not in the best interests of the patient.
The study team makes the final eligibility decision.
Where it's taking place
- Garran, Australian Capital Territory, Australia
- Concord, New South Wales, Australia
- St Leonards, New South Wales, Australia
- Clayton, Victoria, Australia
- Heidelberg, Victoria, Australia
- Melbourne, Victoria, Australia
- St Albans, Victoria, Australia
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 13 months per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Garran, Australian Capital Territory, Australia; Concord, New South Wales, Australia; St Leonards, New South Wales, Australia; Clayton, Victoria, Australia; Heidelberg, Victoria, Australia; Melbourne, Victoria, Australia and 1 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.