Clinical trial · Interventional
Role of Antibiotic Therapy or Immunoglobulin On iNfections in hAematoLogy Platform Trial (RATIONAL-PT)
A Randomised Platform Trial Evaluating the Role of Interventions to Prevent Infection in Patients With Acquired Hypogammaglobulinemia Secondary to Haematological Malignancies - RATIONAL-PT (Core)
NCT07202052CI-TRIAL-00096390recruitingPhase 2 / Phase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Leukemia | Leukemia | ONTOLOGY_EXACT | 0.90 |
| Myeloma | Multiple Myeloma | ALIAS | 0.90 |
| Non-Hodgkin's Lymphoma | Non-Hodgkin Lymphoma | ALIAS | 0.90 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Amoxicillin clavulanic acid | Drug | — | UNRESOLVED |
| Intravenous immunoglobulin | Biological | — | UNRESOLVED |
| Intravenous immunoglobulin (IVIG) | Biological | — | UNRESOLVED |
| Trimethoprim / Sulfamethoxazole | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- OTHER
- label
- Start Immunoglobulin
- description
- Patients eligible to start immunoglobulin are randomly assigned to: * receive either prophylactic antibiotic * or Ig replacement.
- interventionNames
- Biological: Intravenous immunoglobulin
- Drug: Trimethoprim / Sulfamethoxazole
- type
- OTHER
- label
- Stop Immunoglobulin
- 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
- interventionNames
- Biological: Intravenous immunoglobulin
- Drug: Trimethoprim / Sulfamethoxazole
- Drug: Amoxicillin clavulanic acid
- type
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.