EUCTR2019-001261-33-GB
Active, not recruiting
Phase 1
Randomised phase II/III study of Rituximab and Ibrutinib (RI) versus Dexamethasone, Rituximab and Cyclophosphamide (DRC) as initial therapy for Waldenström's macroglobulinaemia - RAINBOW
niversity College London0 sites148 target enrollmentJuly 29, 2019
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Waldenström's macroglobulinaemia
- Sponsor
- niversity College London
- Enrollment
- 148
- Status
- Active, not recruiting
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\.Patients \=18 years
- •2\.Confirmed diagnosis of WM (according to consensus panel / WHO criteria) with measurable IgM paraprotein
- •3\.Previously untreated disease at any stage requiring therapy at the discretion of the treating physician. Suggested criteria for initiating treatment include:
- •\- haematological suppression to Hb \<10g/dl, or neutrophils \<1\.5x109/l or platelets \<150x109/l
- •\- clinical evidence of hyperviscosity
- •\- bulky lymphadenopathy and/or bulky splenomegaly
- •\- presence of B symptoms
- •4\.No previous chemotherapy (prior plasma exchange and steroids are permissible)
- •5\.Eastern Cooperative Oncology Group (ECOG) performance status grade 0 – 2
- •6\.Life expectancy of greater than 6 months
Exclusion Criteria
- •1\. Prior therapy for WM
- •2\. Lymphoplasmacytic lymphoma with no detectable serum IgM paraprotein
- •3\. CNS involvement with WM
- •4\. Autoimmune cytopenias
- •5\. Major surgery within 4 weeks prior to randomisation
- •6\. Clinically significant cardiac disease including the following:
- •o Myocardial infarction within 6 months prior to randomisation
- •o Unstable angina within 3 months prior to randomisation
- •o New York Heart Association class III or IV congestive heart failure
- •o History of clinically significant arrhythmias (e.g. sustained ventricular tachycardia, ventricular fibrillation, torsades de pointes)
Outcomes
Primary Outcomes
Not specified
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