Clinical trial · Interventional
Randomised Trial in Waldenstrom's Macroglobulinaemia
Subcutaneous Bortezomib, Cyclophosphamide and Rituximab (BCR) Versus Fludarabine, Cyclophosphamide and Rituximab (FCR) for Initial Therapy of Waldenstrőm's Macroglobulinaemia (WM): a Randomized Phase II Trial
NCT01592981CI-TRIAL-00052325R2WcompletedPhase 2ClinicalTrials.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)
The purpose of this trial is to assess tolerability and efficacy of the Bortezomib, Cyclophosphamide and Rituximab combination as initial therapy for previously untreated patients with symptomatic Waldenstrom's macroglobulinaemia.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Waldenstrom's Macroglobulinaemia | Waldenstrom Macroglobulinemia | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Bortezomib | Drug | Bortezomib | ALIAS |
| Cyclophosphamide | Drug | Cyclophosphamide | ALIAS |
| Fludarabine | Drug | Fludarabine | ALIAS |
| Rituximab | Biological | Rituximab | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- bortezomib, cyclophosphamide, rituximab
- description
- Bortezomib:1.6 mg/m2 s.c; days 1, 8, 15 of each cycle. Cyclophosphamide:250 mg/m2 oral; days 1, 8, 15 of each cycle. Rituximab: 375 mg/m2 i.v. infusion; days 1, 8, 15 and 22 of cycles 2 and 5 only. Cycle repeated every 28 days. After 3 cycles of treatment, patients are reassessed and those with evidence of progression stop trial treatment. All other patients continue with further 3 cycles (to a total of 6) unless a clear clinical contradiction to further treatment exist.
- interventionNames
- Drug: Bortezomib
- Drug: Cyclophosphamide
- Biological: Rituximab
- type
- ACTIVE_COMPARATOR
- label
- fludarabine, cyclophosphamide, rituximab
- description
- Fludarabine:40 mg/sq m, oral, days 1,2 and 3 of each cycle. Cyclophosphamide:250 mg/sq m; oral, days 1, 2 and 3 of each cycle. Rituximab: 375 mg/sq m i.v. infusion days 1, 8, 15 and 22 of cycles 2 and 5 only. Cycle repeated every 28 days.After 3 cycles of treatment, patients are reassessed and those with evidence of progression stop trial treatment. All other patients continue with further 3 cycles (to a total of 6) unless a clear clinical contradiction to further treatment exist.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Age ≥ 18 years * Confirmed diagnosis of WM (according to consensus panel / WHO criteria) with measurable IgM paraprotein * 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 \<10 g/dl, or neutrophils \<1.5x109/l or platelets \<150x109/l * clinical evidence of hyperviscosity * bulky lymphadenopathy and/or bulky splenomegaly * presence of B symptoms * No previous chemotherapy (prior plasma exchange and steroids are permissible) * Performance status grade 0 - 2 * Life expectancy of greater than 6 months * Informed consent * Agreed compliance with recommended contraceptive precautions where appropriate Exclusion Criteria: * Lymphoplasmacytic lymphoma with no detectable serum IgM paraprotein * Severe pre-existing neuropathy (\> grade 2) * Autoimmune cytopenias * Evidence of active Hepatitis B or C infection (patients with evidence of past HepB infection may be eligible - see appendix 6) * Serological positivity for HIV * Pregnant or lactating women * Life expectancy severely limited by other illness * Renal failure (creatinine clearance \<30 ml/min) * Severe impairment of liver function: alkaline phosphatase/bilirubin \>2.5 times upper limit of normal (ULN), ALT/AST \>2.5 times ULN not related to lymphoma (patients with Gilbert syndrome are eligible) * History of allergic reaction to compounds containing boron or mannitol * Known hypersensitivity to murine compounds. * Diagnosed or treated for a malignancy other than WM within 5 years before day 1 of Cycle 1 with the exception of complete resection of basal cell carcinoma, squamous cell carcinoma of the skin or any other in situ malignancy * Active systemic infection requiring treatment * Concurrent treatment with another investigational agent * Severe or life-threatening cardiac, pulmonary, neurological, psychiatric or metabolic disease
References
Publications (0)
Data not yet available
No reference posted for this study.