Randomised Trial in Waldenstrom's Macroglobulinaemia

• Status: Completed
• Trial end date: 2020-08-02
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University College, London
• Treatments: Bortezomib; Cyclophosphamide; Fludarabine; Fludarabine phosphate; Rituximab; Vidarabine

Criteria

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