Chlorambucil or Fludarabine as First-Line Therapy in Treating Patients With Previously Untreated Waldenström Macroglobulinemia, Splenic Lymphoma, or Lymphoplasmacytic Lymphoma
Lymphoma
About this trial
This is an interventional treatment trial for Lymphoma focused on measuring Waldenström macroglobulinemia, splenic marginal zone lymphoma, stage I marginal zone lymphoma, stage III marginal zone lymphoma, stage IV marginal zone lymphoma, contiguous stage II marginal zone lymphoma, noncontiguous stage II marginal zone lymphoma
Eligibility Criteria
DISEASE CHARACTERISTICS:
Diagnosis of Waldenström macroglobulinemia, splenic lymphoma with villous lymphocytes (SLVL), or non-IgM lymphoplasmacytic lymphoma based on morphological and immunophenotypic criteria
Bone marrow should be assessed by two-color flow cytometry for the expression of the following antigens:
- Surface Ig
- CD19
- CD20
- CD5
- CD10
- CD23
Previously untreated disease requiring therapeutic intervention (as judged by the primary physician), as indicated by ≥ 1 of the following:
- Hemoglobin < 10 g/dL
- ANC < 1.5 x 10^9/L
- Platelet count < 150 x 10^9/L
- Clinical evidence of hyperviscosity in terms of neurological or ocular disturbance
- Patients with disease detected by clonal cells alone are not eligible
PATIENT CHARACTERISTICS:
- Performance status 0-2
- Life expectancy > 6 months
- Serum creatinine < 200 mmol/L
- AST and ALT < 2 times upper limit of normal
- Negative direct Coomb's test
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception during and for ≥ 6 months after completion of study therapy
- No severe or life-threatening cardiac, pulmonary, neurological, psychiatric, or metabolic disease
- No other concurrent malignancy
- No AIDS or AIDS-related complex
- No evidence of active hepatitis C infection
PRIOR CONCURRENT THERAPY:
- Prior plasmapheresis for control of clinically significant hyperviscosity allowed
- Prior splenectomy for SLVL allowed
Sites / Locations
- Canberra Hospital
- Newcastle Mater Misericordiae Hospital
- Princess Alexandra Hospital
- Queen Elizabeth Hospital
- Peter MacCallum Cancer Centre
- Stoke Mandeville Hospital
- North Devon District Hospital
- Basingstoke and North Hampshire NHS Foundation Trust
- Royal United Hospital
- City Hospital - Birmingham
- Birmingham Heartlands Hospital
- Blackpool Victoria Hospital
- Royal Bournemouth Hospital
- Bradford Royal Infirmary
- Queen's Hospital
- Gloucestershire Oncology Centre at Cheltenham General Hospital
- Saint Richards Hospital
- Doncaster Royal Infirmary
- Russells Hall Hospital
- Royal Devon and Exeter Hospital
- Gloucestershire Royal Hospital
- Harrogate District Hospital
- Hereford Hospitals
- Watford General Hospital
- Wycombe General Hospital
- Hull Royal Infirmary
- Queen Elizabeth Hospital
- Leeds General Infirmary
- Saint Bartholomew's Hospital
- University College Hospital - London
- Royal Manchester Children's Hospital
- Trafford General Hospital
- Oxford Radcliffe Hospital
- Derriford Hospital
- Pontefract General Infirmary
- Berkshire Cancer Centre at Royal Berkshire Hospital
- Rotherham General Hospital
- Wexham Park Hospital
- Staffordshire General Hospital
- Taunton and Somerset Hospital
- Torbay Hospital
- Royal Cornwall Hospital
- Kent and Sussex Hospital
- Sandwell General Hospital
- New Cross Hospital
- Monklands General Hospital
- Southern General Hospital
- Pinderfields General Hospital
- Ysbyty Gwynedd