Status:
COMPLETED
Chlorambucil or Fludarabine as First-Line Therapy in Treating Patients With Previously Untreated Waldenström Macroglobulinemia, Splenic Lymphoma, or Lymphoplasmacytic Lymphoma
Lead Sponsor:
Taunton and Somerset Hospital
Conditions:
Lymphoma
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
RATIONALE: Drugs used in chemotherapy, such as chlorambucil and fludarabine, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. I...
Detailed Description
OBJECTIVES: * Compare the efficacy of first-line therapy comprising chlorambucil vs fludarabine phosphate in patients with previously untreated Waldenström macroglobulinemia, splenic lymphoma with vi...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
June 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2013
Estimated Enrollment :
400 Patients enrolled
Trial Details
Trial ID
NCT00608374
Start Date
June 1 2006
End Date
January 1 2013
Last Update
August 26 2013
Active Locations (49)
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1
Canberra Hospital
Garran, Australian Capital Territory, Australia, 2605
2
Newcastle Mater Misericordiae Hospital
Waratah, New South Wales, Australia, 2298
3
Princess Alexandra Hospital
Brisbane, Queensland, Australia, 4102
4
Queen Elizabeth Hospital
Woodville, South Australia, Australia, 5011