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Chlorambucil or Fludarabine as First-Line Therapy in Treating Patients With Previously Untreated Waldenström Macroglobulinemia, Splenic Lymphoma, or Lymphoplasmacytic Lymphoma

This study has been completed.
Sponsor:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00608374
First received: December 21, 2007
Last updated: August 23, 2013
Last verified: June 2009

December 21, 2007
August 23, 2013
June 2006
December 2009   (final data collection date for primary outcome measure)
  • Response to therapy (complete and partial response rates) [ Designated as safety issue: No ]
  • Duration of response [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00608374 on ClinicalTrials.gov Archive Site
  • Improvement in hematological parameters [ Designated as safety issue: No ]
  • Toxicity [ Designated as safety issue: Yes ]
  • Quality of life as assessed by the European Organization for Research and Treatment of Cancer Quality of Life-30 questionnaire [ Designated as safety issue: No ]
  • Survival [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Chlorambucil or Fludarabine as First-Line Therapy in Treating Patients With Previously Untreated Waldenström Macroglobulinemia, Splenic Lymphoma, or Lymphoplasmacytic Lymphoma
A Randomised Trial of Chlorambucil Versus Fludarabine as Initial Therapy of Waldenström's Macroglobulinaemia and Splenic Lymphoma With Villous Lymphocytes

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. It is not yet known whether chlorambucil is more effective than fludarabine in treating Waldenström macroglobulinemia, splenic lymphoma, or lymphoplasmacytic lymphoma.

PURPOSE: This randomized phase III trial is studying chlorambucil to see how well it works compared with fludarabine as first-line therapy in treating patients with previously untreated Waldenström macroglobulinemia, splenic lymphoma, or lymphoplasmacytic lymphoma.

OBJECTIVES:

  • Compare the efficacy of first-line therapy comprising chlorambucil vs fludarabine phosphate in patients with previously untreated Waldenström macroglobulinemia, splenic lymphoma with villous lymphocytes, or non-IgM lymphoplasmacytic lymphoma.

OUTLINE: This is a multicenter study. Patients are stratified according to disease (Waldenström macroglobulinemia vs splenic lymphoma with villous lymphocytes vs non-IgM lymphoplasmacytic lymphoma). Patients are randomized to 1 of 2 treatment arms.

  • Arm I: Patients receive oral chlorambucil on days 1-10. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
  • Arm II: Patients receive fludarabine phosphate orally or IV on days 1-5. Treatment repeats every 28 days for 3-6 courses in the absence of disease progression or unacceptable toxicity.

Patients undergo quality of life assessment at baseline.

Interventional
Phase 3
Allocation: Randomized
Masking: Open Label
Primary Purpose: Treatment
Lymphoma
  • Drug: chlorambucil
  • Drug: fludarabine phosphate
  • Procedure: quality-of-life assessment
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
400
January 2013
December 2009   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Australia,   United Kingdom
 
NCT00608374
CDR0000581143, TSH-WM1, ISRCTN56052618
Not Provided
Not Provided
Taunton and Somerset Hospital
Not Provided
Study Chair: Roger G. Owen, MD, MRCP Leeds Cancer Centre at St. James's University Hospital
National Cancer Institute (NCI)
June 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP