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

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ClinicalTrials.gov Identifier: NCT00608374
Recruitment Status : Completed
First Posted : February 6, 2008
Last Update Posted : August 26, 2013
Sponsor:
Information provided by:
National Cancer Institute (NCI)

Tracking Information
First Submitted Date  ICMJE December 21, 2007
First Posted Date  ICMJE February 6, 2008
Last Update Posted Date August 26, 2013
Study Start Date  ICMJE June 2006
Actual Primary Completion Date December 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 26, 2008)
  • Response to therapy (complete and partial response rates)
  • Duration of response
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT00608374 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: January 26, 2008)
  • Improvement in hematological parameters
  • Toxicity
  • Quality of life as assessed by the European Organization for Research and Treatment of Cancer Quality of Life-30 questionnaire
  • Survival
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Chlorambucil or Fludarabine as First-Line Therapy in Treating Patients With Previously Untreated Waldenström Macroglobulinemia, Splenic Lymphoma, or Lymphoplasmacytic Lymphoma
Official Title  ICMJE A Randomised Trial of Chlorambucil Versus Fludarabine as Initial Therapy of Waldenström's Macroglobulinaemia and Splenic Lymphoma With Villous Lymphocytes
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. 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.

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 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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Lymphoma
Intervention  ICMJE
  • Drug: chlorambucil
  • Drug: fludarabine phosphate
  • Procedure: quality-of-life assessment
Study Arms  ICMJE Not Provided
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Estimated Enrollment  ICMJE
 (submitted: January 26, 2008)
400
Original Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE January 2013
Actual Primary Completion Date December 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Australia,   United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00608374
Other Study ID Numbers  ICMJE CDR0000581143
TSH-WM1
ISRCTN56052618
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE Taunton and Somerset NHS Foundation Trust
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Roger G. Owen, MD, MRCP Leeds Cancer Centre at St. James's University Hospital
PRS Account National Cancer Institute (NCI)
Verification Date June 2009

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