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
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.
|Condition or disease||Intervention/treatment||Phase|
|Lymphoma||Drug: chlorambucil Drug: fludarabine phosphate Procedure: quality-of-life assessment||Phase 3|
- 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 :||Interventional (Clinical Trial)|
|Estimated Enrollment :||400 participants|
|Masking:||None (Open Label)|
|Official Title:||A Randomised Trial of Chlorambucil Versus Fludarabine as Initial Therapy of Waldenström's Macroglobulinaemia and Splenic Lymphoma With Villous Lymphocytes|
|Study Start Date :||June 2006|
|Actual Primary Completion Date :||December 2009|
|Actual Study Completion Date :||January 2013|
- Response to therapy (complete and partial response rates)
- Duration of response
- Improvement in hematological parameters
- Quality of life as assessed by the European Organization for Research and Treatment of Cancer Quality of Life-30 questionnaire
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00608374
Show 49 Study Locations
|Study Chair:||Roger G. Owen, MD, MRCP||Leeds Cancer Centre at St. James's University Hospital|