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

Phase 3

Completed

• Conditions: Lymphoma

• Registration Number: NCT00608374
• Lead Sponsor: Taunton and Somerset Hospital

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 Timeline

• Study Start: 2006-06
• Study First Submitted: 2007-12-21
• Study First Submitted QC: 2008-01-26
• Study First Posted: 2008-02-06
• Status Verified: 2009-06
• Primary Completion: 2009-12
• Study Completion: 2013-01
• Last Update Submitted: 2013-08-23
• Last Update Posted: 2013-08-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 400

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Duration of response
Response to therapy (complete and partial response rates)

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (48)

Canberra Hospital; 🇦🇺 Garran, Australian Capital Territory, Australia

Newcastle Mater Misericordiae Hospital; 🇦🇺 Waratah, New South Wales, Australia

Princess Alexandra Hospital; 🇦🇺 Brisbane, Queensland, Australia

Queen Elizabeth Hospital; 🇬🇧 King's Lynn, England, United Kingdom

Peter MacCallum Cancer Centre; 🇦🇺 East Melbourne, Victoria, Australia

Stoke Mandeville Hospital; 🇬🇧 Aylesbury-Buckinghamshire, England, United Kingdom

North Devon District Hospital; 🇬🇧 Barnstaple, England, United Kingdom

Basingstoke and North Hampshire NHS Foundation Trust; 🇬🇧 Basingstoke, England, United Kingdom

Royal United Hospital; 🇬🇧 Bath, England, United Kingdom

City Hospital - Birmingham; 🇬🇧 Birmingham, England, United Kingdom

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