Chlorambucil or Fludarabine as First-Line Therapy in Treating Patients With Previously Untreated Waldenström Macroglobulinemia, Splenic Lymphoma, or Lymphoplasmacytic Lymphoma
Recruitment status was Recruiting
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
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 | Intervention | Phase |
|---|---|---|
|
Lymphoma |
Drug: chlorambucil Drug: fludarabine phosphate Procedure: quality-of-life assessment |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Randomised Trial of Chlorambucil Versus Fludarabine as Initial Therapy of Waldenström's Macroglobulinaemia and Splenic Lymphoma With Villous Lymphocytes |
- Response to therapy (complete and partial response rates) [ Designated as safety issue: No ]
- Duration of response [ Designated as safety issue: No ]
- 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 ]
| Estimated Enrollment: | 400 |
| Study Start Date: | June 2006 |
| Estimated Primary Completion Date: | December 2009 (Final data collection date for primary outcome measure) |
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Show 49 Study Locations| Study Chair: | Roger G. Owen, MD, MRCP | Leeds Cancer Centre at St. James's University Hospital |
More Information
Additional Information:
No publications provided by National Cancer Institute (NCI)
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| ClinicalTrials.gov Identifier: | NCT00608374 History of Changes |
| Other Study ID Numbers: | CDR0000581143, TSH-WM1, ISRCTN56052618 |
| Study First Received: | December 21, 2007 |
| Last Updated: | October 6, 2009 |
| Health Authority: | Unspecified |
Keywords provided by National Cancer Institute (NCI):
|
Waldenstrom macroglobulinemia splenic marginal zone lymphoma stage I marginal zone lymphoma stage III marginal zone lymphoma |
stage IV marginal zone lymphoma contiguous stage II marginal zone lymphoma noncontiguous stage II marginal zone lymphoma |
Additional relevant MeSH terms:
|
Lymphoma Waldenstrom Macroglobulinemia Neoplasms by Histologic Type Neoplasms Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases Neoplasms, Plasma Cell Hemostatic Disorders Vascular Diseases Cardiovascular Diseases Paraproteinemias Blood Protein Disorders Hematologic Diseases |
Hemorrhagic Disorders Chlorambucil Fludarabine Fludarabine monophosphate Vidarabine Antineoplastic Agents, Alkylating Alkylating Agents Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Antineoplastic Agents Therapeutic Uses Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Antimetabolites, Antineoplastic |
ClinicalTrials.gov processed this record on May 19, 2013