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A Randomised Trial of Chlorambucil Versus Fludarabine as Initial Therapy of Waldenström's Macroglobulinaemia and Splenic Lymphoma With Villous Lymphocytes


Phase 3
18 Years
N/A
Open (Enrolling)
Both
Lymphoma

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Trial Information

A Randomised Trial of Chlorambucil Versus Fludarabine as Initial Therapy of Waldenström's Macroglobulinaemia and Splenic Lymphoma With Villous Lymphocytes


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.

Inclusion Criteria


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Response to therapy (complete and partial response rates)

Safety Issue:

No

Principal Investigator

Roger G. Owen, MD, MRCP

Investigator Role:

Study Chair

Investigator Affiliation:

Leeds Cancer Centre at St. James's University Hospital

Authority:

Unspecified

Study ID:

CDR0000581143

NCT ID:

NCT00608374

Start Date:

June 2006

Completion Date:

Related Keywords:

  • Lymphoma
  • 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
  • Lymphoma
  • Waldenstrom Macroglobulinemia

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