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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT00608374




Registration number
NCT00608374
Ethics application status
Date submitted
21/12/2007
Date registered
6/02/2008
Date last updated
26/08/2013

Titles & IDs
Public title
Chlorambucil or Fludarabine as First-Line Therapy in Treating Patients With Previously Untreated Waldenström Macroglobulinemia, Splenic Lymphoma, or Lymphoplasmacytic Lymphoma
Scientific title
A Randomised Trial of Chlorambucil Versus Fludarabine as Initial Therapy of Waldenström's Macroglobulinaemia and Splenic Lymphoma With Villous Lymphocytes
Secondary ID [1] 0 0
TSH-WM1
Secondary ID [2] 0 0
CDR0000581143
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Lymphoma 0 0
Condition category
Condition code
Cancer 0 0 0 0
Lymphoma (non Hodgkin's lymphoma) - High grade lymphoma
Cancer 0 0 0 0
Lymphoma (non Hodgkin's lymphoma) - Low grade lymphoma
Cancer 0 0 0 0
Children's - Leukaemia & Lymphoma

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - chlorambucil
Treatment: Drugs - fludarabine phosphate
Treatment: Surgery - quality-of-life assessment

Treatment: Drugs: chlorambucil


Treatment: Drugs: fludarabine phosphate


Treatment: Surgery: quality-of-life assessment
Intervention code [1] 0 0
Treatment: Drugs
Intervention code [2] 0 0
Treatment: Surgery
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Response to therapy (complete and partial response rates)
Timepoint [1] 0 0
Primary outcome [2] 0 0
Duration of response
Timepoint [2] 0 0
Secondary outcome [1] 0 0
Improvement in hematological parameters
Timepoint [1] 0 0
Secondary outcome [2] 0 0
Toxicity
Timepoint [2] 0 0
Secondary outcome [3] 0 0
Quality of life as assessed by the European Organization for Research and Treatment of Cancer Quality of Life-30 questionnaire
Timepoint [3] 0 0
Secondary outcome [4] 0 0
Survival
Timepoint [4] 0 0

Eligibility
Key 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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/06/2006
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/01/2013
Sample size
Target
400
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,QLD,SA,VIC
Recruitment hospital [1] 0 0
Canberra Hospital - Garran
Recruitment hospital [2] 0 0
Newcastle Mater Misericordiae Hospital - Waratah
Recruitment hospital [3] 0 0
Princess Alexandra Hospital - Brisbane
Recruitment hospital [4] 0 0
Queen Elizabeth Hospital - Woodville
Recruitment hospital [5] 0 0
Peter MacCallum Cancer Centre - East Melbourne
Recruitment postcode(s) [1] 0 0
2605 - Garran
Recruitment postcode(s) [2] 0 0
2298 - Waratah
Recruitment postcode(s) [3] 0 0
4102 - Brisbane
Recruitment postcode(s) [4] 0 0
5011 - Woodville
Recruitment postcode(s) [5] 0 0
3002 - East Melbourne
Recruitment outside Australia
Country [1] 0 0
United Kingdom
State/province [1] 0 0
England
Country [2] 0 0
United Kingdom
State/province [2] 0 0
Scotland
Country [3] 0 0
United Kingdom
State/province [3] 0 0
Wales

Funding & Sponsors
Primary sponsor type
Other
Name
Taunton and Somerset Hospital
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT00608374
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Roger G. Owen, MD, MRCP
Address 0 0
Leeds Cancer Centre at St. James's University Hospital
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT00608374