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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/NCT00081068




Registration number
NCT00081068
Ethics application status
Date submitted
7/04/2004
Date registered
8/04/2004
Date last updated
8/01/2013

Titles & IDs
Public title
Alemtuzumab in Treating Patients With Waldenstrom's Macroglobulinemia
Scientific title
Phase II Study of Campath-1H in Lymphoplasmacytic Lymphoma (Waldenstrom's Macroglobulinemia)
Secondary ID [1] 0 0
UCLA-0309058
Secondary ID [2] 0 0
CDR0000358811
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
Other interventions - alemtuzumab

Other interventions: alemtuzumab
Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Objective response
Timepoint [1] 0 0
Primary outcome [2] 0 0
Time to treatment failure
Timepoint [2] 0 0
Primary outcome [3] 0 0
Toxicity
Timepoint [3] 0 0

Eligibility
Key inclusion criteria
DISEASE CHARACTERISTICS:

- Diagnosis of Waldenstrom's macroglobulinemia (lymphoplasmacytic lymphoma)

- Immunoglobulin (Ig) M, IgG, and IgA paraprotein

- Measurable monoclonal paraprotein

- Failed at least 1 prior first-line therapy (alkylator agent, nucleoside analogue, or
rituximab)

- CD52-positive tumor determined by either bone marrow immunohistochemistry or flow
cytometry

PATIENT CHARACTERISTICS:

Age

- Over 18

Performance status

- ECOG 0-2

Life expectancy

- At least 6 months

Hematopoietic

- Absolute neutrophil count = 500/mm^3

- Platelet count = 25,000/mm^3

Hepatic

- SGOT = 2.5 times upper limit of normal (ULN)

- Bilirubin = 2.5 times ULN

Renal

- Creatinine = 2.5 mg/dL (> 2.5 mg/dL allowed if due to disease)

Other

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective double-method contraception during and for 6
months after study participation

- No serious comorbid disease

- No uncontrolled bacterial, fungal, or viral infection

- No other active malignancy

PRIOR CONCURRENT THERAPY:

Biologic therapy

- See Disease Characteristics

- No prior alemtuzumab

- More than 3 months since other prior monoclonal antibody therapy

Chemotherapy

- See Disease Characteristics

- More than 21 days since prior chemotherapy

Endocrine therapy

- More than 21 days since prior steroid therapy

Radiotherapy

- More than 21 days since prior radiotherapy

Surgery

- Not specified
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
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 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Withdrawn
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
1/01/2004
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
0
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Peter MacCallum Cancer Centre - East Melbourne
Recruitment postcode(s) [1] 0 0
3002 - East Melbourne
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Colorado
Country [3] 0 0
United States of America
State/province [3] 0 0
Illinois
Country [4] 0 0
United States of America
State/province [4] 0 0
Maryland
Country [5] 0 0
United States of America
State/province [5] 0 0
Massachusetts
Country [6] 0 0
United States of America
State/province [6] 0 0
New York
Country [7] 0 0
United States of America
State/province [7] 0 0
Ohio
Country [8] 0 0
Canada
State/province [8] 0 0
Ontario
Country [9] 0 0
France
State/province [9] 0 0
Lens
Country [10] 0 0
United Kingdom
State/province [10] 0 0
England

Funding & Sponsors
Primary sponsor type
Other
Name
Jonsson Comprehensive Cancer Center
Address
Country
Other collaborator category [1] 0 0
Government body
Name [1] 0 0
National Cancer Institute (NCI)
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
RATIONALE: Monoclonal antibodies, such as alemtuzumab, can locate tumor cells and either kill
them or deliver tumor-killing substances to them without harming normal cells.

PURPOSE: This phase II trial is studying how well alemtuzumab works in treating patients with
Waldenstrom's macroglobulinemia.
Trial website
https://clinicaltrials.gov/ct2/show/NCT00081068
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Jennifer Gansert, MD, PhD
Address 0 0
Jonsson Comprehensive Cancer Center
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/NCT00081068