Alemtuzumab in Treating Patients With Waldenstrom's Macroglobulinemia

• Register: ClinicalTrials.gov
• Last refreshed on: 14 January 2013
• Main ID: NCT00081068
• Date of registration: 07/04/2004
• Primary sponsor: Jonsson Comprehensive Cancer Center
• Public title: Alemtuzumab in Treating Patients With Waldenstrom's Macroglobulinemia
• Scientific title: Phase II Study of Campath-1H in Lymphoplasmacytic Lymphoma (Waldenstrom's Macroglobulinemia)
• Date of first enrolment: January 2004
• Target sample size: 0
• Recruitment status: Withdrawn
• URL: http://clinicaltrials.gov/show/NCT00081068
• Study type: Interventional
• Study design: Masking: Open Label, Primary Purpose: Treatment

Countries of recruitment

Australia, Canada, France, United Kingdom, United States

Contacts

• Name: Jennifer Gansert, MD, PhD
• Affiliation: Jonsson Comprehensive Cancer Center

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Lymphoma

Intervention(s)

Biological: alemtuzumab

Primary Outcome(s)

Objective response [Time Frame: No]

Time to treatment failure [Time Frame: No]

Toxicity [Time Frame: Yes]

Secondary ID(s)

CDR0000358811

UCLA-0309058

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

National Cancer Institute (NCI)