A Phase II, Single-Arm Trial of Naked Epratuzumab, an Anti-CD22 Humanized Antibody, in Patients with Waldenström's Macroglobulinemia - hLL2-18

• Conditions: Waldenström's Macroglobulinemia (WM) is an uncommon B-cell lymphoproliferative disorder that predominantly involves older patients with a slight male preponderance. WM resembles myeloma and chronic lymphocytic leukemia, but has been described as a low-grade lymphoplasmacytic lymphoma characterized by its over production of monoclonal immunoglobulin M (IgM).

• Registration Number: EUCTR2004-001563-21-ES
• Lead Sponsor: Immunomedics, Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2005-05-23
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 53

Inclusion Criteria

1. Male or females, 18 years old or greater.
2. Documented diagnosis of WM satisfying criteria proposed at 2nd International Workshop on WM, Athens, Greece, 2002.
3. Measurable disease, defined as serum monoclonal IgM protein greater than or equal to 1000 mg/dL by electrophoresis.
4. Lymphoplasmacytic infiltration of the bone marrow > 10% involvement.
5. Failed at least one, but no more than 3, regimen(s) of prior therapy.
6. Karnofsky Performance Status (KPS) greater than or equal to 60.
7. Minimal life expectancy of 6 months.
8. Must be willing and able to give informed consent.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. Pregnant women.
2. Lactating women, unless they agree not to breastfeed for a period of 3 months after completing treatment.
3. Women of childbearing potential and fertile men who are unwilling to practice birth control during and for a period of 12 weeks after completing treatment.
4. Major surgery, radiation, chemotherapy, stem cell transplant, or any other therapy within 4 weeks prior to enrollment and recovered from all treatment-related toxicity.
5. Prior therapies must not include more than one prior therapy with rituximab, and patients who were refractory to rituximab are excluded, where refractory is defined as failure to achieve an objective response to rituximab or having progression of disease within 6 months after rituximab.
6. Prior therapy with other murine, chimeric, human or humanized monoclonal antibodies, unless HAHA is negative.
7. Prior treatment with any other investigational agents, unless follow-up is completed and patient is off study.
8. < 2 weeks beyond corticosteroids.
9. Hemoglobin < 7.0 g/dL, absolute neutrophil count, < 1000 mm³, platelets < 50,000/mm³, without ongoing transfusional support.
10. Serum creatinine > 1.5 X Institutional Upper Limit of Normal (IULN).
11. Serum bilirubin > 1.5 X ILUN, Alkaline phosphatase > 1.5 IULN, ALT (SGPT > 1.5 X IULN and/or AST (SGOT) > 1.5 X IULN.
12. Other primary malignancy (other than squamous or basal cell skin cancer, or cervical cancer in-situ) within 5 years.
13. Known HIV positive or active hepatitis B or C or presence of hepatitis B or C surface antigens.
14. Significant concurrent medical condition that could affect the patient's ability to tolerate or complete the study.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified