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).
Conditions
Interventions
Product Name: epratuzumab
Product Code: IMMU-103
Pharmaceutical Form: Intravenous infusion
INN or Proposed INN: epratuzumab
CAS Number: 205923-57-5
Current Sponsor code: IMMU-103
Other descriptive nam
Sponsors
Immunomedics, Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
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
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. 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective is to evaluate the efficacy of epratuzumab in WM as determined by the response rate for patients with partial or complete responses.;Secondary Objective: To evaluate the duration of response (DR) and time to progression (TTP). To examine the safety, tolerability and immunogenicity of epratuzumab as determined by adverse experiences/toxicity, changes in vital signs and criticial laboratory data and human anti-human antibodies (HAHA). To obtain pharmacokinetics determined from serum epratuzumab levels and pharmacodynamics determined from peripheral blood B-cell counts.;Primary end point(s): Toxicity will be graded according to the National Cancer Institute (NCI) Common Toxicity Criteria, version 3.0. Treatment responses will be categorized according to response criteria from 2nd International Workshop on WM. Treatment efficacy will be assessed by overall response rates (PR, CR) as well as duration of response and time-to-progression; safety, from adverse events, toxicity, and changes in vital signs or laboratory values; pharmacokinetics, from IMMU-103 levels; pharmacodynamics, from B-cell levels; and immunogenicity, from HAHA titers. | — |
Countries
Spain
Outcome results
None listed