Ph I/II Study of Subcutaneously Administered Veltuzumab (hA20) in NHL and CLL
Study Details
Study Description
Brief Summary
The purpose of this study is to determine if a subcutaneous (SC) dosing schedule of veltuzumab can be established in NHL or CLL patients and to confirm the safety and efficacy of veltuzumab that was previously established when administered intravenously.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
|
Phase 1/Phase 2 |
Detailed Description
The first study of veltuzumab given IV weekly in NHL patients (IM-T-hA20-01) has shown excellent tolerability and even efficacy at weekly intravenous doses as low as 80-120 mg/m2 over 4 consecutive weeks. These clinical results confirm experiments laboratory studies. Laboratory studies using Veltuzumab administered subcutaneously showed potent activity based on B-cell depletion. The current study's goal is to determine if a subcutaneous (SC) dosing schedule of veltuzumab can be established in patients with NHL or CLL
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: veltuzumab veltuzumab is a humanized CD20 antibody administered subcutaneously in this study. |
Biological: veltuzumab
veltuzumab (hA20) will be studied at different dose levels, administered subcutaneously once a week for 4 weeks.
Other Names:
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Outcome Measures
Primary Outcome Measures
- Safety/tolerability [over 2 years after treatment]
safety will be assessed by monitoring lab results and adverse events, which will be assessed every 3 months for up to 2 years.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Histologically confirmed diagnosis of CD20 positive chronic lymphocytic leukemia (CLL)
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Either previously untreated or relapsed
-
Measurable disease (at least one lesion > 1.5 cm for NHL, or ALC > 5,000 for CLL) see full protocol for additional criteria
Exclusion Criteria:
-
Previously untreated NHL patients with Stage I and II disease (Ann Arbor classification)
-
Previously untreated CLL patients with Stage 0-2 disease (Rai classification) unless specific treatment indications by NCCN guidelines exist (symptomatic, recurrent infections, end-organ function, cytopenias and steady disease progression).
see full protocol for additional criteria
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Lewis Cancer Center and Research Pavilion | Savannah | Georgia | United States | 31405 |
| 2 | Cancer Care at Saint Clare's/Saint Clares Hospital Oncology & Hematology Specialists, P.A. | Denville | New Jersey | United States | 07834 |
| 3 | Morristown Memorial Hospital | Morristown | New Jersey | United States | 07950 |
| 4 | New York Hospital Weill Cornell Medical Center | New York | New York | United States | 10021 |
| 5 | Cleveland Clinic Taussig Cancer Center | Cleveland | Ohio | United States | 44195 |
Sponsors and Collaborators
- Gilead Sciences
Investigators
- Study Director: William Wegener, MD, PhD, Gilead Sciences
Study Documents (Full-Text)
None provided.More Information
Publications
- Goldenberg DM, et al. Characterization and preclinical efficacy of hA20, a humanized anti-CD20 monoclonal antibody, for the treatment of NHL. (Abstract #2393) Proceedings of ASCO 2003; 22:595
- Goldenberg DM, et al. Characterization of new, chimeric and humanized, anti-CD20 monoclonal antibodies, cA20 and hA20, with equivalent efficacy to rituximab in-vitro and in xenografted human non-Hodgkin's lymphoma. (Abstract #2260) Blood 2002; 100/11:575a-576a.
- Morschhauser F, Leonard JP, Coiffier B Petillon M, Coleman M,. Bahkti A, Teoh N, Wegener WA, Goldenberg DM. Phase I/II result of a second-generation humanized anti-CD20 antibody, IMMU-106 (.hA20), in NHL: 2006 ASCO Annual Meeting.Proceedings; 24/18S Part I of II:429s.
- Morschhauser F, Leonard JP, Fayad L, Coiffier B, Petillon M, Coleman M,. Horne H, Teoh N, Wegener WA, Goldenberg DM. Low doses of humanized anti-CD20 antibody, IMMU-106 (hA20), in refractory or recurrent NHL: Phase I/II results. 2007 ASCO Annual Meeting.Proceedings; 25/18S Part I of II:449s.
- Sapra P, et al. Preclinical pharmacology and toxicology of humanized anti-B-cell antibodies (anti-CD22 and anti-CD20) in cynomolgus monkeys (CM). (Abstract #1471) Blood 2005; 106/11:424a.
- Stein R, et al. Mechanisms of anti-lymphoma effects of a new humanized anti-CD20 monoclonal antibody, IMMU-106. (Abstract No. 4917) Blood 2003; 102/11:
- Stein R, Qu Z, Chen S, Rosario A, Shi V, Hayes M, Horak ID, Hansen HJ, Goldenberg DM. Characterization of a new humanized anti-CD20 monoclonal antibody, IMMU-106, and Its use in combination with the humanized anti-CD22 antibody, epratuzumab, for the therapy of non-Hodgkin's lymphoma. Clin Cancer Res. 2004 Apr 15;10(8):2868-78.
- IM-T-hA20-08