Lymphoma, Non-Hodgkin Clinical Trial
Official title:
Phase I/II Study of Subcutaneously Administered Veltuzumab (hA20) in Patients With CD20+ Non-Hodgkin's Lymphoma or Chronic Lymphocytic Leukemia
Verified date | March 2013 |
Source | Gilead Sciences |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 32 |
Est. completion date | March 2013 |
Est. primary completion date | March 2013 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Histologically confirmed diagnosis of CD20 positive chronic lymphocytic leukemia (CLL) - 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 |
Country | Name | City | State |
---|---|---|---|
United States | Cleveland Clinic Taussig Cancer Center | Cleveland | Ohio |
United States | Cancer Care at Saint Clare's/Saint Clares Hospital Oncology & Hematology Specialists, P.A. | Denville | New Jersey |
United States | Morristown Memorial Hospital | Morristown | New Jersey |
United States | New York Hospital Weill Cornell Medical Center | New York | New York |
United States | Lewis Cancer Center and Research Pavilion | Savannah | Georgia |
Lead Sponsor | Collaborator |
---|---|
Gilead Sciences |
United States,
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. — View Citation
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---|---|---|---|---|
Primary | Safety/tolerability | safety will be assessed by monitoring lab results and adverse events, which will be assessed every 3 months for up to 2 years. | over 2 years after treatment |
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