Ph I/II Study of Subcutaneously Administered Veltuzumab (hA20) in NHL and CLL

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00546793
• Other study ID #: IM-T-hA20-08
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: January 2008
• Est. completion date: March 2013

Study information

• Verified date: March 2013
• Source: Gilead Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• CLL
• Leukemia
• Leukemia, B-Cell
• Leukemia, B-Cell, Chronic
• Leukemia, Lymphocytic, Chronic
• Leukemia, Lymphocytic, Chronic, B-Cell
• Leukemia, Lymphoid
• Leukemia, Prolymphocytic
• Leukemia, Small Lymphocytic
• Lymphoma
• Lymphoma, B-Cell
• Lymphoma, Follicular
• Lymphoma, Intermediate-Grade
• Lymphoma, Large-Cell
• Lymphoma, Low-Grade
• Lymphoma, Lymphoplasmacytoid, CLL
• Lymphoma, Mixed-Cell
• Lymphoma, Non-Hodgkin
• Lymphoma, Small Lymphocytic
• Lymphoma, Small-Cell
• Lymphoplasmacytoid Lymphoma, CLL
• NHL
• SLL
• Waldenstrom Macroglobulinemia

Intervention

Biological:
• veltuzumab
veltuzumab (hA20) will be studied at different dose levels, administered subcutaneously once a week for 4 weeks.

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Gilead Sciences

Country where clinical trial is conducted

United States, 

References & Publications (7)

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

Outcome

Type	Measure	Description	Time frame	Safety issue
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