Neoplasms

Blood and Lymph Conditions

Immune System Diseases

All Conditions

Behaviors and Mental Disorders

Nervous System Diseases

Rare Diseases

Lymphoma

Precursor Cell Lymphoblastic Leukemia-Lymphoma

Lymphoma, Large B-Cell, Diffuse

Lymphoma, B-Cell

Aggression

Lymphoma, Non-Hodgkin

Neoplasms by Histologic Type

Lymphoproliferative Disorders

Lymphatic Diseases

Immunoproliferative Disorders

Dementia

Aberrant Motor Behavior in Dementia

Behavioral Symptoms

Lymphosarcoma

Acute Lymphoblastic Leukemia

Lymphoblastic Lymphoma

B-cell Lymphoma

Diffuse Large B-Cell Lymphoma

Antineoplastic Agents

All Drugs and Chemicals

Epratuzumab

Veltuzumab

1,4,7,10-tetraazacyclododecane- 1,4,7,10-tetraacetic acid

Antineoplastic Agents, Immunological

Chelating Agents

Veltuzumab and 90Y-Epratuzumab Tetraxetan target different b-cells. Veltuzumab will be administered in all 4 weekly study drug treatments. 90Y-Epratuzumab Tetraxetan will be administered only on days 8 \& 15. The dose of veltuzumab remains the same for all patients.

90Y-epratuzumab tetraxetan will be administered 6 mCi/m2 on days 8 and 15.

Veltuzumab will be administered subcutaneously in phase 2. 90Y-Epratuzumab tetraxetan will be administered intravenously. Veltuzumab is given once weekly for 4 weeks. 90Y-Epratuzumab is also given at treatment weeks 2 \& 3 (days 8 \& 15).

Veltuzumab and 90Y-Epratuzumab Tetraxetan

90Y-epratuzumab tetraxetan

Veltuzumab will be administered subcutaneously on days 1, 8, 15 and 23

veltuzumab

William Wegener, MD, PhD

The goal of this study is to evaluate a new approach to immunotherapy in NHL by combining two antibodies, veltuzumab and epratuzumab. For treatment, epratuzumab has also been attached to a radioactive isotope called 90yttrium (90Y-epratuzumab). Veltuzumab and 90Y-epratuzumab attack different areas on lymphoma cells. Because of this, treatment with the combination may provide more effective treatment in NHL than either veltuzumab or 90Y-epratuzumab given alone.

The treatment portion of this study consists of study drug administrations each week for four weeks in a row (a total of 4 treatment days). Patients will then return at intervals up to 12 weeks for blood samples and for evaluations to see if their disease responded and to monitor any adverse effects related to treatment. Some blood tests may then need to be repeated at least a few times and/or until any abnormal findings at earlier evaluations have resolved. Otherwise, patients will continue to be evaluated every 3 months for two years, then every 6 months up to 5 years or until the disease worsens. Participation in the study will end when NHL disease worsens.

Study of Veltuzumab and 90Y-Epratuzumab in Relapsed/Refractory, Aggressive NHL

Phase I/II Study of Veltuzumab Combined With 90Y-Epratuzumab Tetraxetan in Patients With Relapsed/Refractory, Aggressive Non- Hodgkin's Lymphoma

Patients are closely monitored during and after all infusions, and then at intervals over a 12-week post-treatment evaluation period. Safety evaluations required in all patients include vital signs, physical examination, CBC, serum chemistries, serum immunoglobulins, urinalysis, peripheral blood B-cell levels (immunophenotyping based on CD19), and HAHA (to be analyzed by Sponsor). Adverse events and abnormal laboratories will be graded for toxicity according to NCI CTC v3.0 criteria.

CT or PET/CT imaging will be used to quantify changes in index lesions identified on baseline imaging, with responses classified according to revised response criteria for NHL (Cheson, 2007).

Patients with stable disease or objective responses continue limited follow-up evaluations, including CT evaluations, physical examinations and serum laboratories every 3 months for the first year and then every 6 months up to a total of 5 years or until progression of disease.

Gilead Sciences

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Study of Veltuzumab and 90Y-Epratuzumab in Relapsed/Refractory, Aggressive NHL	NCT01101581	Non Hodgkin's L... NHL Aggressive NHL Diffuse Large B...	Veltuzumab and ... 90Y-epratuzumab... veltuzumab	18 Years -	Gilead Sciences
Study of Veltuzumab and 90Y-Epratuzumab in Relapsed/Refractory, Aggressive NHL	NCT01101581	Non Hodgkin's L... NHL Aggressive NHL Diffuse Large B...	Veltuzumab and ... 90Y-epratuzumab... veltuzumab	18 Years -	Gilead Sciences
Study of Veltuzumab and 90Y-Epratuzumab in Relapsed/Refractory, Aggressive NHL	NCT01101581	Non Hodgkin's L... NHL Aggressive NHL Diffuse Large B...	Veltuzumab and ... 90Y-epratuzumab... veltuzumab	18 Years -	Gilead Sciences
Study of Veltuzumab and 90Y-Epratuzumab in Relapsed/Refractory, Aggressive NHL	NCT01101581	Non Hodgkin's L... NHL Aggressive NHL Diffuse Large B...	Veltuzumab and ... 90Y-epratuzumab... veltuzumab	18 Years -	Gilead Sciences

Spots Global Cancer Trial Database for diffuse large cell nhl