Study of Veltuzumab and 90Y-Epratuzumab in Relapsed/Refractory, Aggressive NHL
|ClinicalTrials.gov Identifier: NCT01101581|
Recruitment Status : Unknown
Verified March 2015 by Immunomedics, Inc..
Recruitment status was: Active, not recruiting
First Posted : April 12, 2010
Last Update Posted : March 3, 2015
|Condition or disease||Intervention/treatment||Phase|
|Non Hodgkin's Lymphoma NHL Aggressive NHL Diffuse Large B-cell Lymphoma||Drug: Veltuzumab and 90Y-Epratuzumab Tetraxetan Drug: 90Y-epratuzumab tetraxetan Drug: veltuzumab||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||70 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase I/II Study of Veltuzumab Combined With 90Y-Epratuzumab Tetraxetan in Patients With Relapsed/Refractory, Aggressive Non- Hodgkin's Lymphoma|
|Study Start Date :||May 2010|
|Estimated Primary Completion Date :||December 2016|
|Estimated Study Completion Date :||March 2017|
Experimental: Veltuzumab and 90Y-Epratuzumab Tetraxetan
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.
Drug: Veltuzumab and 90Y-Epratuzumab Tetraxetan
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).
Other Names:Drug: 90Y-epratuzumab tetraxetan
Other Names:Drug: veltuzumab
Veltuzumab will be administered subcutaneously on days 1, 8, 15 and 23
Experimental: 90Y-epratuzumab tetraxetan
90Y-epratuzumab tetraxetan will be administered 6 mCi/m2 on days 8 and 15.
Drug: 90Y-epratuzumab tetraxetan
- Safety/dose limiting toxicity [ Time Frame: 12 weeks ]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.
- Efficacy [ Time Frame: 12 weeks-5 years ]
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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01101581
|United States, Delaware|
|Helen F. Graham Cancer Center|
|Newark, Delaware, United States, 19713|
|United States, Florida|
|Orlando, Florida, United States, 32806|
|Moffitt Cancer Center|
|Tampa, Florida, United States, 33612|
|United States, Indiana|
|Goshen Center for Cancer Care|
|Goshen, Indiana, United States, 46526|
|United States, Minnesota|
|Rochester, Minnesota, United States, 55905|
|United States, New York|
|Weill Med College of Cornell Univ/NYH|
|New York, New York, United States, 10021|
|United States, Pennsylvania|
|University of Pennsylvania Cancer Center|
|Philadelphia, Pennsylvania, United States, 19104|
|Study Chair:||William Wegener, MD, PhD||Immunomedics, Inc.|