Ph I/II Study of Subcutaneously Administered Veltuzumab (hA20) in NHL and CLL
This study has been completed.
Sponsor:
Immunomedics, Inc.
Information provided by (Responsible Party):
Immunomedics, Inc.
ClinicalTrials.gov Identifier:
NCT00546793
First received: October 17, 2007
Last updated: March 25, 2013
Last verified: March 2013
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
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 | Intervention | Phase |
|---|---|---|
|
NHL Lymphoma, Non-Hodgkin Lymphoma, B-Cell Lymphoma, Follicular Lymphoma, Intermediate-Grade Lymphoma, Large-Cell Lymphoma, Low-Grade Lymphoma, Mixed-Cell Lymphoma, Small-Cell Leukemia, Lymphocytic, Chronic Leukemia, B-Cell, Chronic Leukemia, Prolymphocytic Leukemia, Small Lymphocytic Lymphoma, Small Lymphocytic Lymphoma, Lymphoplasmacytoid, CLL Lymphoplasmacytoid Lymphoma, CLL CLL SLL |
Biological: veltuzumab |
Phase 1 Phase 2 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Phase I/II Study of Subcutaneously Administered Veltuzumab (hA20) in Patients With CD20+ Non-Hodgkin's Lymphoma or Chronic Lymphocytic Leukemia |
Resource links provided by NLM:
Further study details as provided by Immunomedics, Inc.:
Primary Outcome Measures:
- Safety/tolerability [ Time Frame: over 2 years after treatment ] [ Designated as safety issue: Yes ]safety will be assessed by monitoring lab results and adverse events, which will be assessed every 3 months for up to 2 years.
| Enrollment: | 32 |
| Study Start Date: | January 2008 |
| Study Completion Date: | March 2013 |
| Primary Completion Date: | March 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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:
|
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
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00546793
Locations
| United States, Georgia | |
| Lewis Cancer Center and Research Pavilion | |
| Savannah, Georgia, United States, 31405 | |
| United States, New Jersey | |
| Cancer Care at Saint Clare's/Saint Clares Hospital Oncology & Hematology Specialists, P.A. | |
| Denville, New Jersey, United States, 07834 | |
| Morristown Memorial Hospital | |
| Morristown, New Jersey, United States, 07950 | |
| United States, New York | |
| New York Hospital Weill Cornell Medical Center | |
| New York City, New York, United States, 10021 | |
| United States, Ohio | |
| Cleveland Clinic Taussig Cancer Center | |
| Cleveland, Ohio, United States, 44195 | |
Sponsors and Collaborators
Immunomedics, Inc.
Investigators
| Study Director: | William Wegener, MD, PhD | Immunomedics, Inc. |
More Information
Publications:
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:
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.
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Immunomedics, Inc. |
| ClinicalTrials.gov Identifier: | NCT00546793 History of Changes |
| Other Study ID Numbers: | IM-T-hA20-08 |
| Study First Received: | October 17, 2007 |
| Last Updated: | March 25, 2013 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Immunomedics, Inc.:
|
humanized anti-CD20 veltuzumab (IMMU-106) administered subcutaneously |
Additional relevant MeSH terms:
|
Leukemia Leukemia, Lymphocytic, Chronic, B-Cell Leukemia, Lymphoid Leukemia, Prolymphocytic Lymphoma Lymphoma, Follicular Lymphoma, Non-Hodgkin Waldenstrom Macroglobulinemia Lymphoma, B-Cell Leukemia, B-Cell Neoplasms by Histologic Type Neoplasms |
Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases Neoplasms, Plasma Cell Hemostatic Disorders Vascular Diseases Cardiovascular Diseases Paraproteinemias Blood Protein Disorders Hematologic Diseases Hemorrhagic Disorders |
ClinicalTrials.gov processed this record on May 23, 2013