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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00546793
First Posted: October 19, 2007
Last Update Posted: March 27, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Immunomedics, Inc.
  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: Intervention Model: Single Group Assignment
Masking: None (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 ]
    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:
  • hA20
  • humanized anti-CD20
  • IMMU-106

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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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.
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.
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.

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
First Submitted: October 17, 2007
First Posted: October 19, 2007
Last Update Posted: March 27, 2013
Last Verified: March 2013

Keywords provided by Immunomedics, Inc.:
humanized anti-CD20 veltuzumab (IMMU-106) administered subcutaneously

Additional relevant MeSH terms:
Lymphoma
Leukemia
Lymphoma, Non-Hodgkin
Leukemia, Lymphoid
Lymphoma, B-Cell
Leukemia, Lymphocytic, Chronic, B-Cell
Lymphoma, Follicular
Leukemia, B-Cell
Leukemia, Prolymphocytic
Waldenstrom Macroglobulinemia
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
Rituximab
Antineoplastic Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents


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