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

Sponsor:	Immunomedics, Inc.
Information provided by (Responsible Party):	Immunomedics, Inc.
ClinicalTrials.gov Identifier:	NCT00546793

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:	Allocation: Non-Randomized 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:

Genetics Home Reference related topics: aceruloplasminemia hemophilia

MedlinePlus related topics: Acute Lymphocytic Leukemia Chronic Lymphocytic Leukemia Leukemia Lymphoma

U.S. FDA Resources

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.

Estimated Enrollment:	72
Study Start Date:	January 2008
Estimated Primary Completion Date:	June 2013 (Final data collection date for primary outcome measure)

Intervention Details:

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

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

Contacts

Contact: Heather Horne

973-727-7589

hhorne@immunomedics.com

Locations

United States, Georgia
Lewis Cancer Center and Research Pavilion	Recruiting
Savannah, Georgia, United States, 31405
United States, New Jersey
Cancer Care at Saint Clare's/Saint Clares Hospital Oncology & Hematology Specialists, P.A.	Recruiting
Denville, New Jersey, United States, 07834
Morristown Memorial Hospital	Completed
Morristown, New Jersey, United States, 07950
United States, New York
New York Hospital Weill Cornell Medical Center	Recruiting
New York City, New York, United States, 10021
United States, Ohio
Cleveland Clinic Taussig Cancer Center	Recruiting
Cleveland, Ohio, United States, 44195
Contact: Monica Bruton 216-445-5114 mbruton@ccf.org
United States, West Virginia
Edwards Cancer Center	Withdrawn
Huntington, West Virginia, United States, 25701

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.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Negrea GO, Elstrom R, Allen SL, Rai KR, Abbasi RM, Farber CM, Teoh N, Horne H, Wegener WA, Goldenberg DM. Subcutaneous injections of low-dose veltuzumab (humanized anti-CD20 antibody) are safe and active in patients with indolent non-Hodgkin's lymphoma. Haematologica. 2011 Apr;96(4):567-73. Epub 2010 Dec 20.

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 21, 2012
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
Lymphoma, Large B-Cell, Diffuse
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 22, 2012