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

This study has been completed.
Sponsor:
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
  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:
  • 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
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, see Learn About Clinical Studies.

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, B-Cell
Leukemia, Lymphocytic, Chronic, B-Cell
Leukemia, Lymphoid
Leukemia, Prolymphocytic
Lymphoma
Lymphoma, B-Cell
Lymphoma, Follicular
Lymphoma, Non-Hodgkin
Waldenstrom Macroglobulinemia
Blood Protein Disorders
Cardiovascular Diseases
Hematologic Diseases
Hemorrhagic Disorders
Hemostatic Disorders
Immune System Diseases
Immunoproliferative Disorders
Lymphatic Diseases
Lymphoproliferative Disorders
Neoplasms
Neoplasms by Histologic Type
Neoplasms, Plasma Cell
Paraproteinemias
Vascular Diseases

ClinicalTrials.gov processed this record on November 24, 2014