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

History of Changes

Tracking Information

First Received Date ^ICMJE

October 17, 2007

Last Updated Date

March 25, 2013

Start Date ^ICMJE

January 2008

Primary Completion Date

March 2013 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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.

Original Primary Outcome Measures ^ICMJE

Not Provided

Change History

Complete list of historical versions of study NCT00546793 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

Phase I/II Study of Subcutaneously Administered Veltuzumab (hA20) in Patients With CD20+ Non-Hodgkin's Lymphoma or Chronic Lymphocytic Leukemia

Brief Summary

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.

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

Study Type ^ICMJE

Interventional

Study Phase

Phase 1
Phase 2

Study Design ^ICMJE

Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

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

Intervention ^ICMJE

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

Study Arm (s)

Experimental: veltuzumab

veltuzumab is a humanized CD20 antibody administered subcutaneously in this study.

Intervention: Biological: veltuzumab

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.
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.

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

March 2013

Primary Completion Date

March 2013 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT00546793

Other Study ID Numbers ^ICMJE

IM-T-hA20-08

Has Data Monitoring Committee

Responsible Party

Immunomedics, Inc.

Study Sponsor ^ICMJE

Immunomedics, Inc.

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Director:

William Wegener, MD, PhD

Immunomedics, Inc.

Information Provided By

Immunomedics, Inc.

Verification Date

March 2013

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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