Back to resultsPh I/II Study of Subcutaneously Administered Veltuzumab (hA20) in NHL and CLL
Primary Purpose
NHL, Lymphoma, Non-Hodgkin, Lymphoma, B-Cell
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
veltuzumab
Sponsored by
About this trial
This is an interventional treatment trial for NHL focused on measuring humanized anti-CD20 veltuzumab (IMMU-106) administered subcutaneously
Eligibility 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
Sites / Locations
- Lewis Cancer Center and Research Pavilion
- Cancer Care at Saint Clare's/Saint Clares Hospital Oncology & Hematology Specialists, P.A.
- Morristown Memorial Hospital
- New York Hospital Weill Cornell Medical Center
- Cleveland Clinic Taussig Cancer Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
veltuzumab
Arm Description
veltuzumab is a humanized CD20 antibody administered subcutaneously in this study.
Outcomes
Primary Outcome Measures
Safety/tolerability
safety will be assessed by monitoring lab results and adverse events, which will be assessed every 3 months for up to 2 years.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00546793
Brief Title
Ph I/II Study of Subcutaneously Administered Veltuzumab (hA20) in NHL and CLL
Official Title
Phase I/II Study of Subcutaneously Administered Veltuzumab (hA20) in Patients With CD20+ Non-Hodgkin's Lymphoma or Chronic Lymphocytic Leukemia
Study Type
Interventional
2. Study Status
Record Verification Date
March 2013
Overall Recruitment Status
Completed
Study Start Date
January 2008 (undefined)
Primary Completion Date
March 2013 (Actual)
Study Completion Date
March 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Gilead Sciences
4. Oversight
Data Monitoring Committee
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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
Keywords
humanized anti-CD20 veltuzumab (IMMU-106) administered subcutaneously
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
32 (Actual)
8. Arms, Groups, and Interventions
Arm Title
veltuzumab
Arm Type
Experimental
Arm Description
veltuzumab is a humanized CD20 antibody administered subcutaneously in this study.
Intervention Type
Biological
Intervention Name(s)
veltuzumab
Other Intervention Name(s)
hA20, humanized anti-CD20, IMMU-106
Intervention Description
veltuzumab (hA20) will be studied at different dose levels, administered subcutaneously once a week for 4 weeks.
Primary Outcome Measure Information:
Title
Safety/tolerability
Description
safety will be assessed by monitoring lab results and adverse events, which will be assessed every 3 months for up to 2 years.
Time Frame
over 2 years after treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
William Wegener, MD, PhD
Organizational Affiliation
Gilead Sciences
Official's Role
Study Director
Facility Information:
Facility Name
Lewis Cancer Center and Research Pavilion
City
Savannah
State/Province
Georgia
ZIP/Postal Code
31405
Country
United States
Facility Name
Cancer Care at Saint Clare's/Saint Clares Hospital Oncology & Hematology Specialists, P.A.
City
Denville
State/Province
New Jersey
ZIP/Postal Code
07834
Country
United States
Facility Name
Morristown Memorial Hospital
City
Morristown
State/Province
New Jersey
ZIP/Postal Code
07950
Country
United States
Facility Name
New York Hospital Weill Cornell Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
Facility Name
Cleveland Clinic Taussig Cancer Center
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
12. IPD Sharing Statement
Citations:
Citation
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.
Results Reference
background
Citation
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.
Results Reference
background
PubMed Identifier
15102696
Citation
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. doi: 10.1158/1078-0432.ccr-03-0493.
Results Reference
background
Citation
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.
Results Reference
background
Citation
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:
Results Reference
background
Citation
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
Results Reference
background
Citation
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.
Results Reference
background
PubMed Identifier
26389849
Citation
Kalaycio ME, George Negrea O, Allen SL, Rai KR, Abbasi RM, Horne H, Wegener WA, Goldenberg DM. Subcutaneous injections of low doses of humanized anti-CD20 veltuzumab: a phase I study in chronic lymphocytic leukemia. Leuk Lymphoma. 2016;57(4):803-11. doi: 10.3109/10428194.2015.1085531. Epub 2015 Oct 19.
Results Reference
derived
PubMed Identifier
21173095
Citation
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. doi: 10.3324/haematol.2010.037390. Epub 2010 Dec 20.
Results Reference
derived
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Ph I/II Study of Subcutaneously Administered Veltuzumab (hA20) in NHL and CLL
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