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



Status:Recruiting
Conditions:Blood Cancer, Lymphoma, Hematology
Therapuetic Areas:Hematology, Oncology
Healthy:No
Age Range:Any
Updated:2/4/2013
Start Date:January 2008
Contact:Heather Horne
Email:hhorne@immunomedics.com
Phone:973-727-7589

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


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.


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

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
We found this trial at
6
sites
Huntington, West Virginia 25701
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Huntington, WV
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2010 E 90th St
Cleveland, Ohio 44195
(866) 223-8100
Cleveland Clinic Taussig Cancer Center At Taussig Cancer Institute, more than 250 highly skilled doctors,...
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Cleveland, OH
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Denville, NJ
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100 Madison Ave
Morristown, New Jersey 7960
(973) 971-5000
Morristown Memorial Hospital Atlantic Health System – comprised of Morristown Medical Center, Overlook Medical Center,...
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Morristown, NJ
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New York City, New York 10021
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New York City, NY
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from
Savannah, GA
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