Phase I/II Study of Subcutaneously Administered Veltuzumab (hA20) in Patients With CD20+ Non-Hodgkin's Lymphoma or Chronic Lymphocytic Leukemia
18 Years
N/A
Both
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
Trial Information
Phase I/II Study of Subcutaneously Administered Veltuzumab (hA20) in Patients With CD20+ Non-Hodgkin's Lymphoma or Chronic Lymphocytic Leukemia
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
Type of Study:
Interventional
Study Design:
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Safety/tolerability
Outcome Description:
safety will be assessed by monitoring lab results and adverse events, which will be assessed every 3 months for up to 2 years.
Outcome Time Frame:
over 2 years after treatment
Safety Issue:
Yes
Principal Investigator
William Wegener, MD, PhD
Investigator Role:
Study Director
Investigator Affiliation:
Immunomedics, Inc.
Authority:
United States: Food and Drug Administration
Study ID:
IM-T-hA20-08
NCT ID:
NCT00546793
Start Date:
January 2008
Completion Date:
March 2013
Related Keywords:
- 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
- humanized anti-CD20 veltuzumab (IMMU-106) administered subcutaneously
- 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
Name | Location |
|---|---|
| Morristown Memorial Hospital | Morristown, New Jersey 07962-1956 |
| Cleveland Clinic Taussig Cancer Center | Cleveland, Ohio 44195 |
| Lewis Cancer Center and Research Pavilion | Savannah, Georgia 31405 |
| Cancer Care at Saint Clare's/Saint Clares Hospital Oncology & Hematology Specialists, P.A. | Denville, New Jersey 07834 |
| New York Hospital Weill Cornell Medical Center | New York City, New York 10021 |
