or
forgot password

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


Phase 1/Phase 2
18 Years
N/A
Not Enrolling
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

Thank you

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