Safety Study of Different Doses of hA20 (Veltuzumab) in CD20+ Non-Hodgkin's Lymphoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00596804
Recruitment Status : Completed
First Posted : January 17, 2008
Last Update Posted : February 6, 2012
Information provided by (Responsible Party):
Immunomedics, Inc.

January 8, 2008
January 17, 2008
February 6, 2012
March 2004
November 2007   (Final data collection date for primary outcome measure)
  • Safety of hA20 with this administration schedule and dosing [ Time Frame: first 12 weeks, then over 2 years ]
  • tolerance of hA20 with this administration schedule and dosing [ Time Frame: first 12 weeks ]
  • immunogenicity of hA20 with this administration schedule and dosing [ Time Frame: first 12 weeks, as needed over 2 years ]
Same as current
Complete list of historical versions of study NCT00596804 on Archive Site
  • Pharmacodynamics of hA20 [ Time Frame: first 12 weeks, then up to 2 years ]
  • pharmacokinetics hA20 [ Time Frame: first 12 weeks, then up to 2 years ]
  • assess efficacy [ Time Frame: 4 and 12 weeks, then every 3 months for 2 years ]
Same as current
Not Provided
Not Provided
Safety Study of Different Doses of hA20 (Veltuzumab) in CD20+ Non-Hodgkin's Lymphoma
A Phase I Study of Immunotherapy With hA20 Administered Once Weekly for 4 Consecutive Weeks in Patients With CD20+ Non- Hodgkin's Lymphoma
This study is being done to assess the safety and tolerance of different doses of humanized hA20 in patients with NHL.
Not Provided
Phase 1
Phase 2
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Non-Hodgkin's Lymphoma
  • Lymphoma, Diffuse
  • Lymphoma, Diffuse, Mixed Lymphocytic-Histiocytic
Drug: veltuzumab
once weekly intravenous dosing for 4 weeks
Other Names:
  • IMMU-106
  • hA20
  • humanized anti-CD20
Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Same as current
November 2007
November 2007   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Male or female, >18 years old
  • Histological diagnosis of CD20+ B-cell NHL (all grades) by WHO lymphoma criteria
  • Failed at least one prior standard chemotherapy regimen for NHL
  • Failed rituximab treatment for relapsed NHL
  • Measurable NHL disease by CT, with at least one lesion >1.5 cm in one dimension
  • Adequate performance status (>70 Karnofsky scale, 0-1 ECOG) with an estimated life expectancy of at least 6 months
  • Adequate hematologic status, without ongoing transfusional support (hemoglobin ≥ 10 g/dL, ANC ≥ 1.5 × 109/L, platelets ≥ 100 × 109/L)
  • Adequate renal and hepatic function, defined as: creatinine ≤ 1.5 x Institution Upper Limit of Normal (IULN), bilirubin ≤ 1.5 x IULN, AST and ALT ≤ 2.5 x IULN
  • Otherwise, <Grade 1 toxicity at study entry by NCI CTC version 2.0, including recovery from all acute toxicities incurred as a result of previous surgery, radiotherapy or chemotherapy, whether investigational or conventional.
  • At least 6 months beyond previous rituximab treatment, 12 weeks beyond autologous stem cell transplant, 4 weeks beyond chemotherapy, other experimental treatments, or any radiation therapy to the index lesion(s).
  • Ability to provide signed, informed consent

Exclusion Criteria:

  • Pregnant or lactating women. Women of childbearing potential are required to have a negative pregnancy test
  • Women of childbearing potential and fertile men who are not practicing or who are unwilling to practice birth control while enrolled in the study until at least 12 weeks after the last weekly hA20 infusion.
  • Rituximab resistant, defined as having progressed during or within 6 months of rituximab treatment.
  • Excessive toxicity to rituximab (NCI CTC Grade 3 or 4) or known to be HACA positive
  • Prior radioimmunotherapy, including Zevalin or Bexxar,
  • Prior therapy with other human or humanized monoclonal antibodies, unless HAHA tested and negative
  • Primary CNS lymphoma, HIV lymphoma or transformed lymphoma, or presence of symptomatic CNS metastases or carcinomatous meningitis.
  • Bulky disease by CT, defined as any single mass >10 cm in its greatest diameter
  • Pleural effusion with positive cytology for lymphoma Known to be HIV positive, or hepatitis B or C positive
  • Known autoimmune disease or presence of autoimmune phenomena.
  • Evidence of infection or requiring antibiotics within 5 days.
  • Corticosteroid use within 2 weeks
  • Prior malignancy with less than a 5-year disease-free interval, excluding nonmelanoma skin cancers and carcinoma in situ of the cervix.
  • Other concurrent medical or psychiatric conditions that, in the Investigator's opinion, may be likely to confound study interpretation or prevent completion of studyprocedures and follow-up examinations
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
France,   United Kingdom
Not Provided
Not Provided
Immunomedics, Inc.
Immunomedics, Inc.
Not Provided
Study Chair: William Wegener, MD, PhD Immunomedics, Inc.
Immunomedics, Inc.
February 2012

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