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.

Brief Summary:
This study is being done to assess the safety and tolerance of different doses of humanized hA20 in patients with NHL.

Condition or disease Intervention/treatment Phase
Non-Hodgkin's Lymphoma Lymphoma, Diffuse Lymphoma, Diffuse, Mixed Lymphocytic-Histiocytic Drug: veltuzumab Phase 1 Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 39 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase I Study of Immunotherapy With hA20 Administered Once Weekly for 4 Consecutive Weeks in Patients With CD20+ Non- Hodgkin's Lymphoma
Study Start Date : March 2004
Actual Primary Completion Date : November 2007
Actual Study Completion Date : November 2007

Intervention Details:
  • Drug: veltuzumab
    once weekly intravenous dosing for 4 weeks
    Other Names:
    • IMMU-106
    • hA20
    • humanized anti-CD20

Primary Outcome Measures :
  1. Safety of hA20 with this administration schedule and dosing [ Time Frame: first 12 weeks, then over 2 years ]
  2. tolerance of hA20 with this administration schedule and dosing [ Time Frame: first 12 weeks ]
  3. immunogenicity of hA20 with this administration schedule and dosing [ Time Frame: first 12 weeks, as needed over 2 years ]

Secondary Outcome Measures :
  1. Pharmacodynamics of hA20 [ Time Frame: first 12 weeks, then up to 2 years ]
  2. pharmacokinetics hA20 [ Time Frame: first 12 weeks, then up to 2 years ]
  3. assess efficacy [ Time Frame: 4 and 12 weeks, then every 3 months for 2 years ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00596804

Service Des Maladies Du Sang
Lille, Cedex, France, 59037
Centre hospitalier Lyon
Lyon, Pierre Benite Cedex, France, 69495
United Kingdom
University of Leicester
Leicester, United Kingdom, LE1 9HN
Sponsors and Collaborators
Immunomedics, Inc.
Study Chair: William Wegener, MD, PhD Immunomedics, Inc.

Publications of Results:
Morschhauser F, Leonard JP, Coiffier B Petillon M, Coleman M,. Bahkti A, Teoh N, Wegener WA, Goldenberg DM. Phase I/II result of a seoncd-generation humanized anti- CD20 antibody, IMMU-106 (.hA20), in NHL: 2006 ASCO Annual Meeting.Proceedings; 24/18S Part I of II:429s
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

Other Publications:
Responsible Party: Immunomedics, Inc. Identifier: NCT00596804     History of Changes
Other Study ID Numbers: IM-T-hA20-01EU
First Posted: January 17, 2008    Key Record Dates
Last Update Posted: February 6, 2012
Last Verified: February 2012

Keywords provided by Immunomedics, Inc.:
Non-Hodgkin's lymphoma
follicular lymphoma
B-cell lymphoma
diffuse large cell lymphoma
small lymphoctytic lymphoma
Mantle cell lymphoma
marginal zone lymphoma

Additional relevant MeSH terms:
Lymphoma, Non-Hodgkin
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases