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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Immunomedics, Inc.
ClinicalTrials.gov Identifier:
NCT00596804
First received: January 8, 2008
Last updated: February 2, 2012
Last verified: February 2012

January 8, 2008
February 2, 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 ] [ Designated as safety issue: Yes ]
  • tolerance of hA20 with this administration schedule and dosing [ Time Frame: first 12 weeks ] [ Designated as safety issue: Yes ]
  • immunogenicity of hA20 with this administration schedule and dosing [ Time Frame: first 12 weeks, as needed over 2 years ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00596804 on ClinicalTrials.gov Archive Site
  • Pharmacodynamics of hA20 [ Time Frame: first 12 weeks, then up to 2 years ] [ Designated as safety issue: No ]
  • pharmacokinetics hA20 [ Time Frame: first 12 weeks, then up to 2 years ] [ Designated as safety issue: No ]
  • assess efficacy [ Time Frame: 4 and 12 weeks, then every 3 months for 2 years ] [ Designated as safety issue: No ]
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
Interventional
Phase 1
Phase 2
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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:
  • veltuzumab
  • IMMU-106
  • hA20
  • humanized anti-CD20
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
39
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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
France,   United Kingdom
 
NCT00596804
IM-T-hA20-01EU
No
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