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

NCT00596804 | Completed Phase 1

• 1 other identifier: IM-T-hA20-01EU
• Study Type: interventional
• Target: 39
• Locations: 2 countries
• Sites: 3

Brief Summary

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

Conditions

Non-Hodgkin's Lymphoma; Lymphoma, Diffuse; Lymphoma, Diffuse, Mixed Lymphocytic-Histiocytic

Keywords

NHL; Non-Hodgkin's lymphoma; follicular lymphoma; B-cell lymphoma; diffuse large cell lymphoma; small lymphoctytic lymphoma; Mantle cell lymphoma; MALT; marginal zone lymphoma; High-Grade; Intermediate-Grade; Low-Grade; Mixed

Outcome Measures

Primary Outcomes (3)

• Safety of hA20 with this administration schedule and dosing

  first 12 weeks, then over 2 years

• tolerance of hA20 with this administration schedule and dosing

  first 12 weeks

• immunogenicity of hA20 with this administration schedule and dosing

  first 12 weeks, as needed over 2 years

Secondary Outcomes (3)

• Pharmacodynamics of hA20

  first 12 weeks, then up to 2 years

• pharmacokinetics hA20

  first 12 weeks, then up to 2 years

• assess efficacy

  4 and 12 weeks, then every 3 months for 2 years

Interventions

veltuzumab DRUG

once weekly intravenous dosing for 4 weeks

Also known as: IMMU-106, hA20, humanized anti-CD20

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Gilead Sciences: lead

Study Sites (3)

Service Des Maladies Du Sang

Lille, Cedex, 59037, France

Location

Centre hospitalier Lyon

Lyon, Pierre Benite Cedex, 69495, France

Location

University of Leicester

Leicester, LE1 9HN, United Kingdom

Location

Related Publications (7)

• Stein R, Qu Z, Chen S, Rosario A, Shi V, Hayes M, Horak ID, Hansen HJ, Goldenberg DM. Characterization of a new humanized anti-CD20 monoclonal antibody, IMMU-106, and Its use in combination with the humanized anti-CD22 antibody, epratuzumab, for the therapy of non-Hodgkin's lymphoma. Clin Cancer Res. 2004 Apr 15;10(8):2868-78. doi: 10.1158/1078-0432.ccr-03-0493.

  PMID: 15102696 BACKGROUND

• Stein R, Qu Z, Chen S, Solis D, Hansen HJ, Goldenberg DM. Characterization of a humanized IgG4 anti-HLA-DR monoclonal antibody that lacks effector cell functions but retains direct antilymphoma activity and increases the potency of rituximab. Blood. 2006 Oct 15;108(8):2736-44. doi: 10.1182/blood-2006-04-017921. Epub 2006 Jun 15.

  PMID: 16778139 BACKGROUND

• Goldenberg DM, Morschhauser F, Wegener WA. Veltuzumab (humanized anti-CD20 monoclonal antibody): characterization, current clinical results, and future prospects. Leuk Lymphoma. 2010 May;51(5):747-55. doi: 10.3109/10428191003672123.

  PMID: 20214444 BACKGROUND

• Franck Morschhauser1*, John P Leonard2, Bertrand Coiffier3*, et.al. INITIAL SAFETY AND EFFICACY RESULTS OF A SECOND-GENERATION HUMANIZED ANTI-CD20 ANTIBODY, IMMU-106 (HA20), IN NON-HODGKINS LYMPHOMA: ASH abstract 2005.

  RESULT

• 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

  RESULT

• 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

  RESULT

• Morschhauser F, Leonard JP, Fayad L, Coiffier B, Petillon MO, Coleman M, Schuster SJ, Dyer MJ, Horne H, Teoh N, Wegener WA, Goldenberg DM. Humanized anti-CD20 antibody, veltuzumab, in refractory/recurrent non-Hodgkin's lymphoma: phase I/II results. J Clin Oncol. 2009 Jul 10;27(20):3346-53. doi: 10.1200/JCO.2008.19.9117. Epub 2009 May 18.

  PMID: 19451441 RESULT

MeSH Terms

Conditions

Lymphoma, Non-Hodgkin; Lymphoma, Follicular; Lymphoma, B-Cell; Lymphoma, Large B-Cell, Diffuse; Lymphoma, Mantle-Cell; Lymphoma, B-Cell, Marginal Zone

Interventions

veltuzumab

Condition Hierarchy (Ancestors)

Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• William Wegener, MD, PhD

  Gilead Sciences

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 8, 2008
• First Posted: January 17, 2008
• Study Start: March 1, 2004
• Primary Completion: November 1, 2007
• Study Completion: November 1, 2007
• Last Updated: August 18, 2021

Record last verified: 2012-02

Locations

FR (2); GB (1)