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Non-Hodgkin's LymphomaPhase 1/2NCT00596804

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

A Phase 1/2 study testing veltuzumab in people with Non-Hodgkin's Lymphoma and Lymphoma, Diffuse, run by Gilead Sciences at 3 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

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

Who is it for?
Ages 18 years and older
What is being tested?
veltuzumab
Type of treatment
Injection or infusion
How many people
39 participants
Where
3 sitesin 2 countries
Study dates
Mar 2004to Nov 2007
Phase
Phase 1/2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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

Who cannot join

  • 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
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  • 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

Trial locations and contacts

3 sites in 2 countries.

3 sites in 2 countries

France2 sites

  • Service Des Maladies Du Sang

    Lille, Cedex, 59037

  • Centre hospitalier Lyon

    Lyon, Pierre Benite Cedex, 69495

Other trials in France

United Kingdom1 site

  • University of Leicester

    Leicester, LE1 9HN

Other trials in United Kingdom

About this study

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

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

Being tested
veltuzumab
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
Medical subject headings
Lymphoma, Non-Hodgkin, Lymphoma, Follicular, Lymphoma, B-Cell, Lymphoma, Large B-Cell, Diffuse, Lymphoma, Mantle-Cell, Lymphoma, B-Cell, Marginal Zone

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • veltuzumabDrug

    Also called IMMU-106, hA20, humanized anti-CD20

    once weekly intravenous dosing for 4 weeks

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Safety of hA20 with this administration schedule and dosing

    Measured: first 12 weeks, then over 2 years

  2. tolerance of hA20 with this administration schedule and dosing

    Measured: first 12 weeks

  3. immunogenicity of hA20 with this administration schedule and dosing

    Measured: first 12 weeks, as needed over 2 years

Secondary outcomes (3)

  1. Pharmacodynamics of hA20

    Measured: first 12 weeks, then up to 2 years

  2. pharmacokinetics hA20

    Measured: first 12 weeks, then up to 2 years

  3. assess efficacy

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Jan 2008 (estimated)
  2. Study startMar 2004
  3. Primary completionNov 2007
  4. Study completionNov 2007

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
39 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00596804
Sponsor's protocol ID
IM-T-hA20-01EU
Status last verified
Feb 2012
First submitted
8 Jan 2008
Last updated
18 Aug 2021
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 15102696

  • 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.

    PubMed 16778139

  • 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.

    PubMed 20214444

  • 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.

  • 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

  • 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.

    PubMed 19451441

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing veltuzumab in people with Non-Hodgkin's Lymphoma and Lymphoma, Diffuse, run by Gilead Sciences at 3 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in France, United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Safety of hA20 with this administration schedule and dosing (time frame: first 12 weeks, then over 2 years). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00596804, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Aug 2021.

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