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Non Hodgkin's LymphomaPhase 1/2NCT01101581

Study of Veltuzumab and 90Y-Epratuzumab in Relapsed/Refractory, Aggressive NHL

A Phase 1/2 study testing Veltuzumab and 90Y-Epratuzumab Tetraxetan, 90Y-epratuzumab tetraxetan and veltuzumab in people with Non Hodgkin's Lymphoma and NHL, run by Gilead Sciences at 7 sites in United States.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial summary

The goal of this study is to evaluate a new approach to immunotherapy in NHL by combining two antibodies, veltuzumab and epratuzumab. For treatment, epratuzumab has also been attached to a radioactive isotope called 90yttrium (90Y-epratuzumab). Veltuzumab and 90Y-epratuzumab attack different areas on lymphoma cells. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Non Hodgkin's Lymphoma, NHL, Aggressive NHL
What is being tested?
Veltuzumab and 90Y-Epratuzumab Tetraxetan, 90Y-epratuzumab tetraxetan and veltuzumab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
7 sitesUnited States
Study dates
May 2010to Mar 2017
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, with DLBCL or other aggressive lymphomas by WHO lymphoma criteria including mantle cell lymphoma and transformed follicular lymphoma.
  • Failed at least one prior standard treatment regimen for NHL
  • If DLBCL, either received, ineligible for or refused high-dose chemotherapy with stem cell transplant
  • 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
Show all 14Show fewer
  • Laboratory parameters:
  • Adequate hematology (Hemoglobin >/= 10 g/dL, ANC >/= 1.5 ´ 109/L, platelets >/=100 x 109/L) without ongoing transfusional support
  • Adequate renal and liver function (creatinine and bilirubin </= 1.5 x IULN; AST and ALT </= 2.5 x IULN)
  • Otherwise, <Grade 1 toxicity at study entry by NCI CTC version 3.0.
  • 3 months beyond any prior rituximab or veltuzumab treatment, 12 weeks beyond autologous stem cell transplant and 4 weeks beyond chemotherapy, other experimental treatments, or any radiation therapy to the index lesion(s).
  • Screened for hepatitis B (no time limit) and negative by tests included in NCCN guidelines (hepatitis B surface antigen/antibodies, core antigen/antibodies, hepatitis B e-antigen).
  • Patients of childbearing potential must be willing to practice birth control during the study until at least 12 weeks after last veltuzumab infusion; women of childbearing potential must have a negative urine or serum pregnancy test to enter the study.
  • 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
  • NCI CTC Grade 3 or 4 infusion reaction to prior anti-CD20 antibodies (rituximab, veltuzumab, etc.)
  • A known anti-antibody response to prior antiCD20 antibodies (HACA positive, HAHA positive, etc)
  • Prior radioimmunotherapy, including Zevalin or Bexxar.
  • Prior high-dose chemotherapy with peripheral blood stem cell transplant.
  • 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.
  • Rituximab or veltuzumab resistant, defined as having progressed during or within 6 months of any prior rituximab or veltuzumab treatment.
  • Bulky disease by CT, defined as any single mass >10 cm in its greatest diameter
  • Bone marrow involvement ≥25%
  • Prior external beam radiation therapy to >30% bone marrow.
  • Pleural effusion with positive cytology for lymphoma
  • Patients known to be HIV positive, hepatitis B positive, or hepatitis C positive
  • Known autoimmune disease or presence of autoimmune phenomena.
  • Evidence of infection or requiring antibiotics within 7 days.
  • Use of systemic corticosteroids within 2 weeks, except low dose regimens (prednisone, <20 mg/day, or equivalent) which may continue if unchanged.
  • Prior malignancies (other than non-melanoma skin cancer or carcinoma in situ of the cervix) unless disease free for 5 years.
  • 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 study procedures and follow-up examinations

Trial locations and contacts

7 sites in 1 country.

7 sites in 1 country

United States7 sites

  • Goshen Center for Cancer Care

    Goshen, Indiana, 46526

  • Weill Med College of Cornell Univ/NYH

    New York, New York, 10021

  • Helen F. Graham Cancer Center

    Newark, Delaware, 19713

  • MDACC Orlando

    Orlando, Florida, 32806

  • University of Pennsylvania Cancer Center

    Philadelphia, Pennsylvania, 19104

  • Mayo Clinic

    Rochester, Minnesota, 55905

  • Moffitt Cancer Center

    Tampa, Florida, 33612

Other trials in United States

About this study

Official title: Phase I/II Study of Veltuzumab Combined With 90Y-Epratuzumab Tetraxetan in Patients With Relapsed/Refractory, Aggressive Non- Hodgkin's Lymphoma

The goal of this study is to evaluate a new approach to immunotherapy in NHL by combining two antibodies, veltuzumab and epratuzumab. For treatment, epratuzumab has also been attached to a radioactive isotope called 90yttrium (90Y-epratuzumab). Veltuzumab and 90Y-epratuzumab attack different areas on lymphoma cells. Because of this, treatment with the combination may provide more effective treatment in NHL than either veltuzumab or 90Y-epratuzumab given alone.

Read the detailed description

The treatment portion of this study consists of study drug administrations each week for four weeks in a row (a total of 4 treatment days). Patients will then return at intervals up to 12 weeks for blood samples and for evaluations to see if their disease responded and to monitor any adverse effects related to treatment. Some blood tests may then need to be repeated at least a few times and/or until any abnormal findings at earlier evaluations have resolved. Otherwise, patients will continue to be evaluated every 3 months for two years, then every 6 months up to 5 years or until the disease worsens. Participation in the study will end when NHL disease worsens.

Being tested
Veltuzumab and 90Y-Epratuzumab Tetraxetan, 90Y-epratuzumab tetraxetan, veltuzumab
Keywords
Diffuse Large cell NHL, Mantle cell NHL, Lymphoblastic lymphoma, Diffuse mixed cell lymphoma, Diffuse large cell lymphoma, large noncleaved cell lymphoma
Medical subject headings
Lymphoma, Non-Hodgkin, Lymphoma, Large B-Cell, Diffuse, Precursor Cell Lymphoblastic Leukemia-Lymphoma

What participants receive

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

  • Veltuzumab and 90Y-Epratuzumab TetraxetanDrug

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

    Veltuzumab will be administered subcutaneously in phase 2. 90Y-Epratuzumab tetraxetan will be administered intravenously. Veltuzumab is given once weekly for 4 weeks. 90Y-Epratuzumab is also given at treatment weeks 2 \& 3 (days 8 \& 15).

  • 90Y-epratuzumab tetraxetanDrug

    Also called 90Y-hLL2, 90Y-hLL2-DOTA, 90Y-CD22

  • veltuzumabDrug

    Also called hA20, humanized CD20, IMMU-106

    Veltuzumab will be administered subcutaneously on days 1, 8, 15 and 23

Study groups in NCT01101581
Study groupRoleWhat they receive
Veltuzumab and 90Y-Epratuzumab TetraxetanExperimentalVeltuzumab and 90Y-Epratuzumab Tetraxetan target different b-cells. Veltuzumab will be administered in all 4 weekly study drug treatments. 90Y-Epratuzumab Tetraxetan will be administered only on days 8 \& 15. The dose of veltuzumab remains the same for all patients.
Receives: Drug: Veltuzumab and 90Y-Epratuzumab Tetraxetan; Drug: 90Y-epratuzumab tetraxetan; Drug: veltuzumab
90Y-epratuzumab tetraxetanExperimental90Y-epratuzumab tetraxetan will be administered 6 mCi/m2 on days 8 and 15.
Receives: Drug: 90Y-epratuzumab tetraxetan

What is being measured

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

  1. Safety/dose limiting toxicity

    Patients are closely monitored during and after all infusions, and then at intervals over a 12-week post-treatment evaluation period. Safety evaluations required in all patients include vital signs, physical examination, CBC, serum chemistries, serum immunoglobulins, urinalysis, peripheral blood B-cell levels (immunophenotyping based on CD19), and HAHA (to be analyzed by Sponsor). Adverse events and abnormal laboratories will be graded for toxicity according to NCI CTC v3.0 criteria.

    Measured: 12 weeks

Secondary outcomes (1)

  1. Efficacy

    CT or PET/CT imaging will be used to quantify changes in index lesions identified on baseline imaging, with responses classified according to revised response criteria for NHL (Cheson, 2007).

    Patients with stable disease or objective responses continue limited follow-up evaluations, including CT evaluations, physical examinations and serum laboratories every 3 months for the first year and then every 6 months up to a total of 5 years or until progression of disease.

    Measured: 12 weeks-5 years

Timeline

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

  1. First posted12 Apr 2010 (estimated)
  2. Study startMay 2010
  3. Primary completionDec 2016
  4. Study completionMar 2017

Why it stopped: No subjects enrolled

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
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01101581
Sponsor's protocol ID
IM-T-hA20/90Y-hLL2-01
Status last verified
Dec 2020
First submitted
16 Mar 2010
Last updated
18 Aug 2021
Results posted
No
Data monitoring committee
No

Publications

  • 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

  • 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

  • Morschhauser F, Kraeber-Bodere F, Wegener WA, Harousseau JL, Petillon MO, Huglo D, Trumper LH, Meller J, Pfreundschuh M, Kirsch CM, Naumann R, Kropp J, Horne H, Teoh N, Le Gouill S, Bodet-Milin C, Chatal JF, Goldenberg DM. High rates of durable responses with anti-CD22 fractionated radioimmunotherapy: results of a multicenter, phase I/II study in non-Hodgkin's lymphoma. J Clin Oncol. 2010 Aug 10;28(23):3709-16. doi: 10.1200/JCO.2009.27.7863. Epub 2010 Jul 12.

    PubMed 20625137

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Veltuzumab and 90Y-Epratuzumab Tetraxetan, 90Y-epratuzumab tetraxetan and veltuzumab in people with Non Hodgkin's Lymphoma and NHL, run by Gilead Sciences at 7 sites in United States.

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 14 inclusion and 19 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: withdrawn, 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 7 sites in United States. 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 was withdrawn before enrolling participants, so there are no results.

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/dose limiting toxicity (time frame: 12 weeks). 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 NCT01101581, which also lists 3 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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