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NHLPhase 1/2NCT00421395

Safety Study of NHL With 90Y-hLL2 IgG

A Phase 1/2 study testing 90Y-hLL2 in people with NHL and B-cell NHL, run by Gilead Sciences at 5 sites in 2 countries.

Completed

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

Official record
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Trial summary

This will be an open label, multiple center, non-randomized, dose-escalation Phase I/II trial, designed to evaluate the safety and effectiveness of a repeated, outpatient regimen utilizing IMMU-hLL2 intact monoclonal antibody IgG labeled with different doses of 90Y for the treatment of patients B-cell lymphoma (NHL). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
NHL, B-cell NHL, Non-Hodgkins Lymphoma
What is being tested?
90Y-hLL2
Could I receive a placebo?
No, everyone receives an active treatment
How many people
59 participants
Where
5 sitesin 2 countries
Study dates
Aug 2002to Oct 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

  • All patients must have a histologic or cytological diagnosis of B-cell lymphoma, and have failed at least one regimen of standard chemotherapy. All histologic grades of non-Hodgkin's lymphoma (NHL) will be eligible for these studies.
  • Patients must be > 18 years of age
  • Measurable disease by CT, with at least one lesion > 1.5 cm in one or both dimensions
  • less than 25% bone marrow involvement as determined by bone marrow biopsy
  • Patient must have greater than 15% cellularity of the bone marrow.
  • Patients must be at least 4 weeks beyond any major surgery.
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  • Patients must be at least 4 weeks beyond any radiation therapy to the index lesion and must have recovered from radiation induced toxicity.
  • Patients must be at least 4 weeks beyond prior chemotherapy and/or immunotherapy, or 2-weeks after corticosteroids, and their blood counts must be within the eligibility criteria. Corticosteroids may, however, be given concomitantly if used to treat adrenal insufficiency
  • Patients must have a performance status of 70 or greater on the Karnofsky scale equivalent to ECOG 0-1 (See Appendix A) and a minimal life expectancy of 6 months.
  • Patients must be able to give cognizant informed consent.

Who cannot join

  • Patients with a significant concurrent medical complication including severe anorexia, nausea or vomiting that in the judgement of the Investigator could affect the patient's ability to tolerate or complete this study.
  • Patients with metastasis to the brain.
  • Patients with extensive irradiation to more than 25% of their red marrow will be excluded, except those who had total body irradiation in the context of bone marrow or stem cell transplantation regimen with subsequent engraftment of a functional marrow (i.e., resulting in normal peripheral blood counts). Subjects who have received external radiation to specific organs or areas at the maximum tolerated level are also excluded.
  • Women who test positive for pregnancy.
  • Patients with splenomegaly.
  • Patients with > 4 treatment regimens prior to this protocol, including chemotherapy, radiotherapy and/or other immunotherapy.
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  • Patients with prior radioimmunotherapy treatments (unless for retreatment under this protocol).
  • Patients receiving rituximab within 3 months, unless progressing after treatment.
  • Patients with <50% LVEF by required MUGA or 2-D ECHO.
  • Patients with <60% of predicted value by required pulmonary function tests.
  • Patients who have active Hepatitis B or C or are known HIV positive.
  • Patients with another primary malignancy (except basal/squamous cell carcinoma of the skin or carcinoma in-situ of the cervix.
  • Patients with other serious medical, surgical, or psychiatric history, unless currently stable and well controlled, without significant increase in treatment medications for at least 30 days preceding study entry.

Trial locations and contacts

5 sites in 2 countries.

5 sites in 2 countries

Germany3 sites

  • University Hospital Dresden

    Dresden, 01307

  • Klinikum der Georg-August-Universitat Gottingen

    Göttingen, 37075

  • Universitatsklinikum University of Saarland

    Homburg/Saar, D-66421

Other trials in Germany

France2 sites

  • Service des Maladies du Sang

    Lille, 59037

  • Research Unit 463 INSERM

    Nantes, Cedex, 44035

Other trials in France

About this study

Official title: Phase I/II Radioimmunotherapy of Non-Hodgkin's Lymphoma With Radiolabeled Humanized IMMU-LL2: Treatment With 90Y-hLL2 IgG

This will be an open label, multiple center, non-randomized, dose-escalation Phase I/II trial, designed to evaluate the safety and effectiveness of a repeated, outpatient regimen utilizing IMMU-hLL2 intact monoclonal antibody IgG labeled with different doses of 90Y for the treatment of patients B-cell lymphoma (NHL).

Read the detailed description

90Y-labeled hLL2 will be administered according to a schedule based upon whether or not a patient had prior high-dose chemotherapy with a marrow or stem cell transplant. Patients with both indolent and aggressive types of NHL will be enrolled at each dose level without segregation. However, at the conclusion of the trial, with the maximum tolerated dose (MTD) defined, a minimum number of 6 patients with indolent NHL, 6 patients with aggressive NHL, and 6 patients with >25% bone marrow involvement will be studied at that dose level.

Being tested
90Y-hLL2
Keywords
NHL, B-cell NHL, Non-Hodgkins lymphoma
Medical subject headings
Lymphoma, Non-Hodgkin

What participants receive

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

  • 90Y-hLL2Biological

    Also called epratuzumab, hLL2

    weekly dosing for either 2 or 3 weeks

Study groups in NCT00421395
Study groupRoleWhat they receive
multiExperimentalescalating in increments of 2.5 mCi/m2
Receives: Biological: 90Y-hLL2

What is being measured

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

  1. Safety will be evaluated from physical examinations, hematology and chemistry testing and toxicity evaluation

    Measured: First 12 weeks, total 5 years

Secondary outcomes (3)

  1. Determine maximum tolerated dose (MTD)

    Measured: first 12 weeks

  2. Evaluate the immunogenicity and safety of repeated infusions of 90Y-hLL2 in NHL patients.

    Measured: 6 weeks, 12 weeks, every 3 months if HAHA elevated

  3. Determine the therapeutic effects, in terms of objective response rate and duration, of the therapeutic agent in NHL patients.

    Measured: 6 wks, 12 wks, every 3 mos for 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 Jan 2007 (estimated)
  2. Study startAug 2002
  3. Primary completionOct 2007
  4. Study completionOct 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
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
59 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00421395
Sponsor's protocol ID
IM-T-hLL2-06EU
Status last verified
Jan 2008
First submitted
11 Jan 2007
Last updated
16 Aug 2021
Results posted
No
Data monitoring committee
No

Publications

  • Linden O, Hindorf C, Cavallin-Stahl E, Wegener WA, Goldenberg DM, Horne H, Ohlsson T, Stenberg L, Strand SE, Tennvall J. Dose-fractionated radioimmunotherapy in non-Hodgkin's lymphoma using DOTA-conjugated, 90Y-radiolabeled, humanized anti-CD22 monoclonal antibody, epratuzumab. Clin Cancer Res. 2005 Jul 15;11(14):5215-22. doi: 10.1158/1078-0432.CCR-05-0172.

    PubMed 16033839

  • Linden O, Tennvall J, Cavallin-Stahl E, Darte L, Garkavij M, Lindner KJ, Ljungberg M, Ohlsson T, Sjogreen K, Wingardh K, Strand SE. Radioimmunotherapy using 131I-labeled anti-CD22 monoclonal antibody (LL2) in patients with previously treated B-cell lymphomas. Clin Cancer Res. 1999 Oct;5(10 Suppl):3287s-3291s.

    PubMed 10541377

  • Hindorf C, Linden O, Stenberg L, Tennvall J, Strand SE. Change in tumor-absorbed dose due to decrease in mass during fractionated radioimmunotherapy in lymphoma patients. Clin Cancer Res. 2003 Sep 1;9(10 Pt 2):4003S-6S.

    PubMed 14506200

  • Sharkey RM, Burton J, Goldenberg DM. Radioimmunotherapy of non-Hodgkin's lymphoma: a critical appraisal. Expert Rev Clin Immunol. 2005 May;1(1):47-62. doi: 10.1586/1744666X.1.1.47.

    PubMed 20477654

  • Sharkey RM, Brenner A, Burton J, Hajjar G, Toder SP, Alavi A, Matthies A, Tsai DE, Schuster SJ, Stadtmauer EA, Czuczman MS, Lamonica D, Kraeber-Bodere F, Mahe B, Chatal JF, Rogatko A, Mardirrosian G, Goldenberg DM. Radioimmunotherapy of non-Hodgkin's lymphoma with 90Y-DOTA humanized anti-CD22 IgG (90Y-Epratuzumab): do tumor targeting and dosimetry predict therapeutic response? J Nucl Med. 2003 Dec;44(12):2000-18.

    PubMed 14660727

  • Griffiths GL, Govindan SV, Sharkey RM, Fisher DR, Goldenberg DM. 90Y-DOTA-hLL2: an agent for radioimmunotherapy of non-Hodgkin's lymphoma. J Nucl Med. 2003 Jan;44(1):77-84.

    PubMed 12515879

  • Lindén O, et al. Outcome and absorbed dose following 90-yttrium-epratuzumab in B-cell lymphoma, using a dose-fractionation schedule. (Abstract No. 1479) Blood 2003; 102/11:407a.

  • Postema EJ, Borjesson PK, Buijs WC, Roos JC, Marres HA, Boerman OC, de Bree R, Lang M, Munzert G, van Dongen GA, Oyen WJ. Dosimetric analysis of radioimmunotherapy with 186Re-labeled bivatuzumab in patients with head and neck cancer. J Nucl Med. 2003 Oct;44(10):1690-9.

    PubMed 14530488

  • Leonard JP, Siegel JA, Goldsmith SJ. Comparative physical and pharmacologic characteristics of iodine-131 and yttrium-90: implications for radioimmunotherapy for patients with non-Hodgkin's lymphoma. Cancer Invest. 2003 Apr;21(2):241-52. doi: 10.1081/cnv-120016421.

    PubMed 12743990

  • Lindén O, et al. Radioimmunotherapy with Y-90-Epratuzumab in patients with previously treated B-cell lymphoma. A fractionated dose-escalation study. (Abstract 5.05 Hematology) Special Issue: World Congress of Nuclear Medicine, September 2002; 5/17.

  • Liu, Huaitian, et al. Targeting the CD22 receptor with RNA damaging agents. Cancer Drug Discovery and Development: Tumor Targeting in Cancer Therapy. Edited by: M Pagé, Humana Press Inc., Totowa, NJ: 109-118

  • Lindén O, et al. Durable response to 90-yttrium-epratuzumab (hLL2) in B-cell lymphoma failing chemotherapy by using dose-fractionation schedule. (Abstract presented at the American Society of Hematology 43rd Annual Meeting) Blood 2001; 98/11: 602a

  • Hajjar G. et al. Phase I/II radioimmunotherapy trial with 90Y-labeled epratuzumab (LymphoCide; anti-CD22 monoclonal antibody) in relapsed/refractory non-Hodgkin's lymphoma (NHL). (Abstract #583) J Nucl Med Suppl, May 2001; 42/5: 156P.

  • Goldenberg DM. The role of radiolabeled antibodies in the treatment of non-Hodgkin's lymphoma: the coming of age of radioimmunotherapy. Crit Rev Oncol Hematol. 2001 Jul-Aug;39(1-2):195-201. doi: 10.1016/s1040-8428(01)00108-1.

    PubMed 11418316

  • Juweid M, Schuster SL, et al. Updated results of radioimmunotherapy of relapsed/refractory non-Hodgkin's lymphoma with conventional and stem cell supported doses of 90Y-labeled humanized LL2 anti-CD22 monoclonal antibody. (Abstract #40) Cancer Biother & Radiopharm 2000, 15/4: 408

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing 90Y-hLL2 in people with NHL and B-cell NHL, run by Gilead Sciences at 5 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 10 inclusion and 13 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 16 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 5 sites in Germany, France. 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 will be evaluated from physical examinations, hematology and chemistry testing and toxicity evaluation (time frame: First 12 weeks, total 5 years). 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 NCT00421395, which also lists 20 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 16 Aug 2021.

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