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Non-Hodgkin LymphomaPhase 1NCT00103779

A Safety Study of SGN-40 in Patients With Non-Hodgkin's Lymphoma

A Phase 1 study testing SGN-40 (anti-huCD40 mAb) in people with Non-Hodgkin Lymphoma, run by Seagen Inc. at 5 sites in United States.

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 is an open-label, multi-dose, Phase I, dose escalation study to define the safety profile and preliminary anti-tumor activity of SGN-40 in patients with refractory or recurrent non-Hodgkin B-cell lymphomas. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Non-Hodgkin Lymphoma
What is being tested?
SGN-40 (anti-huCD40 mAb)
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
50 participants
Where
5 sitesUnited States
Study dates
Dec 2004to Mar 2007
Phase
Phase 1
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

  • Patients must have a histological diagnosis of B cell non-Hodgkin's lymphoma, including diffuse large B-cell, mantle cell, follicular, small lymphocytic, and marginal zone lymphoma by the World Health Organization criteria.
  • Patients must have an archived paraffin or fresh tumor specimen available for immunohistologic evaluation of CD40, CD20, \& CD79a.
  • Patients must have relapsed lymphoma and must have failed frontline chemotherapy.
  • Patients who have not received autologous stem cell transplant must have refused or be ineligible for it.
  • Patients must have completed radiotherapy, chemotherapy, and/or treatment with investigational anti-cancer agents 4 weeks prior to registration. Patients must have completed any monoclonal antibody treatment, including rituximab, 6 months prior to registration.
  • Patients must have completed autologous bone marrow transplant 4 months prior to registration.
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  • Patient must have at least one site of measurable disease defined by unidimensional lesion ≥ 2 cm by conventional CT scan.
  • Patients must have an ECOG performance status ≤ 2 and a life expectancy > 3 months.
  • Patients must have the following required baseline laboratory data:
  • Platelet count ≥ 75,000/mm3,
  • Hemoglobin ≥ 9.0 g/dL,
  • Absolute neutrophil count ≥ 1,250/mm3,
  • ALT/AST ≤ 2.5 times ULN,
  • Total bilirubin ≤ 1.5 times ULN,
  • Creatinine < 1.5 mg/dL,
  • Females of childbearing potential must have a negative serum β-hCG pregnancy test result within 3 days prior to the first dose of SGN-40 and must agree to use an effective contraceptive method during the course of the study and for 6 months following the last dose of study drug.
  • If a deep venous thrombosis or other vascular even has required medical or surgical intervention in the past year, patients must either be on stable dose of anticoagulant therapy for at least 3 weeks or have completed anticoagulant therapy at least 3 months prior to registration with radiographic confirmation that thrombosis is resolved.
  • Patients must be at least 18 years of age.
  • Patients must be available for periodic blood sampling, study-related assessments and management of toxicity at the treating institution.

Who cannot join

  • Patients with history or clinical evidence of leptomeningeal or central nervous system (CNS) lymphoma.
  • Patients with a documented history within 6 months of registration of a cerebral vascular event, myocardial infarction, deep venous thrombosis or other vascular event that has required medical or surgical intervention. Patients must have completed anticoagulant therapy at least 3 months prior to registration. Prophylactic anticoagulant therapy for indwelling catheters is acceptable.
  • Patients who have received an allogeneic stem cell transplant.
  • Patients who have had major surgery within 4 weeks prior to registration.
  • Patients with a known hypersensitivity to recombinant proteins or any excipient contained in the drug formulation.
  • Patients with a history of another primary malignancy that has not been in remission for at least 5 years (non-melanoma skin cancer and cervical carcinoma in situ on biopsy or a squamous intraepithelial lesion on PAP smear are exempt from the five year limit).
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  • Patients with any active systemic viral, bacterial, or fungal infection within four weeks prior to registration.
  • Patients with known positivity for HIV, hepatitis B or hepatitis C infection.
  • Patients with a history of significant chronic or recurrent infections requiring treatment.
  • Patients with a history of migraines or severe headaches requiring medical therapy within 12 months of enrollment.
  • Patients on systemic steroids who have not been on a stable daily dose (not exceeding 10 mg prednisone or equivalent) during 4 weeks prior to the first dose of SGN 40.
  • Patients who are pregnant or breastfeeding.
  • Patients with any serious underlying medical condition that would impair their ability to receive or tolerate the planned treatment.
  • Patients with dementia or altered mental status that would preclude the understanding and/or rendering of informed consent.

Trial locations and contacts

5 sites in 1 country.

5 sites in 1 country

United States5 sites

  • University of Alabama at Birmingham

    Birmingham, Alabama, 35294

  • University of Texas MD Anderson Cancer Center

    Houston, Texas, 77030

  • University of Miami

    Miami, Florida, 33136

  • Cornell University

    New York, New York, 10029

  • Stanford University

    Stanford, California, 94305

Other trials in United States

About this study

Official title: A Phase I, Multi-Dose Study of SGN-40 (Anti-huCD40 mAb) in Patients With Non-Hodgkin's Lymphoma

This is an open-label, multi-dose, Phase I, dose escalation study to define the safety profile and preliminary anti-tumor activity of SGN-40 in patients with refractory or recurrent non-Hodgkin B-cell lymphomas.

Read the detailed description

A minimum of 3 patients will be entered into each dose-level cohort for 5 weeks. A dose-escalation schema will be employed in cohorts. The initial dose starts at 1 mg/kg on Day 1 and 4 followed by 2mg/kg on Day 8. Dose escalation will occur on weeks 3-5 with a maximum weekly dose of 8 mg/kg. Patients who meet criteria of at least partial response will be eligible for additional 4 weekly doses at highest dose tolerated.

Being tested
SGN-40 (anti-huCD40 mAb)
Keywords
Antigens, CD40, Antibody, Monoclonal, Lymphoma, Non-Hodgkin, Lymphoma, B-Cell, Hematologic Diseases, Immunoproliferative Disorders, Lymphatic Diseases, Lymphoproliferative Disorders, Lymphoma
Medical subject headings
Lymphoma, Non-Hodgkin, Lymphoma, B-Cell, Hematologic Diseases, Immunoproliferative Disorders, Lymphatic Diseases, Lymphoproliferative Disorders, Lymphoma

What participants receive

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

  • SGN-40 (anti-huCD40 mAb)Drug

    Also called dacetuzumab

    1 mg/kg IV (in the vein) on Day 1; 1-2 mg/kg IV on Day 4; 2-4 mg/kg IV on Day 8; 3-8 mg/kg on Days 15, 22 and 29.

Study groups in NCT00103779
Study groupRoleWhat they receive
1ExperimentalNot described
Receives: Drug: SGN-40 (anti-huCD40 mAb)

What is being measured

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

  1. Adverse events and lab abnormalities.

Timeline

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

  1. First posted15 Feb 2005 (estimated)
  2. Study startDec 2004
  3. Primary completionMar 2007
  4. Study completionMar 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
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
50 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00103779
Sponsor's protocol ID
SG040-0002
Status last verified
Dec 2014
First submitted
14 Feb 2005
Last updated
18 Dec 2014
Results posted
No
Data monitoring committee
No
Expanded access
Available

Publications

  • Advani R, Forero-Torres A, Furman RR, Rosenblatt JD, Younes A, Ren H, Harrop K, Whiting N, Drachman JG. Phase I study of the humanized anti-CD40 monoclonal antibody dacetuzumab in refractory or recurrent non-Hodgkin's lymphoma. J Clin Oncol. 2009 Sep 10;27(26):4371-7. doi: 10.1200/JCO.2008.21.3017. Epub 2009 Jul 27.

    PubMed 19636010

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing SGN-40 (anti-huCD40 mAb) in people with Non-Hodgkin Lymphoma, run by Seagen Inc. at 5 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 19 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 Dec 2014. 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 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 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.

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?

Adverse events and lab abnormalities.. 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 NCT00103779, which also lists 1 linked publication.

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 Dec 2014; AzTrials last refreshed its copy on 7 Nov 2026.

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