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Leukemia, Lymphocytic, ChronicPhase 1/2NCT00283101

A Safety Study in Patients With Chronic Lymphocytic Leukemia

A Phase 1/2 study testing SGN-40 (anti-huCD40 mAb) in people with Leukemia, Lymphocytic, Chronic, run by Seagen Inc. at 4 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, dose-escalation study to determine the tolerability, safety profile, and antitumor activity of SGN-40 in patients with CLL. All patients will receive dose escalation during the first two weeks regardless of cohort designation. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Leukemia, Lymphocytic, Chronic
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
12 participants
Where
4 sitesUnited States
Study dates
Jul 2005to Oct 2006
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

  • Patients must have a histologic diagnosis of CLL as defined by the WHO criteria and exhibit active disease requiring treatment as per the NCI working group on CLL.
  • Patients must have a fresh tumor specimen available (peripheral blood or bone marrow) for flow cytometry evaluation (e.g. CD40, CD38, CD20, CD19, and CD5).For the phase 2 portion of the study, CD40 expression on malignant cells must be confirmed prior to registration.
  • Patients must have relapsed after receiving at least one fludarabine containing regimen or an equivalent purine analog.
  • At study start patients must be at least 8 weeks or 5 plasma half-lives (whichever is greater) from prior chemotherapy/radiation/investigational agents, 8 weeks from prior antibody therapy and 6 months from autologous stem cell transplant.
  • Patients must have an ECOG performance status ≤ 2 and a life expectancy > 3 months.
  • Patients must have the following required baseline laboratory data:
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  • Platelet count ≥ 50,000/mm3 (may be maintained by transfusion)
  • Hemoglobin ≥ 7.5 g/dL (may be maintained by transfusions or growth factors)
  • Absolute neutrophil count ≥ 1,000/mm3 (may be maintained by growth factors)
  • ALT/AST ≤ 2.0 times ULN
  • Total bilirubin ≤ 2.0 times ULN (unless related to hemolysis)
  • Creatinine < 2.0 times ULN
  • Females of childbearing potential must have a negative B-hCG pregnancy test result within 3 days prior to the first dose 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 event has required medical or surgical intervention in the past year, patients must either: a) be on a stable dose of anticoagulant therapy (i.e., Coumadin and/or Heparin) for at least three weeks or b) have completed anticoagulant therapy at least three months prior to registration with radiographic confirmation that thrombosis is resolved. Prophylactic anticoagulant therapy for indwelling catheters is acceptable.
  • 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.
  • Patients must give written informed consent. A copy of the signed informed consent form will be retained by the treating institution.

Who cannot join

  • Patients who have been treated previously with any anti-CD40 antibody.
  • Patients with a documented history within 6 months of registration of a cerebral vascular event (stroke or TIA), unstable angina, or myocardial infarction.
  • Patients with active CNS or leptomeningeal disease.
  • Patients who have received allogeneic stem cell transplant.
  • Patients who have had major surgery within four weeks prior to enrollment.
  • Patients with a known hypersensitivity to recombinant proteins or any excipient contained in the drug formulation.
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  • 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).
  • Patients with any systemic viral, bacterial, or fungal infection that has required antibiotic therapy within four weeks prior to enrollment. Prophylactic antibiotics and antiviral therapy are permitted prior to registration and are required during the study period (e.g. Bactrim, acyclovir).
  • Patients with known HIV, hepatitis B (by surface antigen expression), or active hepatitis C infection.
  • Patients on systemic steroids who have not been on a stable daily dose during the four weeks immediately prior to first dose of SGN-40. Maximum steroid dose is 10 mg prednisone per day or equivalent.
  • Patients with a history of migraines or severe headaches requiring medical therapy (other than occasional acetaminophen, aspirin, or non-steroidal anti-inflammatory drugs) within 12 months of enrollment.
  • 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

4 sites in 1 country.

United States4 sites

  • University of Alabama at Birmingham

    Birmingham, Alabama, 35294

  • University of Miami, Sylvester Comprehensive Cancer Center

    Miami, Florida, 33136

  • Weill Medical College/Cornell University

    New York, New York, 10021

  • Fred Hutchinson Cancer Research Center

    Seattle, Washington, 98109

Other trials in United States

About this study

Official title: A Phase 1/2, Multi-Dose Study of SGN-40 (Anti-huCD40 mAb) in Patients With Chronic Lymphocytic Leukemia

This is an open-label, dose-escalation study to determine the tolerability, safety profile, and antitumor activity of SGN-40 in patients with CLL. All patients will receive dose escalation during the first two weeks regardless of cohort designation.

Read the detailed description

A minimum of three patients will be entered into each dose-level cohort for five weeks. Escalation to the next cohort will occur when three patients have received at least one infusion at the highest scheduled dose level, and at least one patient has completed the entire five week dosing schedule. Cohorts will be enrolled at a maximal dose level of 3, 4, 6, or 8 mg/kg/week. Initial therapy will last for 5 weeks. Responding patients will receive additional infusions every two weeks x 4 at the maximal dose for each specific cohort.

Being tested
SGN-40 (anti-huCD40 mAb)
Keywords
Antigens, CD40, Antibody, Monoclonal, Leukemia, Lymphocytic, Chronic, B-Cell, Hematologic Diseases, Immunoproliferatic Disorders, Lymphatic Diseases, Lymphoproliferative Disorders, Leukemia
Medical subject headings
Leukemia, Lymphocytic, Chronic, B-Cell, Hematologic Diseases, Lymphatic Diseases, Lymphoproliferative Disorders, Leukemia

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

    1-8 mg/kg IV; Days 1, 4, 8, 15, 22, 29 of Cycle 1 and Days 1, 15, 29 and 43 of Cycles 2-6.

Study groups in NCT00283101
Study groupRoleWhat they receive
1ExperimentalSGN-40
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. To determine the maximum tolerated dose (MTD) of multiple doses of SGN-40

  2. To evaluate the safety profile, immunogenicity, and pharmacokinetics of SGN-40

  3. To test the antitumor activity of SGN-40 in patients with CLL who have demonstrated recurrence or progression after at least one systemic therapy

Timeline

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

  1. First posted27 Jan 2006 (estimated)
  2. Study startJul 2005
  3. Primary completionOct 2006
  4. Study completionOct 2006

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
12 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00283101
Sponsor's protocol ID
SG040-0003
Status last verified
Dec 2014
First submitted
25 Jan 2006
Last updated
18 Dec 2014
Results posted
No
Data monitoring committee
No

Publications

  • Furman RR, Forero-Torres A, Shustov A, Drachman JG. A phase I study of dacetuzumab (SGN-40, a humanized anti-CD40 monoclonal antibody) in patients with chronic lymphocytic leukemia. Leuk Lymphoma. 2010 Feb;51(2):228-35. doi: 10.3109/10428190903440946.

    PubMed 20038235

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing SGN-40 (anti-huCD40 mAb) in people with Leukemia, Lymphocytic, Chronic, run by Seagen Inc. at 4 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 17 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 4 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 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?

To determine the maximum tolerated dose (MTD) of multiple doses of SGN-40. 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 NCT00283101, 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.

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