Lymphoma, Large B-Cell, DiffusePhase 2NCT00435916
Study of SGN-40 in Patients With Relapsed Diffuse Large B-Cell Lymphoma
A Phase 2 study testing SGN-40 in people with Lymphoma, Large B-Cell, Diffuse and Lymphoma, Non-Hodgkin, run by Seagen Inc. at 14 sites in United States.
Trial summary
This is a Phase II, open-label, multidose trial of SGN-40 designed to estimate objective response rate and assess toxicity in patients with relapsed DLBCL. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lymphoma, Large B-Cell, Diffuse, Lymphoma, Non-Hodgkin
- What is being tested?
- SGN-40
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 14 sitesUnited States
- Study dates
- Dec 2006to Jan 2009
- Phase
- Phase 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
- Diagnosis of DLBCL.
- Received at least one combination chemotherapy regimen with rituximab, such as R-CHOP, R-ESHAP or equivalent.
- Progression or relapse since most recent therapy.
- At least one measurable lesion that is both greater than or equal to 2 cm by conventional CT or greater than or equal to 1.5 cm by spiral CT.
Who cannot join
- Previous diagnosis or treatment for indolent lymphoma, leptomeningeal lymphoma, or central nervous system lymphoma.
- Primary refractory disease.
- Received an allogenic stem cell transplant.
Trial locations and contacts
14 sites in 1 country.
14 sites in 1 country
United States14 sites
University of Alabama at Birmingham
Birmingham, Alabama, 35294
Charleston Hematology Oncology Associates, PA
Charleston, South Carolina, 29403
Northwestern University
Chicago, Illinois, 60611
Rush University Medical Center
Chicago, Illinois, 60612
University of California Los Angeles
Los Angeles, California, 90095
University of Wisconsin
Madison, Wisconsin, 53792
Weill Medical College of Cornell University
New York, New York, 10021
Stanford University Medical Center
Palo Alto, California, 94305
Mayo Clinic-Rochester
Rochester, Minnesota, 55905
Sharp Healthcare
San Diego, California, 92123
Mayo Clinic-Arizona
Scottsdale, Arizona, 85259
Swedish Cancer Institute
Seattle, Washington, 98104
Washington University School of Medicine
St Louis, Missouri, 63110
Georgetown University
Washington D.C., District of Columbia, 20007
About this study
Official title: A Phase II Study of SGN-40 (Anti-huCD40 mAb) in Patients With Relapsed Diffuse Large B-Cell Lymphoma (DLBCL)
This is a Phase II, open-label, multidose trial of SGN-40 designed to estimate objective response rate and assess toxicity in patients with relapsed DLBCL.
- Being tested
- SGN-40
- Keywords
- Antigens, CD40, Antibody, Monoclonal, Lymphoma, Large B-Cell, Diffuse, Lymphoma, Non-Hodgkin, Hematologic Diseases, Immunoproliferative Disorders, Lymphatic Diseases, Lymphoproliferative Disorders, Lymphoma
- Medical subject headings
- Lymphoma, Large B-Cell, Diffuse, Lymphoma, Non-Hodgkin, 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-40Drug
Also called dacetuzumab
1-8 mg/kg IV (in the vein) on Days 1, 4, 8, 15, 22 and 29 of Cycle 1; 8 mg/kg IV (in the vein) on Days 1, 8, 15, and 22 for Cycles 2-12.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Drug: SGN-40 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective response as assessed by CT and PET scans and revised response criteria for malignant lymphoma.
Measured: Every 1 or 2 months
Secondary outcomes (3)
Progression-free survival, disease-free survival, and overall survival.
Measured: Study duration
Adverse events, laboratory values, and anti-drug antibody immune responses.
Measured: Within 3 weeks of final infusion
PK profile.
Measured: Within 3 weeks of final infusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Feb 2007 (estimated)
- Study startDec 2006
- Primary completionJan 2009
- Study completionJan 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Lymphoma, Large B-Cell, DiffuseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seagen Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Genentech, Inc.
- Responsible party
- Sponsor
- Investigators
- Nancy Whiting, PharmD, Study director, Seagen Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00435916
- Sponsor's protocol ID
- SG040-0004
- Status last verified
- Dec 2014
- First submitted
- 14 Feb 2007
- Last updated
- 7 Jan 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
de Vos S, Forero-Torres A, Ansell SM, Kahl B, Cheson BD, Bartlett NL, Furman RR, Winter JN, Kaplan H, Timmerman J, Whiting NC, Drachman JG, Advani R. A phase II study of dacetuzumab (SGN-40) in patients with relapsed diffuse large B-cell lymphoma (DLBCL) and correlative analyses of patient-specific factors. J Hematol Oncol. 2014 Jun 12;7:44. doi: 10.1186/1756-8722-7-44.
PubMed 24919462
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study of SGN-40 (Anti-huCD40 mAb) in Patients With Relapsed Diffuse Large B-Cell Lymphoma (DLBCL)
- ClinicalTrials.gov ID
- NCT00435916
- Acronym / sponsor ID
- SG040-0004
- Keywords
- Antigens, CD40, Antibody, Monoclonal, Lymphoma, Large B-Cell, Diffuse, Lymphoma, Non-Hodgkin, Hematologic Diseases, Immunoproliferative Disorders, Lymphatic Diseases, Lymphoproliferative Disorders
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Seagen Inc.Industry (pharma, biotech, devices)
- Collaborators
- Genentech, Inc.
- Study start
- Dec 2006
- Primary completion
- Jan 2009 (actual)
- Study completion
- Jan 2009 (actual)
- First posted
- 16 Feb 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a Phase II, open-label, multidose trial of SGN-40 designed to estimate objective response rate and assess toxicity in patients with relapsed DLBCL.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: SGN-40 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Diagnosis of DLBCL.
- Received at least one combination chemotherapy regimen with rituximab, such as R-CHOP, R-ESHAP or equivalent.
- Progression or relapse since most recent therapy.
- At least one measurable lesion that is both greater than or equal to 2 cm by conventional CT or greater than or equal to 1.5 cm by spiral CT.
Key exclusion criteria (3 listed)
- Previous diagnosis or treatment for indolent lymphoma, leptomeningeal lymphoma, or central nervous system lymphoma.
- Primary refractory disease.
- Received an allogenic stem cell transplant.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SGN-40Also: dacetuzumab1-8 mg/kg IV (in the vein) on Days 1, 4, 8, 15, 22 and 29 of Cycle 1; 8 mg/kg IV (in the vein) on Days 1, 8, 15, and 22 for Cycles 2-12. | Drug | 1 |
Primary outcome
Objective response as assessed by CT and PET scans and revised response criteria for malignant lymphoma.
Time frame: Every 1 or 2 months
3 secondary outcomes
Progression-free survival, disease-free survival, and overall survival.
Time frame: Study duration
Adverse events, laboratory values, and anti-drug antibody immune responses.
Time frame: Within 3 weeks of final infusion
PK profile.
Time frame: Within 3 weeks of final infusion
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jan 2015.
- Results publication: PubMed 24919462de Vos S, Forero-Torres A, Ansell SM, Kahl B, Cheson BD, Bartlett NL, Furman RR, Winter JN, Kaplan H, Timmerman J, Whiting NC, Drachman JG, Advani R. A phase II study of dacetuzumab (SGN-40) in patients with relapsed diffuse large B-cell lymphoma (DLBCL) and correlative analyses of patient-specific factors. J Hematol Oncol. 2014 Jun 12;7:44. doi: 10.1186/1756-8722-7-44.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nancy Whiting, PharmD study director
Seagen Inc.
14 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing SGN-40 in people with Lymphoma, Large B-Cell, Diffuse and Lymphoma, Non-Hodgkin, run by Seagen Inc. at 14 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 4 inclusion and 3 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 7 Jan 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 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 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?
Objective response as assessed by CT and PET scans and revised response criteria for malignant lymphoma. (time frame: Every 1 or 2 months). 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 NCT00435916, 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 7 Jan 2015.