Lymphoma, Large-Cell, AnaplasticPhase 2NCT00866047
A Phase 2 Open Label Trial of Brentuximab Vedotin (SGN-35) for Systemic Anaplastic Large Cell Lymphoma
A Phase 2 study testing brentuximab vedotin in people with Lymphoma, Large-Cell, Anaplastic and Lymphoma, Non-Hodgkin, run by Seagen Inc. at 22 sites in 5 countries.
Trial summary
This is a single-arm, open-label, multicenter, clinical trial to evaluate the efficacy and safety of brentuximab vedotin (SGN-35) as a single agent in patients with relapsed or refractory ALCL. Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Lymphoma, Large-Cell, Anaplastic, Lymphoma, Non-Hodgkin
- What is being tested?
- brentuximab vedotin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 58 participants
- Where
- 22 sitesin 5 countries
- Study dates
- Mar 2009to Jun 2016
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients with relapsed or refractory systemic ALCL who have previously received front line chemotherapy.
- Documented anaplastic lymphoma kinase (ALK) status.
- Histologically-confirmed CD30-positive disease; tissue from the most recent post diagnostic biopsy of relapsed/refractory disease must be available for confirmation of CD30 expression via slides or tumor block.
- Fluorodeoxyglucose-avid and measurable disease of at least 1.5 cm as documented by both positron emission tomography and spiral computed tomography.
- Received any previous autologous stem cell transplant at least 12 weeks (3 months) prior.
- At US sites, patients greater than or equal to 12 years of age may be enrolled. At non-US sites, patients must be greater than or equal to 18 years of age.
Who cannot join
- Previous treatment with brentuximab vedotin.
- Previously received an allogeneic transplant.
- Patients with current diagnosis of primary cutaneous ALCL (patients who have transformed to systemic ALCL are eligible).
- Known cerebral/meningeal disease.
Trial locations and contacts
22 sites in 5 countries.
22 sites in 5 countries
United States15 sites
University of Alabama at Birmingham
Birmingham, Alabama, 35294-3300
Northwestern University
Chicago, Illinois, 60611
Nationwide Children's Hospital
Columbus, Ohio, 43205
Baylor Sammons Cancer Center / Texas Oncology
Dallas, Texas, 75246
Rocky Mountain Cancer Centers
Denver, Colorado, 80218
Karmanos Cancer Institute / Wayne State University
Detroit, Michigan, 48201
MD Anderson Cancer Center / University of Texas
Houston, Texas, 77030-4003
University of Miami Sylvester Comprehensive Cancer Center
Miami, Florida, 33136
Memorial Sloan Kettering Cancer Center
New York, New York, 10021
Weill Cornell Medical College
New York, New York, 10021
Stanford University Medical Center
Palo Alto, California, 94304
Oregon Health & Science University
Portland, Oregon, 97239
Mayo Clinic Rochester
Rochester, Minnesota, 55905
University of Washington
Seattle, Washington, 98109
Washington University School of Medicine
St Louis, Missouri, 63110
France3 sites
Institut Paoli Calmettes
Marseille, 13273
Hospital Saint Louis
Paris, 75475
Centre Henri Becquerel
Rouen, 76038
Canada2 sites
Princess Margaret Hospital
Toronto, Ontario, M5G 2M9
B.C Cancer Agency
Vancouver, British Columbia, V5Z 4E6
About this study
Official title: A Phase 2 Study of SGN-35 in Treatment of Patients With Relapsed or Refractory Systemic Anaplastic Large Cell Lymphoma (ALCL)
This is a single-arm, open-label, multicenter, clinical trial to evaluate the efficacy and safety of brentuximab vedotin (SGN-35) as a single agent in patients with relapsed or refractory ALCL.
- Being tested
- brentuximab vedotin
- Keywords
- Antigens, CD30, Antibody-Drug Conjugate, Antibodies, Monoclonal, Lymphoma, Non-Hodgkin, Lymphoma, Large-Cell, Anaplastic, monomethyl auristatin E, Drug Therapy, Immunotherapy, Hematologic Diseases, Lymphoma
- Medical subject headings
- Lymphoma, Large-Cell, Anaplastic, Lymphoma, Non-Hodgkin, Hematologic Diseases, Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
brentuximab vedotinDrug
Also called SGN-35, ADCETRIS
1.8 mg/kg every 3 weeks by IV infusion
| Study group | Role | What they receive |
|---|---|---|
| Brentuximab vedotin | Experimental | Brentuximab vedotin 1.8 mg/kg every 3 weeks by intravenous (IV) infusion Receives: Drug: brentuximab vedotin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective Response Rate by Independent Review Group
Percentage of participants who achieved a best response of complete remission (CR, disappearance of all evidence of disease) or partial remission (PR, regression of greater than or equal to 50% of measurable disease and no new sites) per Cheson 2007 Revised Response Criteria for Malignant Lymphoma.
Measured: up to 12 months
Secondary outcomes (11)
Complete Remission Rate by Independent Review Group
Percentage of participants who achieved a best response of CR (disappearance of all evidence of disease) per Cheson 2007 Revised Response Criteria for Malignant Lymphoma.
Measured: up to 12 months
Duration of Objective Response by Kaplan-Meier Analysis
Duration of objective response (CR + PR) by independent review group, defined as time of initial response until disease progression or death.
Measured: up to approximately 3 years
Duration of Objective Response in Participants With Complete Remission by Kaplan-Meier Analysis
Duration of response from start of first objective tumor response (CR or PR) by independent review group to disease progression or death due to any cause in participants with CR.
Measured: up to approximately 3 years
Progression-free Survival by Kaplan-Meier Analysis
Time from start of study treatment to disease progression per independent review group or death due to any cause.
Measured: up to approximately 3 years
Overall Survival
Time from start of study treatment to date of death due to any cause.
Measured: up to approximately 7 years
Adverse Events by Severity, Seriousness, and Relationship to Treatment
Counts of participants who had adverse events or treatment-emergent adverse events (TEAE, defined as newly occurring or worsening after first dose). Serious adverse events are reported from the time of informed consent. National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE version 3.0) were used to assess severity (1=mild, 2=moderate, 3=severe, 4=life threatening/disabling, 5=death). Relatedness to study drug was assessed by the investigator (Yes/No). Participants with multiple occurrences of an adverse event within a category are counted once within the category.
Measured: up to 12 months
Hematology Laboratory Abnormalities >/= Grade 3
Counts of study participants with post-baseline hematology laboratory abnormalities of Grade 3 or greater per NCI CTCAE version 3.0. Participants with multiple occurrences of a laboratory abnormality within a category are counted once in that category.
Measured: up to 12 months
Chemistry Laboratory Abnormalities >/= Grade 3
Counts of study participants with post-baseline chemistry laboratory abnormalities of Grade 3 or greater per NCI CTCAE version 3.0. Participants with multiple occurrences of a laboratory abnormality within a category are counted once in that category.
Measured: up to 12 months
Area Under the Curve
Area under the serum concentration-time curve from time 0 to 21 days following the first dose of brentuximab vedotin
Measured: 3 weeks
Maximum Serum Concentration
Maximum serum concentration from 0 to 21 days following the first dose of brentuximab vedotin
Measured: 3 weeks
Time of Maximum Serum Concentration
Time of maximum serum concentration from 0 to 21 days following the first dose of brentuximab vedotin
Measured: 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2009 (estimated)
- Study startMar 2009
- Primary completionAug 2010
- Study completionJun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Lymphoma, Large-Cell, AnaplasticStudies 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
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seagen Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Millennium Pharmaceuticals, Inc.
- Responsible party
- Sponsor
- Investigators
- Dana Kennedy, PharmD, Study director, Seagen Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00866047
- Sponsor's protocol ID
- SG035-0004
- Other IDs
- 2008-006035-12, 2008
- Status last verified
- Dec 2016
- First submitted
- 19 Mar 2009
- Last updated
- 22 Mar 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Pro B, Advani R, Brice P, Bartlett NL, Rosenblatt JD, Illidge T, Matous J, Ramchandren R, Fanale M, Connors JM, Yang Y, Sievers EL, Kennedy DA, Shustov A. Brentuximab vedotin (SGN-35) in patients with relapsed or refractory systemic anaplastic large-cell lymphoma: results of a phase II study. J Clin Oncol. 2012 Jun 20;30(18):2190-6. doi: 10.1200/JCO.2011.38.0402. Epub 2012 May 21.
PubMed 22614995Pro B, Advani R, Brice P, Bartlett NL, Rosenblatt JD, Illidge T, Matous J, Ramchandren R, Fanale M, Connors JM, Fenton K, Huebner D, Pinelli JM, Kennedy DA, Shustov A. Five-year results of brentuximab vedotin in patients with relapsed or refractory systemic anaplastic large cell lymphoma. Blood. 2017 Dec 21;130(25):2709-2717. doi: 10.1182/blood-2017-05-780049. Epub 2017 Oct 3.
PubMed 28974506
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2 Study of SGN-35 in Treatment of Patients With Relapsed or Refractory Systemic Anaplastic Large Cell Lymphoma (ALCL)
- ClinicalTrials.gov ID
- NCT00866047
- Acronym / sponsor ID
- SG035-0004
- Keywords
- Antigens, CD30, Antibody-Drug Conjugate, Antibodies, Monoclonal, Lymphoma, Non-Hodgkin, Lymphoma, Large-Cell, Anaplastic, monomethyl auristatin E, Drug Therapy, Immunotherapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- Seagen Inc.Industry (pharma, biotech, devices)
- Collaborators
- Millennium Pharmaceuticals, Inc.
- Study start
- Mar 2009
- Primary completion
- Aug 2010 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 20 Mar 2009 (estimated)
- Results
- Posted 26 Oct 2011
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 single-arm, open-label, multicenter, clinical trial to evaluate the efficacy and safety of brentuximab vedotin (SGN-35) as a single agent in patients with relapsed or refractory ALCL.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Brentuximab vedotin | Experimental | Drug: brentuximab vedotinBrentuximab vedotin 1.8 mg/kg every 3 weeks by intravenous (IV) infusion |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- Patients with relapsed or refractory systemic ALCL who have previously received front line chemotherapy.
- Documented anaplastic lymphoma kinase (ALK) status.
- Histologically-confirmed CD30-positive disease; tissue from the most recent post diagnostic biopsy of relapsed/refractory disease must be available for confirmation of CD30 expression via slides or tumor block.
- Fluorodeoxyglucose-avid and measurable disease of at least 1.5 cm as documented by both positron emission tomography and spiral computed tomography.
- Received any previous autologous stem cell transplant at least 12 weeks (3 months) prior.
Key exclusion criteria (4 listed)
- Previous treatment with brentuximab vedotin.
- Previously received an allogeneic transplant.
- Patients with current diagnosis of primary cutaneous ALCL (patients who have transformed to systemic ALCL are eligible).
- Known cerebral/meningeal disease.
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 |
|---|---|---|
| brentuximab vedotinAlso: SGN-35, ADCETRIS1.8 mg/kg every 3 weeks by IV infusion | Drug | Brentuximab vedotin |
Primary outcome
Objective Response Rate by Independent Review Group
Time frame: up to 12 months
Percentage of participants who achieved a best response of complete remission (CR, disappearance of all evidence of disease) or partial remission (PR, regression of greater than or equal to 50% of measurable disease and no new sites) per Cheson 2007 Revised Response Criteria for Malignant Lymphoma.
11 secondary outcomes
Complete Remission Rate by Independent Review Group
Time frame: up to 12 months
Duration of Objective Response by Kaplan-Meier Analysis
Time frame: up to approximately 3 years
Duration of Objective Response in Participants With Complete Remission by Kaplan-Meier Analysis
Time frame: up to approximately 3 years
Progression-free Survival by Kaplan-Meier Analysis
Time frame: up to approximately 3 years
Overall Survival
Time frame: up to approximately 7 years
Adverse Events by Severity, Seriousness, and Relationship to Treatment
Time frame: up to 12 months
Hematology Laboratory Abnormalities >/= Grade 3
Time frame: up to 12 months
Chemistry Laboratory Abnormalities >/= Grade 3
Time frame: up to 12 months
Area Under the Curve
Time frame: 3 weeks
Maximum Serum Concentration
Time frame: 3 weeks
Time of Maximum Serum Concentration
Time frame: 3 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Mar 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 22614995Pro B, Advani R, Brice P, Bartlett NL, Rosenblatt JD, Illidge T, Matous J, Ramchandren R, Fanale M, Connors JM, Yang Y, Sievers EL, Kennedy DA, Shustov A. Brentuximab vedotin (SGN-35) in patients with relapsed or refractory systemic anaplastic large-cell lymphoma: results of a phase II study. J Clin Oncol. 2012 Jun 20;30(18):2190-6. doi: 10.1200/JCO.2011.38.0402. Epub 2012 May 21.
- Derived from this study: PubMed 28974506Pro B, Advani R, Brice P, Bartlett NL, Rosenblatt JD, Illidge T, Matous J, Ramchandren R, Fanale M, Connors JM, Fenton K, Huebner D, Pinelli JM, Kennedy DA, Shustov A. Five-year results of brentuximab vedotin in patients with relapsed or refractory systemic anaplastic large cell lymphoma. Blood. 2017 Dec 21;130(25):2709-2717. doi: 10.1182/blood-2017-05-780049. Epub 2017 Oct 3.
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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.
Dana Kennedy, PharmD study director
Seagen Inc.
22 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing brentuximab vedotin in people with Lymphoma, Large-Cell, Anaplastic and Lymphoma, Non-Hodgkin, run by Seagen Inc. at 22 sites in 5 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 6 inclusion and 4 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 22 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 22 sites in United States, France, Canada, Belgium, United Kingdom. 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?
Yes. Results are posted in the registry (first posted 26 Oct 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 Rate by Independent Review Group (time frame: up to 12 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 NCT00866047, which also lists 2 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 22 Mar 2017.