Disease, HodgkinPhase 2NCT00947856

A Brentuximab Vedotin Trial for Patients Who Have Previously Participated in a Brentuximab Vedotin Study

A Phase 2 study testing brentuximab vedotin in people with Disease, Hodgkin and Lymphoma, Large-Cell, Anaplastic, run by Seagen Inc. at 17 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 is a multicenter, open-label study to evaluate the safety and efficacy of treatment with brentuximab vedotin (SGN-35) in patients who have previously participated in an brentuximab vedotin study. Read more about this study

Who is it for?: Ages 6 years and older
Conditions the study is for: Disease, Hodgkin, 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: 110 participants
Where: 17 sitesin 2 countries
Study dates: Jul 2009to Mar 2013
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 6 years and older
All sexes
No healthy volunteers
Child, Adult, Older adult

Who may be able to join

Participated in a previous brentuximab vedotin study.
CD30-positive hematologic malignancy.
At a minimum, experienced clinical benefit in the prior brentuximab vedotin study. For retreatment, patients must have previously achieved either complete or partial remission with brentuximab vedotin and experienced disease progression after discontinuing the prior brentuximab vedotin study.

Who cannot join

Withdrew consent to participate in any prior brentuximab vedotin study.

Trial locations and contacts

17 sites in 2 countries.

Country

City, postcode or hospital

17 sites in 2 countries

United States16 sites

University of Alabama at Birmingham
Birmingham, Alabama, 35294-3300
Nationwide Children's Hospital
Columbus, Ohio, 43205
Charles A. Sammons Cancer Center
Dallas, Texas, 75246
Colorado Blood Cancer Institute
Denver, Colorado, 80218
Karmanos Cancer Institute / Wayne State University
Detroit, Michigan, 48201
City of Hope National Medical Center
Duarte, California, 91010
The John Theurer Cancer Center, Hackensack University Medical Center
Hackensack, New Jersey, 07601
MD Anderson Cancer Center /The University of Texas
Houston, Texas, 77030
St. Francis Medical Group Oncology & Hematology Specialists
Indianapolis, Indiana, 46237
Loyola University Medical Center - Cardinal Bernadin Cancer Center
Maywood, Illinois, 60153
University of Miami Miller School of Medicine / Sylvester Comprehensive Cancer Center
Miami, Florida, 33136
NYU Clinical Cancer Center
New York, New York, 10016
Columbia University Medical Center
New York, New York, 10019
Seattle Cancer Care Alliance / University of Washington Medical Center
Seattle, Washington, 98109-1023
Washington University School of Medicine
St Louis, Missouri, 63110
Stanford Cancer Center
Stanford, California, 94305

Other trials in United States

France1 site

Hopital Saint-Louis/Service d'Hematologie
Paris, Cedex 10, 75475

Other trials in France

About this study

Official title: Treatment With SGN-35 in Patients With CD30-positive Hematologic Malignancies Who Have Previously Participated in an SGN-35 Study

Read the detailed description

This is a multicenter, open-label study to evaluate single-agent brentuximab vedotin (SGN-35) treatment in patients who previously participated in a brentuximab vedotin study, including Studies SGN35-005 (NCT01100502), SGN35-007 (NCT01026233), and SGN35-008 (NCT01026415). Patients treated on this study (SGN35-006) could re-enroll on study if eligible. The study consisted of 2 arms, as follows:

Retreatment arm: Patients with CD30-positive hematologic malignancies who experienced a complete remission (CR) or partial remission (PR) with previous brentuximab vedotin treatment on a clinical study and subsequently experienced disease progression or relapse. The purpose of this arm was to assess safety and efficacy of retreatment with brentuximab vedotin.
Extension treatment arm: Patients with either CD30-positive hematologic or nonhematologic malignancies who completed treatment in a prior brentuximab vedotin study without unacceptable toxicity and experienced clinical benefit as assessed by the investigator. The purpose of this arm was to enable patients who participated in certain prior brentuximab vedotin trials to receive extension treatment and to assess patient safety and survival in the extension treatment setting.

Conditions: Disease, Hodgkin, Lymphoma, Large-Cell, Anaplastic, Lymphoma, Non-Hodgkin
Being tested: brentuximab vedotin
Keywords: Antibodies, Monoclonal, Antibody-Drug Conjugate, Antigens, CD30, Drug Therapy, Hematologic Diseases, Immunotherapy, Monomethylauristatin E
Medical subject headings: Hodgkin Disease, Lymphoma, Large-Cell, Anaplastic, Lymphoma, Non-Hodgkin, Hematologic Diseases

What participants receive

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

brentuximab vedotinDrug
Also called Adcetris
Every 3 weeks by IV infusion (1.2 or 1.8 mg/kg) until disease progression, unacceptable toxicity, or study closure

Study groups in NCT00947856
Study group	Role	What they receive
BV Retreatment	Experimental	Brentuximab vedotin 1.2 or 1.8 mg/kg every 3 weeks by IV infusion (retreatment after relapse) Receives: Drug: brentuximab vedotin
BV Extension	Experimental	Brentuximab vedotin 1.2 or 1.8 mg/kg every 3 weeks by IV infusion (continued treatment) 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 Investigator
Percentage of participants in the retreatment arm 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 approximately 38 months
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 on SGN35-006). 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 39 months
Laboratory Abnormalities >/= Grade 3
Counts of study participants with post-baseline 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 39 months

Secondary outcomes (4)

Duration of Objective Response by Kaplan-Meier Analysis
Duration of objective response (CR + PR) on retreatment, defined as time of initial response until disease progression or death
Measured: Up to 38 months
Progression-free Survival by Kaplan-Meier Analysis
Progression-free survival, defined as time from start of study treatment in the retreatment arm to disease progression per investigator or death due to any cause
Measured: Up to approximately 29 months
Overall Survival
Overall survival for both extension and retreatment arms, defined as time from start of study treatment to date of death due to any cause
Measured: Up to approximately 41 months
Incidence of Antitherapeutic Antibodies
Counts of participants with anti-brentuximab vedotin antibodies at any time during extension treatment on Study SGN35-006 or number of retreatment experiences with anti-brentuximab vedotin antibodies at any time during retreatment
Measured: Up to 39 months

Timeline

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

Jul 2009Mar 2013

First posted28 Jul 2009 (estimated)
Study startJul 2009
Primary completionMar 2013
Study completionMar 2013

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 Disease, HodgkinStudies 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: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 110 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00947856
Sponsor's protocol ID: SGN35-006
Other IDs: 2010-019932-11
Status last verified: Dec 2016
First submitted: 24 Jul 2009
Last updated: 2 Feb 2017
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Expanded access: Available

Publications

Bartlett NL, Chen R, Fanale MA, Brice P, Gopal A, Smith SE, Advani R, Matous JV, Ramchandren R, Rosenblatt JD, Huebner D, Levine P, Grove L, Forero-Torres A. Retreatment with brentuximab vedotin in patients with CD30-positive hematologic malignancies. J Hematol Oncol. 2014 Mar 19;7:24. doi: 10.1186/1756-8722-7-24.
PubMed 24642247
Gopal AK, Ramchandren R, O'Connor OA, Berryman RB, Advani RH, Chen R, Smith SE, Cooper M, Rothe A, Matous JV, Grove LE, Zain J. Safety and efficacy of brentuximab vedotin for Hodgkin lymphoma recurring after allogeneic stem cell transplantation. Blood. 2012 Jul 19;120(3):560-8. doi: 10.1182/blood-2011-12-397893. Epub 2012 Apr 17.
PubMed 22510871

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Disease, Hodgkin trials

Study at a glance

From the registry record, last updated by the sponsor on 2 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Treatment With SGN-35 in Patients With CD30-positive Hematologic Malignancies Who Have Previously Participated in an SGN-35 Study
ClinicalTrials.gov ID: NCT00947856
Acronym / sponsor ID: SGN35-006
Conditions: Disease, Hodgkin, Lymphoma, Large-Cell, Anaplastic, Lymphoma, Non-Hodgkin
Keywords: Antibodies, Monoclonal, Antibody-Drug Conjugate, Antigens, CD30, Drug Therapy, Hematologic Diseases, Immunotherapy, Monomethylauristatin E
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 110 participants (actual)
Lead sponsor: Seagen Inc.Industry (pharma, biotech, devices)
Collaborators: Millennium Pharmaceuticals, Inc.
Study start: Jul 2009
Primary completion: Mar 2013 (actual)
Study completion: Mar 2013 (actual)
First posted: 28 Jul 2009 (estimated)
Results: Posted 26 May 2014

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Retreatment arm: Patients with CD30-positive hematologic malignancies who experienced a complete remission (CR) or partial remission (PR) with previous brentuximab vedotin treatment on a clinical study and subsequently experienced disease progression or relapse. The purpose of this arm was to assess safety and efficacy of retreatment with brentuximab vedotin.
Extension treatment arm: Patients with either CD30-positive hematologic or nonhematologic malignancies who completed treatment in a prior brentuximab vedotin study without unacceptable toxicity and experienced clinical benefit as assessed by the investigator. The purpose of this arm was to enable patients who participated in certain prior brentuximab vedotin trials to receive extension treatment and to assess patient safety and survival in the extension treatment setting.

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
BV Retreatment	Experimental	Drug: brentuximab vedotinBrentuximab vedotin 1.2 or 1.8 mg/kg every 3 weeks by IV infusion (retreatment after relapse)
BV Extension	Experimental	Drug: brentuximab vedotinBrentuximab vedotin 1.2 or 1.8 mg/kg every 3 weeks by IV infusion (continued treatment)

Who may qualify

Ages: 6 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (3 listed)

Participated in a previous brentuximab vedotin study.
CD30-positive hematologic malignancy.
At a minimum, experienced clinical benefit in the prior brentuximab vedotin study. For retreatment, patients must have previously achieved either complete or partial remission with brentuximab vedotin and experienced disease progression after discontinuing the prior brentuximab vedotin study.

Key exclusion criteria (1 listed)

Withdrew consent to participate in any prior brentuximab vedotin study.

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: AdcetrisEvery 3 weeks by IV infusion (1.2 or 1.8 mg/kg) until disease progression, unacceptable toxicity, or study closure	Drug	BV Extension, BV Retreatment

Primary outcome

Objective Response Rate by Investigator
Time frame: Up to approximately 38 months
Percentage of participants in the retreatment arm 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.
Adverse Events by Severity, Seriousness, and Relationship to Treatment
Time frame: up to 39 months
Counts of participants who had adverse events or treatment-emergent adverse events (TEAE, defined as newly occurring or worsening after first dose on SGN35-006). 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.
Laboratory Abnormalities >/= Grade 3
Time frame: Up to 39 months
Counts of study participants with post-baseline 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.

4 secondary outcomes

Duration of Objective Response by Kaplan-Meier Analysis
Time frame: Up to 38 months
Progression-free Survival by Kaplan-Meier Analysis
Time frame: Up to approximately 29 months
Overall Survival
Time frame: Up to approximately 41 months
Incidence of Antitherapeutic Antibodies
Time frame: Up to 39 months

Results and safety

Results posted to the registry on 26 May 2014, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
BV Extension	78	0
BV Retreatment	32	0

Primary outcome: Objective Response Rate by Investigator

Time frame: Up to approximately 38 months. Number (95% Confidence Interval). Unit: percentage of retreatment experiences

Measure	BV Retreatment - HL n = 21	BV Retreatment - ALCL n = 8	BV Retreatment - Other n = 3	BV Retreatment Total n = 32
Value	60 (36.1 to 80.9)	91 (58.7 to 99.8)	33 (0.8 to 90.6)	68 (49.5 to 82.6)

Population analysed: Any patient who received retreatment and had postbaseline response results; 1 HL patient did not have postbaseline response results and 3 ALCL patients were retreated more than once.

Primary outcome: Adverse Events by Severity, Seriousness, and Relationship to Treatment

Time frame: up to 39 months. Number. Unit: participants

Measure	BV Extension n = 78	BV Retreatment n = 32
Any TEAE	75	31
TEAE related to study drug	65	27
TEAE with severity grade >/=3	37	16
Discontinued treatment due to adverse event	13	9
Serious adverse event	16	9
Serious adverse event related to study drug	10	4

Population analysed: All participants who received treatment

Primary outcome: Laboratory Abnormalities >/= Grade 3

Time frame: Up to 39 months. Number. Unit: participants

Measure	BV Extension n = 78	BV Retreatment n = 32
Any >/= Grade 3 laboratory abnormality	29	12
Lymphocytes (low)	16	8
Leukocytes (low)	3	3
Neutrophils (low)	7	3
Phosphate (low)	7	3
Platelets (low)	4	3
Aspartate aminotransferase (high)	1	2
Glucose (high)	3	2

Population analysed: All participants who received treatment

4 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
BV Extension	16 of 78 (20.5%)	75 of 78 (96.2%)	Not reported
BV Retreatment	9 of 32 (28.1%)	31 of 32 (96.9%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 2 Feb 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 24642247Bartlett NL, Chen R, Fanale MA, Brice P, Gopal A, Smith SE, Advani R, Matous JV, Ramchandren R, Rosenblatt JD, Huebner D, Levine P, Grove L, Forero-Torres A. Retreatment with brentuximab vedotin in patients with CD30-positive hematologic malignancies. J Hematol Oncol. 2014 Mar 19;7:24. doi: 10.1186/1756-8722-7-24.
Derived from this study: PubMed 22510871Gopal AK, Ramchandren R, O'Connor OA, Berryman RB, Advani RH, Chen R, Smith SE, Cooper M, Rothe A, Matous JV, Grove LE, Zain J. Safety and efficacy of brentuximab vedotin for Hodgkin lymphoma recurring after allogeneic stem cell transplantation. Blood. 2012 Jul 19;120(3):560-8. doi: 10.1182/blood-2011-12-397893. Epub 2012 Apr 17.

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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.

Laurie Grove, PA-C study director

Seagen Inc.

17 sites in 2 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 Disease, Hodgkin and Lymphoma, Large-Cell, Anaplastic, run by Seagen Inc. at 17 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 3 inclusion and 1 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 2 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 17 sites in United States, 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 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 May 2014). 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 Investigator (time frame: Up to approximately 38 months). 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 NCT00947856, 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 2 Feb 2017.