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Lymphoma, B-CellPhase 2NCT01421667

A Study of Brentuximab Vedotin in Relapsed or Refractory Non-Hodgkin Lymphoma

A Phase 2 study testing brentuximab vedotin and rituximab in people with Lymphoma, B-Cell and Lymphoma, Large B-Cell, Diffuse, run by Seagen Inc. at 34 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

This is an open-label, multicenter, phase 2 clinical trial to evaluate the efficacy and safety of brentuximab vedotin as a single agent in patients with CD30-positive non-Hodgkin lymphoma (NHL) (Part A). Read more about this study

Who is it for?
Ages 6 years and older
What is being tested?
brentuximab vedotin and rituximab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
176 participants
Where
34 sitesin 2 countries
Study dates
Aug 2011to Jun 2015
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

  • Histologically-confirmed NHL (DLBCL only for Parts B and C)
  • Relapsed or refractory disease following at least 1 prior systemic therapy
  • Measurable disease of at least 1.5 cm as documented by CT
  • Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to 2

Who cannot join

  • History of another primary invasive malignancy that has not been in remission for at least 3 years
  • Current diagnosis of systemic or cutaneous anaplastic large cell lymphoma or mycosis fungoides
  • B cell lymphoma previously treated with only single-agent rituximab (for patients receiving brentuximab vedotin only) or corticosteroids as monotherapy
  • Known cerebral/meningeal disease

Trial locations and contacts

34 sites in 2 countries.

34 sites in 2 countries

United States33 sites

  • New York Oncology Hematology, P.C.

    Albany, New York, 12206

  • Emory Winship Cancer Institute

    Atlanta, Georgia, 30322

  • Rocky Mountain Cancer Centers - Aurora

    Aurora, Colorado, 80012

  • University of Alabama at Birmingham

    Birmingham, Alabama, 35294-3300

  • Dana-Farber Cancer Institute

    Boston, Massachusetts, 02215

  • Medical University of South Carolina

    Charleston, South Carolina, 29425

  • Northwestern University

    Chicago, Illinois, 60611

  • University of Chicago

    Chicago, Illinois, 60637-1470

  • Cleveland Clinic, The

    Cleveland, Ohio, 44195

  • Texas Oncology - Medical City Dallas

    Dallas, Texas, 75230

  • Charles A. Sammons Cancer Center

    Dallas, Texas, 75246

  • Colorado Blood Cancer Institute

    Denver, Colorado, 80218

  • City of Hope

    Duarte, California, 91010-3000

  • Swedish Cancer Institute Medical Oncology

    Edmonds, Washington, 98026

  • Willamette Valley Cancer and Research / USOR

    Eugene, Oregon, 97401

  • Virginia Cancer Specialists, PC

    Fairfax, Virginia, 22031

  • Texas Oncology-Southwest Fort Worth

    Fort Worth, Texas, 76132

  • St. Francis Hospital

    Greenville, South Carolina, 29605

  • Hackensack University Medical Center

    Hackensack, New Jersey, 07601

  • MD Anderson Cancer Center / University of Texas

    Houston, Texas, 77030-4003

  • Comprehensive Cancer Centers of Nevada

    Las Vegas, Nevada, 89169

  • Minnesota Oncology Hematology P.A.

    Minneapolis, Minnesota, 55404

  • NYU Clinical Cancer Center

    New York, New York, 10016

  • Columbia University Medical Center

    New York, New York, 10019

  • Memorial Sloan Kettering Cancer Center

    New York, New York, 10021

  • PMK Medical Group Inc., DBA Ventura County Hematology Oncology Specialists

    Oxnard, California, 93030

  • Texas Oncology - Seton Williamson

    Round Rock, Texas, 78665

  • Cancer Specialists of North Florida - St. Augustine

    Saint Augustine, Florida, 32086

  • Seattle Cancer Care Alliance / University of Washington Medical Center

    Seattle, Washington, 98109

  • Washington University School of Medicine

    St Louis, Missouri, 63110

  • Stanford Cancer Center

    Stanford, California, 94305-5821

  • Texas Oncology - Tyler

    Tyler, Texas, 75702

  • Northwest Cancer Specialists, P.C.

    Vancouver, Washington, 98684

Other trials in United States

Canada1 site

  • British Columbia Cancer Agency - Vancouver Centre

    Vancouver, British Columbia, V5Z 4E6

Other trials in Canada

About this study

Official title: A Phase 2 Study of Brentuximab Vedotin in Relapsed or Refractory Non-Hodgkin Lymphoma (NHL)

This is an open-label, multicenter, phase 2 clinical trial to evaluate the efficacy and safety of brentuximab vedotin as a single agent in patients with CD30-positive non-Hodgkin lymphoma (NHL) (Part A). The study will also evaluate the safety and efficacy of brentuximab vedotin in combination with rituximab in patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) (Part B) as well as further evaluate correlation of CD30 expression and response in DLBCL (Part C).

Being tested
brentuximab vedotin, rituximab
Keywords
Lymphoma, Large B-Cell, Diffuse, Antigens, CD30, Antibody-Drug Conjugate, Antibodies, Monoclonal, Lymphoma, Non-Hodgkin, Monomethyl auristatin E, Drug Therapy, Immunotherapy, Hematologic Diseases, Lymphoma, Lymphoma, B-Cell, Lymphoma, T-Cell
Medical subject headings
Lymphoma, B-Cell, Lymphoma, Large B-Cell, Diffuse, Lymphoma, Non-Hodgkin, Lymphoma, T-Cell, 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 Adcetris; SGN-35

    1.8 mg/kg every 3 weeks by IV infusion

  • rituximabDrug

    375 mg/m2 every 3 weeks by IV infusion

Study groups in NCT01421667
Study groupRoleWhat they receive
Brentuximab vedotin+rituximabExperimentalNot described
Receives: Drug: brentuximab vedotin; Drug: rituximab
Brentuximab vedotinExperimentalNot described
Receives: Drug: brentuximab vedotin

What is being measured

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

  1. Objective Response Rate (ORR) by Investigator With Brentuximab Vedotin Monotherapy

    Percentage of participants treated with brentuximab vedotin monotherapy 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 3 years

  2. Adverse Events by Severity, Seriousness, and Relationship to Treatment With Brentuximab Vedotin Plus Rituximab

    Counts of participants who had treatment-emergent adverse events (TEAE, defined as newly occurring or worsening after first dose on Study SGN35-012). Serious adverse events are reported from the time of informed consent. National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE version 4.03) were used to assess severity (1=mild, 2=moderate, 3=severe, 4=life-threatening/disabling, 5=fatal). 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 3 years

Secondary outcomes (12)

  1. Objective Response Rate (ORR) by Investigator With Brentuximab Vedotin Plus Rituximab

    Percentage of participants treated with brentuximab vedotin plus rituximab 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 3 years

  2. Complete Remission (CR) Rate by Investigator

    Percentage of participants treated with brentuximab vedotin monotherapy or brentuximab vedotin plus rituximab who achieved a best response of complete remission (CR, disappearance of all evidence of disease) per Cheson 2007 Revised Response Criteria for Malignant Lymphoma.

    Measured: Up to approximately 3 years

  3. Duration of Objective Response With Brentuximab Vedotin Monotherapy by Kaplan-Meier Analysis

    Duration of complete remission (CR) or partial remission (PR), defined as time of initial response until disease progression or death. Response criteria per Cheson 2007 Revised Response Criteria for Malignant Lymphoma.

    Measured: Up to approximately 3 years

  4. Duration of Complete Remission With Brentuximab Vedotin Monotherapy by Kaplan-Meier Analysis

    Duration of complete remission (CR), defined as time of initial response until disease progression or death. Response criteria per Cheson 2007 Revised Response Criteria for Malignant Lymphoma.

    Measured: Up to approximately 3 years

  5. Progression-Free Survival With Brentuximab Vedotin Monotherapy by Kaplan-Meier Analysis

    Progression-free survival, defined as time from start of study treatment to disease progression per investigator or death due to any cause

    Measured: Up to approximately 3 years

  6. Correlation Between Antitumor Activity of Brentuximab Vedotin Monotherapy and CD30 Expression

    Percentage of participants treated with brentuximab vedotin monotherapy who achieved a best response of complete remission (CR, disappearance of all evidence of disease), partial remission (PR, regression of greater than or equal to 50% of measurable disease and no new sites), or stable disease (SD, no new sites and no change in size of previous lesions) per Cheson 2007 Revised Response Criteria for Malignant Lymphoma. Patients are grouped by CD30-positivity or CD30u (undetectable CD30).

    Measured: Up to 3 years

  7. Adverse Events by Severity, Seriousness, and Relationship to Treatment With Brentuximab Vedotin Monotherapy

    Counts of participants who had treatment-emergent adverse events (TEAE, defined as newly occurring or worsening after first dose on Study SGN35-012). Serious adverse events are reported from the time of informed consent. National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE version 4.03) were used to assess severity (1=mild, 2=moderate, 3=severe, 4=life-threatening/disabling, 5=fatal). 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 3 years

  8. Brentuximab Vedotin Antibody-Drug Conjugate (ADC) Concentration at End of Infusion (Ceoi) (Cycle 1)

    End of infusion concentration of ADC following the first dose of brentuximab vedotin

    Measured: 1 day

  9. Brentuximab Vedotin Antibody-Drug Conjugate (ADC) Trough Concentration (Ctrough) (Cycle 1)

    Trough concentration of ADC from 0 to 21 days following the first dose of brentuximab vedotin

    Measured: 3 weeks

  10. Maximum Concentration (Cmax) of Brentuximab Vedotin Monomethyl Auristatin E (MMAE) (Cycle 1)

    Maximum serum concentration of MMAE from 0 to 21 days following the first dose of brentuximab vedotin

    Measured: 3 weeks

  11. Time to Maximum Concentration (Tmax) of Brentuximab Vedotin Monomethyl Auristatin E (MMAE)

    Time of maximum serum concentration of MMAE from 0 to 21 days following the first dose of brentuximab vedotin

    Measured: 3 weeks

  12. Baseline Soluble CD30 Expression

    Serum concentration of soluble CD30 before first dose of brentuximab vedotin

    Measured: Baseline

Timeline

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

  1. First posted23 Aug 2011 (estimated)
  2. Study startAug 2011
  3. Primary completionJun 2015
  4. Study completionJun 2015

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 2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
176 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01421667
Sponsor's protocol ID
SGN35-012
Status last verified
Jun 2015
First submitted
19 Aug 2011
Last updated
28 Nov 2016
Data monitoring committee
No

Publications

  • Horwitz SM, Advani RH, Bartlett NL, Jacobsen ED, Sharman JP, O'Connor OA, Siddiqi T, Kennedy DA, Oki Y. Objective responses in relapsed T-cell lymphomas with single-agent brentuximab vedotin. Blood. 2014 May 15;123(20):3095-100. doi: 10.1182/blood-2013-12-542142. Epub 2014 Mar 20.

    PubMed 24652992

  • Jacobsen ED, Sharman JP, Oki Y, Advani RH, Winter JN, Bello CM, Spitzer G, Palanca-Wessels MC, Kennedy DA, Levine P, Yang J, Bartlett NL. Brentuximab vedotin demonstrates objective responses in a phase 2 study of relapsed/refractory DLBCL with variable CD30 expression. Blood. 2015 Feb 26;125(9):1394-402. doi: 10.1182/blood-2014-09-598763. Epub 2015 Jan 8.

    PubMed 25573987

  • Bartlett NL, Smith MR, Siddiqi T, Advani RH, O'Connor OA, Sharman JP, Feldman T, Savage KJ, Shustov AR, Diefenbach CS, Oki Y, Palanca-Wessels MC, Uttarwar M, Li M, Yang J, Jacobsen ED. Brentuximab vedotin activity in diffuse large B-cell lymphoma with CD30 undetectable by visual assessment of conventional immunohistochemistry. Leuk Lymphoma. 2017 Jul;58(7):1607-1616. doi: 10.1080/10428194.2016.1256481. Epub 2016 Nov 20.

    PubMed 27868471

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing brentuximab vedotin and rituximab in people with Lymphoma, B-Cell and Lymphoma, Large B-Cell, Diffuse, run by Seagen Inc. at 34 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 4 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 28 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 34 sites in United States, Canada. 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 13 Oct 2016). 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 (ORR) by Investigator With Brentuximab Vedotin Monotherapy (time frame: Up to approximately 3 years). The study lists 2 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 NCT01421667, which also lists 3 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 28 Nov 2016.

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