Hodgkin DiseasePhase 1/2NCT01874054

Study of Brentuximab Vedotin Combined With Bendamustine in Patients With Hodgkin Lymphoma

A Phase 1/2 study testing brentuximab vedotin and bendamustine in people with Hodgkin Disease, run by Seagen Inc. at 13 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

The purpose of this study is to assess safety and efficacy of brentuximab vedotin in combination with bendamustine in patients with relapsed or refractory Hodgkin lymphoma. It is an open-label, 2-stage study designed to determine the recommended dose level of bendamustine in combination with brentuximab vedotin. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Hodgkin Disease
What is being tested?: brentuximab vedotin and bendamustine
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 55 participants
Where: 13 sitesUnited States
Study dates: Jun 2013to 20 Feb 2018
Phase: Phase 1/2
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 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Histopathological diagnosis of classical Hodgkin lymphoma
Failed standard front-line therapy
Measurable disease of at least 1.5 cm as documented by radiographic technique
Eastern Cooperative Oncology Group performance status less than or equal to 2

Who cannot join

Received prior salvage therapy, including radiotherapy
Chemotherapy, radiotherapy, biologics, and/or other treatment with immunotherapy not completed 4 weeks prior to first dose of study drug
Concurrent use of other investigational agents

Trial locations and contacts

13 sites in 1 country.

City, postcode or hospital

13 sites in 1 country

United States13 sites

University of Alabama at Birmingham
Birmingham, Alabama, 35294
Dana Farber Cancer Institute
Boston, Massachusetts, 02215
Jewish Hospital, The
Cincinnati, Ohio, 45236
Case Western Reserve University / University Hospitals Case Medical Center
Cleveland, Ohio, 44106
Charles A. Sammons Cancer Center / Baylor University Medical Center
Dallas, Texas, 75246
Colorado Blood Cancer Institute
Denver, Colorado, 80218
Saint Francis Hospital / Bon Secours
Greenville, South Carolina, 29601
Columbia University Medical Center
New York, New York, 10022
University of Nebraska Medical Center
Omaha, Nebraska, 68198-7680
Mayo Clinic Minnesota
Rochester, Minnesota, 55905
Pacific Hematology Oncology Associates
San Francisco, California, 94115
Stanford Cancer Center
Stanford, California, 94305
Oncology Institute of Hope & Innovation, The
Whittier, California, 90603

Other trials in United States

About this study

Official title: A Phase 1/2 Single-arm, Open-label Study to Evaluate the Safety and Efficacy of Brentuximab Vedotin in Combination With Bendamustine in Patients With Relapsed or Refractory Hodgkin Lymphoma (HL)

Conditions: Hodgkin Disease
Being tested: brentuximab vedotin, bendamustine
Keywords: Antibody-Drug Conjugate, Antibodies, Monoclonal, Hodgkin Disease, Hematologic Diseases, Drug Therapy, Immunotherapy, Antigens, CD30, Lymphoma, monomethylauristatin E
Medical subject headings: Hodgkin Disease, 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 intravenous (IV) infusion
bendamustineDrug
90 mg/m2 on Days 1 and 2 of 3-week cycles

Study groups in NCT01874054
Study group	Role	What they receive
Brentuximab Vedotin + Bendamustine	Experimental	Brentuximab vedotin 1.8 mg/kg every 3 weeks for up to 16 cycles by IV infusion and bendamustine 90 mg/m2 on Days 1 and 2 every 3 weeks by IV infusion for up to 6 cycles Receives: Drug: brentuximab vedotin; Drug: bendamustine

What is being measured

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

Complete Remission Rate
Complete remission rate among all subjects (Phase 1 and 2 combined) treated at the dose level selected for Phase 2. Complete remission (CR) per Cheson 2007 Revised Response Criteria for Malignant Lymphoma is a disappearance of all evidence of disease.
Measured: Up to 4.6 months
Incidence of Adverse Events (AEs)
All AEs reported after initiation of treatment and pre-existing conditions that worsen after initiation of treatment will be considered treatment-emergent AEs (TEAEs). All AEs will be coded by system organ class, MedDRA preferred term, and severity grade using NCI CTCAE V4.03. All recorded AEs will be included in the data listings.
Measured: Up to 13.8 months

Secondary outcomes (4)

Incidence of Dose-limiting Toxicities
Incidence of dose-limiting toxicity (DLT) was evaluated in an initial safety cohort of 10 patients who were followed for protocol-defined DLT events until Cycle 2 Day 1.
Measured: Up to 3 weeks; first cycle of therapy through the first day of Cycle 2
Overall Best Response Rate
Percentage of participants 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), stable disease (SD, failure to obtain a complete or partial response or progressive disease), or progressive disease (PD, any new lesion or increase by 50% or more of previously involved sites from nadir) per Cheson 2007 Revised Response Criteria for Malignant Lymphoma
Measured: Up to 4.6 months
Duration of Response
The time from first observation of remission to disease progression/relapse or death from any cause, whichever occurs first.
Measured: Up to 47.8 months
Progression-free Survival
The time from first dose of study medication to first documentation of disease progression/relapse, or to death due to any cause, whichever occurs first.
Measured: Up to 49 months

Timeline

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

Jun 201320 Feb 2018

First posted10 Jun 2013 (estimated)
Study startJun 2013
Primary completionDec 2015
Study completion20 Feb 2018

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 (1)Papers the sponsor has linked to this study.
Other trials for Hodgkin DiseaseStudies 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 1/2
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 55 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01874054
Sponsor's protocol ID: SGN35-016
Status last verified: Jan 2019
First submitted: 6 Jun 2013
Last updated: 12 Feb 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

LaCasce AS, Bociek RG, Sawas A, Caimi P, Agura E, Matous J, Ansell SM, Crosswell HE, Islas-Ohlmayer M, Behler C, Cheung E, Forero-Torres A, Vose J, O'Connor OA, Josephson N, Wang Y, Advani R. Brentuximab vedotin plus bendamustine: a highly active first salvage regimen for relapsed or refractory Hodgkin lymphoma. Blood. 2018 Jul 5;132(1):40-48. doi: 10.1182/blood-2017-11-815183. Epub 2018 Apr 27.
PubMed 29703778

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 Hodgkin Disease trials

Study at a glance

From the registry record, last updated by the sponsor on 12 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 1/2 Single-arm, Open-label Study to Evaluate the Safety and Efficacy of Brentuximab Vedotin in Combination With Bendamustine in Patients With Relapsed or Refractory Hodgkin Lymphoma (HL)
ClinicalTrials.gov ID: NCT01874054
Acronym / sponsor ID: SGN35-016
Conditions: Hodgkin Disease
Keywords: Antibody-Drug Conjugate, Antibodies, Monoclonal, Hodgkin Disease, Hematologic Diseases, Drug Therapy, Immunotherapy, Antigens, CD30, Lymphoma
Phase: Phase 1/2
Study type: Interventional
Recruitment status: Completed
Enrolment: 55 participants (actual)
Lead sponsor: Seagen Inc.Industry (pharma, biotech, devices)
Study start: Jun 2013
Primary completion: Dec 2015 (actual)
Study completion: 20 Feb 2018 (actual)
First posted: 10 Jun 2013 (estimated)
Results: Posted 6 Apr 2017

Clinical summary

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

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 + Bendamustine	Experimental	Drug: brentuximab vedotin, Drug: bendamustineBrentuximab vedotin 1.8 mg/kg every 3 weeks for up to 16 cycles by IV infusion and bendamustine 90 mg/m2 on Days 1 and 2 every 3 weeks by IV infusion for up to 6 cycles

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

Histopathological diagnosis of classical Hodgkin lymphoma
Failed standard front-line therapy
Measurable disease of at least 1.5 cm as documented by radiographic technique
Eastern Cooperative Oncology Group performance status less than or equal to 2

Key exclusion criteria (3 listed)

Received prior salvage therapy, including radiotherapy
Chemotherapy, radiotherapy, biologics, and/or other treatment with immunotherapy not completed 4 weeks prior to first dose of study drug
Concurrent use of other investigational agents

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: Adcetris; SGN-351.8 mg/kg every 3 weeks by intravenous (IV) infusion	Drug	Brentuximab Vedotin + Bendamustine
bendamustine90 mg/m2 on Days 1 and 2 of 3-week cycles	Drug	Brentuximab Vedotin + Bendamustine

Primary outcome

Complete Remission Rate
Time frame: Up to 4.6 months
Complete remission rate among all subjects (Phase 1 and 2 combined) treated at the dose level selected for Phase 2. Complete remission (CR) per Cheson 2007 Revised Response Criteria for Malignant Lymphoma is a disappearance of all evidence of disease.
Incidence of Adverse Events (AEs)
Time frame: Up to 13.8 months
All AEs reported after initiation of treatment and pre-existing conditions that worsen after initiation of treatment will be considered treatment-emergent AEs (TEAEs). All AEs will be coded by system organ class, MedDRA preferred term, and severity grade using NCI CTCAE V4.03. All recorded AEs will be included in the data listings.

4 secondary outcomes

Incidence of Dose-limiting Toxicities
Time frame: Up to 3 weeks; first cycle of therapy through the first day of Cycle 2
Overall Best Response Rate
Time frame: Up to 4.6 months
Duration of Response
Time frame: Up to 47.8 months
Progression-free Survival
Time frame: Up to 49 months

Results and safety

Results posted to the registry on 6 Apr 2017, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Brentuximab Vedotin + Bendamustine	55	0

Primary outcome: Complete Remission Rate

Time frame: Up to 4.6 months. Number (95% Confidence Interval). Unit: percentage of participants

Measure	Brentuximab Vedotin + Bendamustine n = 53
Value	73.6 (59.67 to 84.74)

Population analysed: All patients who received at least 2 cycles of combination treatment at the recommended dose level and had a baseline tumor assessment and at least 1 postbaseline tumor assessment, or who had documented disease progression (including clinical disease progression) at any time after the first dose of combination therapy at the recommended dose level.

Primary outcome: Incidence of Adverse Events (AEs)

Time frame: Up to 13.8 months. Count of participants. Unit: Participants

Measure	Brentuximab Vedotin + Bendamustine n = 55
Any Treatment-Emergent Adverse Event (TEAE)	55
Any TEAE with Severity >= Grade 3	31
Any Treatment-Related Adverse Event	54
Any Serious Adverse Event	18
Any Treatment-Related Serious Adverse Event	15
Treatment Discontinuation Due to Adverse Event	20

Population analysed: All subjects who were enrolled and received at least 1 dose of brentuximab vedotin.

4 secondary outcomes are reported in the full results.

Adverse events

Time frame: Up to 13.8 months. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Brentuximab Vedotin + Bendamustine	18 of 55 (32.7%)	55 of 55 (100%)	5 of 55

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 29703778LaCasce AS, Bociek RG, Sawas A, Caimi P, Agura E, Matous J, Ansell SM, Crosswell HE, Islas-Ohlmayer M, Behler C, Cheung E, Forero-Torres A, Vose J, O'Connor OA, Josephson N, Wang Y, Advani R. Brentuximab vedotin plus bendamustine: a highly active first salvage regimen for relapsed or refractory Hodgkin lymphoma. Blood. 2018 Jul 5;132(1):40-48. doi: 10.1182/blood-2017-11-815183. Epub 2018 Apr 27.

Related trials for Hodgkin Disease

RecruitingPhase 2
Ibrutinib Combination Therapy in Transplant Ineligible Individuals With Newly Diagnosed Primary CNS Lymphoma
Non-hodgkin Lymphoma
RecruitingObservational study
Blood, Urine, and Tissue Collection for Cutaneous Lymphoma, Eczema, and Atopic Dermatitis Research
Cutaneous T-cell Lymphoma, Sezary Syndrome
Active, not recruitingPhase 2
Brentuximab Vedotin and Combination Chemotherapy in Treating Patients With CD30-Positive Peripheral T-cell Lymphoma
Adult T-Cell Leukemia/Lymphoma, Anaplastic Large Cell Lymphoma, ALK-Negative
Active, not recruitingPhase 1/2
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NSCLC, SCLC
Active, not recruitingPhase 2
Dosing of Brentuximab Vedotin for Mycosis Fungoides, Sezary Syndrome Patients
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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.

Neil Josephson, MD study director

Seagen Inc.

13 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing brentuximab vedotin and bendamustine in people with Hodgkin Disease, run by Seagen Inc. at 13 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 12 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 13 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?

Yes. Results are posted in the registry (first posted 6 Apr 2017). 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?

Complete Remission Rate (time frame: Up to 4.6 months). 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 NCT01874054, 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 12 Feb 2019.