Neoplasms

Blood and Lymph Conditions

Immune System Diseases

All Conditions

Rare Diseases

Lymphoma

Lymphoma, T-Cell

Lymphoma, T-Cell, Peripheral

Hodgkin Disease

Hematologic Diseases

Neoplasms by Histologic Type

Lymphoproliferative Disorders

Lymphatic Diseases

Immunoproliferative Disorders

Lymphoma, Non-Hodgkin

Lymphosarcoma

Peripheral T-cell Lymphoma

Hodgkin Lymphoma

Antineoplastic Agents

All Drugs and Chemicals

Nivolumab

Antibodies

Antibodies, Monoclonal

Bendamustine Hydrochloride

Immunoglobulins

Brentuximab Vedotin

Dacarbazine

Antineoplastic Agents, Immunological

Immune Checkpoint Inhibitors

Antineoplastic Agents, Alkylating

Alkylating Agents

Immunotoxins

Immunoconjugates

Immunologic Factors

brentuximab vedotin

70 mg/m\^2 by IV infusion on Days 1 and 2 of 3-week cycle

bendamustine

dacarbazine

nivolumab

Robert Sims, MD

This trial will study brentuximab vedotin to find out whether it is an effective treatment for Hodgkin lymphoma (HL) and peripheral T-cell lymphoma (PTCL). Participants in this study will be older or will have other conditions that make them unable to have standard chemotherapy treatment. The study will look at brentuximab vedotin alone and combined with other drugs.

This study is designed to evaluate the efficacy and tolerability of brentuximab vedotin as monotherapy and in combination with other agents as frontline therapy. There are 6 parts of the study. The population to be studied includes treatment-naïve patients with classical Hodgkin lymphoma (HL) or treatment-naïve patients with CD30-expressing peripheral T-cell lymphoma (PTCL).

A Study of Brentuximab Vedotin With Hodgkin Lymphoma (HL) and CD30-expressing Peripheral T-cell Lymphoma (PTCL)

A Phase 2 Open-label Study of Brentuximab Vedotin in Front-line Therapy of Hodgkin Lymphoma (HL) an dCD30-expressing Peripheral T-cell Lymphoma (PTCL) in Older Patients or Patients With Significant Comorbidities Ineligible for Standard Chemotherapy

Defined as the proportion of patients with complete response (CR) or (PR)

Defined as the proportion of patients with CR

Defined as the time from start of the first documentation of complete tumor response (CR) to the first documentation of tumor progression or death

Defined as the time from start of the first documentation of objective tumor response (CR or PR) to the first documentation of tumor progression or death

Defined as the time from start of study treatment to first documentation of tumor progression or death due to any cause

Defined as the proportion of patients with CR, PR, or stable disease (SD)

Defined as the proportion of patients with lymphoma-related B symptoms at baseline who achieve resolution of all B symptoms at any time during the treatment period

Defined as the proportion of patients who develop ATA to brentuximab vedotin at any time during the study

Defined as the proportion of patients who develop ATA to nivolumab at any time during the study

Defined as the time from start of study treatment to date of death due to any cause

Bristol-Myers Squibb

Seagen Inc.

Immunomodulating Agents

brentuximab vedotin 1.8 mg/kg every 3 weeks by IV infusion

placebo

Julie Lisano, PharmD

This is a randomized, double-blind, placebo-controlled, multicenter phase 3 trial to evaluate the efficacy and safety of brentuximab vedotin (SGN-35) and best supportive care (BSC) compared to placebo and BSC in treatment of residual Hodgkin lymphoma (HL) following autologous stem cell transplant (ASCT).

A Phase 3 Study of Brentuximab Vedotin (SGN-35) in Patients at High Risk of Residual Hodgkin Lymphoma Following Stem Cell Transplant (The AETHERA Trial)

A Randomized, Double-Blind, Placebo-Controlled Phase 3 Study of SGN-35 and Best Supportive Care (BSC) Versus Placebo and BSC in the Treatment of Patients at High Risk of Residual Hodgkin Lymphoma Following Autologous Stem Cell Transplant

Time from date of randomization to the first documentation of disease progression by independent review or to death due to any cause, whichever comes first

Time from date of randomization to date of death due to any cause

Millennium Pharmaceuticals, Inc.

Safety Analysis Set includes all patients who received at least 1 dose of brentuximab vedotin or only received placebo: 2 patients randomized to placebo received a single dose of brentuximab vedotin and are included in the brentuximab vedotin arm; 2 patients randomized to placebo received no study treatment and are not included in the analysis

Placebo

Total

Age, Continuous

Sex: Female, Male

Race (NIH/OMB)

Russian Federation

Romania

Hungary

United States

United Kingdom

Spain

Czech Republic

Poland

Italy

France

Serbia

Bulgaria

Germany

Region of Enrollment

0=Normal activity; 1=Symptoms but ambulatory; 2=In bed \<50% of the time; 3= In bed \>50% of the time; 4=100% bedridden; 5=Dead

Eastern Cooperative Oncology Group Performance Status

Refractory

Relapse in less than 12 months

Relapse 12 months or later with extranodal disease

Hodgkin Lymphoma Status after end of Frontline Therapy

Complete remission

Partial remission

Stable disease

Best Response to Salvage Therapy pre-ASCT

Chief Medical Officer

Progression-free Survival by Independent Review

Overall Survival

Any Treatment-Emergent Adverse Event

Any Treatment-Related Adverse Event

Any Adverse Event with Severity >= Grade 3

Any Serious Adverse Event

Any Treatment-Related Serious Adverse Events

Treatment Discontinuation Due to Adverse Event

Any Laboratory Abnormalities Severity >=Grade 3

Incidence of Adverse Events or Laboratory Abnormalities

Baseline Negative

Baseline Negative: -'ve Postbaseline

Baseline Negative: Transiently +'ve Postbaseline

Baseline Negative: Persistently +'ve Postbaseline

Baseline Positive

Baseline Positive: -'ve Postbaseline

Baseline Positive: Transiently +'ve Postbaseline

Baseline Positive: Persistently +'ve Postbaseline

ATA-evaluable patients (patients with a baseline and at least 1 postbaseline sample)

Incidence of Anti-therapeutic Antibodies (ATA) to Brentuximab Vedotin

Overall Study

1.8 mg/kg every 3 weeks by intravenous infusion

Abraham Fong, MD, PhD

This is a single-arm, open-label, multicenter, pivotal clinical trial to evaluate the efficacy and safety of brentuximab vedotin (SGN-35) as a single agent in patients with relapsed or refractory Hodgkin lymphoma.

A Pivotal Open-Label Trial of Brentuximab Vedotin for Hodgkin Lymphoma

A Pivotal Study of SGN-35 in Treatment of Patients With Relapsed or Refractory Hodgkin Lymphoma (HL)

Percentage of participants with lymphoma-related symptoms (B symptoms: fever, night sweats, or weight loss \>10%) at baseline who achieved resolution of all B symptoms at any time during the treatment period.

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.

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.

Duration of objective response (CR + PR) by independent review group, defined as time of initial response until disease progression or death.

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.

Time from start of study treatment to disease progression per independent review group or death due to any cause.

Time from start of study treatment to date of death due to any cause.

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.

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.

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.

Area under the serum concentration-time curve from time 0 to 21 days following the first dose of brentuximab vedotin

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

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

Brentuximab vedotin 1.8 mg/kg every 3 weeks by IV infusion

Age, Customized

0 = Normal activity

1. = Symptoms but ambulatory
2. = In bed \<50% of the time
3. = In bed \>50% of the time
4. = 100% bedridden
5. = Dead

Objective Response Rate by Independent Review Group

Complete Remission Rate by Independent Review Group

Participants with objective response among the intention to treat population

Duration of Objective Response by Kaplan-Meier Analysis

Participants with complete remission among the intention to treat population

Duration of Objective Response in Participants With Complete Remission by Kaplan-Meier Analysis

Progression-free Survival by Kaplan-Meier Analysis

Any TEAE

TEAE related to study drug

TEAE with severity grade >/=3

Serious adverse event

Serious adverse event related to study drug

Discontinued treatment due to adverse event

Adverse Events by Severity, Seriousness, and Relationship to Treatment

Any >/= Grade 3 hematology laboratory abnormality

Hemoglobin (low)

Leukocytes (low)

Lymphocytes (low)

Neutrophils (low)

Platelets (low)

Hematology Laboratory Abnormalities >/= Grade 3

Any >/= Grade 3 chemistry laboratory abnormality

Alanine aminotransferase (high)

Albumin (low)

Calcium (low)

Glucose (high)

Potassium (low)

Sodium (high)

Urate (high)

Chemistry Laboratory Abnormalities >/= Grade 3

Area Under the Curve

B Symptom Resolution

Maximum Serum Concentration

Time of Maximum Serum Concentration

Brentuximab vedotin 1.8 mg/kg every 3 weeks by intravenous (IV) infusion

Treatment Period

Follow-up Period

Lymphoma, Large-Cell, Anaplastic

Naomi Hunder, MD

The purpose of this study is to evaluate cardiac safety of brentuximab vedotin (SGN-35) in patients with CD30-positive cancers. The study will assess electrical activity of the heart before and after brentuximab vedotin administration. Patients who have stable or improving disease may receive up to 1 year of brentuximab vedotin treatment.

Cardiac Safety Study of Brentuximab Vedotin (SGN-35)

An Intensive QT/QTc Study to Investigate the Effects of SGN-35 (Brentuximab Vedotin) on Cardiac Ventricular Repolarization in Patients With CD30-Positive Malignancies

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

1.8 mg/kg every 3 weeks by intravenous (IV) infusion

90 mg/m2 on Days 1 and 2 of 3-week cycles

Neil Josephson, MD

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. The study will assess the safety profile of the combination treatment and determine what proportion of patients achieve a complete remission.

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

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)

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.

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.

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.

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

The time from first observation of remission to disease progression/relapse or death from any cause, whichever occurs first.

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.

Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug.

brentuximab vedotin: 1.8 mg/kg on Day 1 of 3-week cycles by intravenous (IV) infusion

bendamustine: 90 mg/m\^2 on Days 1 and 2 of 3-week cycles by intravenous (IV) infusion

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
A Study of Brentuximab Vedotin With Hodgkin Lymphoma (HL) and CD30-expressing Peripheral T-cell Lymphoma (PTCL)	NCT01716806	Hodgkin Disease Peripheral T Ce...	brentuximab ved... bendamustine dacarbazine nivolumab	18 Years -	Seagen Inc.
A Phase 3 Study of Brentuximab Vedotin (SGN-35) in Patients at High Risk of Residual Hodgkin Lymphoma Following Stem Cell Transplant (The AETHERA Trial)	NCT01100502	Disease, Hodgki...	brentuximab ved... placebo	18 Years -	Seagen Inc.
A Pivotal Open-Label Trial of Brentuximab Vedotin for Hodgkin Lymphoma	NCT00848926	Disease, Hodgki...	brentuximab ved...	12 Years -	Seagen Inc.
Cardiac Safety Study of Brentuximab Vedotin (SGN-35)	NCT01026233	Disease, Hodgki... Lymphoma, Large... Lymphoma, Non-H...	brentuximab ved...	18 Years -	Seagen Inc.
Study of Brentuximab Vedotin Combined With Bendamustine in Patients With Hodgkin Lymphoma	NCT01874054	Hodgkin Disease	brentuximab ved... bendamustine	18 Years -	Seagen Inc.
A Brentuximab Vedotin Trial for Patients Who Have Previously Participated in a Brentuximab Vedotin Study	NCT00947856	Disease, Hodgki... Lymphoma, Large... Lymphoma, Non-H...	brentuximab ved...	6 Years -	Seagen Inc.
A Study of Brentuximab Vedotin With Hodgkin Lymphoma (HL) and CD30-expressing Peripheral T-cell Lymphoma (PTCL)	NCT01716806	Hodgkin Disease Peripheral T Ce...	brentuximab ved... bendamustine dacarbazine nivolumab	18 Years -	Seagen Inc.

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