Neoplasms

Blood and Lymph Conditions

Immune System Diseases

All Conditions

Rare Diseases

Lymphoma

Hodgkin Disease

Hematologic Diseases

Neoplasms by Histologic Type

Lymphoproliferative Disorders

Lymphatic Diseases

Immunoproliferative Disorders

Lymphosarcoma

Hodgkin Lymphoma

All Drugs and Chemicals

Antineoplastic Agents

Antibodies

Antibodies, Monoclonal

Bendamustine Hydrochloride

Immunomodulating Agents

Immunoglobulins

Brentuximab Vedotin

Antineoplastic Agents, Alkylating

Alkylating Agents

Antineoplastic Agents, Immunological

Immunotoxins

Immunoconjugates

Immunologic Factors

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

brentuximab vedotin

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

bendamustine

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.

Seagen Inc.

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

Brentuximab Vedotin + Bendamustine

Age, Categorical

Age, Continuous

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

United States

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 Group Oncology Performance Status

All subjects who enrolled and received at least 1 dose of brentuximab vedotin.

Chief Medical Officer

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.

Complete Remission Rate

Any Treatment-Emergent Adverse Event (TEAE)

Any TEAE with Severity >= Grade 3

Any Treatment-Related Adverse Event

Any Serious Adverse Event

Any Treatment-Related Serious Adverse Event

Treatment Discontinuation Due to Adverse Event

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

Incidence of Adverse Events (AEs)

An initial safety cohort of 10 patients who enrolled and received at least 1 dose of brentuximab vedotin were evaluated for this outcome.

Incidence of Dose-limiting Toxicities

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

Overall Best Response Rate

Patients with a complete or partial response who received at least 2 cycles of combination treatment and had a baseline tumor assessment and at least 2 post-baseline tumor assessment, or who had documented disease progression (including clinical disease progression) at any time after the first dose of combination therapy.

Duration of Response

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

Progression-free Survival

brentuximab vedotin (BV): 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

Spots Global Cancer Trial Database for Study of Brentuximab Vedotin Combined With Bendamustine in Patients With Hodgkin Lymphoma

Trial Identification

Conditions

Interventions

Study Description

Keywords

Eligibility

Locations

Contact Details

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