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

Immunomodulating Agents

Immunoglobulins

Brentuximab Vedotin

Antineoplastic Agents, Immunological

Immunotoxins

Immunoconjugates

Immunologic Factors

1.8 mg/kg every 3 weeks by intravenous infusion

brentuximab vedotin

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

Millennium Pharmaceuticals, Inc.

Seagen Inc.

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

Age, Customized

Sex: Female, Male

Race (NIH/OMB)

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

Chief Medical Officer

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

Overall Survival

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

Spots Global Cancer Trial Database for A Pivotal Open-Label Trial of Brentuximab Vedotin for Hodgkin Lymphoma

Trial Identification

Conditions

Interventions

Study Description

Keywords

Eligibility

Locations

Contact Details

Useful links and downloads for this trial