Neoplasms

Blood and Lymph Conditions

Immune System Diseases

All Conditions

Rare Diseases

Lymphoma

Hodgkin Disease

Lymphoma, Large-Cell, Anaplastic

Lymphoma, Non-Hodgkin

Neoplasms by Histologic Type

Lymphoproliferative Disorders

Lymphatic Diseases

Immunoproliferative Disorders

Lymphoma, T-Cell

Lymphosarcoma

Hodgkin Lymphoma

Anaplastic Large Cell Lymphoma

Antineoplastic Agents

All Drugs and Chemicals

Brentuximab Vedotin

Antineoplastic Agents, Immunological

Immunotoxins

Immunoconjugates

Immunologic Factors

Intravenous infusion of 1.8 mg/kg (body weight) of brentuximab vedotin (recombinant) administered once every three weeks

Brentuximab vedotin (recombinant) for IV infusion

Brentuximab vedotin (recombinant)

Study Director

The purpose of this study is to evaluate the safety of brentuximab vedotin (recombinant) for intravenous (IV) infusion (ADCETRIS IV Infusion 50 mg) in patients with relapsed/refractory CD30+ Hodgkin's lymphoma or anaplastic large cell lymphoma in the routine clinical setting, as well as to collect efficacy information for reference.

The present survey was designed to evaluate the safety of brentuximab vedotin (recombinant) for IV infusion (ADCETRIS IV Infusion 50 mg) in patients with relapsed/refractory CD30+ Hodgkin's lymphoma or anaplastic large cell lymphoma in the routine clinical setting.

The usual adult dosage is 1.8 mg/kg (body weight) of brentuximab vedotin (recombinant) infused intravenously once every three weeks. The dose should be adjusted depending on the participant's condition. See the "PRECAUTIONS" section of the package insert.

Brentuximab Vedotin (Recombinant) for IV Infusion - Special Drug Use Surveillance (All-case Surveillance) "Relapsed or Refractory CD30+ Hodgkin's Lymphoma or Anaplastic Large Cell Lymphoma"

Brentuximab Vedotin (ADCETRIS) IV Infusion - Special Drug Use Surveillance (All-case Surveillance) "Relapsed or Refractory CD30+ Hodgkin's Lymphoma or Anaplastic Large Cell Lymphoma"

Best response is defined as the cumulative numbers of participants who achieve each level of best response including partial response (PR), complete response uncertain (CRu) (when no positron emission tomography \[PET\] data are available), and complete response (CR) after each cycle of treatment. Reported data are divided into 4 populations; Hodgkin's lymphoma (HL) participants with PET data, HL participants without PET data, anaplastic large cell lymphoma (ALCL) participants with PET data, and ALCL participants without PET data. PET is used in cancer diagnosis and treatment.

OS is defined as the period from the start of therapy in standard medical care to the time when death (regardless of the cause of death) is confirmed. Reported data as OS was point estimates of 1 year survival rate for HL and ALCL participants.

Takeda

At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. For data of "Other Adverse Events", participants may be represented in more than 1 category.

Intravenous infusion of 1.8 mg/kg (body weight) of brentuximab vedotin (recombinant) administered once every three weeks. Participants received interventions as part of routine medical care.

Brentuximab Vedotin Infusion

Age, Continuous

Sex: Female, Male

Race and Ethnicity were not collected from any participant.

Race and Ethnicity Not Collected

Japan

Region of Enrollment

Mean duration between start of study and first time of diagnosis of HL or ALCL was reported.

Duration of Diagnosis of Hodgkin's Lymphoma (HL) or Anaplastic Large Cell Lymphoma (ALCL)

Diagnosis

Recurrent and Refractory or Primary

Number of participants with CD30 Positive

This baseline characteristic was analyzed only in participants who had been diagnosed with ALCL.

ALK Positive or Negative

Lymphoma is classified with following stages. Stage 1; Lymphoma in only 1 group of lymph nodes. Stage 2; Lymphoma in 2 or more groups of lymph nodes. Stage 3; There are lymph nodes that contain lymphoma on both sides of the diaphragm. Stage 4; The most advanced stage of lymphoma and lymphoma cells have spread to at least 1 body organ outside the lymphatic system.

Staging of Lymphoma

B symptom means participants have 1 or more these symptoms as following; Unintentional weight loss (more than 10% in the 6 months before you were diagnosed), Night sweats, Fevers (temperatures above 38 Celsius degrees).

B Symptom

Following are ECOG grades. 0: Fully active, perform all pre-disease activities without restriction. 1: Restricted in physically strenuous activity but ambulatory, carry out work of a light or sedentary nature. 2: Ambulatory, capable of selfcare, unable to carry out any work activities, up and about more than (\>) 50% of waking hours. 3: Capable of limited selfcare, confined to bed or chair \>50% of waking hours. 4: Completely disabled, not capable of any selfcare, totally confined to bed or chair.

Eastern Cooperative Oncology Group (ECOG) Performance Status

Participants were categorized as outpatient and inpatient.

Healthcare Category

The baseline characteristic was analyzed in participants who had a liability or tendency to suffer from hypersensitivity.

Predisposition to Hypersensitivity

Hepatitis C Virus (HCV) Antibody Positive or Negative

Hepatitis B Surface (HBs) Antigen Positive or Negative

HBs Antibody Positive or Negative

Hepatitis B Virus Deoxyribonucleic Acid (HBV DNA) Positive or Negative

Medical history defined as a disease or a health condition for each participant before start of the study. Medical history was classified as congenital anomalies, hematologic disorders, psychiatric and nervous system disorders, cardiovascular disorders, respiratory disorders, GI disorders, hepatic and biliary disorders, renal disease and other medical history. Other medical history included all medical history except for those mentioned above.

Medical History of Lung Disorder

Complications defined as a disease or a health condition for each participant at the start of study. Complications were classified as congenital anomalies, endocrine disorders, hematologic disorders, psychiatric and nervous system disorders, cardiovascular disorders, respiratory disorders, gastrointestinal (GI) disorders, renal disease and other complications. Other complications included all complications except for those mentioned above.

Medical Complications of Lung Disorder

Medical History of Malignant Tumor

Medical Complications of Malignant Tumor

Medical History (Other Than Lung Disorder or Malignant Tumor)

Medical Complications (Other Than Lung Disorder or Malignant Tumor)

Concomitant Hepatic Disorder

Concomitant Renal Disorder

Weight

Body Mass Index = weight (kg)/\[height (m)\^2\]

Smoking Classification

Drug Therapy before Start of Brentuximab Vedotin Administration

Population Analysis Description: This baseline characteristic was analyzed only in participants who had drug therapy before start of Brentuximab Vedotin administration.

Number of Regimens before Start of Brentuximab Vedotin Administration

Time in Days from Last Month of Previous Drug Therapy Regimen to First Cycle of Brentuximab Vendotin

Radiotherapy before Start of Brentuximab Vedotin Administration

Population Analysis Description: This baseline characteristic was analyzed only in participants who had radiotherapy before start of Brentuximab Vedotin administration. The number analyzed is the number of participants with data available for analysis.

Time in Days from Last Month of Most Recent Radiotherapy to First Cycle of Brentuximab Vendotin

Hematopoietic Stem Cell Transplantation before Start of Brentuximab Vedotin Administration

This baseline characteristic was analyzed only in female participants.

Number of Participants Who Were Not Pregnant

Safety Analysis Set; The safety analysis set was defined as all participants who had the safety data defined on the protocol.

Medical Director

Number of Participants Who Had One or More Adverse Events (AE) and Serious Adverse Events (SAE)

HL Participants with PET Data

HL Participants without PET Data

ALCL Participants with PET Data

ALCL Participants without PET Data

Efficacy assessment population; The efficacy assessment population was defined as participants who met the requirement of this study and had efficacy data available for analysis. The number analyzed is the number of participants with data available for analysis in the given timeframe.

Percentage of Participants Who Achieve or Maintain Any Best Response

HL Participants

ALCL Participants

Efficacy assessment population; The efficacy assessment population was defined as participants who met the requirement of this study and had efficacy data available for analysis.

Spots Global Cancer Trial Database for Brentuximab Vedotin (Recombinant) for IV Infusion - Special Drug Use Surveillance (All-case Surveillance) "Relapsed or Refractory CD30+ Hodgkin's Lymphoma or Anaplastic Large Cell Lymphoma"

Trial Identification

Conditions

Interventions

Study Description

Keywords

Eligibility

Locations

Contact Details

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