Relapsed or Refractory CD30+ Hodgkin's Lymphoma or Anaplastic Large Cell Lymphoma
Conditions
Keywords
Pharmacological therapy
Brief summary
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.
Detailed description
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.
Interventions
DRUGBrentuximab vedotin (recombinant)
Brentuximab vedotin (recombinant) for IV infusion
Sponsors
Takeda
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* All patients treated with brentuximab vedotin IV Infusion
Exclusion criteria
* None
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of Participants Who Had One or More Adverse Events (AE) and Serious Adverse Events (SAE) | Up to Week 48 or until discontinuation of treatment |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Who Achieve or Maintain Any Best Response | Up to Week 48 or until discontinuation of treatment | 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. |
| Overall Survival (OS) | Up to Week 48 or until discontinuation of 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. |
Countries
Japan
Participant flow
Recruitment details
Participants took part in the study at 198 investigative sites in Japan, from 17 April 2014 to 30 June 2017. Registration period for patients was from 17 April 2014 to 30 September 2014.
Pre-assignment details
Participants with a historical diagnosis of relapsed/refractory CD30+ Hodgkin's lymphoma (HL) or anaplastic large cell lymphoma (ALCL) were enrolled. Participants received interventions as part of routine medical care.
Participants by arm
| Arm | Count |
|---|---|
| Brentuximab Vedotin Infusion 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. | 284 |
| Total | 284 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Case Report Forms Uncollected | 8 |
Baseline characteristics
| Characteristic | Brentuximab Vedotin Infusion | — |
|---|---|---|
| Age, Continuous | 56.7 Years STANDARD_DEVIATION 19.8 | — |
| ALK Positive or Negative ALK-Negative | 77 Participants | — |
| ALK Positive or Negative ALK-Positive | 15 Participants | — |
| ALK Positive or Negative Unknown | 9 Participants | — |
| BMI | 22.00 kg/meter (m)^2 STANDARD_DEVIATION 3.991 | — |
| B Symptom Had B symptom | 124 Participants | — |
| B Symptom Had No B symptom | 160 Participants | — |
| Concomitant Hepatic Disorder Had Concomitant Hepatic Disorder | 25 Participants | — |
| Concomitant Hepatic Disorder Had No Concomitant Hepatic Disorder | 259 Participants | — |
| Concomitant Renal Disorder Had Concomitant Renal Disorder | 20 Participants | — |
| Concomitant Renal Disorder Had No Concomitant Renal Disorder | 264 Participants | — |
| Diagnosis ALCL | 101 Participants | — |
| Diagnosis HL | 182 Participants | — |
| Diagnosis Others | 1 Participants | — |
| Drug Therapy before Start of Brentuximab Vedotin Administration Had Drug Therapy | 279 Participants | — |
| Drug Therapy before Start of Brentuximab Vedotin Administration Had No Drug Therapy | 5 Participants | — |
| Duration of Diagnosis of Hodgkin's Lymphoma (HL) or Anaplastic Large Cell Lymphoma (ALCL) < 1 Year | 75 Participants | — |
| Duration of Diagnosis of Hodgkin's Lymphoma (HL) or Anaplastic Large Cell Lymphoma (ALCL) >= 1 Year and < 3 Years | 105 Participants | — |
| Duration of Diagnosis of Hodgkin's Lymphoma (HL) or Anaplastic Large Cell Lymphoma (ALCL) >= 3 Years and < 5 Years | 47 Participants | — |
| Duration of Diagnosis of Hodgkin's Lymphoma (HL) or Anaplastic Large Cell Lymphoma (ALCL) >= 5 Years | 55 Participants | — |
| Duration of Diagnosis of Hodgkin's Lymphoma (HL) or Anaplastic Large Cell Lymphoma (ALCL) Unknown | 2 Participants | — |
| Eastern Cooperative Oncology Group (ECOG) Performance Status 0 | 114 Participants | — |
| Eastern Cooperative Oncology Group (ECOG) Performance Status 1 | 104 Participants | — |
| Eastern Cooperative Oncology Group (ECOG) Performance Status 2 | 32 Participants | — |
| Eastern Cooperative Oncology Group (ECOG) Performance Status 3 | 19 Participants | — |
| Eastern Cooperative Oncology Group (ECOG) Performance Status 4 | 15 Participants | — |
| HBs Antibody Positive or Negative HBs Antibody- Negative | 208 Participants | — |
| HBs Antibody Positive or Negative HBs Antibody-Positive | 41 Participants | — |
| HBs Antibody Positive or Negative Unknown | 35 Participants | — |
| Healthcare Category Inpatient | 238 Participants | — |
| Healthcare Category Outpatient | 45 Participants | — |
| Healthcare Category Unknown | 1 Participants | — |
| Hematopoietic Stem Cell Transplantation before Start of Brentuximab Vedotin Administration Had Allogeneic Transplantation | 9 Participants | — |
| Hematopoietic Stem Cell Transplantation before Start of Brentuximab Vedotin Administration Had Autologous and Allogeneic Transplantation | 12 Participants | — |
| Hematopoietic Stem Cell Transplantation before Start of Brentuximab Vedotin Administration Had Autologous Transplantation | 43 Participants | — |
| Hematopoietic Stem Cell Transplantation before Start of Brentuximab Vedotin Administration Had No Hematopoietic Stem Cell Transplantation | 219 Participants | — |
| Hematopoietic Stem Cell Transplantation before Start of Brentuximab Vedotin Administration Unknown | 1 Participants | — |
| Hepatitis B Surface (HBs) Antigen Positive or Negative HBs Antigen-Negative | 271 Participants | — |
| Hepatitis B Surface (HBs) Antigen Positive or Negative HBs Antigen-Positive | 6 Participants | — |
| Hepatitis B Surface (HBs) Antigen Positive or Negative Unknown | 7 Participants | — |
| Hepatitis B Virus Deoxyribonucleic Acid (HBV DNA) Positive or Negative HBV DNA-Negative | 106 Participants | — |
| Hepatitis B Virus Deoxyribonucleic Acid (HBV DNA) Positive or Negative HBV DNA-Positive | 4 Participants | — |
| Hepatitis B Virus Deoxyribonucleic Acid (HBV DNA) Positive or Negative Unknown | 174 Participants | — |
| Hepatitis C Virus (HCV) Antibody Positive or Negative HCV Antibody- Negative | 274 Participants | — |
| Hepatitis C Virus (HCV) Antibody Positive or Negative HCV Antibody-Positive | 6 Participants | — |
| Hepatitis C Virus (HCV) Antibody Positive or Negative Unknown | 4 Participants | — |
| Medical Complications of Lung Disorder Had No Presence of Medical Complications | 264 Participants | — |
| Medical Complications of Lung Disorder Had Presence of Medical Complications | 20 Participants | — |
| Medical Complications of Malignant Tumor Had No Presence of Medical Complications | 279 Participants | — |
| Medical Complications of Malignant Tumor Had Presence of Medical Complications | 5 Participants | — |
| Medical Complications (Other Than Lung Disorder or Malignant Tumor) Had No Presence of Medical Complications | 102 Participants | — |
| Medical Complications (Other Than Lung Disorder or Malignant Tumor) Had Presence of Medical Complications | 182 Participants | — |
| Medical History of Lung Disorder Had Medical History | 9 Participants | — |
| Medical History of Lung Disorder Had No Medical History | 275 Participants | — |
| Medical History of Malignant Tumor Had No Presence of Medical History | 251 Participants | — |
| Medical History of Malignant Tumor Had Presence of Medical History | 33 Participants | — |
| Medical History (Other Than Lung Disorder or Malignant Tumor) Had No Presence of Medical History | 216 Participants | — |
| Medical History (Other Than Lung Disorder or Malignant Tumor) Had Presence of Medical History | 68 Participants | — |
| Number of Participants Who Were Not Pregnant | 100 Participants | — |
| Number of participants with CD30 Positive | 284 Participants | — |
| Number of Regimens before Start of Brentuximab Vedotin Administration | 2.7 Number of Regimens STANDARD_DEVIATION 1.57 | — |
| Predisposition to Hypersensitivity Had No Predisposition to Hypersensitivity | 231 Participants | — |
| Predisposition to Hypersensitivity Had Predisposition to Hypersensitivity | 51 Participants | — |
| Predisposition to Hypersensitivity Unknown | 2 Participants | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Radiotherapy before Start of Brentuximab Vedotin Administration Had No Radiotherapy | 179 Participants | — |
| Radiotherapy before Start of Brentuximab Vedotin Administration Had Radiotherapy | 105 Participants | — |
| Recurrent and Refractory or Primary Primary | 3 Participants | — |
| Recurrent and Refractory or Primary Recurrent and Refractory | 281 Participants | — |
| Region of Enrollment Japan | 284 Participants | — |
| Sex: Female, Male Female | 100 Participants | — |
| Sex: Female, Male Male | 184 Participants | — |
| Smoking Classification Current Smoker | 16 Participants | — |
| Smoking Classification Ex-Smoker | 84 Participants | — |
| Smoking Classification Never Smoked | 130 Participants | — |
| Smoking Classification Unknown | 54 Participants | — |
| Staging of Lymphoma Stage 1 | 10 Participants | — |
| Staging of Lymphoma Stage 2 | 63 Participants | — |
| Staging of Lymphoma Stage 3 | 70 Participants | — |
| Staging of Lymphoma Stage 4 | 140 Participants | — |
| Staging of Lymphoma Unknown | 1 Participants | — |
| Time in Days from Last Month of Most Recent Radiotherapy to First Cycle of Brentuximab Vendotin | 703.4 Days STANDARD_DEVIATION 954.27 | — |
| Time in Days from Last Month of Previous Drug Therapy Regimen to First Cycle of Brentuximab Vendotin | 299.1 Days STANDARD_DEVIATION 564.04 | — |
| Weight | 58.158 Kilograms (kg) STANDARD_DEVIATION 13.0751 | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 51 / 284 |
| other Total, other adverse events | 238 / 284 |
| serious Total, serious adverse events | 97 / 284 |
Outcome results
Primary
Number of Participants Who Had One or More Adverse Events (AE) and Serious Adverse Events (SAE)
Time frame: Up to Week 48 or until discontinuation of treatment
Population: Safety Analysis Set; The safety analysis set was defined as all participants who had the safety data defined on the protocol.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Brentuximab Vedotin Infusion | Number of Participants Who Had One or More Adverse Events (AE) and Serious Adverse Events (SAE) | AE | 238 Participants |
| Brentuximab Vedotin Infusion | Number of Participants Who Had One or More Adverse Events (AE) and Serious Adverse Events (SAE) | SAE | 97 Participants |
Secondary
Overall Survival (OS)
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.
Time frame: Up to Week 48 or until discontinuation of treatment
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Brentuximab Vedotin Infusion | Overall Survival (OS) | ALCL Participants | 79.3 Percentage of participants |
| Brentuximab Vedotin Infusion | Overall Survival (OS) | HL Participants | 82.7 Percentage of participants |
Secondary
Percentage of Participants Who Achieve or Maintain Any Best Response
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.
Time frame: Up to Week 48 or until discontinuation of treatment
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Brentuximab Vedotin Infusion | Percentage of Participants Who Achieve or Maintain Any Best Response | HL Participants with PET Data | 64.9 Percentage of participants |
| Brentuximab Vedotin Infusion | Percentage of Participants Who Achieve or Maintain Any Best Response | HL Participants without PET Data | 36.5 Percentage of participants |
| Brentuximab Vedotin Infusion | Percentage of Participants Who Achieve or Maintain Any Best Response | ALCL Participants with PET Data | 67.6 Percentage of participants |
| Brentuximab Vedotin Infusion | Percentage of Participants Who Achieve or Maintain Any Best Response | ALCL Participants without PET Data | 57.1 Percentage of participants |