Anaplastic Large Cell Lymphoma, Hodgkin Lymphoma, Peripheral T Cell Lymphoma
Conditions
Keywords
CD30-expression, sALCL, PTCL, cHL, Seattle Genetics
Brief summary
This study will look at whether brentuximab vedotin works and is safe in the re-treatment setting. To be in this study, patients must have already received brentuximab vedotin as treatment and have cancer that progressed (got worse) after stopping treatment.
Detailed description
This is a study to determine the safety and efficacy of brentuximab vedotin in subjects with classic Hodgkin lymphoma (cHL) and systemic anaplastic large cell lymphoma (sALCL) or other CD30-expressing peripheral T cell lymphoma (PTCL) who experienced complete response (CR) or partial response (PR) with a brentuximab vedotin-containing regimen and subsequently experienced disease progression or relapse.
Interventions
DRUGbrentuximab vedotin
1.8 mg/kg given intravenously (IV)
Sponsors
Seagen Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Histologically confirmed cHL, sALCL, or other CD30-expressing PTCL * Previously treated with brentuximab vedotin containing regimen, with evidence of objective response, and subsequent disease progression or relapse after discontinuing treatment * Documentation of disease relapse or progression ≥6 months after the last dose of brentuximab vedotin * Fluorodeoxyglucose positron emission tomography- (FDG-PET) avid and bidimensional measurable disease of at least 1.5 cm in longest axis as documented by radiographic technique * Eastern Cooperative Oncology Group (ECOG) performance status of less than or equal to 2 * Must not be pregnant and, if of childbearing or fathering potential, must agree to use 2 effective contraception methods during study and for 6 months following last dose of study drug
Exclusion criteria
* Previously discontinued brentuximab vedotin due to any Grade 3 or higher toxicity * Existing Grade 2 or higher peripheral neuropathy * Previously refractory to treatment with brentuximab vedotin * History of a cerebral vascular event, unstable angina, or myocardial infarction within 6 months prior to first dose * History of another malignancy within 3 years before first dose of study drug or any evidence of residual disease from previously diagnosed malignancy * Acute or chronic graft-versus-host-disease (GvHD) or receiving immunosuppressive therapy as treatment for or prophylaxis agent against GvHD * Active cerebral/meningeal disease * History of progressive multifocal leukoencephalopathy (PML) * Active uncontrolled Grade 3 (per NCI CTCAE v5.0) or higher viral, bacterial, or fungal infection within 2 weeks prior to first dose of study drug * Chemotherapy, radiotherapy, biologics, and/or other antitumor treatment with immunotherapy that is not completed 4 weeks prior to first dose of study drug, unless underlying disease has progressed on treatment
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Objective Response Rate (ORR) Per BICR According to Modified Lugano Response Criteria | Up to 18.3 months | Objective Response Rate (ORR) is defined as the percentage of participants with complete response (CR) or partial response (PR) according to the modified Lugano Criteria for Response Assessment (Cheson 2014) based on BICR |
| Number of Participants With Adverse Events | Up to 36 months | An AE is any untoward medical occurrence in a patient or clinical investigational participant administered a medicinal product and which does not necessarily have a causal relationship with this treatment. Treatment emergent AEs (TEAEs) are defined as events that are new or worsened on or after receiving the first dose of study treatment and up through 30 days after the last dose of study treatment. |
| Number of Participants With Laboratory Abnormalities | Up to 36 months | Laboratory data was summarized by the worst post-baseline grade, by NCI CTCAE v5.0 or higher for each parameter. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Rate of Complete Response (CR) Per BICR According to Modified Lugano Response Criteria | Up to 18.3 months | CR rate is defined as the percentage of participants with CR according to the modified Lugano Criteria for Response Assessment (Cheson 2014) |
| ORR Per Investigator Assessment According to Modified Lugano Response Criteria | Up to 18.3 months | Objective Response Rate (ORR) is defined as the percentage of participants with CR or PR according to the modified Lugano Criteria for Response Assessment (Cheson 2014) based on investigator assessment |
| DOR Per Investigator Assessment According to Modified Lugano Response Criteria | Up to 17.1 months | Duration of response is defined as the time from start of the first documentation of objective tumor response (CR or PR), according to the Modified Lugano Criteria for Response Assessment (Cheson 2007), to the first documentation of objective tumor progression or to death due to any cause, whichever comes first. |
| Duration of Response (DOR) Per BICR According to Modified Lugano Response Criteria | Up to 17.1 months | Duration of response is defined as the time from start of the first documentation of objective tumor response (CR or PR), according to the Modified Lugano Criteria for Response Assessment (Cheson 2007), to the first documentation of objective tumor progression or to death due to any cause, whichever comes first. |
| Rate of Complete Response Per Investigator Assessment According to Modified Lugano Response Criteria | Up to 18.3 months | CR rate is defined as the percentage of participants with CR according to the Modified Lugano Criteria for Response Assessment (Cheson 2014). |
| ORR Per BICR According to Lugano Response Criteria | Up to 18.3 months | ORR is defined as the percentage of participants with CR or PR, assessed according to Lugano Criteria for Response Assessment (Cheson 2014) |
| Progression-free Survival Per Investigator Assessment According to Modified Lugano Response Criteria | Up to 18.3 months | PFS is defined as the time from start of study treatment to first documentation of objective tumor progression according to the Modified Lugano Criteria for Response Assessment (Cheson 2007) or to death due to any cause, whichever comes first. |
| Progression-free Survival (PFS) Per BICR According to Modified Lugano Response Criteria | up to 18.3 months | PFS is defined as the time from start of study treatment to first documentation of objective tumor progression according to the Modified Lugano Criteria for Response Assessment (Cheson 2007) or to death due to any cause, whichever comes first. |
| Overall Survival (OS) | Up to 35.8 months | OS is defined as the time from date of enrollment to date of death due to any cause. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Classic Hodgkin Lymphoma Participants with classic Hodgkin lymphoma | 5 |
| PTCL Participants with peripheral T cell lymphoma | 6 |
| Total | 11 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Death | 0 | 2 |
| Overall Study | Lost to Follow-up | 2 | 0 |
| Overall Study | Study Closure by Sponsor | 2 | 2 |
| Overall Study | Withdrawal by Subject | 2 | 2 |
Baseline characteristics
| Characteristic | PTCL | Total | Classic Hodgkin Lymphoma |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 3 Participants | 3 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 3 Participants | 8 Participants | 5 Participants |
| Age, Continuous | 63 Years | 50 Years | 31 Years |
| Eastern Cooperative Oncology Group (ECOG) Performance Status Grade 0 | 2 Participants | 5 Participants | 3 Participants |
| Eastern Cooperative Oncology Group (ECOG) Performance Status Grade 1 | 4 Participants | 6 Participants | 2 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 1 Participants | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 6 Participants | 10 Participants | 4 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 3 Participants | 6 Participants | 3 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 3 Participants | 5 Participants | 2 Participants |
| Sex: Female, Male Female | 2 Participants | 5 Participants | 3 Participants |
| Sex: Female, Male Male | 4 Participants | 6 Participants | 2 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 6 | 2 / 6 |
| other Total, other adverse events | 5 / 5 | 6 / 6 |
| serious Total, serious adverse events | 0 / 5 | 2 / 6 |
Outcome results
Primary
Number of Participants With Adverse Events
An AE is any untoward medical occurrence in a patient or clinical investigational participant administered a medicinal product and which does not necessarily have a causal relationship with this treatment. Treatment emergent AEs (TEAEs) are defined as events that are new or worsened on or after receiving the first dose of study treatment and up through 30 days after the last dose of study treatment.
Time frame: Up to 36 months
Population: The full analysis set includes participants who received at least one dose of study treatment.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Classic Hodgkin Lymphoma | Number of Participants With Adverse Events | Any TEAE | 5 Participants |
| Classic Hodgkin Lymphoma | Number of Participants With Adverse Events | Treatment-related TEAE | 4 Participants |
| Classic Hodgkin Lymphoma | Number of Participants With Adverse Events | Any Treatment-Emergent SAE | 0 Participants |
| Classic Hodgkin Lymphoma | Number of Participants With Adverse Events | Discontinuation of treatment due to TEAE | 1 Participants |
| Classic Hodgkin Lymphoma | Number of Participants With Adverse Events | Discontinuation of treatment due to treatment-related TEAE | 1 Participants |
| Classic Hodgkin Lymphoma | Number of Participants With Adverse Events | TEAE leading to death | 0 Participants |
| PTCL | Number of Participants With Adverse Events | Discontinuation of treatment due to treatment-related TEAE | 3 Participants |
| PTCL | Number of Participants With Adverse Events | Any TEAE | 6 Participants |
| PTCL | Number of Participants With Adverse Events | Discontinuation of treatment due to TEAE | 3 Participants |
| PTCL | Number of Participants With Adverse Events | Treatment-related TEAE | 5 Participants |
| PTCL | Number of Participants With Adverse Events | TEAE leading to death | 0 Participants |
| PTCL | Number of Participants With Adverse Events | Any Treatment-Emergent SAE | 2 Participants |
Primary
Number of Participants With Laboratory Abnormalities
Laboratory data was summarized by the worst post-baseline grade, by NCI CTCAE v5.0 or higher for each parameter.
Time frame: Up to 36 months
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Classic Hodgkin Lymphoma | Number of Participants With Laboratory Abnormalities | Hemoglobin Low, Grade 1-2 | 3 Participants |
| Classic Hodgkin Lymphoma | Number of Participants With Laboratory Abnormalities | Alkaline Phosphatase High, Grade 4 | 0 Participants |
| Classic Hodgkin Lymphoma | Number of Participants With Laboratory Abnormalities | Neutrophils Low, Grade 4 | 0 Participants |
| Classic Hodgkin Lymphoma | Number of Participants With Laboratory Abnormalities | Aspartate Aminotransferase High, Grade 1-2 | 3 Participants |
| Classic Hodgkin Lymphoma | Number of Participants With Laboratory Abnormalities | Leukocytes Low, Grade 4 | 0 Participants |
| Classic Hodgkin Lymphoma | Number of Participants With Laboratory Abnormalities | Aspartate Aminotransferase High, Grade 3 | 0 Participants |
| Classic Hodgkin Lymphoma | Number of Participants With Laboratory Abnormalities | Platelets Low, Grade 1-2 | 1 Participants |
| Classic Hodgkin Lymphoma | Number of Participants With Laboratory Abnormalities | Aspartate Aminotransferase High, Grade 4 | 0 Participants |
| Classic Hodgkin Lymphoma | Number of Participants With Laboratory Abnormalities | Hemoglobin Low, Grade 4 | 0 Participants |
| Classic Hodgkin Lymphoma | Number of Participants With Laboratory Abnormalities | Bilirubin High, Grade 1-2 | 0 Participants |
| Classic Hodgkin Lymphoma | Number of Participants With Laboratory Abnormalities | Platelets Low, Grade 3 | 0 Participants |
| Classic Hodgkin Lymphoma | Number of Participants With Laboratory Abnormalities | Bilirubin High, Grade 3 | 0 Participants |
| Classic Hodgkin Lymphoma | Number of Participants With Laboratory Abnormalities | Lymphocytes Low, Grade 1-2 | 1 Participants |
| Classic Hodgkin Lymphoma | Number of Participants With Laboratory Abnormalities | Bilirubin High, Grade 4 | 0 Participants |
| Classic Hodgkin Lymphoma | Number of Participants With Laboratory Abnormalities | Platelets Low, Grade 4 | 0 Participants |
| Classic Hodgkin Lymphoma | Number of Participants With Laboratory Abnormalities | Calcium Corrected for Albumin Low, Grade 1-2 | 0 Participants |
| Classic Hodgkin Lymphoma | Number of Participants With Laboratory Abnormalities | Lactate Dehydrogenase High, Grade 4 | 0 Participants |
| Classic Hodgkin Lymphoma | Number of Participants With Laboratory Abnormalities | Calcium Corrected for Albumin Low, Grade 3 | 0 Participants |
| Classic Hodgkin Lymphoma | Number of Participants With Laboratory Abnormalities | Alanine Aminotransferase High, Grade 1-2 | 1 Participants |
| Classic Hodgkin Lymphoma | Number of Participants With Laboratory Abnormalities | Calcium Corrected for Albumin Low, Grade 4 | 0 Participants |
| Classic Hodgkin Lymphoma | Number of Participants With Laboratory Abnormalities | Lymphocytes Low, Grade 3 | 0 Participants |
| Classic Hodgkin Lymphoma | Number of Participants With Laboratory Abnormalities | Creatinine High, Grade 1-2 | 1 Participants |
| Classic Hodgkin Lymphoma | Number of Participants With Laboratory Abnormalities | Alanine Aminotransferase High, Grade 3 | 0 Participants |
| Classic Hodgkin Lymphoma | Number of Participants With Laboratory Abnormalities | Creatinine High, Grade 3 | 0 Participants |
| Classic Hodgkin Lymphoma | Number of Participants With Laboratory Abnormalities | Leukocytes Low, Grade 1-2 | 1 Participants |
| Classic Hodgkin Lymphoma | Number of Participants With Laboratory Abnormalities | Creatinine High, Grade 4 | 0 Participants |
| Classic Hodgkin Lymphoma | Number of Participants With Laboratory Abnormalities | Alanine Aminotransferase High, Grade 4 | 0 Participants |
| Classic Hodgkin Lymphoma | Number of Participants With Laboratory Abnormalities | Lactate Dehydrogenase High, Grade 1-2 | 3 Participants |
| Classic Hodgkin Lymphoma | Number of Participants With Laboratory Abnormalities | Lymphocytes Low, Grade 4 | 0 Participants |
| Classic Hodgkin Lymphoma | Number of Participants With Laboratory Abnormalities | Albumin Low, Grade 1-2 | 0 Participants |
| Classic Hodgkin Lymphoma | Number of Participants With Laboratory Abnormalities | Potassium Low, Grade 1-2 | 1 Participants |
| Classic Hodgkin Lymphoma | Number of Participants With Laboratory Abnormalities | Hemoglobin Low, Grade 3 | 0 Participants |
| Classic Hodgkin Lymphoma | Number of Participants With Laboratory Abnormalities | Potassium Low, Grade 3 | 0 Participants |
| Classic Hodgkin Lymphoma | Number of Participants With Laboratory Abnormalities | Albumin Low, Grade 3 | 0 Participants |
| Classic Hodgkin Lymphoma | Number of Participants With Laboratory Abnormalities | Potassium Low, Grade 4 | 0 Participants |
| Classic Hodgkin Lymphoma | Number of Participants With Laboratory Abnormalities | Neutrophils Low, Grade 1-2 | 0 Participants |
| Classic Hodgkin Lymphoma | Number of Participants With Laboratory Abnormalities | Sodium High, Grade 1-2 | 0 Participants |
| Classic Hodgkin Lymphoma | Number of Participants With Laboratory Abnormalities | Albumin Low, Grade 4 | 0 Participants |
| Classic Hodgkin Lymphoma | Number of Participants With Laboratory Abnormalities | Sodium High, Grade 3 | 0 Participants |
| Classic Hodgkin Lymphoma | Number of Participants With Laboratory Abnormalities | Leukocytes Low, Grade 3 | 0 Participants |
| Classic Hodgkin Lymphoma | Number of Participants With Laboratory Abnormalities | Sodium High, Grade 4 | 0 Participants |
| Classic Hodgkin Lymphoma | Number of Participants With Laboratory Abnormalities | Alkaline Phosphatase High, Grade 1-2 | 1 Participants |
| Classic Hodgkin Lymphoma | Number of Participants With Laboratory Abnormalities | Sodium Low, Grade 1-2 | 3 Participants |
| Classic Hodgkin Lymphoma | Number of Participants With Laboratory Abnormalities | Neutrophils Low, Grade 3 | 0 Participants |
| Classic Hodgkin Lymphoma | Number of Participants With Laboratory Abnormalities | Sodium Low, Grade 3 | 0 Participants |
| Classic Hodgkin Lymphoma | Number of Participants With Laboratory Abnormalities | Alkaline Phosphatase High, Grade 3 | 0 Participants |
| Classic Hodgkin Lymphoma | Number of Participants With Laboratory Abnormalities | Sodium Low, Grade 4 | 0 Participants |
| Classic Hodgkin Lymphoma | Number of Participants With Laboratory Abnormalities | Lactate Dehydrogenase High, Grade 3 | 0 Participants |
| PTCL | Number of Participants With Laboratory Abnormalities | Sodium Low, Grade 4 | 0 Participants |
| PTCL | Number of Participants With Laboratory Abnormalities | Lactate Dehydrogenase High, Grade 3 | 0 Participants |
| PTCL | Number of Participants With Laboratory Abnormalities | Hemoglobin Low, Grade 1-2 | 2 Participants |
| PTCL | Number of Participants With Laboratory Abnormalities | Hemoglobin Low, Grade 3 | 0 Participants |
| PTCL | Number of Participants With Laboratory Abnormalities | Hemoglobin Low, Grade 4 | 0 Participants |
| PTCL | Number of Participants With Laboratory Abnormalities | Leukocytes Low, Grade 1-2 | 2 Participants |
| PTCL | Number of Participants With Laboratory Abnormalities | Leukocytes Low, Grade 3 | 0 Participants |
| PTCL | Number of Participants With Laboratory Abnormalities | Leukocytes Low, Grade 4 | 0 Participants |
| PTCL | Number of Participants With Laboratory Abnormalities | Lymphocytes Low, Grade 1-2 | 1 Participants |
| PTCL | Number of Participants With Laboratory Abnormalities | Lymphocytes Low, Grade 3 | 1 Participants |
| PTCL | Number of Participants With Laboratory Abnormalities | Lymphocytes Low, Grade 4 | 0 Participants |
| PTCL | Number of Participants With Laboratory Abnormalities | Neutrophils Low, Grade 1-2 | 2 Participants |
| PTCL | Number of Participants With Laboratory Abnormalities | Neutrophils Low, Grade 3 | 1 Participants |
| PTCL | Number of Participants With Laboratory Abnormalities | Neutrophils Low, Grade 4 | 0 Participants |
| PTCL | Number of Participants With Laboratory Abnormalities | Platelets Low, Grade 1-2 | 2 Participants |
| PTCL | Number of Participants With Laboratory Abnormalities | Platelets Low, Grade 3 | 0 Participants |
| PTCL | Number of Participants With Laboratory Abnormalities | Platelets Low, Grade 4 | 0 Participants |
| PTCL | Number of Participants With Laboratory Abnormalities | Alanine Aminotransferase High, Grade 1-2 | 0 Participants |
| PTCL | Number of Participants With Laboratory Abnormalities | Alanine Aminotransferase High, Grade 3 | 0 Participants |
| PTCL | Number of Participants With Laboratory Abnormalities | Alanine Aminotransferase High, Grade 4 | 0 Participants |
| PTCL | Number of Participants With Laboratory Abnormalities | Albumin Low, Grade 1-2 | 3 Participants |
| PTCL | Number of Participants With Laboratory Abnormalities | Albumin Low, Grade 3 | 0 Participants |
| PTCL | Number of Participants With Laboratory Abnormalities | Albumin Low, Grade 4 | 0 Participants |
| PTCL | Number of Participants With Laboratory Abnormalities | Alkaline Phosphatase High, Grade 1-2 | 3 Participants |
| PTCL | Number of Participants With Laboratory Abnormalities | Alkaline Phosphatase High, Grade 3 | 0 Participants |
| PTCL | Number of Participants With Laboratory Abnormalities | Alkaline Phosphatase High, Grade 4 | 0 Participants |
| PTCL | Number of Participants With Laboratory Abnormalities | Aspartate Aminotransferase High, Grade 1-2 | 2 Participants |
| PTCL | Number of Participants With Laboratory Abnormalities | Aspartate Aminotransferase High, Grade 3 | 0 Participants |
| PTCL | Number of Participants With Laboratory Abnormalities | Aspartate Aminotransferase High, Grade 4 | 0 Participants |
| PTCL | Number of Participants With Laboratory Abnormalities | Bilirubin High, Grade 1-2 | 1 Participants |
| PTCL | Number of Participants With Laboratory Abnormalities | Bilirubin High, Grade 3 | 0 Participants |
| PTCL | Number of Participants With Laboratory Abnormalities | Bilirubin High, Grade 4 | 0 Participants |
| PTCL | Number of Participants With Laboratory Abnormalities | Calcium Corrected for Albumin Low, Grade 1-2 | 1 Participants |
| PTCL | Number of Participants With Laboratory Abnormalities | Calcium Corrected for Albumin Low, Grade 3 | 0 Participants |
| PTCL | Number of Participants With Laboratory Abnormalities | Calcium Corrected for Albumin Low, Grade 4 | 0 Participants |
| PTCL | Number of Participants With Laboratory Abnormalities | Creatinine High, Grade 1-2 | 1 Participants |
| PTCL | Number of Participants With Laboratory Abnormalities | Creatinine High, Grade 3 | 1 Participants |
| PTCL | Number of Participants With Laboratory Abnormalities | Creatinine High, Grade 4 | 0 Participants |
| PTCL | Number of Participants With Laboratory Abnormalities | Lactate Dehydrogenase High, Grade 1-2 | 4 Participants |
| PTCL | Number of Participants With Laboratory Abnormalities | Lactate Dehydrogenase High, Grade 4 | 0 Participants |
| PTCL | Number of Participants With Laboratory Abnormalities | Potassium Low, Grade 1-2 | 2 Participants |
| PTCL | Number of Participants With Laboratory Abnormalities | Potassium Low, Grade 3 | 1 Participants |
| PTCL | Number of Participants With Laboratory Abnormalities | Potassium Low, Grade 4 | 0 Participants |
| PTCL | Number of Participants With Laboratory Abnormalities | Sodium High, Grade 1-2 | 1 Participants |
| PTCL | Number of Participants With Laboratory Abnormalities | Sodium High, Grade 3 | 0 Participants |
| PTCL | Number of Participants With Laboratory Abnormalities | Sodium High, Grade 4 | 0 Participants |
| PTCL | Number of Participants With Laboratory Abnormalities | Sodium Low, Grade 1-2 | 1 Participants |
| PTCL | Number of Participants With Laboratory Abnormalities | Sodium Low, Grade 3 | 0 Participants |
Primary
Objective Response Rate (ORR) Per BICR According to Modified Lugano Response Criteria
Objective Response Rate (ORR) is defined as the percentage of participants with complete response (CR) or partial response (PR) according to the modified Lugano Criteria for Response Assessment (Cheson 2014) based on BICR
Time frame: Up to 18.3 months
Population: The full analysis set includes participants who received at least one dose of study treatment.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Classic Hodgkin Lymphoma | Objective Response Rate (ORR) Per BICR According to Modified Lugano Response Criteria | 40.0 percentage of participants |
| PTCL | Objective Response Rate (ORR) Per BICR According to Modified Lugano Response Criteria | 83.3 percentage of participants |
Secondary
DOR Per Investigator Assessment According to Modified Lugano Response Criteria
Duration of response is defined as the time from start of the first documentation of objective tumor response (CR or PR), according to the Modified Lugano Criteria for Response Assessment (Cheson 2007), to the first documentation of objective tumor progression or to death due to any cause, whichever comes first.
Time frame: Up to 17.1 months
Population: The full analysis set includes participants who received at least one dose of study treatment. This is a subset analysis of participants with complete response or partial response.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Classic Hodgkin Lymphoma | DOR Per Investigator Assessment According to Modified Lugano Response Criteria | NA Months |
| PTCL | DOR Per Investigator Assessment According to Modified Lugano Response Criteria | NA Months |
Secondary
Duration of Response (DOR) Per BICR According to Modified Lugano Response Criteria
Duration of response is defined as the time from start of the first documentation of objective tumor response (CR or PR), according to the Modified Lugano Criteria for Response Assessment (Cheson 2007), to the first documentation of objective tumor progression or to death due to any cause, whichever comes first.
Time frame: Up to 17.1 months
Population: The full analysis set includes participants who received at least one dose of study treatment. This is a subset analysis of participants with complete response or partial response.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Classic Hodgkin Lymphoma | Duration of Response (DOR) Per BICR According to Modified Lugano Response Criteria | NA months |
| PTCL | Duration of Response (DOR) Per BICR According to Modified Lugano Response Criteria | NA months |
Secondary
ORR Per BICR According to Lugano Response Criteria
ORR is defined as the percentage of participants with CR or PR, assessed according to Lugano Criteria for Response Assessment (Cheson 2014)
Time frame: Up to 18.3 months
Population: The full analysis set includes participants who received at least one dose of study treatment.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Classic Hodgkin Lymphoma | ORR Per BICR According to Lugano Response Criteria | 60.0 Percentage of Participants |
| PTCL | ORR Per BICR According to Lugano Response Criteria | 83.3 Percentage of Participants |
Secondary
ORR Per Investigator Assessment According to Modified Lugano Response Criteria
Objective Response Rate (ORR) is defined as the percentage of participants with CR or PR according to the modified Lugano Criteria for Response Assessment (Cheson 2014) based on investigator assessment
Time frame: Up to 18.3 months
Population: The full analysis set includes participants who received at least one dose of study treatment.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Classic Hodgkin Lymphoma | ORR Per Investigator Assessment According to Modified Lugano Response Criteria | 60.0 Percentage of Participants |
| PTCL | ORR Per Investigator Assessment According to Modified Lugano Response Criteria | 83.3 Percentage of Participants |
Secondary
Overall Survival (OS)
OS is defined as the time from date of enrollment to date of death due to any cause.
Time frame: Up to 35.8 months
Population: The full analysis set includes participants who received at least one dose of study treatment.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Classic Hodgkin Lymphoma | Overall Survival (OS) | NA Months |
| PTCL | Overall Survival (OS) | NA Months |
Secondary
Progression-free Survival Per Investigator Assessment According to Modified Lugano Response Criteria
PFS is defined as the time from start of study treatment to first documentation of objective tumor progression according to the Modified Lugano Criteria for Response Assessment (Cheson 2007) or to death due to any cause, whichever comes first.
Time frame: Up to 18.3 months
Population: The full analysis set includes participants who received at least one dose of study treatment.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Classic Hodgkin Lymphoma | Progression-free Survival Per Investigator Assessment According to Modified Lugano Response Criteria | 6.5 Months |
| PTCL | Progression-free Survival Per Investigator Assessment According to Modified Lugano Response Criteria | NA Months |
Secondary
Progression-free Survival (PFS) Per BICR According to Modified Lugano Response Criteria
PFS is defined as the time from start of study treatment to first documentation of objective tumor progression according to the Modified Lugano Criteria for Response Assessment (Cheson 2007) or to death due to any cause, whichever comes first.
Time frame: up to 18.3 months
Population: The full analysis set includes participants who received at least one dose of study treatment.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Classic Hodgkin Lymphoma | Progression-free Survival (PFS) Per BICR According to Modified Lugano Response Criteria | NA Months |
| PTCL | Progression-free Survival (PFS) Per BICR According to Modified Lugano Response Criteria | NA Months |
Secondary
Rate of Complete Response (CR) Per BICR According to Modified Lugano Response Criteria
CR rate is defined as the percentage of participants with CR according to the modified Lugano Criteria for Response Assessment (Cheson 2014)
Time frame: Up to 18.3 months
Population: The full analysis set includes participants who received at least one dose of study treatment.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Classic Hodgkin Lymphoma | Rate of Complete Response (CR) Per BICR According to Modified Lugano Response Criteria | 20.0 Percentage of Participants |
| PTCL | Rate of Complete Response (CR) Per BICR According to Modified Lugano Response Criteria | 66.7 Percentage of Participants |
Secondary
Rate of Complete Response Per Investigator Assessment According to Modified Lugano Response Criteria
CR rate is defined as the percentage of participants with CR according to the Modified Lugano Criteria for Response Assessment (Cheson 2014).
Time frame: Up to 18.3 months
Population: The full analysis set includes participants who received at least one dose of study treatment.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Classic Hodgkin Lymphoma | Rate of Complete Response Per Investigator Assessment According to Modified Lugano Response Criteria | 40.0 Percentage of Participants |
| PTCL | Rate of Complete Response Per Investigator Assessment According to Modified Lugano Response Criteria | 66.7 Percentage of Participants |