Acute Lymphoid Leukemia, Acute Myeloid Leukemia, Anemia, Refractory, With Excess of Blasts, Solid Tumors
Conditions
Keywords
Acute Lymphoid Leukemia, Myelodysplastic Syndrome, Acute Myeloid Leukemia, Solid Tumors, Anemia, Refractory, with Excess of Blasts, Antibodies, Monoclonal, Antibody-Drug Conjugate, Antigens, CD30, Drug Therapy, Hematologic Diseases, Immunotherapy, Monomethyl Auristatin E
Brief summary
This is an open-label, multicenter, phase 2 clinical trial to evaluate the antitumor activity of brentuximab vedotin as a single agent in patients with CD30-positive nonlymphomatous malignancies.
Interventions
DRUGbrentuximab vedotin
1.8 mg/kg every 3 weeks by intravenous (IV) infusion
Sponsors
Seagen Inc.
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
6 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Histologically-confirmed by central review CD30-positive nonlymphomatous malignancy * Have failed, refused, or have been deemed ineligible for standard therapy * Measurable disease * Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 or 1 or a Karnofsky or Lansky Performance Status score greater than or equal to 70
Exclusion criteria
* Primary diagnosis of lymphoma or central nervous system (CNS) malignancy * History of another primary invasive malignancy that has not been definitively treated or in remission for at least 3 years * Evidence of active cerebral/meningeal disease
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Objective Response Rate (ORR) by Investigator | Up to approximately 3 years | Percentage of participants who achieved a best response of complete response/remission (CR), CR without hematologic recovery (CRi; leukemia only), or partial remission (PR) per the applicable response criteria. Response criteria for solid tumors (by radiographic tumor imaging) per Response Evaluation Criteria for Solid Tumors (RECIST) 1.1 (Eisenhauer 2009); response criteria for leukemia (by peripheral blood and bone marrow aspirate or biopsy) per International Working Group (Cheson 2003). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Duration of Objective Response by Kaplan-Meier Analysis | Up to approximately 2 years | Duration of objective response (CR \[+CRi; leukemia\] + PR), defined as time of initial response until disease progression or death. Response criteria for solid tumors (by radiographic tumor imaging) per Response Evaluation Criteria for Solid Tumors (RECIST) 1.1 (Eisenhauer 2009); response criteria for leukemia (by peripheral blood and bone marrow aspirate or biopsy) per International Working Group (Cheson 2003). |
| Duration of Complete Response by Kaplan-Meier Analysis | Up to approximately 2 years | Duration of CR, defined as time of initial response until disease progression or death. Response criteria for solid tumors (by radiographic tumor imaging) per Response Evaluation Criteria for Solid Tumors (RECIST) 1.1 (Eisenhauer 2009); response criteria for leukemia (by peripheral blood and bone marrow aspirate or biopsy) per International Working Group (Cheson 2003). |
| Progression-Free Survival by Kaplan-Meier Analysis | Up to approximately 2 years | Progression-free survival, defined as time from start of study treatment to disease progression per investigator or death due to any cause |
| Adverse Events by Severity, Seriousness, and Relationship to Treatment | Up to approximately 3 years | Counts of participants who had treatment-emergent adverse events (TEAE, defined as newly occurring or worsening after first dose on Study SGN35-013). Serious adverse events are reported from the time of informed consent. National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE version 4.03) were used to assess severity (1=mild, 2=moderate, 3=severe, 4=life-threatening/disabling, 5=fatal). 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. |
| Laboratory Abnormalities >/= Grade 3 | Up to approximately 3 years | Counts of study participants with post-baseline laboratory abnormalities of Grade 3 or greater per NCI CTCAE version 4.03. Participants with multiple occurrences of a laboratory abnormality within a category are counted once in that category |
| Complete Remission (CR) Rate by Investigator | Up to approximately 3 years | Percentage of participants who achieved a best response of CR per the applicable response criteria. Response criteria for solid tumors (by radiographic tumor imaging) per Response Evaluation Criteria for Solid Tumors (RECIST) 1.1 (Eisenhauer 2009); response criteria for leukemia (by peripheral blood and bone marrow aspirate or biopsy) per International Working Group (Cheson 2003). |
| Brentuximab Vedotin Antibody-Drug Conjugate (ADC) Trough Concentration (Ctrough) | Up to approximately 3 years | — |
| Maximum Concentration (Cmax) of Brentuximab Vedotin Monomethyl Auristatin E (MMAE) | Up to approximately 3 years | — |
| Brentuximab Vedotin Monomethyl Auristatin E (MMAE) Trough Concentration (Ctrough) | Up to approximately 3 years | — |
| Incidence of Anti-therapeutic Antibodies (ATA) | Up to approximately 3 years | Counts of participants with post-baseline anti-brentuximab vedotin antibodies. Persistently positive is defined as confirmed ATA in more than 2 post-baseline samples and transiently positive is defined as confirmed ATA in 1 or 2 post-baseline samples. |
| Brentuximab Vedotin Antibody-Drug Conjugate (ADC) Concentration at End of Infusion (Ceoi) | Up to approximately 3 years | — |
Countries
United States
Participant flow
Recruitment details
Oct 2011 - Dec 2014
Pre-assignment details
One additional patient enrolled, but withdrew prior to treatment group assignment.
Participants by arm
| Arm | Count |
|---|---|
| BV 1.8 mg/kg Q3Week Brentuximab vedotin 1.8 mg/kg every 3 weeks by intravenous (IV) infusion in patients with CD30-positive solid tumors or leukemia | 46 |
| BV 2.4 mg/kg Q3Week Brentuximab vedotin 2.4 mg/kg every 3 weeks by intravenous (IV) infusion in patients with CD30-positive solid tumors or leukemia | 28 |
| BV 1.2 mg/kg Q1Week Brentuximab vedotin 1.2 mg/kg weekly, 3 out of 4 weeks, by intravenous (IV) infusion in patients with acute leukemia or myelodysplastic syndrome (MDS) | 9 |
| Total | 83 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Death | 15 | 6 | 2 |
| Overall Study | Study Stopped by Sponsor | 2 | 1 | 0 |
| Overall Study | Withdrawal by Subject | 1 | 1 | 0 |
Baseline characteristics
| Characteristic | BV 2.4 mg/kg Q3Week | Total | BV 1.8 mg/kg Q3Week | BV 1.2 mg/kg Q1Week |
|---|---|---|---|---|
| Age, Continuous | 64 years | 65 years | 64 years | 76 years |
| Body Mass Index | 27.4 kg per meter squared (kg/m^2) | 26.0 kg per meter squared (kg/m^2) | 25.3 kg per meter squared (kg/m^2) | 26.3 kg per meter squared (kg/m^2) |
| Eastern Cooperative Oncology Group Performance Status 0 | 5 participants | 19 participants | 13 participants | 1 participants |
| Eastern Cooperative Oncology Group Performance Status 1 | 15 participants | 40 participants | 20 participants | 5 participants |
| Eastern Cooperative Oncology Group Performance Status 2 | 0 participants | 1 participants | 0 participants | 1 participants |
| Eastern Cooperative Oncology Group Performance Status 3-5 | 0 participants | 0 participants | 0 participants | 0 participants |
| Eastern Cooperative Oncology Group Performance Status Missing | 8 participants | 23 participants | 13 participants | 2 participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 2 Participants | 4 Participants | 2 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 26 Participants | 79 Participants | 44 Participants | 9 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Height | 171.9 centimeters (cm) | 170.2 centimeters (cm) | 170.2 centimeters (cm) | 167.6 centimeters (cm) |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 2 Participants | 3 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 2 Participants | 2 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants | 2 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) White | 25 Participants | 76 Participants | 42 Participants | 9 Participants |
| Region of Enrollment United States | 28 participants | 83 participants | 46 participants | 9 participants |
| Sex: Female, Male Female | 12 Participants | 37 Participants | 21 Participants | 4 Participants |
| Sex: Female, Male Male | 16 Participants | 46 Participants | 25 Participants | 5 Participants |
| Weight | 75.1 kilograms (kg) | 74.8 kilograms (kg) | 74.8 kilograms (kg) | 73.4 kilograms (kg) |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 42 / 46 | 28 / 28 | 8 / 9 |
| serious Total, serious adverse events | 24 / 46 | 13 / 28 | 5 / 9 |
Outcome results
Primary
Objective Response Rate (ORR) by Investigator
Percentage of participants who achieved a best response of complete response/remission (CR), CR without hematologic recovery (CRi; leukemia only), or partial remission (PR) per the applicable response criteria. Response criteria for solid tumors (by radiographic tumor imaging) per Response Evaluation Criteria for Solid Tumors (RECIST) 1.1 (Eisenhauer 2009); response criteria for leukemia (by peripheral blood and bone marrow aspirate or biopsy) per International Working Group (Cheson 2003).
Time frame: Up to approximately 3 years
Population: Efficacy-evaluable population
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Solid Tumors | Objective Response Rate (ORR) by Investigator | 12 percentage of participants |
| Leukemia | Objective Response Rate (ORR) by Investigator | 14 percentage of participants |
Secondary
Adverse Events by Severity, Seriousness, and Relationship to Treatment
Counts of participants who had treatment-emergent adverse events (TEAE, defined as newly occurring or worsening after first dose on Study SGN35-013). Serious adverse events are reported from the time of informed consent. National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE version 4.03) were used to assess severity (1=mild, 2=moderate, 3=severe, 4=life-threatening/disabling, 5=fatal). 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.
Time frame: Up to approximately 3 years
Population: All treated patients
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Solid Tumors | Adverse Events by Severity, Seriousness, and Relationship to Treatment | TEAE related to study drug | 31 participants |
| Solid Tumors | Adverse Events by Severity, Seriousness, and Relationship to Treatment | Serious adverse event | 24 participants |
| Solid Tumors | Adverse Events by Severity, Seriousness, and Relationship to Treatment | Discontinued treatment due to adverse event | 5 participants |
| Solid Tumors | Adverse Events by Severity, Seriousness, and Relationship to Treatment | Any TEAE | 45 participants |
| Solid Tumors | Adverse Events by Severity, Seriousness, and Relationship to Treatment | Deaths (within 30 days of last dose) | 10 participants |
| Solid Tumors | Adverse Events by Severity, Seriousness, and Relationship to Treatment | Serious adverse event related to study drug | 5 participants |
| Solid Tumors | Adverse Events by Severity, Seriousness, and Relationship to Treatment | TEAE with severity grade >/=3 | 31 participants |
| Leukemia | Adverse Events by Severity, Seriousness, and Relationship to Treatment | Discontinued treatment due to adverse event | 2 participants |
| Leukemia | Adverse Events by Severity, Seriousness, and Relationship to Treatment | Any TEAE | 28 participants |
| Leukemia | Adverse Events by Severity, Seriousness, and Relationship to Treatment | TEAE related to study drug | 24 participants |
| Leukemia | Adverse Events by Severity, Seriousness, and Relationship to Treatment | TEAE with severity grade >/=3 | 18 participants |
| Leukemia | Adverse Events by Severity, Seriousness, and Relationship to Treatment | Serious adverse event | 13 participants |
| Leukemia | Adverse Events by Severity, Seriousness, and Relationship to Treatment | Serious adverse event related to study drug | 6 participants |
| Leukemia | Adverse Events by Severity, Seriousness, and Relationship to Treatment | Deaths (within 30 days of last dose) | 6 participants |
| BV 1.2 mg/kg Q1Week | Adverse Events by Severity, Seriousness, and Relationship to Treatment | Serious adverse event | 5 participants |
| BV 1.2 mg/kg Q1Week | Adverse Events by Severity, Seriousness, and Relationship to Treatment | TEAE related to study drug | 5 participants |
| BV 1.2 mg/kg Q1Week | Adverse Events by Severity, Seriousness, and Relationship to Treatment | Deaths (within 30 days of last dose) | 2 participants |
| BV 1.2 mg/kg Q1Week | Adverse Events by Severity, Seriousness, and Relationship to Treatment | Serious adverse event related to study drug | 2 participants |
| BV 1.2 mg/kg Q1Week | Adverse Events by Severity, Seriousness, and Relationship to Treatment | Discontinued treatment due to adverse event | 2 participants |
| BV 1.2 mg/kg Q1Week | Adverse Events by Severity, Seriousness, and Relationship to Treatment | TEAE with severity grade >/=3 | 7 participants |
| BV 1.2 mg/kg Q1Week | Adverse Events by Severity, Seriousness, and Relationship to Treatment | Any TEAE | 9 participants |
Secondary
Brentuximab Vedotin Antibody-Drug Conjugate (ADC) Concentration at End of Infusion (Ceoi)
Time frame: Up to approximately 3 years
Population: All treated patients with available ADC Ceoi results
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Solid Tumors | Brentuximab Vedotin Antibody-Drug Conjugate (ADC) Concentration at End of Infusion (Ceoi) | 40 ug/mL | Geometric Coefficient of Variation 26 |
| Leukemia | Brentuximab Vedotin Antibody-Drug Conjugate (ADC) Concentration at End of Infusion (Ceoi) | 54 ug/mL | Geometric Coefficient of Variation 28 |
| BV 1.2 mg/kg Q1Week | Brentuximab Vedotin Antibody-Drug Conjugate (ADC) Concentration at End of Infusion (Ceoi) | 25 ug/mL | Geometric Coefficient of Variation 23 |
Secondary
Brentuximab Vedotin Antibody-Drug Conjugate (ADC) Trough Concentration (Ctrough)
Time frame: Up to approximately 3 years
Population: All treated patients with available ADC Ctrough results
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Solid Tumors | Brentuximab Vedotin Antibody-Drug Conjugate (ADC) Trough Concentration (Ctrough) | 0.36 ug/mL | Geometric Coefficient of Variation 180 |
| Leukemia | Brentuximab Vedotin Antibody-Drug Conjugate (ADC) Trough Concentration (Ctrough) | 0.55 ug/mL | Geometric Coefficient of Variation 210 |
| BV 1.2 mg/kg Q1Week | Brentuximab Vedotin Antibody-Drug Conjugate (ADC) Trough Concentration (Ctrough) | 1.5 ug/mL | Geometric Coefficient of Variation 48 |
Secondary
Brentuximab Vedotin Monomethyl Auristatin E (MMAE) Trough Concentration (Ctrough)
Time frame: Up to approximately 3 years
Population: All treated patients with available MMAE Ctrough results
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Solid Tumors | Brentuximab Vedotin Monomethyl Auristatin E (MMAE) Trough Concentration (Ctrough) | 0.22 ng/mL | Geometric Coefficient of Variation 92 |
| Leukemia | Brentuximab Vedotin Monomethyl Auristatin E (MMAE) Trough Concentration (Ctrough) | 0.35 ng/mL | Geometric Coefficient of Variation 82 |
| BV 1.2 mg/kg Q1Week | Brentuximab Vedotin Monomethyl Auristatin E (MMAE) Trough Concentration (Ctrough) | 1.5 ng/mL | Geometric Coefficient of Variation 65 |
Secondary
Complete Remission (CR) Rate by Investigator
Percentage of participants who achieved a best response of CR per the applicable response criteria. Response criteria for solid tumors (by radiographic tumor imaging) per Response Evaluation Criteria for Solid Tumors (RECIST) 1.1 (Eisenhauer 2009); response criteria for leukemia (by peripheral blood and bone marrow aspirate or biopsy) per International Working Group (Cheson 2003).
Time frame: Up to approximately 3 years
Population: Efficacy-evaluable population
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Solid Tumors | Complete Remission (CR) Rate by Investigator | 2 percentage of participants |
| Leukemia | Complete Remission (CR) Rate by Investigator | 0 percentage of participants |
Secondary
Duration of Complete Response by Kaplan-Meier Analysis
Duration of CR, defined as time of initial response until disease progression or death. Response criteria for solid tumors (by radiographic tumor imaging) per Response Evaluation Criteria for Solid Tumors (RECIST) 1.1 (Eisenhauer 2009); response criteria for leukemia (by peripheral blood and bone marrow aspirate or biopsy) per International Working Group (Cheson 2003).
Time frame: Up to approximately 2 years
Population: Participants with CR
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Solid Tumors | Duration of Complete Response by Kaplan-Meier Analysis | 22.3 months |
Secondary
Duration of Objective Response by Kaplan-Meier Analysis
Duration of objective response (CR \[+CRi; leukemia\] + PR), defined as time of initial response until disease progression or death. Response criteria for solid tumors (by radiographic tumor imaging) per Response Evaluation Criteria for Solid Tumors (RECIST) 1.1 (Eisenhauer 2009); response criteria for leukemia (by peripheral blood and bone marrow aspirate or biopsy) per International Working Group (Cheson 2003).
Time frame: Up to approximately 2 years
Population: Participants with objective response (CR \[+CRi; leukemia\] + PR)
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Solid Tumors | Duration of Objective Response by Kaplan-Meier Analysis | 2.9 months |
| Leukemia | Duration of Objective Response by Kaplan-Meier Analysis | 2.1 months |
Secondary
Incidence of Anti-therapeutic Antibodies (ATA)
Counts of participants with post-baseline anti-brentuximab vedotin antibodies. Persistently positive is defined as confirmed ATA in more than 2 post-baseline samples and transiently positive is defined as confirmed ATA in 1 or 2 post-baseline samples.
Time frame: Up to approximately 3 years
Population: Immunogenicity-evaluable set
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Solid Tumors | Incidence of Anti-therapeutic Antibodies (ATA) | Baseline (BL) negative | 33 participants |
| Solid Tumors | Incidence of Anti-therapeutic Antibodies (ATA) | BL negative, negative post-BL | 14 participants |
| Solid Tumors | Incidence of Anti-therapeutic Antibodies (ATA) | BL negative, transiently positive post-BL | 18 participants |
| Solid Tumors | Incidence of Anti-therapeutic Antibodies (ATA) | BL negative, persistently positive post-BL | 1 participants |
| Solid Tumors | Incidence of Anti-therapeutic Antibodies (ATA) | BL positive | 3 participants |
| Solid Tumors | Incidence of Anti-therapeutic Antibodies (ATA) | BL positive, negative post-BL | 1 participants |
| Solid Tumors | Incidence of Anti-therapeutic Antibodies (ATA) | BL positive, transiently positive post-BL | 2 participants |
| Solid Tumors | Incidence of Anti-therapeutic Antibodies (ATA) | BL positive, persistently positive post-BL | 0 participants |
| Leukemia | Incidence of Anti-therapeutic Antibodies (ATA) | BL negative, transiently positive post-BL | 6 participants |
| Leukemia | Incidence of Anti-therapeutic Antibodies (ATA) | BL positive, transiently positive post-BL | 1 participants |
| Leukemia | Incidence of Anti-therapeutic Antibodies (ATA) | BL negative, persistently positive post-BL | 1 participants |
| Leukemia | Incidence of Anti-therapeutic Antibodies (ATA) | BL positive | 2 participants |
| Leukemia | Incidence of Anti-therapeutic Antibodies (ATA) | BL positive, negative post-BL | 0 participants |
| Leukemia | Incidence of Anti-therapeutic Antibodies (ATA) | Baseline (BL) negative | 21 participants |
| Leukemia | Incidence of Anti-therapeutic Antibodies (ATA) | BL negative, negative post-BL | 14 participants |
| Leukemia | Incidence of Anti-therapeutic Antibodies (ATA) | BL positive, persistently positive post-BL | 1 participants |
| BV 1.2 mg/kg Q1Week | Incidence of Anti-therapeutic Antibodies (ATA) | BL negative, transiently positive post-BL | 0 participants |
| BV 1.2 mg/kg Q1Week | Incidence of Anti-therapeutic Antibodies (ATA) | BL negative, negative post-BL | 8 participants |
| BV 1.2 mg/kg Q1Week | Incidence of Anti-therapeutic Antibodies (ATA) | Baseline (BL) negative | 8 participants |
| BV 1.2 mg/kg Q1Week | Incidence of Anti-therapeutic Antibodies (ATA) | BL negative, persistently positive post-BL | 0 participants |
| BV 1.2 mg/kg Q1Week | Incidence of Anti-therapeutic Antibodies (ATA) | BL positive, transiently positive post-BL | 0 participants |
| BV 1.2 mg/kg Q1Week | Incidence of Anti-therapeutic Antibodies (ATA) | BL positive, negative post-BL | 0 participants |
| BV 1.2 mg/kg Q1Week | Incidence of Anti-therapeutic Antibodies (ATA) | BL positive | 0 participants |
| BV 1.2 mg/kg Q1Week | Incidence of Anti-therapeutic Antibodies (ATA) | BL positive, persistently positive post-BL | 0 participants |
Secondary
Laboratory Abnormalities >/= Grade 3
Counts of study participants with post-baseline laboratory abnormalities of Grade 3 or greater per NCI CTCAE version 4.03. Participants with multiple occurrences of a laboratory abnormality within a category are counted once in that category
Time frame: Up to approximately 3 years
Population: All treated patients
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Solid Tumors | Laboratory Abnormalities >/= Grade 3 | Albumin low | 2 participants |
| Solid Tumors | Laboratory Abnormalities >/= Grade 3 | Hemoglobin low | 4 participants |
| Solid Tumors | Laboratory Abnormalities >/= Grade 3 | Glucose high | 2 participants |
| Solid Tumors | Laboratory Abnormalities >/= Grade 3 | Platelets low | 4 participants |
| Solid Tumors | Laboratory Abnormalities >/= Grade 3 | Absolute neutrophil count low | 6 participants |
| Solid Tumors | Laboratory Abnormalities >/= Grade 3 | Glucose low | 1 participants |
| Solid Tumors | Laboratory Abnormalities >/= Grade 3 | Lymphocytes low | 9 participants |
| Solid Tumors | Laboratory Abnormalities >/= Grade 3 | Alkaline phosphatase high | 0 participants |
| Solid Tumors | Laboratory Abnormalities >/= Grade 3 | Prothrombin INR high | 0 participants |
| Solid Tumors | Laboratory Abnormalities >/= Grade 3 | Sodium low | 4 participants |
| Solid Tumors | Laboratory Abnormalities >/= Grade 3 | Alanine aminotransferase high | 0 participants |
| Solid Tumors | Laboratory Abnormalities >/= Grade 3 | Urate high | 2 participants |
| Solid Tumors | Laboratory Abnormalities >/= Grade 3 | Lymphocytes high | 1 participants |
| Solid Tumors | Laboratory Abnormalities >/= Grade 3 | Aspartate aminotransferase high | 0 participants |
| Solid Tumors | Laboratory Abnormalities >/= Grade 3 | Any >/= Grade 3 laboratory abnormality | 24 participants |
| Solid Tumors | Laboratory Abnormalities >/= Grade 3 | Leukocytes low | 4 participants |
| Solid Tumors | Laboratory Abnormalities >/= Grade 3 | Bilirubin high | 0 participants |
| Solid Tumors | Laboratory Abnormalities >/= Grade 3 | Neutrophils low | 6 participants |
| Solid Tumors | Laboratory Abnormalities >/= Grade 3 | Leukocytes high | 0 participants |
| Solid Tumors | Laboratory Abnormalities >/= Grade 3 | Calcium low | 1 participants |
| Leukemia | Laboratory Abnormalities >/= Grade 3 | Leukocytes high | 1 participants |
| Leukemia | Laboratory Abnormalities >/= Grade 3 | Any >/= Grade 3 laboratory abnormality | 12 participants |
| Leukemia | Laboratory Abnormalities >/= Grade 3 | Alanine aminotransferase high | 1 participants |
| Leukemia | Laboratory Abnormalities >/= Grade 3 | Albumin low | 3 participants |
| Leukemia | Laboratory Abnormalities >/= Grade 3 | Alkaline phosphatase high | 1 participants |
| Leukemia | Laboratory Abnormalities >/= Grade 3 | Aspartate aminotransferase high | 1 participants |
| Leukemia | Laboratory Abnormalities >/= Grade 3 | Bilirubin high | 1 participants |
| Leukemia | Laboratory Abnormalities >/= Grade 3 | Calcium low | 1 participants |
| Leukemia | Laboratory Abnormalities >/= Grade 3 | Glucose high | 1 participants |
| Leukemia | Laboratory Abnormalities >/= Grade 3 | Glucose low | 0 participants |
| Leukemia | Laboratory Abnormalities >/= Grade 3 | Lymphocytes high | 2 participants |
| Leukemia | Laboratory Abnormalities >/= Grade 3 | Sodium low | 2 participants |
| Leukemia | Laboratory Abnormalities >/= Grade 3 | Urate high | 0 participants |
| Leukemia | Laboratory Abnormalities >/= Grade 3 | Prothrombin INR high | 0 participants |
| Leukemia | Laboratory Abnormalities >/= Grade 3 | Absolute neutrophil count low | 2 participants |
| Leukemia | Laboratory Abnormalities >/= Grade 3 | Hemoglobin low | 0 participants |
| Leukemia | Laboratory Abnormalities >/= Grade 3 | Leukocytes low | 0 participants |
| Leukemia | Laboratory Abnormalities >/= Grade 3 | Lymphocytes low | 3 participants |
| Leukemia | Laboratory Abnormalities >/= Grade 3 | Neutrophils low | 3 participants |
| Leukemia | Laboratory Abnormalities >/= Grade 3 | Platelets low | 4 participants |
| BV 1.2 mg/kg Q1Week | Laboratory Abnormalities >/= Grade 3 | Absolute neutrophil count low | 5 participants |
| BV 1.2 mg/kg Q1Week | Laboratory Abnormalities >/= Grade 3 | Calcium low | 0 participants |
| BV 1.2 mg/kg Q1Week | Laboratory Abnormalities >/= Grade 3 | Platelets low | 7 participants |
| BV 1.2 mg/kg Q1Week | Laboratory Abnormalities >/= Grade 3 | Hemoglobin low | 3 participants |
| BV 1.2 mg/kg Q1Week | Laboratory Abnormalities >/= Grade 3 | Bilirubin high | 0 participants |
| BV 1.2 mg/kg Q1Week | Laboratory Abnormalities >/= Grade 3 | Lymphocytes high | 0 participants |
| BV 1.2 mg/kg Q1Week | Laboratory Abnormalities >/= Grade 3 | Leukocytes high | 1 participants |
| BV 1.2 mg/kg Q1Week | Laboratory Abnormalities >/= Grade 3 | Aspartate aminotransferase high | 0 participants |
| BV 1.2 mg/kg Q1Week | Laboratory Abnormalities >/= Grade 3 | Neutrophils low | 7 participants |
| BV 1.2 mg/kg Q1Week | Laboratory Abnormalities >/= Grade 3 | Leukocytes low | 4 participants |
| BV 1.2 mg/kg Q1Week | Laboratory Abnormalities >/= Grade 3 | Alkaline phosphatase high | 0 participants |
| BV 1.2 mg/kg Q1Week | Laboratory Abnormalities >/= Grade 3 | Albumin low | 0 participants |
| BV 1.2 mg/kg Q1Week | Laboratory Abnormalities >/= Grade 3 | Sodium low | 0 participants |
| BV 1.2 mg/kg Q1Week | Laboratory Abnormalities >/= Grade 3 | Any >/= Grade 3 laboratory abnormality | 9 participants |
| BV 1.2 mg/kg Q1Week | Laboratory Abnormalities >/= Grade 3 | Urate high | 0 participants |
| BV 1.2 mg/kg Q1Week | Laboratory Abnormalities >/= Grade 3 | Glucose low | 0 participants |
| BV 1.2 mg/kg Q1Week | Laboratory Abnormalities >/= Grade 3 | Lymphocytes low | 1 participants |
| BV 1.2 mg/kg Q1Week | Laboratory Abnormalities >/= Grade 3 | Prothrombin INR high | 1 participants |
| BV 1.2 mg/kg Q1Week | Laboratory Abnormalities >/= Grade 3 | Glucose high | 0 participants |
| BV 1.2 mg/kg Q1Week | Laboratory Abnormalities >/= Grade 3 | Alanine aminotransferase high | 1 participants |
Secondary
Maximum Concentration (Cmax) of Brentuximab Vedotin Monomethyl Auristatin E (MMAE)
Time frame: Up to approximately 3 years
Population: All treated patients with available Cmax of MMAE results
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Solid Tumors | Maximum Concentration (Cmax) of Brentuximab Vedotin Monomethyl Auristatin E (MMAE) | 4.0 ng/mL | Geometric Coefficient of Variation 78 |
| Leukemia | Maximum Concentration (Cmax) of Brentuximab Vedotin Monomethyl Auristatin E (MMAE) | 6.2 ng/mL | Geometric Coefficient of Variation 71 |
| BV 1.2 mg/kg Q1Week | Maximum Concentration (Cmax) of Brentuximab Vedotin Monomethyl Auristatin E (MMAE) | 2.6 ng/mL | Geometric Coefficient of Variation 83 |
Secondary
Progression-Free Survival by Kaplan-Meier Analysis
Progression-free survival, defined as time from start of study treatment to disease progression per investigator or death due to any cause
Time frame: Up to approximately 2 years
Population: All treated patients, excluding 3 patients without available response results
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Solid Tumors | Progression-Free Survival by Kaplan-Meier Analysis | 2.1 months |
| Leukemia | Progression-Free Survival by Kaplan-Meier Analysis | 0.7 months |