Trial Outcomes & Findings for Brentuximab Vedotin and Chemotherapy in CD30+ PMBL, Diffuse Large B-Cell, and Grey Zone Lymphoma Patients (NCT NCT01994850)
NCT ID: NCT01994850
Last Updated: 2021-01-05
Results Overview
Dose-limiting toxicity (DLT) is any grade 3 or 4 new non-hematologic toxicity occurring during Cycle 1 requiring a dose delay of \>14 days from the planned Day 1 of Cycle 2 (21 days from Day 1 of Cycle 1). The initial planned dose of brentuximab vedotin for the Phase I cohort of 6 patients is 1.8 mg/kg. This cohort will be evaluated for DLT in the first cycle of treatment. Dose de-escalation to 1.2 mg/kg will occur if ≥ 2 of 6 patients at the 1.8 mg/kg dose level experience a DLT.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
32 participants
Primary outcome timeframe
21 days (Cycle 1)
Results posted on
2021-01-05
Participant Flow
Participant milestones
| Measure |
Phase I/II
Total of six 21-day cycles of brentuximab vedotin in combination with rituximab, cyclophosphamide, doxorubicin and prednisone (R-CHP). Cycle 1 rituximab dose divided between Days 1 and 2 to prevent severe infusion reactions in rituximab naïve patients; brentuximab vedotin and cytotoxic chemotherapy administered on Day 2. Cycles 2 through 6 brentuximab vedotin and R-CHP administered on Day 1. Prednisone (or steroid equivalent) administered Days 1-5 of each cycle (prior to rituximab infusion).
Cycle 1:
Days 1-5: Prednisone (or equivalent) 100 mg PO/IV; Day 1: Rituximab 100 mg/m2 IV; Day 2: Rituximab 275 mg/m2 IV, Cyclophosphamide 750 mg/m2 IV, Doxorubicin 50 mg/m² IV, Brentuximab vedotin 1.8 mg/kg or 1.2 mg/kg (Phase I data established a MTD of 1.8 mg/kg brentuximab vedotin)
Cycles 2-6:
Days 1-5: Prednisone (or equivalent) 100 mg PO/IV; Day 1: Rituximab 375 mg/m2 IV, Cyclophosphamide 750 mg/m2 IV, Doxorubicin 50 mg/m² IV, Brentuximab vedotin 1.8 mg/kg
|
|---|---|
|
Overall Study
STARTED
|
32
|
|
Overall Study
COMPLETED
|
30
|
|
Overall Study
NOT COMPLETED
|
2
|
Reasons for withdrawal
| Measure |
Phase I/II
Total of six 21-day cycles of brentuximab vedotin in combination with rituximab, cyclophosphamide, doxorubicin and prednisone (R-CHP). Cycle 1 rituximab dose divided between Days 1 and 2 to prevent severe infusion reactions in rituximab naïve patients; brentuximab vedotin and cytotoxic chemotherapy administered on Day 2. Cycles 2 through 6 brentuximab vedotin and R-CHP administered on Day 1. Prednisone (or steroid equivalent) administered Days 1-5 of each cycle (prior to rituximab infusion).
Cycle 1:
Days 1-5: Prednisone (or equivalent) 100 mg PO/IV; Day 1: Rituximab 100 mg/m2 IV; Day 2: Rituximab 275 mg/m2 IV, Cyclophosphamide 750 mg/m2 IV, Doxorubicin 50 mg/m² IV, Brentuximab vedotin 1.8 mg/kg or 1.2 mg/kg (Phase I data established a MTD of 1.8 mg/kg brentuximab vedotin)
Cycles 2-6:
Days 1-5: Prednisone (or equivalent) 100 mg PO/IV; Day 1: Rituximab 375 mg/m2 IV, Cyclophosphamide 750 mg/m2 IV, Doxorubicin 50 mg/m² IV, Brentuximab vedotin 1.8 mg/kg
|
|---|---|
|
Overall Study
Physician Decision
|
1
|
|
Overall Study
Withdrawal by Subject
|
1
|
Baseline Characteristics
Brentuximab Vedotin and Chemotherapy in CD30+ PMBL, Diffuse Large B-Cell, and Grey Zone Lymphoma Patients
Baseline characteristics by cohort
| Measure |
Phase I/II
n=32 Participants
Total of six 21-day cycles of brentuximab vedotin in combination with rituximab, cyclophosphamide, doxorubicin and prednisone (R-CHP). Cycle 1 rituximab dose divided between Days 1 and 2 to prevent severe infusion reactions in rituximab naïve patients; brentuximab vedotin and cytotoxic chemotherapy administered on Day 2. Cycles 2 through 6 brentuximab vedotin and R-CHP administered on Day 1. Prednisone (or steroid equivalent) administered Days 1-5 of each cycle (prior to rituximab infusion).
Cycle 1:
Days 1-5: Prednisone (or equivalent) 100 mg PO/IV; Day 1: Rituximab 100 mg/m2 IV; Day 2: Rituximab 275 mg/m2 IV, Cyclophosphamide 750 mg/m2 IV, Doxorubicin 50 mg/m² IV, Brentuximab vedotin 1.8 mg/kg or 1.2 mg/kg (Phase I data established a MTD of 1.8 mg/kg brentuximab vedotin)
Cycles 2-6:
Days 1-5: Prednisone (or equivalent) 100 mg PO/IV; Day 1: Rituximab 375 mg/m2 IV, Cyclophosphamide 750 mg/m2 IV, Doxorubicin 50 mg/m² IV, Brentuximab vedotin 1.8 mg/kg
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
29 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
3 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
16 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
16 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
28 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
27 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
32 participants
n=5 Participants
|
|
Lymphoma subtype
Primary Mediastinal Large B-cell Lymphoma
|
23 Participants
n=5 Participants
|
|
Lymphoma subtype
Diffuse Large B-Cell Lymphoma
|
6 Participants
n=5 Participants
|
|
Lymphoma subtype
Gray Zone Lymphoma
|
2 Participants
n=5 Participants
|
|
Lymphoma subtype
Not included (Subject withdrew)
|
1 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 21 days (Cycle 1)Population: A total of 6 subjects were evaluated for dose limiting toxicities during Phase I. Since no DLTs were observed, the Phase I subjects were included in the efficacy analysis as they received the same dose of brentuximab vedotin 1.8 mg/kg as the Phase II subjects.
Dose-limiting toxicity (DLT) is any grade 3 or 4 new non-hematologic toxicity occurring during Cycle 1 requiring a dose delay of \>14 days from the planned Day 1 of Cycle 2 (21 days from Day 1 of Cycle 1). The initial planned dose of brentuximab vedotin for the Phase I cohort of 6 patients is 1.8 mg/kg. This cohort will be evaluated for DLT in the first cycle of treatment. Dose de-escalation to 1.2 mg/kg will occur if ≥ 2 of 6 patients at the 1.8 mg/kg dose level experience a DLT.
Outcome measures
| Measure |
Phase I/II
n=6 Participants
Total of six 21-day cycles of brentuximab vedotin in combination with rituximab, cyclophosphamide, doxorubicin and prednisone (R-CHP). Cycle 1 rituximab dose divided between Days 1 and 2 to prevent severe infusion reactions in rituximab naïve patients; brentuximab vedotin and cytotoxic chemotherapy administered on Day 2. Cycles 2 through 6 brentuximab vedotin and R-CHP administered on Day 1. Prednisone (or steroid equivalent) administered Days 1-5 of each cycle (prior to rituximab infusion).
Cycle 1:
Days 1-5: Prednisone (or equivalent) 100 mg PO/IV; Day 1: Rituximab 100 mg/m2 IV; Day 2: Rituximab 275 mg/m2 IV, Cyclophosphamide 750 mg/m2 IV, Doxorubicin 50 mg/m² IV, Brentuximab vedotin 1.8 mg/kg or 1.2 mg/kg (Phase I data established a MTD of 1.8 mg/kg brentuximab vedotin)
Cycles 2-6:
Days 1-5: Prednisone (or equivalent) 100 mg PO/IV; Day 1: Rituximab 375 mg/m2 IV, Cyclophosphamide 750 mg/m2 IV, Doxorubicin 50 mg/m² IV, Brentuximab vedotin 1.8 mg/kg
|
|---|---|
|
Number of Subjects With Dose-limiting Toxicities
|
0 Participants
|
PRIMARY outcome
Timeframe: Three to five weeks after the completion of Cycle 6 (approximately 5 months after start if treatment)Population: 32 patients were enrolled: 1 patient withdrew, 1 was removed for protocol non-compliance, 1 was removed due to regimen violation; a total of 29 were evaluable for efficacy.
Overall response rate (ORR) is defined as the proportion of patients with CR or PR according to the International Working Group Response Criteria for non-Hodgkin Lymphoma at the conclusion of systemic therapy.
Outcome measures
| Measure |
Phase I/II
n=29 Participants
Total of six 21-day cycles of brentuximab vedotin in combination with rituximab, cyclophosphamide, doxorubicin and prednisone (R-CHP). Cycle 1 rituximab dose divided between Days 1 and 2 to prevent severe infusion reactions in rituximab naïve patients; brentuximab vedotin and cytotoxic chemotherapy administered on Day 2. Cycles 2 through 6 brentuximab vedotin and R-CHP administered on Day 1. Prednisone (or steroid equivalent) administered Days 1-5 of each cycle (prior to rituximab infusion).
Cycle 1:
Days 1-5: Prednisone (or equivalent) 100 mg PO/IV; Day 1: Rituximab 100 mg/m2 IV; Day 2: Rituximab 275 mg/m2 IV, Cyclophosphamide 750 mg/m2 IV, Doxorubicin 50 mg/m² IV, Brentuximab vedotin 1.8 mg/kg or 1.2 mg/kg (Phase I data established a MTD of 1.8 mg/kg brentuximab vedotin)
Cycles 2-6:
Days 1-5: Prednisone (or equivalent) 100 mg PO/IV; Day 1: Rituximab 375 mg/m2 IV, Cyclophosphamide 750 mg/m2 IV, Doxorubicin 50 mg/m² IV, Brentuximab vedotin 1.8 mg/kg
|
|---|---|
|
Overall Response Rate (ORR)
Complete response
|
25 Participants
|
|
Overall Response Rate (ORR)
Partial resonse
|
4 Participants
|
Adverse Events
Phase I/II
Serious events: 12 serious events
Other events: 29 other events
Deaths: 2 deaths
Serious adverse events
| Measure |
Phase I/II
n=31 participants at risk
Total of six 21-day cycles of brentuximab vedotin in combination with rituximab, cyclophosphamide, doxorubicin and prednisone (R-CHP). Cycle 1 rituximab dose divided between Days 1 and 2 to prevent severe infusion reactions in rituximab naïve patients; brentuximab vedotin and cytotoxic chemotherapy administered on Day 2. Cycles 2 through 6 brentuximab vedotin and R-CHP administered on Day 1. Prednisone (or steroid equivalent) administered Days 1-5 of each cycle (prior to rituximab infusion).
Cycle 1:
Days 1-5: Prednisone (or equivalent) 100 mg PO/IV; Day 1: Rituximab 100 mg/m2 IV; Day 2: Rituximab 275 mg/m2 IV, Cyclophosphamide 750 mg/m2 IV, Doxorubicin 50 mg/m² IV, Brentuximab vedotin 1.8 mg/kg or 1.2 mg/kg (Phase I data established a MTD of 1.8 mg/kg brentuximab vedotin)
Cycles 2-6:
Days 1-5: Prednisone (or equivalent) 100 mg PO/IV; Day 1: Rituximab 375 mg/m2 IV, Cyclophosphamide 750 mg/m2 IV, Doxorubicin 50 mg/m² IV, Brentuximab vedotin 1.8 mg/kg
|
|---|---|
|
General disorders
Fever
|
3.2%
1/31 • Number of events 1 • Adverse event data were collected from the initiation of the first study treatment (Cycle 1/Day 1) to 30 days following the last administration of study treatment, which is approximately 5 months.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
19.4%
6/31 • Number of events 7 • Adverse event data were collected from the initiation of the first study treatment (Cycle 1/Day 1) to 30 days following the last administration of study treatment, which is approximately 5 months.
|
|
Cardiac disorders
Left ventricular systolic dysfunction
|
3.2%
1/31 • Number of events 1 • Adverse event data were collected from the initiation of the first study treatment (Cycle 1/Day 1) to 30 days following the last administration of study treatment, which is approximately 5 months.
|
|
Infections and infestations
Abdominal infection
|
3.2%
1/31 • Number of events 1 • Adverse event data were collected from the initiation of the first study treatment (Cycle 1/Day 1) to 30 days following the last administration of study treatment, which is approximately 5 months.
|
|
Infections and infestations
Gum infection
|
3.2%
1/31 • Number of events 1 • Adverse event data were collected from the initiation of the first study treatment (Cycle 1/Day 1) to 30 days following the last administration of study treatment, which is approximately 5 months.
|
|
Infections and infestations
Urinary tract infection
|
3.2%
1/31 • Number of events 1 • Adverse event data were collected from the initiation of the first study treatment (Cycle 1/Day 1) to 30 days following the last administration of study treatment, which is approximately 5 months.
|
|
Metabolism and nutrition disorders
Lactic acidosis
|
3.2%
1/31 • Number of events 2 • Adverse event data were collected from the initiation of the first study treatment (Cycle 1/Day 1) to 30 days following the last administration of study treatment, which is approximately 5 months.
|
|
Vascular disorders
Thromboembolic event
|
3.2%
1/31 • Number of events 1 • Adverse event data were collected from the initiation of the first study treatment (Cycle 1/Day 1) to 30 days following the last administration of study treatment, which is approximately 5 months.
|
|
Infections and infestations
MRSA bacteremia
|
3.2%
1/31 • Number of events 1 • Adverse event data were collected from the initiation of the first study treatment (Cycle 1/Day 1) to 30 days following the last administration of study treatment, which is approximately 5 months.
|
|
Infections and infestations
Catheter related infection
|
3.2%
1/31 • Number of events 1 • Adverse event data were collected from the initiation of the first study treatment (Cycle 1/Day 1) to 30 days following the last administration of study treatment, which is approximately 5 months.
|
Other adverse events
| Measure |
Phase I/II
n=31 participants at risk
Total of six 21-day cycles of brentuximab vedotin in combination with rituximab, cyclophosphamide, doxorubicin and prednisone (R-CHP). Cycle 1 rituximab dose divided between Days 1 and 2 to prevent severe infusion reactions in rituximab naïve patients; brentuximab vedotin and cytotoxic chemotherapy administered on Day 2. Cycles 2 through 6 brentuximab vedotin and R-CHP administered on Day 1. Prednisone (or steroid equivalent) administered Days 1-5 of each cycle (prior to rituximab infusion).
Cycle 1:
Days 1-5: Prednisone (or equivalent) 100 mg PO/IV; Day 1: Rituximab 100 mg/m2 IV; Day 2: Rituximab 275 mg/m2 IV, Cyclophosphamide 750 mg/m2 IV, Doxorubicin 50 mg/m² IV, Brentuximab vedotin 1.8 mg/kg or 1.2 mg/kg (Phase I data established a MTD of 1.8 mg/kg brentuximab vedotin)
Cycles 2-6:
Days 1-5: Prednisone (or equivalent) 100 mg PO/IV; Day 1: Rituximab 375 mg/m2 IV, Cyclophosphamide 750 mg/m2 IV, Doxorubicin 50 mg/m² IV, Brentuximab vedotin 1.8 mg/kg
|
|---|---|
|
Vascular disorders
Thromboembolic event
|
9.7%
3/31 • Adverse event data were collected from the initiation of the first study treatment (Cycle 1/Day 1) to 30 days following the last administration of study treatment, which is approximately 5 months.
|
|
Skin and subcutaneous tissue disorders
Scalp pain
|
3.2%
1/31 • Adverse event data were collected from the initiation of the first study treatment (Cycle 1/Day 1) to 30 days following the last administration of study treatment, which is approximately 5 months.
|
|
Skin and subcutaneous tissue disorders
Other psoriasis
|
3.2%
1/31 • Adverse event data were collected from the initiation of the first study treatment (Cycle 1/Day 1) to 30 days following the last administration of study treatment, which is approximately 5 months.
|
|
Skin and subcutaneous tissue disorders
Skin hyperpigmentation
|
3.2%
1/31 • Adverse event data were collected from the initiation of the first study treatment (Cycle 1/Day 1) to 30 days following the last administration of study treatment, which is approximately 5 months.
|
|
Vascular disorders
Hematoma
|
3.2%
1/31 • Adverse event data were collected from the initiation of the first study treatment (Cycle 1/Day 1) to 30 days following the last administration of study treatment, which is approximately 5 months.
|
|
Vascular disorders
Hot flashes
|
12.9%
4/31 • Adverse event data were collected from the initiation of the first study treatment (Cycle 1/Day 1) to 30 days following the last administration of study treatment, which is approximately 5 months.
|
|
Vascular disorders
Hypertension
|
6.5%
2/31 • Adverse event data were collected from the initiation of the first study treatment (Cycle 1/Day 1) to 30 days following the last administration of study treatment, which is approximately 5 months.
|
|
Vascular disorders
Hypotension
|
3.2%
1/31 • Adverse event data were collected from the initiation of the first study treatment (Cycle 1/Day 1) to 30 days following the last administration of study treatment, which is approximately 5 months.
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
3.2%
1/31 • Adverse event data were collected from the initiation of the first study treatment (Cycle 1/Day 1) to 30 days following the last administration of study treatment, which is approximately 5 months.
|
|
Vascular disorders
Phlebitis
|
3.2%
1/31 • Adverse event data were collected from the initiation of the first study treatment (Cycle 1/Day 1) to 30 days following the last administration of study treatment, which is approximately 5 months.
|
|
Blood and lymphatic system disorders
Anemia
|
67.7%
21/31 • Adverse event data were collected from the initiation of the first study treatment (Cycle 1/Day 1) to 30 days following the last administration of study treatment, which is approximately 5 months.
|
|
Blood and lymphatic system disorders
Hemolytic uremic syndrome
|
3.2%
1/31 • Adverse event data were collected from the initiation of the first study treatment (Cycle 1/Day 1) to 30 days following the last administration of study treatment, which is approximately 5 months.
|
|
Cardiac disorders
Palpitations
|
6.5%
2/31 • Adverse event data were collected from the initiation of the first study treatment (Cycle 1/Day 1) to 30 days following the last administration of study treatment, which is approximately 5 months.
|
|
Cardiac disorders
Sinus tachycardia
|
3.2%
1/31 • Adverse event data were collected from the initiation of the first study treatment (Cycle 1/Day 1) to 30 days following the last administration of study treatment, which is approximately 5 months.
|
|
Ear and labyrinth disorders
Other, left ear fullness
|
3.2%
1/31 • Adverse event data were collected from the initiation of the first study treatment (Cycle 1/Day 1) to 30 days following the last administration of study treatment, which is approximately 5 months.
|
|
Ear and labyrinth disorders
Hearing impaired
|
3.2%
1/31 • Adverse event data were collected from the initiation of the first study treatment (Cycle 1/Day 1) to 30 days following the last administration of study treatment, which is approximately 5 months.
|
|
Ear and labyrinth disorders
Vertigo
|
3.2%
1/31 • Adverse event data were collected from the initiation of the first study treatment (Cycle 1/Day 1) to 30 days following the last administration of study treatment, which is approximately 5 months.
|
|
Eye disorders
Blurred vision
|
6.5%
2/31 • Adverse event data were collected from the initiation of the first study treatment (Cycle 1/Day 1) to 30 days following the last administration of study treatment, which is approximately 5 months.
|
|
Eye disorders
other
|
9.7%
3/31 • Adverse event data were collected from the initiation of the first study treatment (Cycle 1/Day 1) to 30 days following the last administration of study treatment, which is approximately 5 months.
|
|
Gastrointestinal disorders
Abdominal pain
|
12.9%
4/31 • Adverse event data were collected from the initiation of the first study treatment (Cycle 1/Day 1) to 30 days following the last administration of study treatment, which is approximately 5 months.
|
|
Gastrointestinal disorders
Constipation
|
51.6%
16/31 • Adverse event data were collected from the initiation of the first study treatment (Cycle 1/Day 1) to 30 days following the last administration of study treatment, which is approximately 5 months.
|
|
Gastrointestinal disorders
Dry mouth
|
3.2%
1/31 • Adverse event data were collected from the initiation of the first study treatment (Cycle 1/Day 1) to 30 days following the last administration of study treatment, which is approximately 5 months.
|
|
Gastrointestinal disorders
Diarrhea
|
41.9%
13/31 • Adverse event data were collected from the initiation of the first study treatment (Cycle 1/Day 1) to 30 days following the last administration of study treatment, which is approximately 5 months.
|
|
Gastrointestinal disorders
Dyspepsia
|
3.2%
1/31 • Adverse event data were collected from the initiation of the first study treatment (Cycle 1/Day 1) to 30 days following the last administration of study treatment, which is approximately 5 months.
|
|
Gastrointestinal disorders
Esophageal pain
|
3.2%
1/31 • Adverse event data were collected from the initiation of the first study treatment (Cycle 1/Day 1) to 30 days following the last administration of study treatment, which is approximately 5 months.
|
|
Gastrointestinal disorders
Flatulence
|
3.2%
1/31 • Adverse event data were collected from the initiation of the first study treatment (Cycle 1/Day 1) to 30 days following the last administration of study treatment, which is approximately 5 months.
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
19.4%
6/31 • Adverse event data were collected from the initiation of the first study treatment (Cycle 1/Day 1) to 30 days following the last administration of study treatment, which is approximately 5 months.
|
|
Gastrointestinal disorders
Gingival pain
|
6.5%
2/31 • Adverse event data were collected from the initiation of the first study treatment (Cycle 1/Day 1) to 30 days following the last administration of study treatment, which is approximately 5 months.
|
|
Gastrointestinal disorders
Other
|
6.5%
2/31 • Adverse event data were collected from the initiation of the first study treatment (Cycle 1/Day 1) to 30 days following the last administration of study treatment, which is approximately 5 months.
|
|
Gastrointestinal disorders
Hemorrhoidal hemorrhage
|
3.2%
1/31 • Adverse event data were collected from the initiation of the first study treatment (Cycle 1/Day 1) to 30 days following the last administration of study treatment, which is approximately 5 months.
|
|
Gastrointestinal disorders
Nausea
|
67.7%
21/31 • Adverse event data were collected from the initiation of the first study treatment (Cycle 1/Day 1) to 30 days following the last administration of study treatment, which is approximately 5 months.
|
|
Gastrointestinal disorders
Oral dysesthesia
|
3.2%
1/31 • Adverse event data were collected from the initiation of the first study treatment (Cycle 1/Day 1) to 30 days following the last administration of study treatment, which is approximately 5 months.
|
|
Gastrointestinal disorders
Mucositis oral
|
29.0%
9/31 • Adverse event data were collected from the initiation of the first study treatment (Cycle 1/Day 1) to 30 days following the last administration of study treatment, which is approximately 5 months.
|
|
Gastrointestinal disorders
Toothache
|
3.2%
1/31 • Adverse event data were collected from the initiation of the first study treatment (Cycle 1/Day 1) to 30 days following the last administration of study treatment, which is approximately 5 months.
|
|
Gastrointestinal disorders
Vomiting
|
12.9%
4/31 • Adverse event data were collected from the initiation of the first study treatment (Cycle 1/Day 1) to 30 days following the last administration of study treatment, which is approximately 5 months.
|
|
General disorders
Chills
|
9.7%
3/31 • Adverse event data were collected from the initiation of the first study treatment (Cycle 1/Day 1) to 30 days following the last administration of study treatment, which is approximately 5 months.
|
|
General disorders
Edema face
|
6.5%
2/31 • Adverse event data were collected from the initiation of the first study treatment (Cycle 1/Day 1) to 30 days following the last administration of study treatment, which is approximately 5 months.
|
|
Gastrointestinal disorders
Edema limbs
|
6.5%
2/31 • Adverse event data were collected from the initiation of the first study treatment (Cycle 1/Day 1) to 30 days following the last administration of study treatment, which is approximately 5 months.
|
|
General disorders
Edema trunk
|
3.2%
1/31 • Adverse event data were collected from the initiation of the first study treatment (Cycle 1/Day 1) to 30 days following the last administration of study treatment, which is approximately 5 months.
|
|
General disorders
Fatigue
|
64.5%
20/31 • Adverse event data were collected from the initiation of the first study treatment (Cycle 1/Day 1) to 30 days following the last administration of study treatment, which is approximately 5 months.
|
|
General disorders
Fever
|
22.6%
7/31 • Adverse event data were collected from the initiation of the first study treatment (Cycle 1/Day 1) to 30 days following the last administration of study treatment, which is approximately 5 months.
|
|
General disorders
Infusion related reaction
|
12.9%
4/31 • Adverse event data were collected from the initiation of the first study treatment (Cycle 1/Day 1) to 30 days following the last administration of study treatment, which is approximately 5 months.
|
|
General disorders
Infusion site extravasation
|
3.2%
1/31 • Adverse event data were collected from the initiation of the first study treatment (Cycle 1/Day 1) to 30 days following the last administration of study treatment, which is approximately 5 months.
|
|
General disorders
Irritability
|
3.2%
1/31 • Adverse event data were collected from the initiation of the first study treatment (Cycle 1/Day 1) to 30 days following the last administration of study treatment, which is approximately 5 months.
|
|
General disorders
Non-cardiac chest pain
|
6.5%
2/31 • Adverse event data were collected from the initiation of the first study treatment (Cycle 1/Day 1) to 30 days following the last administration of study treatment, which is approximately 5 months.
|
|
General disorders
Pain
|
16.1%
5/31 • Adverse event data were collected from the initiation of the first study treatment (Cycle 1/Day 1) to 30 days following the last administration of study treatment, which is approximately 5 months.
|
|
Immune system disorders
Allergic reaction
|
6.5%
2/31 • Adverse event data were collected from the initiation of the first study treatment (Cycle 1/Day 1) to 30 days following the last administration of study treatment, which is approximately 5 months.
|
|
Infections and infestations
Bronchial infection
|
3.2%
1/31 • Adverse event data were collected from the initiation of the first study treatment (Cycle 1/Day 1) to 30 days following the last administration of study treatment, which is approximately 5 months.
|
|
Injury, poisoning and procedural complications
Bruising
|
6.5%
2/31 • Adverse event data were collected from the initiation of the first study treatment (Cycle 1/Day 1) to 30 days following the last administration of study treatment, which is approximately 5 months.
|
|
Injury, poisoning and procedural complications
Fall
|
3.2%
1/31 • Adverse event data were collected from the initiation of the first study treatment (Cycle 1/Day 1) to 30 days following the last administration of study treatment, which is approximately 5 months.
|
|
Investigations
Alanine aminotransferase increased
|
16.1%
5/31 • Adverse event data were collected from the initiation of the first study treatment (Cycle 1/Day 1) to 30 days following the last administration of study treatment, which is approximately 5 months.
|
|
Investigations
Alkaline phosphatase increased
|
12.9%
4/31 • Adverse event data were collected from the initiation of the first study treatment (Cycle 1/Day 1) to 30 days following the last administration of study treatment, which is approximately 5 months.
|
|
Investigations
Aspartate aminotransferase increased
|
19.4%
6/31 • Adverse event data were collected from the initiation of the first study treatment (Cycle 1/Day 1) to 30 days following the last administration of study treatment, which is approximately 5 months.
|
|
Investigations
Creatinine increased
|
3.2%
1/31 • Adverse event data were collected from the initiation of the first study treatment (Cycle 1/Day 1) to 30 days following the last administration of study treatment, which is approximately 5 months.
|
|
Investigations
Lymphocyte count decreased
|
83.9%
26/31 • Adverse event data were collected from the initiation of the first study treatment (Cycle 1/Day 1) to 30 days following the last administration of study treatment, which is approximately 5 months.
|
|
Investigations
Neutrophil count decreased
|
58.1%
18/31 • Adverse event data were collected from the initiation of the first study treatment (Cycle 1/Day 1) to 30 days following the last administration of study treatment, which is approximately 5 months.
|
|
Investigations
Platelet count decreased
|
22.6%
7/31 • Adverse event data were collected from the initiation of the first study treatment (Cycle 1/Day 1) to 30 days following the last administration of study treatment, which is approximately 5 months.
|
|
Investigations
Weight loss
|
3.2%
1/31 • Adverse event data were collected from the initiation of the first study treatment (Cycle 1/Day 1) to 30 days following the last administration of study treatment, which is approximately 5 months.
|
|
Investigations
White blood cell decreased
|
77.4%
24/31 • Adverse event data were collected from the initiation of the first study treatment (Cycle 1/Day 1) to 30 days following the last administration of study treatment, which is approximately 5 months.
|
|
Metabolism and nutrition disorders
Anorexia
|
12.9%
4/31 • Adverse event data were collected from the initiation of the first study treatment (Cycle 1/Day 1) to 30 days following the last administration of study treatment, which is approximately 5 months.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
16.1%
5/31 • Adverse event data were collected from the initiation of the first study treatment (Cycle 1/Day 1) to 30 days following the last administration of study treatment, which is approximately 5 months.
|
|
Metabolism and nutrition disorders
Hyperuricemia
|
6.5%
2/31 • Adverse event data were collected from the initiation of the first study treatment (Cycle 1/Day 1) to 30 days following the last administration of study treatment, which is approximately 5 months.
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
9.7%
3/31 • Adverse event data were collected from the initiation of the first study treatment (Cycle 1/Day 1) to 30 days following the last administration of study treatment, which is approximately 5 months.
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
9.7%
3/31 • Adverse event data were collected from the initiation of the first study treatment (Cycle 1/Day 1) to 30 days following the last administration of study treatment, which is approximately 5 months.
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
3.2%
1/31 • Adverse event data were collected from the initiation of the first study treatment (Cycle 1/Day 1) to 30 days following the last administration of study treatment, which is approximately 5 months.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
9.7%
3/31 • Adverse event data were collected from the initiation of the first study treatment (Cycle 1/Day 1) to 30 days following the last administration of study treatment, which is approximately 5 months.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
32.3%
10/31 • Adverse event data were collected from the initiation of the first study treatment (Cycle 1/Day 1) to 30 days following the last administration of study treatment, which is approximately 5 months.
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
6.5%
2/31 • Adverse event data were collected from the initiation of the first study treatment (Cycle 1/Day 1) to 30 days following the last administration of study treatment, which is approximately 5 months.
|
|
Infections and infestations
Thrush
|
3.2%
1/31 • Adverse event data were collected from the initiation of the first study treatment (Cycle 1/Day 1) to 30 days following the last administration of study treatment, which is approximately 5 months.
|
|
Infections and infestations
Papulopustular rash
|
3.2%
1/31 • Adverse event data were collected from the initiation of the first study treatment (Cycle 1/Day 1) to 30 days following the last administration of study treatment, which is approximately 5 months.
|
|
Infections and infestations
Sinusitis
|
3.2%
1/31 • Adverse event data were collected from the initiation of the first study treatment (Cycle 1/Day 1) to 30 days following the last administration of study treatment, which is approximately 5 months.
|
|
Infections and infestations
Upper respiratory infection
|
3.2%
1/31 • Adverse event data were collected from the initiation of the first study treatment (Cycle 1/Day 1) to 30 days following the last administration of study treatment, which is approximately 5 months.
|
|
Infections and infestations
Urinary tract infection
|
12.9%
4/31 • Adverse event data were collected from the initiation of the first study treatment (Cycle 1/Day 1) to 30 days following the last administration of study treatment, which is approximately 5 months.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
9.7%
3/31 • Adverse event data were collected from the initiation of the first study treatment (Cycle 1/Day 1) to 30 days following the last administration of study treatment, which is approximately 5 months.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
3.2%
1/31 • Adverse event data were collected from the initiation of the first study treatment (Cycle 1/Day 1) to 30 days following the last administration of study treatment, which is approximately 5 months.
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness lower limb
|
6.5%
2/31 • Adverse event data were collected from the initiation of the first study treatment (Cycle 1/Day 1) to 30 days following the last administration of study treatment, which is approximately 5 months.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
9.7%
3/31 • Adverse event data were collected from the initiation of the first study treatment (Cycle 1/Day 1) to 30 days following the last administration of study treatment, which is approximately 5 months.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
3.2%
1/31 • Adverse event data were collected from the initiation of the first study treatment (Cycle 1/Day 1) to 30 days following the last administration of study treatment, which is approximately 5 months.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
6.5%
2/31 • Adverse event data were collected from the initiation of the first study treatment (Cycle 1/Day 1) to 30 days following the last administration of study treatment, which is approximately 5 months.
|
|
Nervous system disorders
Dizziness
|
29.0%
9/31 • Adverse event data were collected from the initiation of the first study treatment (Cycle 1/Day 1) to 30 days following the last administration of study treatment, which is approximately 5 months.
|
|
Musculoskeletal and connective tissue disorders
Dysgeusia
|
6.5%
2/31 • Adverse event data were collected from the initiation of the first study treatment (Cycle 1/Day 1) to 30 days following the last administration of study treatment, which is approximately 5 months.
|
|
Nervous system disorders
Headache
|
35.5%
11/31 • Adverse event data were collected from the initiation of the first study treatment (Cycle 1/Day 1) to 30 days following the last administration of study treatment, which is approximately 5 months.
|
|
Nervous system disorders
Paresthesia
|
3.2%
1/31 • Adverse event data were collected from the initiation of the first study treatment (Cycle 1/Day 1) to 30 days following the last administration of study treatment, which is approximately 5 months.
|
|
Nervous system disorders
Peripheral motor neuropathy
|
6.5%
2/31 • Adverse event data were collected from the initiation of the first study treatment (Cycle 1/Day 1) to 30 days following the last administration of study treatment, which is approximately 5 months.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
61.3%
19/31 • Adverse event data were collected from the initiation of the first study treatment (Cycle 1/Day 1) to 30 days following the last administration of study treatment, which is approximately 5 months.
|
|
Psychiatric disorders
Anxiety
|
12.9%
4/31 • Adverse event data were collected from the initiation of the first study treatment (Cycle 1/Day 1) to 30 days following the last administration of study treatment, which is approximately 5 months.
|
|
Psychiatric disorders
Depression
|
3.2%
1/31 • Adverse event data were collected from the initiation of the first study treatment (Cycle 1/Day 1) to 30 days following the last administration of study treatment, which is approximately 5 months.
|
|
Psychiatric disorders
Insomnia
|
9.7%
3/31 • Adverse event data were collected from the initiation of the first study treatment (Cycle 1/Day 1) to 30 days following the last administration of study treatment, which is approximately 5 months.
|
|
Renal and urinary disorders
Hematuria
|
3.2%
1/31 • Adverse event data were collected from the initiation of the first study treatment (Cycle 1/Day 1) to 30 days following the last administration of study treatment, which is approximately 5 months.
|
|
Renal and urinary disorders
Urinary frequency
|
9.7%
3/31 • Adverse event data were collected from the initiation of the first study treatment (Cycle 1/Day 1) to 30 days following the last administration of study treatment, which is approximately 5 months.
|
|
Renal and urinary disorders
Urinary retention
|
3.2%
1/31 • Adverse event data were collected from the initiation of the first study treatment (Cycle 1/Day 1) to 30 days following the last administration of study treatment, which is approximately 5 months.
|
|
Renal and urinary disorders
Urinary urgency
|
3.2%
1/31 • Adverse event data were collected from the initiation of the first study treatment (Cycle 1/Day 1) to 30 days following the last administration of study treatment, which is approximately 5 months.
|
|
Respiratory, thoracic and mediastinal disorders
Allergic rhinitis
|
12.9%
4/31 • Adverse event data were collected from the initiation of the first study treatment (Cycle 1/Day 1) to 30 days following the last administration of study treatment, which is approximately 5 months.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
19.4%
6/31 • Adverse event data were collected from the initiation of the first study treatment (Cycle 1/Day 1) to 30 days following the last administration of study treatment, which is approximately 5 months.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
16.1%
5/31 • Adverse event data were collected from the initiation of the first study treatment (Cycle 1/Day 1) to 30 days following the last administration of study treatment, which is approximately 5 months.
|
|
Respiratory, thoracic and mediastinal disorders
Hoarseness
|
3.2%
1/31 • Adverse event data were collected from the initiation of the first study treatment (Cycle 1/Day 1) to 30 days following the last administration of study treatment, which is approximately 5 months.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
6.5%
2/31 • Adverse event data were collected from the initiation of the first study treatment (Cycle 1/Day 1) to 30 days following the last administration of study treatment, which is approximately 5 months.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
3.2%
1/31 • Adverse event data were collected from the initiation of the first study treatment (Cycle 1/Day 1) to 30 days following the last administration of study treatment, which is approximately 5 months.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
3.2%
1/31 • Adverse event data were collected from the initiation of the first study treatment (Cycle 1/Day 1) to 30 days following the last administration of study treatment, which is approximately 5 months.
|
|
Respiratory, thoracic and mediastinal disorders
Postnasal drip
|
3.2%
1/31 • Adverse event data were collected from the initiation of the first study treatment (Cycle 1/Day 1) to 30 days following the last administration of study treatment, which is approximately 5 months.
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
3.2%
1/31 • Adverse event data were collected from the initiation of the first study treatment (Cycle 1/Day 1) to 30 days following the last administration of study treatment, which is approximately 5 months.
|
|
Respiratory, thoracic and mediastinal disorders
Voice alteration
|
3.2%
1/31 • Adverse event data were collected from the initiation of the first study treatment (Cycle 1/Day 1) to 30 days following the last administration of study treatment, which is approximately 5 months.
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
3.2%
1/31 • Adverse event data were collected from the initiation of the first study treatment (Cycle 1/Day 1) to 30 days following the last administration of study treatment, which is approximately 5 months.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
19.4%
6/31 • Adverse event data were collected from the initiation of the first study treatment (Cycle 1/Day 1) to 30 days following the last administration of study treatment, which is approximately 5 months.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
6.5%
2/31 • Adverse event data were collected from the initiation of the first study treatment (Cycle 1/Day 1) to 30 days following the last administration of study treatment, which is approximately 5 months.
|
|
Skin and subcutaneous tissue disorders
Nail discoloration
|
3.2%
1/31 • Adverse event data were collected from the initiation of the first study treatment (Cycle 1/Day 1) to 30 days following the last administration of study treatment, which is approximately 5 months.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
3.2%
1/31 • Adverse event data were collected from the initiation of the first study treatment (Cycle 1/Day 1) to 30 days following the last administration of study treatment, which is approximately 5 months.
|
|
Skin and subcutaneous tissue disorders
Other skin irritation
|
3.2%
1/31 • Adverse event data were collected from the initiation of the first study treatment (Cycle 1/Day 1) to 30 days following the last administration of study treatment, which is approximately 5 months.
|
|
Skin and subcutaneous tissue disorders
Rash acneiform
|
3.2%
1/31 • Adverse event data were collected from the initiation of the first study treatment (Cycle 1/Day 1) to 30 days following the last administration of study treatment, which is approximately 5 months.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
6.5%
2/31 • Adverse event data were collected from the initiation of the first study treatment (Cycle 1/Day 1) to 30 days following the last administration of study treatment, which is approximately 5 months.
|
Additional Information
Jakub Svoboda, MD
University of Pennsylvania Abramson Cancer Center
Phone: 855-216-0098
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee Neither the complete nor any part of the results of the study carried out under this protocol, nor any of the information provided by the sponsor for the purposes of performing the study, will be published or passed on to any third party without the consent of the study sponsor. Any investigator involved with this study is obligated to provide the sponsor with complete test results and all data derived from the study.
- Publication restrictions are in place
Restriction type: OTHER