Trial Outcomes & Findings for Venetoclax and Romidepsin in Treating Patients With Recurrent or Refractory Mature T-Cell Lymphoma (NCT NCT03534180)

Last Updated: 2023-10-19

Results Overview

Graded according to Common Terminology Criteria for Adverse Events (CTCAE) version (v.) 5.0. During the first 2 cycles, all grades of toxicity will be collected. After cycle 2, only the highest grade of any toxicity will be collected for each cycle during protocol treatment and for the period of safety follow-up after end of treatment.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

12 participants

Primary outcome timeframe

Up to 30 days post-treatment, an average of 4 months.

Results posted on

2023-10-19

Participant Flow

12 participants consented to the study. 9 of them became eligible and received the study treatment.

Participant milestones

Participant milestones
Measure	Treatment (Venetoclax, Romidepsin) Patients receive venetoclax PO QD on days 1-28 and romidepsin IV on days 1, 8, and 15. Treatment repeats every 28 days for up to 26 cycles in the absence of disease progression or unacceptable toxicity. Laboratory Biomarker Analysis: Correlative studies Romidepsin: Given IV Venetoclax: Given PO
Overall Study STARTED	9
Overall Study COMPLETED	8
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Treatment (Venetoclax, Romidepsin) Patients receive venetoclax PO QD on days 1-28 and romidepsin IV on days 1, 8, and 15. Treatment repeats every 28 days for up to 26 cycles in the absence of disease progression or unacceptable toxicity. Laboratory Biomarker Analysis: Correlative studies Romidepsin: Given IV Venetoclax: Given PO
Overall Study Withdrawal by Subject	1

Baseline Characteristics

Venetoclax and Romidepsin in Treating Patients With Recurrent or Refractory Mature T-Cell Lymphoma

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Treatment (Venetoclax, Romidepsin) n=9 Participants Patients receive venetoclax PO QD on days 1-28 and romidepsin IV on days 1, 8, and 15. Treatment repeats every 28 days for up to 26 cycles in the absence of disease progression or unacceptable toxicity. Laboratory Biomarker Analysis: Correlative studies Romidepsin: Given IV Venetoclax: Given PO
Age, Continuous	70 years n=5 Participants
Sex: Female, Male Female	3 Participants n=5 Participants
Sex: Female, Male Male	6 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	4 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	3 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	2 Participants n=5 Participants
Region of Enrollment United States	9 participants n=5 Participants

PRIMARY outcome

Timeframe: Up to 30 days post-treatment, an average of 4 months.

Outcome measures

Outcome measures
Measure	Treatment (Venetoclax, Romidepsin) n=9 Participants Patients receive venetoclax PO QD on days 1-28 and romidepsin IV on days 1, 8, and 15. Treatment repeats every 28 days for up to 26 cycles in the absence of disease progression or unacceptable toxicity. Laboratory Biomarker Analysis: Correlative studies Romidepsin: Given IV Venetoclax: Given PO
Number of Patients With Grade 3 or Above Toxicities	9 Participants

SECONDARY outcome

Timeframe: From the start of study treatment up to 100 days

Overall survival (OS) was measured from start of the study treatment to death from any cause. OS to be estimated using the product-limit method of Kaplan- Meier with the Greenwood estimator of standard error.

Outcome measures

Outcome measures
Measure	Treatment (Venetoclax, Romidepsin) n=9 Participants Patients receive venetoclax PO QD on days 1-28 and romidepsin IV on days 1, 8, and 15. Treatment repeats every 28 days for up to 26 cycles in the absence of disease progression or unacceptable toxicity. Laboratory Biomarker Analysis: Correlative studies Romidepsin: Given IV Venetoclax: Given PO
Overall Survival at 100 Days	63 percent probability Interval 23.0 to 86.0

Adverse Events

Treatment (Venetoclax, Romidepsin)

Serious events: 5 serious events

Other events: 9 other events

Deaths: 6 deaths

Serious adverse events

Serious adverse events
Measure	Treatment (Venetoclax, Romidepsin) n=9 participants at risk Patients receive venetoclax PO QD on days 1-28 and romidepsin IV on days 1, 8, and 15. Treatment repeats every 28 days for up to 26 cycles in the absence of disease progression or unacceptable toxicity. Laboratory Biomarker Analysis: Correlative studies Romidepsin: Given IV Venetoclax: Given PO
Gastrointestinal disorders Constipation	11.1% 1/9 • Number of events 1 • Adverse events were monitored/assessed up to 30 days post treatment, an average of 4 months. All-Cause Mortality monitored/assessed up to 5 months post treatment.
General disorders Edema face	11.1% 1/9 • Number of events 1 • Adverse events were monitored/assessed up to 30 days post treatment, an average of 4 months. All-Cause Mortality monitored/assessed up to 5 months post treatment.
Infections and infestations Wound infection	11.1% 1/9 • Number of events 1 • Adverse events were monitored/assessed up to 30 days post treatment, an average of 4 months. All-Cause Mortality monitored/assessed up to 5 months post treatment.
Metabolism and nutrition disorders Hyperphosphatemia	11.1% 1/9 • Number of events 1 • Adverse events were monitored/assessed up to 30 days post treatment, an average of 4 months. All-Cause Mortality monitored/assessed up to 5 months post treatment.
Musculoskeletal and connective tissue disorders Generalized muscle weakness	11.1% 1/9 • Number of events 1 • Adverse events were monitored/assessed up to 30 days post treatment, an average of 4 months. All-Cause Mortality monitored/assessed up to 5 months post treatment.
Respiratory, thoracic and mediastinal disorders Pulmonary Embolism	11.1% 1/9 • Number of events 1 • Adverse events were monitored/assessed up to 30 days post treatment, an average of 4 months. All-Cause Mortality monitored/assessed up to 5 months post treatment.

Other adverse events

Other adverse events
Measure	Treatment (Venetoclax, Romidepsin) n=9 participants at risk Patients receive venetoclax PO QD on days 1-28 and romidepsin IV on days 1, 8, and 15. Treatment repeats every 28 days for up to 26 cycles in the absence of disease progression or unacceptable toxicity. Laboratory Biomarker Analysis: Correlative studies Romidepsin: Given IV Venetoclax: Given PO
Blood and lymphatic system disorders Anemia	77.8% 7/9 • Number of events 40 • Adverse events were monitored/assessed up to 30 days post treatment, an average of 4 months. All-Cause Mortality monitored/assessed up to 5 months post treatment.
Blood and lymphatic system disorders Febrile neutropenia	11.1% 1/9 • Number of events 3 • Adverse events were monitored/assessed up to 30 days post treatment, an average of 4 months. All-Cause Mortality monitored/assessed up to 5 months post treatment.
Blood and lymphatic system disorders Leukocytosis	22.2% 2/9 • Number of events 4 • Adverse events were monitored/assessed up to 30 days post treatment, an average of 4 months. All-Cause Mortality monitored/assessed up to 5 months post treatment.
Blood and lymphatic system disorders Thrombotic thrombocytopenic purpura	11.1% 1/9 • Number of events 1 • Adverse events were monitored/assessed up to 30 days post treatment, an average of 4 months. All-Cause Mortality monitored/assessed up to 5 months post treatment.
Blood and lymphatic system disorders pancytopenia	11.1% 1/9 • Number of events 1 • Adverse events were monitored/assessed up to 30 days post treatment, an average of 4 months. All-Cause Mortality monitored/assessed up to 5 months post treatment.
Blood and lymphatic system disorders pulmonary embolism	11.1% 1/9 • Number of events 1 • Adverse events were monitored/assessed up to 30 days post treatment, an average of 4 months. All-Cause Mortality monitored/assessed up to 5 months post treatment.
Cardiac disorders Sinus tachycardia	33.3% 3/9 • Number of events 6 • Adverse events were monitored/assessed up to 30 days post treatment, an average of 4 months. All-Cause Mortality monitored/assessed up to 5 months post treatment.
Eye disorders Blurred vision	11.1% 1/9 • Number of events 1 • Adverse events were monitored/assessed up to 30 days post treatment, an average of 4 months. All-Cause Mortality monitored/assessed up to 5 months post treatment.
Eye disorders Periorbital edema	22.2% 2/9 • Number of events 2 • Adverse events were monitored/assessed up to 30 days post treatment, an average of 4 months. All-Cause Mortality monitored/assessed up to 5 months post treatment.
Gastrointestinal disorders Abdominal pain	11.1% 1/9 • Number of events 1 • Adverse events were monitored/assessed up to 30 days post treatment, an average of 4 months. All-Cause Mortality monitored/assessed up to 5 months post treatment.
Gastrointestinal disorders Constipation	55.6% 5/9 • Number of events 6 • Adverse events were monitored/assessed up to 30 days post treatment, an average of 4 months. All-Cause Mortality monitored/assessed up to 5 months post treatment.
Gastrointestinal disorders Diarrhea	22.2% 2/9 • Number of events 8 • Adverse events were monitored/assessed up to 30 days post treatment, an average of 4 months. All-Cause Mortality monitored/assessed up to 5 months post treatment.
Gastrointestinal disorders Dysphagia	33.3% 3/9 • Number of events 4 • Adverse events were monitored/assessed up to 30 days post treatment, an average of 4 months. All-Cause Mortality monitored/assessed up to 5 months post treatment.
Gastrointestinal disorders Fecal incontinence	11.1% 1/9 • Number of events 2 • Adverse events were monitored/assessed up to 30 days post treatment, an average of 4 months. All-Cause Mortality monitored/assessed up to 5 months post treatment.
Gastrointestinal disorders Hemorrhoids	11.1% 1/9 • Number of events 1 • Adverse events were monitored/assessed up to 30 days post treatment, an average of 4 months. All-Cause Mortality monitored/assessed up to 5 months post treatment.
Gastrointestinal disorders Nausea	55.6% 5/9 • Number of events 7 • Adverse events were monitored/assessed up to 30 days post treatment, an average of 4 months. All-Cause Mortality monitored/assessed up to 5 months post treatment.
Gastrointestinal disorders Vomiting	33.3% 3/9 • Number of events 4 • Adverse events were monitored/assessed up to 30 days post treatment, an average of 4 months. All-Cause Mortality monitored/assessed up to 5 months post treatment.
General disorders Chills	22.2% 2/9 • Number of events 6 • Adverse events were monitored/assessed up to 30 days post treatment, an average of 4 months. All-Cause Mortality monitored/assessed up to 5 months post treatment.
General disorders Edema limbs	44.4% 4/9 • Number of events 9 • Adverse events were monitored/assessed up to 30 days post treatment, an average of 4 months. All-Cause Mortality monitored/assessed up to 5 months post treatment.
General disorders Fatigue	55.6% 5/9 • Number of events 6 • Adverse events were monitored/assessed up to 30 days post treatment, an average of 4 months. All-Cause Mortality monitored/assessed up to 5 months post treatment.
General disorders Fever	44.4% 4/9 • Number of events 12 • Adverse events were monitored/assessed up to 30 days post treatment, an average of 4 months. All-Cause Mortality monitored/assessed up to 5 months post treatment.
General disorders Fluid overload	11.1% 1/9 • Number of events 1 • Adverse events were monitored/assessed up to 30 days post treatment, an average of 4 months. All-Cause Mortality monitored/assessed up to 5 months post treatment.
General disorders Gait disturbance	22.2% 2/9 • Number of events 2 • Adverse events were monitored/assessed up to 30 days post treatment, an average of 4 months. All-Cause Mortality monitored/assessed up to 5 months post treatment.
General disorders Localized edema	11.1% 1/9 • Number of events 1 • Adverse events were monitored/assessed up to 30 days post treatment, an average of 4 months. All-Cause Mortality monitored/assessed up to 5 months post treatment.
General disorders Shortness Of Breath	11.1% 1/9 • Number of events 1 • Adverse events were monitored/assessed up to 30 days post treatment, an average of 4 months. All-Cause Mortality monitored/assessed up to 5 months post treatment.
General disorders Sore tongue	11.1% 1/9 • Number of events 1 • Adverse events were monitored/assessed up to 30 days post treatment, an average of 4 months. All-Cause Mortality monitored/assessed up to 5 months post treatment.
General disorders intermittent lower right quadrant pain	11.1% 1/9 • Number of events 1 • Adverse events were monitored/assessed up to 30 days post treatment, an average of 4 months. All-Cause Mortality monitored/assessed up to 5 months post treatment.
General disorders left shoulder pain	11.1% 1/9 • Number of events 1 • Adverse events were monitored/assessed up to 30 days post treatment, an average of 4 months. All-Cause Mortality monitored/assessed up to 5 months post treatment.
General disorders night sweats	11.1% 1/9 • Number of events 1 • Adverse events were monitored/assessed up to 30 days post treatment, an average of 4 months. All-Cause Mortality monitored/assessed up to 5 months post treatment.
General disorders nose bleeding	11.1% 1/9 • Number of events 1 • Adverse events were monitored/assessed up to 30 days post treatment, an average of 4 months. All-Cause Mortality monitored/assessed up to 5 months post treatment.
General disorders numbness	11.1% 1/9 • Number of events 1 • Adverse events were monitored/assessed up to 30 days post treatment, an average of 4 months. All-Cause Mortality monitored/assessed up to 5 months post treatment.
General disorders stomach discomfort	11.1% 1/9 • Number of events 1 • Adverse events were monitored/assessed up to 30 days post treatment, an average of 4 months. All-Cause Mortality monitored/assessed up to 5 months post treatment.
General disorders tachypnea	11.1% 1/9 • Number of events 1 • Adverse events were monitored/assessed up to 30 days post treatment, an average of 4 months. All-Cause Mortality monitored/assessed up to 5 months post treatment.
General disorders taste appetite disturbed	11.1% 1/9 • Number of events 1 • Adverse events were monitored/assessed up to 30 days post treatment, an average of 4 months. All-Cause Mortality monitored/assessed up to 5 months post treatment.
Hepatobiliary disorders Portal vein thrombosis	11.1% 1/9 • Number of events 2 • Adverse events were monitored/assessed up to 30 days post treatment, an average of 4 months. All-Cause Mortality monitored/assessed up to 5 months post treatment.
Injury, poisoning and procedural complications Fall	11.1% 1/9 • Number of events 1 • Adverse events were monitored/assessed up to 30 days post treatment, an average of 4 months. All-Cause Mortality monitored/assessed up to 5 months post treatment.
Investigations Alanine aminotransferase increased	22.2% 2/9 • Number of events 2 • Adverse events were monitored/assessed up to 30 days post treatment, an average of 4 months. All-Cause Mortality monitored/assessed up to 5 months post treatment.
Investigations Alkaline phosphatase increased	11.1% 1/9 • Number of events 5 • Adverse events were monitored/assessed up to 30 days post treatment, an average of 4 months. All-Cause Mortality monitored/assessed up to 5 months post treatment.
Investigations Aspartate aminotransferase increased	44.4% 4/9 • Number of events 4 • Adverse events were monitored/assessed up to 30 days post treatment, an average of 4 months. All-Cause Mortality monitored/assessed up to 5 months post treatment.
Investigations Blood bilirubin increased	33.3% 3/9 • Number of events 9 • Adverse events were monitored/assessed up to 30 days post treatment, an average of 4 months. All-Cause Mortality monitored/assessed up to 5 months post treatment.
Investigations Blood lactate dehydrogenase increased	22.2% 2/9 • Number of events 3 • Adverse events were monitored/assessed up to 30 days post treatment, an average of 4 months. All-Cause Mortality monitored/assessed up to 5 months post treatment.
Investigations Cholesterol high	11.1% 1/9 • Number of events 1 • Adverse events were monitored/assessed up to 30 days post treatment, an average of 4 months. All-Cause Mortality monitored/assessed up to 5 months post treatment.
Investigations Creatinine increased	22.2% 2/9 • Number of events 12 • Adverse events were monitored/assessed up to 30 days post treatment, an average of 4 months. All-Cause Mortality monitored/assessed up to 5 months post treatment.
Investigations Lymphocyte count decreased	77.8% 7/9 • Number of events 42 • Adverse events were monitored/assessed up to 30 days post treatment, an average of 4 months. All-Cause Mortality monitored/assessed up to 5 months post treatment.
Investigations Neutrophil count decreased	77.8% 7/9 • Number of events 47 • Adverse events were monitored/assessed up to 30 days post treatment, an average of 4 months. All-Cause Mortality monitored/assessed up to 5 months post treatment.
Investigations Platelet count decreased	88.9% 8/9 • Number of events 37 • Adverse events were monitored/assessed up to 30 days post treatment, an average of 4 months. All-Cause Mortality monitored/assessed up to 5 months post treatment.
Investigations Weight gain	11.1% 1/9 • Number of events 2 • Adverse events were monitored/assessed up to 30 days post treatment, an average of 4 months. All-Cause Mortality monitored/assessed up to 5 months post treatment.
Investigations Weight loss	22.2% 2/9 • Number of events 2 • Adverse events were monitored/assessed up to 30 days post treatment, an average of 4 months. All-Cause Mortality monitored/assessed up to 5 months post treatment.
Investigations White blood cell decreased	88.9% 8/9 • Number of events 40 • Adverse events were monitored/assessed up to 30 days post treatment, an average of 4 months. All-Cause Mortality monitored/assessed up to 5 months post treatment.
Metabolism and nutrition disorders Anorexia	55.6% 5/9 • Number of events 5 • Adverse events were monitored/assessed up to 30 days post treatment, an average of 4 months. All-Cause Mortality monitored/assessed up to 5 months post treatment.
Metabolism and nutrition disorders Dehydration	11.1% 1/9 • Number of events 2 • Adverse events were monitored/assessed up to 30 days post treatment, an average of 4 months. All-Cause Mortality monitored/assessed up to 5 months post treatment.
Metabolism and nutrition disorders Hypercalcemia	11.1% 1/9 • Number of events 2 • Adverse events were monitored/assessed up to 30 days post treatment, an average of 4 months. All-Cause Mortality monitored/assessed up to 5 months post treatment.
Metabolism and nutrition disorders Hyperglycemia	33.3% 3/9 • Number of events 10 • Adverse events were monitored/assessed up to 30 days post treatment, an average of 4 months. All-Cause Mortality monitored/assessed up to 5 months post treatment.
Metabolism and nutrition disorders Hypermagnesemia	11.1% 1/9 • Number of events 1 • Adverse events were monitored/assessed up to 30 days post treatment, an average of 4 months. All-Cause Mortality monitored/assessed up to 5 months post treatment.
Metabolism and nutrition disorders Hypernatremia	11.1% 1/9 • Number of events 1 • Adverse events were monitored/assessed up to 30 days post treatment, an average of 4 months. All-Cause Mortality monitored/assessed up to 5 months post treatment.
Metabolism and nutrition disorders Hyperphosphatemia	22.2% 2/9 • Number of events 7 • Adverse events were monitored/assessed up to 30 days post treatment, an average of 4 months. All-Cause Mortality monitored/assessed up to 5 months post treatment.
Metabolism and nutrition disorders Hyperuricemia	11.1% 1/9 • Number of events 2 • Adverse events were monitored/assessed up to 30 days post treatment, an average of 4 months. All-Cause Mortality monitored/assessed up to 5 months post treatment.
Metabolism and nutrition disorders Hypoalbuminemia	77.8% 7/9 • Number of events 17 • Adverse events were monitored/assessed up to 30 days post treatment, an average of 4 months. All-Cause Mortality monitored/assessed up to 5 months post treatment.
Metabolism and nutrition disorders Hypocalcemia	22.2% 2/9 • Number of events 2 • Adverse events were monitored/assessed up to 30 days post treatment, an average of 4 months. All-Cause Mortality monitored/assessed up to 5 months post treatment.
Metabolism and nutrition disorders Hypokalemia	55.6% 5/9 • Number of events 15 • Adverse events were monitored/assessed up to 30 days post treatment, an average of 4 months. All-Cause Mortality monitored/assessed up to 5 months post treatment.
Metabolism and nutrition disorders Hypomagnesemia	33.3% 3/9 • Number of events 7 • Adverse events were monitored/assessed up to 30 days post treatment, an average of 4 months. All-Cause Mortality monitored/assessed up to 5 months post treatment.
Metabolism and nutrition disorders Hyponatremia	77.8% 7/9 • Number of events 20 • Adverse events were monitored/assessed up to 30 days post treatment, an average of 4 months. All-Cause Mortality monitored/assessed up to 5 months post treatment.
Metabolism and nutrition disorders Hypophosphatemia	55.6% 5/9 • Number of events 10 • Adverse events were monitored/assessed up to 30 days post treatment, an average of 4 months. All-Cause Mortality monitored/assessed up to 5 months post treatment.
Musculoskeletal and connective tissue disorders Back pain	11.1% 1/9 • Number of events 1 • Adverse events were monitored/assessed up to 30 days post treatment, an average of 4 months. All-Cause Mortality monitored/assessed up to 5 months post treatment.
Musculoskeletal and connective tissue disorders Generalized muscle weakness	44.4% 4/9 • Number of events 7 • Adverse events were monitored/assessed up to 30 days post treatment, an average of 4 months. All-Cause Mortality monitored/assessed up to 5 months post treatment.
Musculoskeletal and connective tissue disorders Muscle cramp	11.1% 1/9 • Number of events 1 • Adverse events were monitored/assessed up to 30 days post treatment, an average of 4 months. All-Cause Mortality monitored/assessed up to 5 months post treatment.
Musculoskeletal and connective tissue disorders Muscle weakness lower limb	11.1% 1/9 • Number of events 1 • Adverse events were monitored/assessed up to 30 days post treatment, an average of 4 months. All-Cause Mortality monitored/assessed up to 5 months post treatment.
Musculoskeletal and connective tissue disorders Neck pain	11.1% 1/9 • Number of events 1 • Adverse events were monitored/assessed up to 30 days post treatment, an average of 4 months. All-Cause Mortality monitored/assessed up to 5 months post treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tumor pain	22.2% 2/9 • Number of events 2 • Adverse events were monitored/assessed up to 30 days post treatment, an average of 4 months. All-Cause Mortality monitored/assessed up to 5 months post treatment.
Nervous system disorders Dizziness	22.2% 2/9 • Number of events 2 • Adverse events were monitored/assessed up to 30 days post treatment, an average of 4 months. All-Cause Mortality monitored/assessed up to 5 months post treatment.
Nervous system disorders Dysgeusia	11.1% 1/9 • Number of events 1 • Adverse events were monitored/assessed up to 30 days post treatment, an average of 4 months. All-Cause Mortality monitored/assessed up to 5 months post treatment.
Nervous system disorders Headache	33.3% 3/9 • Number of events 4 • Adverse events were monitored/assessed up to 30 days post treatment, an average of 4 months. All-Cause Mortality monitored/assessed up to 5 months post treatment.
Nervous system disorders Lethargy	11.1% 1/9 • Number of events 2 • Adverse events were monitored/assessed up to 30 days post treatment, an average of 4 months. All-Cause Mortality monitored/assessed up to 5 months post treatment.
Nervous system disorders Memory impairment	22.2% 2/9 • Number of events 3 • Adverse events were monitored/assessed up to 30 days post treatment, an average of 4 months. All-Cause Mortality monitored/assessed up to 5 months post treatment.
Nervous system disorders Peripheral sensory neuropathy	22.2% 2/9 • Number of events 2 • Adverse events were monitored/assessed up to 30 days post treatment, an average of 4 months. All-Cause Mortality monitored/assessed up to 5 months post treatment.
Psychiatric disorders Agitation	11.1% 1/9 • Number of events 4 • Adverse events were monitored/assessed up to 30 days post treatment, an average of 4 months. All-Cause Mortality monitored/assessed up to 5 months post treatment.
Psychiatric disorders Anxiety	22.2% 2/9 • Number of events 2 • Adverse events were monitored/assessed up to 30 days post treatment, an average of 4 months. All-Cause Mortality monitored/assessed up to 5 months post treatment.
Psychiatric disorders Confusion	11.1% 1/9 • Number of events 3 • Adverse events were monitored/assessed up to 30 days post treatment, an average of 4 months. All-Cause Mortality monitored/assessed up to 5 months post treatment.
Psychiatric disorders Insomnia	22.2% 2/9 • Number of events 2 • Adverse events were monitored/assessed up to 30 days post treatment, an average of 4 months. All-Cause Mortality monitored/assessed up to 5 months post treatment.
Psychiatric disorders Irritability	11.1% 1/9 • Number of events 1 • Adverse events were monitored/assessed up to 30 days post treatment, an average of 4 months. All-Cause Mortality monitored/assessed up to 5 months post treatment.
Psychiatric disorders Restlessness	11.1% 1/9 • Number of events 1 • Adverse events were monitored/assessed up to 30 days post treatment, an average of 4 months. All-Cause Mortality monitored/assessed up to 5 months post treatment.
Renal and urinary disorders Proteinuria	11.1% 1/9 • Number of events 4 • Adverse events were monitored/assessed up to 30 days post treatment, an average of 4 months. All-Cause Mortality monitored/assessed up to 5 months post treatment.
Renal and urinary disorders Urinary incontinence	22.2% 2/9 • Number of events 2 • Adverse events were monitored/assessed up to 30 days post treatment, an average of 4 months. All-Cause Mortality monitored/assessed up to 5 months post treatment.
Reproductive system and breast disorders Pelvic pain	11.1% 1/9 • Number of events 1 • Adverse events were monitored/assessed up to 30 days post treatment, an average of 4 months. All-Cause Mortality monitored/assessed up to 5 months post treatment.
Reproductive system and breast disorders Vaginal hemorrhage	11.1% 1/9 • Number of events 1 • Adverse events were monitored/assessed up to 30 days post treatment, an average of 4 months. All-Cause Mortality monitored/assessed up to 5 months post treatment.
Respiratory, thoracic and mediastinal disorders Cough	44.4% 4/9 • Number of events 5 • Adverse events were monitored/assessed up to 30 days post treatment, an average of 4 months. All-Cause Mortality monitored/assessed up to 5 months post treatment.
Respiratory, thoracic and mediastinal disorders Dyspnea	22.2% 2/9 • Number of events 2 • Adverse events were monitored/assessed up to 30 days post treatment, an average of 4 months. All-Cause Mortality monitored/assessed up to 5 months post treatment.
Respiratory, thoracic and mediastinal disorders Epistaxis	11.1% 1/9 • Number of events 1 • Adverse events were monitored/assessed up to 30 days post treatment, an average of 4 months. All-Cause Mortality monitored/assessed up to 5 months post treatment.
Respiratory, thoracic and mediastinal disorders Hypoxia	11.1% 1/9 • Number of events 3 • Adverse events were monitored/assessed up to 30 days post treatment, an average of 4 months. All-Cause Mortality monitored/assessed up to 5 months post treatment.
Respiratory, thoracic and mediastinal disorders Pulmonary Embolism	11.1% 1/9 • Number of events 1 • Adverse events were monitored/assessed up to 30 days post treatment, an average of 4 months. All-Cause Mortality monitored/assessed up to 5 months post treatment.
Respiratory, thoracic and mediastinal disorders Shortness of Breath at rest	11.1% 1/9 • Number of events 1 • Adverse events were monitored/assessed up to 30 days post treatment, an average of 4 months. All-Cause Mortality monitored/assessed up to 5 months post treatment.
Respiratory, thoracic and mediastinal disorders Upper Respiratory Infection	11.1% 1/9 • Number of events 1 • Adverse events were monitored/assessed up to 30 days post treatment, an average of 4 months. All-Cause Mortality monitored/assessed up to 5 months post treatment.
Skin and subcutaneous tissue disorders Fungal Rash Chest	11.1% 1/9 • Number of events 1 • Adverse events were monitored/assessed up to 30 days post treatment, an average of 4 months. All-Cause Mortality monitored/assessed up to 5 months post treatment.
Skin and subcutaneous tissue disorders Pain of skin	11.1% 1/9 • Number of events 1 • Adverse events were monitored/assessed up to 30 days post treatment, an average of 4 months. All-Cause Mortality monitored/assessed up to 5 months post treatment.
Skin and subcutaneous tissue disorders Pruritus	11.1% 1/9 • Number of events 2 • Adverse events were monitored/assessed up to 30 days post treatment, an average of 4 months. All-Cause Mortality monitored/assessed up to 5 months post treatment.
Skin and subcutaneous tissue disorders Rash acneiform	11.1% 1/9 • Number of events 3 • Adverse events were monitored/assessed up to 30 days post treatment, an average of 4 months. All-Cause Mortality monitored/assessed up to 5 months post treatment.
Skin and subcutaneous tissue disorders Scalp pain	11.1% 1/9 • Number of events 4 • Adverse events were monitored/assessed up to 30 days post treatment, an average of 4 months. All-Cause Mortality monitored/assessed up to 5 months post treatment.
Skin and subcutaneous tissue disorders Skin ulceration	11.1% 1/9 • Number of events 5 • Adverse events were monitored/assessed up to 30 days post treatment, an average of 4 months. All-Cause Mortality monitored/assessed up to 5 months post treatment.
Vascular disorders Flushing	11.1% 1/9 • Number of events 1 • Adverse events were monitored/assessed up to 30 days post treatment, an average of 4 months. All-Cause Mortality monitored/assessed up to 5 months post treatment.
Vascular disorders Hypertension	55.6% 5/9 • Number of events 61 • Adverse events were monitored/assessed up to 30 days post treatment, an average of 4 months. All-Cause Mortality monitored/assessed up to 5 months post treatment.
Vascular disorders Hypotension	55.6% 5/9 • Number of events 7 • Adverse events were monitored/assessed up to 30 days post treatment, an average of 4 months. All-Cause Mortality monitored/assessed up to 5 months post treatment.
Vascular disorders Jaudice	11.1% 1/9 • Number of events 1 • Adverse events were monitored/assessed up to 30 days post treatment, an average of 4 months. All-Cause Mortality monitored/assessed up to 5 months post treatment.

Additional Information

Dr. Jasmine Zain, MD

City of Hope

Phone: 6263598111

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place