Trial Outcomes & Findings for Intermittent Duvelisib Dosing in Treating Patients With Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma (NCT NCT03961672)

Last Updated: 2026-01-05

Results Overview

Progression is defined using IWCLL 2018 guidelines (Section 5.3 of Hallek et al, 2018). Proportion of subjects achieving 12-month PFS were estimated along with a two-sided exact Clopper-Pearson 95% confidence interval. PFS was estimated from start of duvelisib treatment until death, time of progression, start of new therapy, or end of follow-up, whichever occurs first. PFS was censored at the start of new therapy or end of follow-up, whichever occurs first.

Recruitment status

ACTIVE_NOT_RECRUITING

Study phase

PHASE2

Target enrollment

15 participants

Primary outcome timeframe

First dose of duvelisib until death, time of progression, start of new therapy, or 12 months from start of therapy, whichever occurs first

Results posted on

2026-01-05

Participant Flow

Participant milestones

Participant milestones
Measure	Treatment (Duvelisib) INDUCTION: Patients receive duvelisib PO BID on days 1-28. Cycles repeat every 28 days for 12 weeks in the absence of disease progression or unacceptable toxicity. MAINTENANCE: Patients receive duvelisib PO BID on days 1-2, 8-9, 15-16, and 22-23. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Duvelisib: Given PO
Overall Study STARTED	15
Overall Study COMPLETED	15
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Intermittent Duvelisib Dosing in Treating Patients With Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Treatment (Duvelisib) n=15 Participants INDUCTION: Patients receive duvelisib PO BID on days 1-28. Cycles repeat every 28 days for 12 weeks in the absence of disease progression or unacceptable toxicity. MAINTENANCE: Patients receive duvelisib PO BID on days 1-2, 8-9, 15-16, and 22-23. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Duvelisib: Given PO
Age, Continuous	74 years n=9667 Participants
Sex: Female, Male Female	8 Participants n=9667 Participants
Sex: Female, Male Male	7 Participants n=9667 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=9667 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	15 Participants n=9667 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=9667 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=9667 Participants
Race (NIH/OMB) Asian	1 Participants n=9667 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=9667 Participants
Race (NIH/OMB) Black or African American	1 Participants n=9667 Participants
Race (NIH/OMB) White	13 Participants n=9667 Participants
Race (NIH/OMB) More than one race	0 Participants n=9667 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=9667 Participants
Region of Enrollment United States	15 participants n=9667 Participants

PRIMARY outcome

Timeframe: First dose of duvelisib until death, time of progression, start of new therapy, or 12 months from start of therapy, whichever occurs first

Outcome measures

Outcome measures
Measure	Treatment (Duvelisib) n=15 Participants INDUCTION: Patients receive duvelisib PO BID on days 1-28. Cycles repeat every 28 days for 12 weeks in the absence of disease progression or unacceptable toxicity. MAINTENANCE: Patients receive duvelisib PO BID on days 1-2, 8-9, 15-16, and 22-23. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Duvelisib: Given PO
Progression Free Survival (PFS) at 12 Months	48 percentage of participants Interval 21.0 to 71.0

SECONDARY outcome

Timeframe: First dose of duvelisib up to 12 months after discontinuation of duvelisib

Population: 4 participants were not evaluated for response due to early discontinuations for toxicity, myelodysplastic syndrome and COVID-19.

Treatment responses were defined by using IWCLL 2018 guidelines (Hallek et al, 2018). Overall Response (OR) = CR + PR. Probability of having ORR was measured and reported with 95% exact confidence interval.

Outcome measures

Outcome measures
Measure	Treatment (Duvelisib) n=11 Participants INDUCTION: Patients receive duvelisib PO BID on days 1-28. Cycles repeat every 28 days for 12 weeks in the absence of disease progression or unacceptable toxicity. MAINTENANCE: Patients receive duvelisib PO BID on days 1-2, 8-9, 15-16, and 22-23. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Duvelisib: Given PO
Objective Response Rate (ORR) (Including Complete Response [CR] and Partial Response [PR])	82 percentage of participants Interval 48.0 to 98.0

SECONDARY outcome

Timeframe: First dose of duvelisib until death, time of progression, or start of new therapy, whichever occurs first, assessed up to 12 months after discontinuation of duvelisib

Progression is defined using IWCLL 2018 guidelines (Section 5.3 of Hallek et al, 2018). Estimated distribution of the PFS was plotted using Kaplan Meier curves and reported with median PFS and 95% confidence intervals.

Outcome measures

Outcome measures
Measure	Treatment (Duvelisib) n=15 Participants INDUCTION: Patients receive duvelisib PO BID on days 1-28. Cycles repeat every 28 days for 12 weeks in the absence of disease progression or unacceptable toxicity. MAINTENANCE: Patients receive duvelisib PO BID on days 1-2, 8-9, 15-16, and 22-23. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Duvelisib: Given PO
Median Progression-Free Survival (PFS)	9.9 months Interval 5.5 to 29.0

SECONDARY outcome

Timeframe: From time of ORR until death, time of progression, start of new therapy, or end of follow-up, whichever occurs first, assessed up to 12 months after discontinuation of duvelisib

Population: 9 participants achieved objective responses.

Duration of response (DOR), for participants who responded to the study intervention, was measured from the time of first documented objective response (i.e., CR or PR/PR-L) until evidence of progressive disease, start of new therapy, death, or end of follow-up. DOR was censored at the start of new therapy or end of follow-up, whichever occurs first. Proportion of the participants achieving 12-month DOR and the 95% confidence interval were reported.

Outcome measures

Outcome measures
Measure	Treatment (Duvelisib) n=9 Participants INDUCTION: Patients receive duvelisib PO BID on days 1-28. Cycles repeat every 28 days for 12 weeks in the absence of disease progression or unacceptable toxicity. MAINTENANCE: Patients receive duvelisib PO BID on days 1-2, 8-9, 15-16, and 22-23. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Duvelisib: Given PO
Percentage of the Participants With 12-month Duration of Response (DOR)	30 percentage of participants Interval 5.0 to 61.0

SECONDARY outcome

Timeframe: From first dose of duvelisib until 3 months post-discontinuation of duvelisib

Percentage of participants, that received at least one dose of duvelisib, had developed grade 3 4 5 toxicities at least possibly related to duvelisib. The 95% confidence interval was calculated by the Clopper-Pearson (exact) method.

Outcome measures

Outcome measures
Measure	Treatment (Duvelisib) n=15 Participants INDUCTION: Patients receive duvelisib PO BID on days 1-28. Cycles repeat every 28 days for 12 weeks in the absence of disease progression or unacceptable toxicity. MAINTENANCE: Patients receive duvelisib PO BID on days 1-2, 8-9, 15-16, and 22-23. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Duvelisib: Given PO
Percentage of Participants With Grade 3 4 5 Toxicity Related to Duvelisib	67 percentage of participants Interval 38.0 to 88.0

SECONDARY outcome

Timeframe: From first dose of duvelisib until time of duvelisib discontinuation up to 5 years.

Number of study treatment cycles that participants received from the first dose of study drug until therapy was discontinued for any reason.

Outcome measures

Outcome measures
Measure	Treatment (Duvelisib) n=15 Participants INDUCTION: Patients receive duvelisib PO BID on days 1-28. Cycles repeat every 28 days for 12 weeks in the absence of disease progression or unacceptable toxicity. MAINTENANCE: Patients receive duvelisib PO BID on days 1-2, 8-9, 15-16, and 22-23. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Duvelisib: Given PO
Number of Administrated Cycles of the Study Treatment	5 cycles Interval 1.0 to 31.0

Adverse Events

Treatment (Duvelisib)

Serious events: 7 serious events

Other events: 15 other events

Deaths: 3 deaths

Serious adverse events

Serious adverse events
Measure	Treatment (Duvelisib) n=15 participants at risk INDUCTION: Patients receive duvelisib PO BID on days 1-28. Cycles repeat every 28 days for 12 weeks in the absence of disease progression or unacceptable toxicity. MAINTENANCE: Patients receive duvelisib PO BID on days 1-2, 8-9, 15-16, and 22-23. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Duvelisib: Given PO
Cardiac disorders ATRIAL FIBRILLATION	6.7% 1/15 • Number of events 1 • Averse events were assessed from the initial treatment to 30 calendar days after the last study drug dose. Adverse events were monitored and assessed at each cycle of the study treatment. Vital status was assessed from the initial treatment up to 12 months after the end of the treatment.
Cardiac disorders HEART FAILURE	6.7% 1/15 • Number of events 1 • Averse events were assessed from the initial treatment to 30 calendar days after the last study drug dose. Adverse events were monitored and assessed at each cycle of the study treatment. Vital status was assessed from the initial treatment up to 12 months after the end of the treatment.
Gastrointestinal disorders COLITIS	6.7% 1/15 • Number of events 1 • Averse events were assessed from the initial treatment to 30 calendar days after the last study drug dose. Adverse events were monitored and assessed at each cycle of the study treatment. Vital status was assessed from the initial treatment up to 12 months after the end of the treatment.
Gastrointestinal disorders PANCREATITIS	6.7% 1/15 • Number of events 1 • Averse events were assessed from the initial treatment to 30 calendar days after the last study drug dose. Adverse events were monitored and assessed at each cycle of the study treatment. Vital status was assessed from the initial treatment up to 12 months after the end of the treatment.
Infections and infestations COVID-19	6.7% 1/15 • Number of events 1 • Averse events were assessed from the initial treatment to 30 calendar days after the last study drug dose. Adverse events were monitored and assessed at each cycle of the study treatment. Vital status was assessed from the initial treatment up to 12 months after the end of the treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) SCC TUMOR	6.7% 1/15 • Number of events 1 • Averse events were assessed from the initial treatment to 30 calendar days after the last study drug dose. Adverse events were monitored and assessed at each cycle of the study treatment. Vital status was assessed from the initial treatment up to 12 months after the end of the treatment.
Nervous system disorders HEADACHE	6.7% 1/15 • Number of events 1 • Averse events were assessed from the initial treatment to 30 calendar days after the last study drug dose. Adverse events were monitored and assessed at each cycle of the study treatment. Vital status was assessed from the initial treatment up to 12 months after the end of the treatment.

Other adverse events

Other adverse events
Measure	Treatment (Duvelisib) n=15 participants at risk INDUCTION: Patients receive duvelisib PO BID on days 1-28. Cycles repeat every 28 days for 12 weeks in the absence of disease progression or unacceptable toxicity. MAINTENANCE: Patients receive duvelisib PO BID on days 1-2, 8-9, 15-16, and 22-23. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Duvelisib: Given PO
Blood and lymphatic system disorders ANEMIA	6.7% 1/15 • Number of events 1 • Averse events were assessed from the initial treatment to 30 calendar days after the last study drug dose. Adverse events were monitored and assessed at each cycle of the study treatment. Vital status was assessed from the initial treatment up to 12 months after the end of the treatment.
Blood and lymphatic system disorders FEBRILE NEUTROPENIA	6.7% 1/15 • Number of events 1 • Averse events were assessed from the initial treatment to 30 calendar days after the last study drug dose. Adverse events were monitored and assessed at each cycle of the study treatment. Vital status was assessed from the initial treatment up to 12 months after the end of the treatment.
Blood and lymphatic system disorders LEUKOCYTOSIS	26.7% 4/15 • Number of events 5 • Averse events were assessed from the initial treatment to 30 calendar days after the last study drug dose. Adverse events were monitored and assessed at each cycle of the study treatment. Vital status was assessed from the initial treatment up to 12 months after the end of the treatment.
Blood and lymphatic system disorders LYMPH NODE PAIN	13.3% 2/15 • Number of events 2 • Averse events were assessed from the initial treatment to 30 calendar days after the last study drug dose. Adverse events were monitored and assessed at each cycle of the study treatment. Vital status was assessed from the initial treatment up to 12 months after the end of the treatment.
Blood and lymphatic system disorders THROMBOTIC THROMBOCYTOPENIC PURPURA	6.7% 1/15 • Number of events 1 • Averse events were assessed from the initial treatment to 30 calendar days after the last study drug dose. Adverse events were monitored and assessed at each cycle of the study treatment. Vital status was assessed from the initial treatment up to 12 months after the end of the treatment.
Cardiac disorders ATRIAL FIBRILLATION	13.3% 2/15 • Number of events 3 • Averse events were assessed from the initial treatment to 30 calendar days after the last study drug dose. Adverse events were monitored and assessed at each cycle of the study treatment. Vital status was assessed from the initial treatment up to 12 months after the end of the treatment.
Cardiac disorders HEART FAILURE	6.7% 1/15 • Number of events 1 • Averse events were assessed from the initial treatment to 30 calendar days after the last study drug dose. Adverse events were monitored and assessed at each cycle of the study treatment. Vital status was assessed from the initial treatment up to 12 months after the end of the treatment.
Cardiac disorders PALPITATIONS	13.3% 2/15 • Number of events 2 • Averse events were assessed from the initial treatment to 30 calendar days after the last study drug dose. Adverse events were monitored and assessed at each cycle of the study treatment. Vital status was assessed from the initial treatment up to 12 months after the end of the treatment.
Cardiac disorders SINUS TACHYCARDIA	13.3% 2/15 • Number of events 2 • Averse events were assessed from the initial treatment to 30 calendar days after the last study drug dose. Adverse events were monitored and assessed at each cycle of the study treatment. Vital status was assessed from the initial treatment up to 12 months after the end of the treatment.
Eye disorders RIGHT EYE RED	6.7% 1/15 • Number of events 1 • Averse events were assessed from the initial treatment to 30 calendar days after the last study drug dose. Adverse events were monitored and assessed at each cycle of the study treatment. Vital status was assessed from the initial treatment up to 12 months after the end of the treatment.
Gastrointestinal disorders ABDOMINAL DISTENSION	6.7% 1/15 • Number of events 1 • Averse events were assessed from the initial treatment to 30 calendar days after the last study drug dose. Adverse events were monitored and assessed at each cycle of the study treatment. Vital status was assessed from the initial treatment up to 12 months after the end of the treatment.
Gastrointestinal disorders ABDOMINAL PAIN	20.0% 3/15 • Number of events 3 • Averse events were assessed from the initial treatment to 30 calendar days after the last study drug dose. Adverse events were monitored and assessed at each cycle of the study treatment. Vital status was assessed from the initial treatment up to 12 months after the end of the treatment.
Gastrointestinal disorders COLITIS	13.3% 2/15 • Number of events 2 • Averse events were assessed from the initial treatment to 30 calendar days after the last study drug dose. Adverse events were monitored and assessed at each cycle of the study treatment. Vital status was assessed from the initial treatment up to 12 months after the end of the treatment.
Gastrointestinal disorders CONSTIPATION	6.7% 1/15 • Number of events 1 • Averse events were assessed from the initial treatment to 30 calendar days after the last study drug dose. Adverse events were monitored and assessed at each cycle of the study treatment. Vital status was assessed from the initial treatment up to 12 months after the end of the treatment.
Gastrointestinal disorders DIARRHEA	33.3% 5/15 • Number of events 13 • Averse events were assessed from the initial treatment to 30 calendar days after the last study drug dose. Adverse events were monitored and assessed at each cycle of the study treatment. Vital status was assessed from the initial treatment up to 12 months after the end of the treatment.
Gastrointestinal disorders ESOPHAGEAL ULCER	6.7% 1/15 • Number of events 1 • Averse events were assessed from the initial treatment to 30 calendar days after the last study drug dose. Adverse events were monitored and assessed at each cycle of the study treatment. Vital status was assessed from the initial treatment up to 12 months after the end of the treatment.
Gastrointestinal disorders GASTROESOPHAGEAL REFLUX DISEASE	6.7% 1/15 • Number of events 1 • Averse events were assessed from the initial treatment to 30 calendar days after the last study drug dose. Adverse events were monitored and assessed at each cycle of the study treatment. Vital status was assessed from the initial treatment up to 12 months after the end of the treatment.
Gastrointestinal disorders MUCOSITIS ORAL	13.3% 2/15 • Number of events 8 • Averse events were assessed from the initial treatment to 30 calendar days after the last study drug dose. Adverse events were monitored and assessed at each cycle of the study treatment. Vital status was assessed from the initial treatment up to 12 months after the end of the treatment.
Gastrointestinal disorders NAUSEA	33.3% 5/15 • Number of events 6 • Averse events were assessed from the initial treatment to 30 calendar days after the last study drug dose. Adverse events were monitored and assessed at each cycle of the study treatment. Vital status was assessed from the initial treatment up to 12 months after the end of the treatment.
Gastrointestinal disorders PANNICULTIS	6.7% 1/15 • Number of events 1 • Averse events were assessed from the initial treatment to 30 calendar days after the last study drug dose. Adverse events were monitored and assessed at each cycle of the study treatment. Vital status was assessed from the initial treatment up to 12 months after the end of the treatment.
Gastrointestinal disorders VOMITING	33.3% 5/15 • Number of events 6 • Averse events were assessed from the initial treatment to 30 calendar days after the last study drug dose. Adverse events were monitored and assessed at each cycle of the study treatment. Vital status was assessed from the initial treatment up to 12 months after the end of the treatment.
General disorders BODY ACHES	6.7% 1/15 • Number of events 1 • Averse events were assessed from the initial treatment to 30 calendar days after the last study drug dose. Adverse events were monitored and assessed at each cycle of the study treatment. Vital status was assessed from the initial treatment up to 12 months after the end of the treatment.
General disorders CERVICAL LYMPH NODE SWELLING FROM BUG BITE ON NECK	6.7% 1/15 • Number of events 1 • Averse events were assessed from the initial treatment to 30 calendar days after the last study drug dose. Adverse events were monitored and assessed at each cycle of the study treatment. Vital status was assessed from the initial treatment up to 12 months after the end of the treatment.
General disorders CHILLS	26.7% 4/15 • Number of events 5 • Averse events were assessed from the initial treatment to 30 calendar days after the last study drug dose. Adverse events were monitored and assessed at each cycle of the study treatment. Vital status was assessed from the initial treatment up to 12 months after the end of the treatment.
General disorders FATIGUE	53.3% 8/15 • Number of events 9 • Averse events were assessed from the initial treatment to 30 calendar days after the last study drug dose. Adverse events were monitored and assessed at each cycle of the study treatment. Vital status was assessed from the initial treatment up to 12 months after the end of the treatment.
General disorders FEVER	6.7% 1/15 • Number of events 3 • Averse events were assessed from the initial treatment to 30 calendar days after the last study drug dose. Adverse events were monitored and assessed at each cycle of the study treatment. Vital status was assessed from the initial treatment up to 12 months after the end of the treatment.
General disorders FLU LIKE SYMPTOMS	6.7% 1/15 • Number of events 1 • Averse events were assessed from the initial treatment to 30 calendar days after the last study drug dose. Adverse events were monitored and assessed at each cycle of the study treatment. Vital status was assessed from the initial treatment up to 12 months after the end of the treatment.
General disorders GAIT DISTURBANCE	6.7% 1/15 • Number of events 1 • Averse events were assessed from the initial treatment to 30 calendar days after the last study drug dose. Adverse events were monitored and assessed at each cycle of the study treatment. Vital status was assessed from the initial treatment up to 12 months after the end of the treatment.
General disorders PAIN	6.7% 1/15 • Number of events 1 • Averse events were assessed from the initial treatment to 30 calendar days after the last study drug dose. Adverse events were monitored and assessed at each cycle of the study treatment. Vital status was assessed from the initial treatment up to 12 months after the end of the treatment.
Infections and infestations COVID-19	6.7% 1/15 • Number of events 2 • Averse events were assessed from the initial treatment to 30 calendar days after the last study drug dose. Adverse events were monitored and assessed at each cycle of the study treatment. Vital status was assessed from the initial treatment up to 12 months after the end of the treatment.
Infections and infestations UPPER RESPIRATORY INFECTION	6.7% 1/15 • Number of events 1 • Averse events were assessed from the initial treatment to 30 calendar days after the last study drug dose. Adverse events were monitored and assessed at each cycle of the study treatment. Vital status was assessed from the initial treatment up to 12 months after the end of the treatment.
Infections and infestations URINARY TRACT INFECTION	6.7% 1/15 • Number of events 1 • Averse events were assessed from the initial treatment to 30 calendar days after the last study drug dose. Adverse events were monitored and assessed at each cycle of the study treatment. Vital status was assessed from the initial treatment up to 12 months after the end of the treatment.
Injury, poisoning and procedural complications BRUISING	13.3% 2/15 • Number of events 2 • Averse events were assessed from the initial treatment to 30 calendar days after the last study drug dose. Adverse events were monitored and assessed at each cycle of the study treatment. Vital status was assessed from the initial treatment up to 12 months after the end of the treatment.
Injury, poisoning and procedural complications FALL	6.7% 1/15 • Number of events 1 • Averse events were assessed from the initial treatment to 30 calendar days after the last study drug dose. Adverse events were monitored and assessed at each cycle of the study treatment. Vital status was assessed from the initial treatment up to 12 months after the end of the treatment.
Investigations ALANINE AMINOTRANSFERASE INCREASED	26.7% 4/15 • Number of events 16 • Averse events were assessed from the initial treatment to 30 calendar days after the last study drug dose. Adverse events were monitored and assessed at each cycle of the study treatment. Vital status was assessed from the initial treatment up to 12 months after the end of the treatment.
Investigations ALKALINE PHOSPHATASE INCREASED	26.7% 4/15 • Number of events 4 • Averse events were assessed from the initial treatment to 30 calendar days after the last study drug dose. Adverse events were monitored and assessed at each cycle of the study treatment. Vital status was assessed from the initial treatment up to 12 months after the end of the treatment.
Investigations ASPARTATE AMINOTRANSFERASE INCREASED	20.0% 3/15 • Number of events 15 • Averse events were assessed from the initial treatment to 30 calendar days after the last study drug dose. Adverse events were monitored and assessed at each cycle of the study treatment. Vital status was assessed from the initial treatment up to 12 months after the end of the treatment.
Investigations BLOOD BILIRUBIN INCREASED	13.3% 2/15 • Number of events 3 • Averse events were assessed from the initial treatment to 30 calendar days after the last study drug dose. Adverse events were monitored and assessed at each cycle of the study treatment. Vital status was assessed from the initial treatment up to 12 months after the end of the treatment.
Investigations BLOOD LACTATE DEHYDROGENASE INCREASED	26.7% 4/15 • Number of events 6 • Averse events were assessed from the initial treatment to 30 calendar days after the last study drug dose. Adverse events were monitored and assessed at each cycle of the study treatment. Vital status was assessed from the initial treatment up to 12 months after the end of the treatment.
Investigations CREATININE INCREASED	13.3% 2/15 • Number of events 3 • Averse events were assessed from the initial treatment to 30 calendar days after the last study drug dose. Adverse events were monitored and assessed at each cycle of the study treatment. Vital status was assessed from the initial treatment up to 12 months after the end of the treatment.
Investigations LYMPHOCYTE COUNT INCREASED	26.7% 4/15 • Number of events 4 • Averse events were assessed from the initial treatment to 30 calendar days after the last study drug dose. Adverse events were monitored and assessed at each cycle of the study treatment. Vital status was assessed from the initial treatment up to 12 months after the end of the treatment.
Investigations NEUTROPHIL COUNT DECREASED	13.3% 2/15 • Number of events 3 • Averse events were assessed from the initial treatment to 30 calendar days after the last study drug dose. Adverse events were monitored and assessed at each cycle of the study treatment. Vital status was assessed from the initial treatment up to 12 months after the end of the treatment.
Investigations PLATELET COUNT DECREASED	33.3% 5/15 • Number of events 10 • Averse events were assessed from the initial treatment to 30 calendar days after the last study drug dose. Adverse events were monitored and assessed at each cycle of the study treatment. Vital status was assessed from the initial treatment up to 12 months after the end of the treatment.
Investigations WEIGHT LOSS	13.3% 2/15 • Number of events 2 • Averse events were assessed from the initial treatment to 30 calendar days after the last study drug dose. Adverse events were monitored and assessed at each cycle of the study treatment. Vital status was assessed from the initial treatment up to 12 months after the end of the treatment.
Investigations WHITE BLOOD CELL DECREASED	6.7% 1/15 • Number of events 1 • Averse events were assessed from the initial treatment to 30 calendar days after the last study drug dose. Adverse events were monitored and assessed at each cycle of the study treatment. Vital status was assessed from the initial treatment up to 12 months after the end of the treatment.
Metabolism and nutrition disorders ANOREXIA	6.7% 1/15 • Number of events 1 • Averse events were assessed from the initial treatment to 30 calendar days after the last study drug dose. Adverse events were monitored and assessed at each cycle of the study treatment. Vital status was assessed from the initial treatment up to 12 months after the end of the treatment.
Metabolism and nutrition disorders DEHYDRATION	6.7% 1/15 • Number of events 1 • Averse events were assessed from the initial treatment to 30 calendar days after the last study drug dose. Adverse events were monitored and assessed at each cycle of the study treatment. Vital status was assessed from the initial treatment up to 12 months after the end of the treatment.
Metabolism and nutrition disorders HYPERGLYCEMIA	13.3% 2/15 • Number of events 2 • Averse events were assessed from the initial treatment to 30 calendar days after the last study drug dose. Adverse events were monitored and assessed at each cycle of the study treatment. Vital status was assessed from the initial treatment up to 12 months after the end of the treatment.
Metabolism and nutrition disorders HYPERKALEMIA	13.3% 2/15 • Number of events 2 • Averse events were assessed from the initial treatment to 30 calendar days after the last study drug dose. Adverse events were monitored and assessed at each cycle of the study treatment. Vital status was assessed from the initial treatment up to 12 months after the end of the treatment.
Metabolism and nutrition disorders HYPERURICEMIA	6.7% 1/15 • Number of events 1 • Averse events were assessed from the initial treatment to 30 calendar days after the last study drug dose. Adverse events were monitored and assessed at each cycle of the study treatment. Vital status was assessed from the initial treatment up to 12 months after the end of the treatment.
Metabolism and nutrition disorders HYPOCALCEMIA	13.3% 2/15 • Number of events 3 • Averse events were assessed from the initial treatment to 30 calendar days after the last study drug dose. Adverse events were monitored and assessed at each cycle of the study treatment. Vital status was assessed from the initial treatment up to 12 months after the end of the treatment.
Metabolism and nutrition disorders HYPONATREMIA	13.3% 2/15 • Number of events 3 • Averse events were assessed from the initial treatment to 30 calendar days after the last study drug dose. Adverse events were monitored and assessed at each cycle of the study treatment. Vital status was assessed from the initial treatment up to 12 months after the end of the treatment.
Musculoskeletal and connective tissue disorders ARTHRALGIA	26.7% 4/15 • Number of events 4 • Averse events were assessed from the initial treatment to 30 calendar days after the last study drug dose. Adverse events were monitored and assessed at each cycle of the study treatment. Vital status was assessed from the initial treatment up to 12 months after the end of the treatment.
Musculoskeletal and connective tissue disorders BACK PAIN	6.7% 1/15 • Number of events 1 • Averse events were assessed from the initial treatment to 30 calendar days after the last study drug dose. Adverse events were monitored and assessed at each cycle of the study treatment. Vital status was assessed from the initial treatment up to 12 months after the end of the treatment.
Musculoskeletal and connective tissue disorders BONE PAIN	13.3% 2/15 • Number of events 2 • Averse events were assessed from the initial treatment to 30 calendar days after the last study drug dose. Adverse events were monitored and assessed at each cycle of the study treatment. Vital status was assessed from the initial treatment up to 12 months after the end of the treatment.
Musculoskeletal and connective tissue disorders COMPRESSION FRACTURE (T9)	6.7% 1/15 • Number of events 1 • Averse events were assessed from the initial treatment to 30 calendar days after the last study drug dose. Adverse events were monitored and assessed at each cycle of the study treatment. Vital status was assessed from the initial treatment up to 12 months after the end of the treatment.
Musculoskeletal and connective tissue disorders FLANK PAIN	6.7% 1/15 • Number of events 1 • Averse events were assessed from the initial treatment to 30 calendar days after the last study drug dose. Adverse events were monitored and assessed at each cycle of the study treatment. Vital status was assessed from the initial treatment up to 12 months after the end of the treatment.
Musculoskeletal and connective tissue disorders MUSCLE CRAMP	13.3% 2/15 • Number of events 2 • Averse events were assessed from the initial treatment to 30 calendar days after the last study drug dose. Adverse events were monitored and assessed at each cycle of the study treatment. Vital status was assessed from the initial treatment up to 12 months after the end of the treatment.
Musculoskeletal and connective tissue disorders NECK PAIN	6.7% 1/15 • Number of events 1 • Averse events were assessed from the initial treatment to 30 calendar days after the last study drug dose. Adverse events were monitored and assessed at each cycle of the study treatment. Vital status was assessed from the initial treatment up to 12 months after the end of the treatment.
Musculoskeletal and connective tissue disorders PAIN IN EXTREMITY	6.7% 1/15 • Number of events 1 • Averse events were assessed from the initial treatment to 30 calendar days after the last study drug dose. Adverse events were monitored and assessed at each cycle of the study treatment. Vital status was assessed from the initial treatment up to 12 months after the end of the treatment.
Nervous system disorders DIZZINESS	13.3% 2/15 • Number of events 2 • Averse events were assessed from the initial treatment to 30 calendar days after the last study drug dose. Adverse events were monitored and assessed at each cycle of the study treatment. Vital status was assessed from the initial treatment up to 12 months after the end of the treatment.
Nervous system disorders HEADACHE	33.3% 5/15 • Number of events 5 • Averse events were assessed from the initial treatment to 30 calendar days after the last study drug dose. Adverse events were monitored and assessed at each cycle of the study treatment. Vital status was assessed from the initial treatment up to 12 months after the end of the treatment.
Nervous system disorders NEUROPATHY "INTERMITTENT ELECTRICAL SHOCKS TO FEET/LOWER LEGS"	6.7% 1/15 • Number of events 1 • Averse events were assessed from the initial treatment to 30 calendar days after the last study drug dose. Adverse events were monitored and assessed at each cycle of the study treatment. Vital status was assessed from the initial treatment up to 12 months after the end of the treatment.
Nervous system disorders PARESTHESIA	6.7% 1/15 • Number of events 1 • Averse events were assessed from the initial treatment to 30 calendar days after the last study drug dose. Adverse events were monitored and assessed at each cycle of the study treatment. Vital status was assessed from the initial treatment up to 12 months after the end of the treatment.
Nervous system disorders PERIPHERAL SENSORY NEUROPATHY	6.7% 1/15 • Number of events 2 • Averse events were assessed from the initial treatment to 30 calendar days after the last study drug dose. Adverse events were monitored and assessed at each cycle of the study treatment. Vital status was assessed from the initial treatment up to 12 months after the end of the treatment.
Psychiatric disorders ANXIETY	6.7% 1/15 • Number of events 1 • Averse events were assessed from the initial treatment to 30 calendar days after the last study drug dose. Adverse events were monitored and assessed at each cycle of the study treatment. Vital status was assessed from the initial treatment up to 12 months after the end of the treatment.
Psychiatric disorders CONFUSION	6.7% 1/15 • Number of events 1 • Averse events were assessed from the initial treatment to 30 calendar days after the last study drug dose. Adverse events were monitored and assessed at each cycle of the study treatment. Vital status was assessed from the initial treatment up to 12 months after the end of the treatment.
Psychiatric disorders INSOMNIA	6.7% 1/15 • Number of events 1 • Averse events were assessed from the initial treatment to 30 calendar days after the last study drug dose. Adverse events were monitored and assessed at each cycle of the study treatment. Vital status was assessed from the initial treatment up to 12 months after the end of the treatment.
Renal and urinary disorders ACUTE KIDNEY INJURY	6.7% 1/15 • Number of events 1 • Averse events were assessed from the initial treatment to 30 calendar days after the last study drug dose. Adverse events were monitored and assessed at each cycle of the study treatment. Vital status was assessed from the initial treatment up to 12 months after the end of the treatment.
Respiratory, thoracic and mediastinal disorders COUGH	20.0% 3/15 • Number of events 3 • Averse events were assessed from the initial treatment to 30 calendar days after the last study drug dose. Adverse events were monitored and assessed at each cycle of the study treatment. Vital status was assessed from the initial treatment up to 12 months after the end of the treatment.
Respiratory, thoracic and mediastinal disorders DYSPNEA	13.3% 2/15 • Number of events 2 • Averse events were assessed from the initial treatment to 30 calendar days after the last study drug dose. Adverse events were monitored and assessed at each cycle of the study treatment. Vital status was assessed from the initial treatment up to 12 months after the end of the treatment.
Respiratory, thoracic and mediastinal disorders EPISTAXIS	6.7% 1/15 • Number of events 1 • Averse events were assessed from the initial treatment to 30 calendar days after the last study drug dose. Adverse events were monitored and assessed at each cycle of the study treatment. Vital status was assessed from the initial treatment up to 12 months after the end of the treatment.
Skin and subcutaneous tissue disorders PRURITIC RASH ON ARMS	6.7% 1/15 • Number of events 1 • Averse events were assessed from the initial treatment to 30 calendar days after the last study drug dose. Adverse events were monitored and assessed at each cycle of the study treatment. Vital status was assessed from the initial treatment up to 12 months after the end of the treatment.
Skin and subcutaneous tissue disorders SPOT ON HEAD	6.7% 1/15 • Number of events 1 • Averse events were assessed from the initial treatment to 30 calendar days after the last study drug dose. Adverse events were monitored and assessed at each cycle of the study treatment. Vital status was assessed from the initial treatment up to 12 months after the end of the treatment.
Skin and subcutaneous tissue disorders HYPERHIDROSIS	6.7% 1/15 • Number of events 1 • Averse events were assessed from the initial treatment to 30 calendar days after the last study drug dose. Adverse events were monitored and assessed at each cycle of the study treatment. Vital status was assessed from the initial treatment up to 12 months after the end of the treatment.
Skin and subcutaneous tissue disorders PRURITUS	6.7% 1/15 • Number of events 1 • Averse events were assessed from the initial treatment to 30 calendar days after the last study drug dose. Adverse events were monitored and assessed at each cycle of the study treatment. Vital status was assessed from the initial treatment up to 12 months after the end of the treatment.
Skin and subcutaneous tissue disorders RASH MACULO-PAPULAR	6.7% 1/15 • Number of events 1 • Averse events were assessed from the initial treatment to 30 calendar days after the last study drug dose. Adverse events were monitored and assessed at each cycle of the study treatment. Vital status was assessed from the initial treatment up to 12 months after the end of the treatment.
Vascular disorders FLUSHING	6.7% 1/15 • Number of events 1 • Averse events were assessed from the initial treatment to 30 calendar days after the last study drug dose. Adverse events were monitored and assessed at each cycle of the study treatment. Vital status was assessed from the initial treatment up to 12 months after the end of the treatment.
Vascular disorders HYPERTENSION	26.7% 4/15 • Number of events 8 • Averse events were assessed from the initial treatment to 30 calendar days after the last study drug dose. Adverse events were monitored and assessed at each cycle of the study treatment. Vital status was assessed from the initial treatment up to 12 months after the end of the treatment.
Vascular disorders HYPOTENSION	6.7% 1/15 • Number of events 1 • Averse events were assessed from the initial treatment to 30 calendar days after the last study drug dose. Adverse events were monitored and assessed at each cycle of the study treatment. Vital status was assessed from the initial treatment up to 12 months after the end of the treatment.

Additional Information

Dr. Alexey Danilov, MD

City of Hope Medical Center

Phone: 626-359-8111

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place