Trial Outcomes & Findings for Ofatumumab and Dinaciclib in Treating Patients With Relapsed or Refractory Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma, or B-Cell Prolymphocytic Leukemia (NCT NCT01515176)

Last Updated: 2018-03-15

Results Overview

Graded according to the National Cancer Institute (NCI) CTCAE version (v)4.0. Assessed using the continuous variables as the outcome measures (primarily nadir and percent change from baseline values) as well as categorization.

Recruitment status

COMPLETED

Study phase

PHASE1/PHASE2

Target enrollment

36 participants

Primary outcome timeframe

Day 56

Results posted on

2018-03-15

Participant Flow

Participant milestones

Participant milestones
Measure	Dose Level I: Treatment (Ofatumumab, Dinaciclib) Patients receive ofatumumab IV over 4-6 hours on days 1, 8, 15, and 22 of courses 1-2, and on day 1 of courses 4-7. Beginning on course 2, patients also receive dinaciclib 7 mg/m2 as a 2-hour infusion on cycle 2 day 2, escalated to 10 mg/m2 beginning with cycle 2 day 8 and continuing thereafter.	Dose Level II: Treatment (Ofatumumab, Dinaciclib) Patients receive ofatumumab IV over 4-6 hours on days 1, 8, 15, and 22 of courses 1-2, and on day 1 of courses 4-7. Beginning on course 2, patients also receive dinaciclib 7 mg/m2 as a 2-hour infusion on cycle 2 day 2, escalated to 10 mg/m2 as a 2-hour infusion on cycle 2 day 8, and to 14 mg/m2 on cycle 2 day 15 and continuing thereafter
Overall Study STARTED	4	32
Overall Study COMPLETED	4	32
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Ofatumumab and Dinaciclib in Treating Patients With Relapsed or Refractory Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma, or B-Cell Prolymphocytic Leukemia

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Dose Level I: Treatment (Ofatumumab, Dinaciclib) n=4 Participants Patients receive ofatumumab IV over 4-6 hours on days 1, 8, 15, and 22 of courses 1-2, and on day 1 of courses 4-7. Beginning on course 2, patients also receive dinaciclib 7 mg/m2 as a 2-hour infusion on cycle 2 day 2, escalated to 10 mg/m2 beginning with cycle 2 day 8 and continuing thereafter.	Dose Level II: n=32 Participants Patients receive ofatumumab IV over 4-6 hours on days 1, 8, 15, and 22 of courses 1-2, and on day 1 of courses 4-7. Beginning on course 2, patients also receive dinaciclib 7 mg/m2 as a 2-hour infusion on cycle 2 day 2, escalated to 10 mg/m2 as a 2-hour infusion on cycle 2 day 8, and to 14 mg/m2 on cycle 2 day 15 and continuing thereafter	Total n=36 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	2 Participants n=5 Participants	15 Participants n=7 Participants	17 Participants n=5 Participants
Age, Categorical >=65 years	2 Participants n=5 Participants	17 Participants n=7 Participants	19 Participants n=5 Participants
Sex: Female, Male Female	2 Participants n=5 Participants	11 Participants n=7 Participants	13 Participants n=5 Participants
Sex: Female, Male Male	2 Participants n=5 Participants	21 Participants n=7 Participants	23 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	4 Participants n=5 Participants	32 Participants n=7 Participants	36 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	5 Participants n=7 Participants	5 Participants n=5 Participants
Race (NIH/OMB) White	4 Participants n=5 Participants	27 Participants n=7 Participants	31 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	4 participants n=5 Participants	32 participants n=7 Participants	36 participants n=5 Participants

PRIMARY outcome

Timeframe: Day 56

Outcome measures

Outcome measures
Measure	Treatment (Ofatumumab, Dinaciclib) n=36 Participants Patients receive ofatumumab IV over 4-6 hours on days 1, 8, 15, and 22 of courses 1-2, and on day 1 of courses 4-7. Beginning on course 2, patients also receive dinaciclib IV over 2 hours on days 2, 8, and 15 of course 2, and on days 1, 8, and 15 of courses 3-7. Treatment repeats every 28 days for up to 7 courses in the absence of disease progression or unacceptable toxicity. Dinaciclib: Given IV Laboratory Biomarker Analysis: Correlative studies Ofatumumab: Given IV Pharmacological Study: Correlative studies	Dose Level II: Treatment (Ofatumumab, Dinaciclib) Patients receive ofatumumab IV over 4-6 hours on days 1, 8, 15, and 22 of courses 1-2, and on day 1 of courses 4-7. Beginning on course 2, patients also receive dinaciclib 7 mg/m2 as a 2-hour infusion on cycle 2 day 2, escalated to 10 mg/m2 as a 2-hour infusion on cycle 2 day 8, and to 14 mg/m2 on cycle 2 day 15 and continuing thereafter
Maximum-tolerated Dose of Dinaciclib When Given in Combination With Ofatumumab, Defined as a Dose Level Where at Most One of 6 Evaluable Patients Has a Dose Limiting Toxicity (Phase Ia) 2 hr infusion cycle 2 day 2	7 mg/m2	—
Maximum-tolerated Dose of Dinaciclib When Given in Combination With Ofatumumab, Defined as a Dose Level Where at Most One of 6 Evaluable Patients Has a Dose Limiting Toxicity (Phase Ia) 2 hr infusion cycle 2 day 8	10 mg/m2	—
Maximum-tolerated Dose of Dinaciclib When Given in Combination With Ofatumumab, Defined as a Dose Level Where at Most One of 6 Evaluable Patients Has a Dose Limiting Toxicity (Phase Ia) cycle 2 day 8	14 mg/m2	—

PRIMARY outcome

Timeframe: Up to day 56

Hematologic dose-limiting toxicity measures will be assessed using the continuous variables as the outcome measures (primarily nadir and percent change from baseline values) as well as categorization via CTCAE version 4 standard toxicity grading. Non-hematologic dose-limiting toxicities such as dyspnea and renal will be evaluated via the ordinal CTCAE standard toxicity grading only.

Outcome measures

Outcome measures
Measure	Treatment (Ofatumumab, Dinaciclib) n=4 Participants Patients receive ofatumumab IV over 4-6 hours on days 1, 8, 15, and 22 of courses 1-2, and on day 1 of courses 4-7. Beginning on course 2, patients also receive dinaciclib IV over 2 hours on days 2, 8, and 15 of course 2, and on days 1, 8, and 15 of courses 3-7. Treatment repeats every 28 days for up to 7 courses in the absence of disease progression or unacceptable toxicity. Dinaciclib: Given IV Laboratory Biomarker Analysis: Correlative studies Ofatumumab: Given IV Pharmacological Study: Correlative studies	Dose Level II: Treatment (Ofatumumab, Dinaciclib) n=32 Participants Patients receive ofatumumab IV over 4-6 hours on days 1, 8, 15, and 22 of courses 1-2, and on day 1 of courses 4-7. Beginning on course 2, patients also receive dinaciclib 7 mg/m2 as a 2-hour infusion on cycle 2 day 2, escalated to 10 mg/m2 as a 2-hour infusion on cycle 2 day 8, and to 14 mg/m2 on cycle 2 day 15 and continuing thereafter
Number of Patients With Dose-limiting Toxicity Incidents Graded According to the NCI CTCAE v4.0 (Phase I)	0 Participants	0 Participants

PRIMARY outcome

Timeframe: Up to 28 weeks

Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.

Outcome measures

Outcome measures
Measure	Treatment (Ofatumumab, Dinaciclib) n=36 Participants Patients receive ofatumumab IV over 4-6 hours on days 1, 8, 15, and 22 of courses 1-2, and on day 1 of courses 4-7. Beginning on course 2, patients also receive dinaciclib IV over 2 hours on days 2, 8, and 15 of course 2, and on days 1, 8, and 15 of courses 3-7. Treatment repeats every 28 days for up to 7 courses in the absence of disease progression or unacceptable toxicity. Dinaciclib: Given IV Laboratory Biomarker Analysis: Correlative studies Ofatumumab: Given IV Pharmacological Study: Correlative studies	Dose Level II: Treatment (Ofatumumab, Dinaciclib) Patients receive ofatumumab IV over 4-6 hours on days 1, 8, 15, and 22 of courses 1-2, and on day 1 of courses 4-7. Beginning on course 2, patients also receive dinaciclib 7 mg/m2 as a 2-hour infusion on cycle 2 day 2, escalated to 10 mg/m2 as a 2-hour infusion on cycle 2 day 8, and to 14 mg/m2 on cycle 2 day 15 and continuing thereafter
Percentage of Patients Who Achieve an Overall Response, Defined as Achieving a Complete Response, an Unconfirmed Complete Response (SLL Only), or a Partial Response (Phase II)	39 percentage of patients Interval 23.0 to 57.0	—

SECONDARY outcome

Timeframe: Up to 28 weeks

Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions

Outcome measures

Outcome measures
Measure	Treatment (Ofatumumab, Dinaciclib) n=36 Participants Patients receive ofatumumab IV over 4-6 hours on days 1, 8, 15, and 22 of courses 1-2, and on day 1 of courses 4-7. Beginning on course 2, patients also receive dinaciclib IV over 2 hours on days 2, 8, and 15 of course 2, and on days 1, 8, and 15 of courses 3-7. Treatment repeats every 28 days for up to 7 courses in the absence of disease progression or unacceptable toxicity. Dinaciclib: Given IV Laboratory Biomarker Analysis: Correlative studies Ofatumumab: Given IV Pharmacological Study: Correlative studies	Dose Level II: Treatment (Ofatumumab, Dinaciclib) Patients receive ofatumumab IV over 4-6 hours on days 1, 8, 15, and 22 of courses 1-2, and on day 1 of courses 4-7. Beginning on course 2, patients also receive dinaciclib 7 mg/m2 as a 2-hour infusion on cycle 2 day 2, escalated to 10 mg/m2 as a 2-hour infusion on cycle 2 day 8, and to 14 mg/m2 on cycle 2 day 15 and continuing thereafter
Complete Response Rate	0 patients with complete response Interval 0.0 to 0.0	—

SECONDARY outcome

Timeframe: Time from study entry to death due to any cause, assessed up to 5 years

Distributions will be explored and assessed using the methods of Kaplan and Meier.

Outcome measures

Outcome measures
Measure	Treatment (Ofatumumab, Dinaciclib) n=36 Participants Patients receive ofatumumab IV over 4-6 hours on days 1, 8, 15, and 22 of courses 1-2, and on day 1 of courses 4-7. Beginning on course 2, patients also receive dinaciclib IV over 2 hours on days 2, 8, and 15 of course 2, and on days 1, 8, and 15 of courses 3-7. Treatment repeats every 28 days for up to 7 courses in the absence of disease progression or unacceptable toxicity. Dinaciclib: Given IV Laboratory Biomarker Analysis: Correlative studies Ofatumumab: Given IV Pharmacological Study: Correlative studies	Dose Level II: Treatment (Ofatumumab, Dinaciclib) Patients receive ofatumumab IV over 4-6 hours on days 1, 8, 15, and 22 of courses 1-2, and on day 1 of courses 4-7. Beginning on course 2, patients also receive dinaciclib 7 mg/m2 as a 2-hour infusion on cycle 2 day 2, escalated to 10 mg/m2 as a 2-hour infusion on cycle 2 day 8, and to 14 mg/m2 on cycle 2 day 15 and continuing thereafter
Overall Survival	990 days Interval 678.0 to Time point to reach the lower bound of 95% CI for median survival rate not reached yet	—

SECONDARY outcome

Timeframe: Time from study entry to documentation of disease progression and/or death, assessed up to 5 years

95% confidence intervals will be constructed using the methods of Duffy and Santner with the assumption that these rates are binomially distributed. Distributions will be explored and assessed using the methods of Kaplan and Meier.

Outcome measures

Outcome measures
Measure	Treatment (Ofatumumab, Dinaciclib) n=36 Participants Patients receive ofatumumab IV over 4-6 hours on days 1, 8, 15, and 22 of courses 1-2, and on day 1 of courses 4-7. Beginning on course 2, patients also receive dinaciclib IV over 2 hours on days 2, 8, and 15 of course 2, and on days 1, 8, and 15 of courses 3-7. Treatment repeats every 28 days for up to 7 courses in the absence of disease progression or unacceptable toxicity. Dinaciclib: Given IV Laboratory Biomarker Analysis: Correlative studies Ofatumumab: Given IV Pharmacological Study: Correlative studies	Dose Level II: Treatment (Ofatumumab, Dinaciclib) Patients receive ofatumumab IV over 4-6 hours on days 1, 8, 15, and 22 of courses 1-2, and on day 1 of courses 4-7. Beginning on course 2, patients also receive dinaciclib 7 mg/m2 as a 2-hour infusion on cycle 2 day 2, escalated to 10 mg/m2 as a 2-hour infusion on cycle 2 day 8, and to 14 mg/m2 on cycle 2 day 15 and continuing thereafter
Progression Free Survival	322 days Interval 223.0 to 402.0	—

SECONDARY outcome

Timeframe: Time from study entry to the date patients end treatment, up to 28 weeks

Distributions will be explored and assessed using the methods of Kaplan and Meier.

Outcome measures

Outcome measures
Measure	Treatment (Ofatumumab, Dinaciclib) n=36 Participants Patients receive ofatumumab IV over 4-6 hours on days 1, 8, 15, and 22 of courses 1-2, and on day 1 of courses 4-7. Beginning on course 2, patients also receive dinaciclib IV over 2 hours on days 2, 8, and 15 of course 2, and on days 1, 8, and 15 of courses 3-7. Treatment repeats every 28 days for up to 7 courses in the absence of disease progression or unacceptable toxicity. Dinaciclib: Given IV Laboratory Biomarker Analysis: Correlative studies Ofatumumab: Given IV Pharmacological Study: Correlative studies	Dose Level II: Treatment (Ofatumumab, Dinaciclib) Patients receive ofatumumab IV over 4-6 hours on days 1, 8, 15, and 22 of courses 1-2, and on day 1 of courses 4-7. Beginning on course 2, patients also receive dinaciclib 7 mg/m2 as a 2-hour infusion on cycle 2 day 2, escalated to 10 mg/m2 as a 2-hour infusion on cycle 2 day 8, and to 14 mg/m2 on cycle 2 day 15 and continuing thereafter
Time to Treatment Failure	248 days Interval 113.0 to 347.0	—

Adverse Events

Dose Level I: Treatment (Ofatumumab, Dinaciclib)

Serious events: 3 serious events

Other events: 4 other events

Deaths: 0 deaths

Dose Level II: Treatment (Ofatumumab, Dinaciclib)

Serious events: 32 serious events

Other events: 32 other events

Deaths: 1 deaths

Serious adverse events

Other adverse events

Additional Information

Jeffrey Jones, MD

The Ohio State University Comprehensive Cancer Center

Phone: 614-293-3507

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60

Measure	Dose Level I: Treatment (Ofatumumab, Dinaciclib) n=4 participants at risk Patients receive ofatumumab IV over 4-6 hours on days 1, 8, 15, and 22 of courses 1-2, and on day 1 of courses 4-7. Beginning on course 2, patients also receive dinaciclib 7 mg/m2 as a 2-hour infusion on cycle 2 day 2, escalated to 10 mg/m2 beginning with cycle 2 day 8 and continuing thereafter.	Dose Level II: Treatment (Ofatumumab, Dinaciclib) n=32 participants at risk Patients receive ofatumumab IV over 4-6 hours on days 1, 8, 15, and 22 of courses 1-2, and on day 1 of courses 4-7. Beginning on course 2, patients also receive dinaciclib 7 mg/m2 as a 2-hour infusion on cycle 2 day 2, escalated to 10 mg/m2 as a 2-hour infusion on cycle 2 day 8, and to 14 mg/m2 on cycle 2 day 15 and continuing thereafter
Blood and lymphatic system disorders FEBRILE NEUTROPENIA	0.00% 0/4 All toxicities will be assessed using the CTEP Active Version of the NCI Common Terminology Criteria for Adverse Events (CTCAE).	3.1% 1/32 • Number of events 2 All toxicities will be assessed using the CTEP Active Version of the NCI Common Terminology Criteria for Adverse Events (CTCAE).
Blood and lymphatic system disorders LEUKOCYTOSIS	25.0% 1/4 • Number of events 1 All toxicities will be assessed using the CTEP Active Version of the NCI Common Terminology Criteria for Adverse Events (CTCAE).	0.00% 0/32 All toxicities will be assessed using the CTEP Active Version of the NCI Common Terminology Criteria for Adverse Events (CTCAE).
Cardiac disorders HEART FAILURE	0.00% 0/4 All toxicities will be assessed using the CTEP Active Version of the NCI Common Terminology Criteria for Adverse Events (CTCAE).	3.1% 1/32 • Number of events 1 All toxicities will be assessed using the CTEP Active Version of the NCI Common Terminology Criteria for Adverse Events (CTCAE).
Cardiac disorders SUPRAVENTRICULAR TACHYCARDIA	0.00% 0/4 All toxicities will be assessed using the CTEP Active Version of the NCI Common Terminology Criteria for Adverse Events (CTCAE).	3.1% 1/32 • Number of events 1 All toxicities will be assessed using the CTEP Active Version of the NCI Common Terminology Criteria for Adverse Events (CTCAE).
Gastrointestinal disorders ABDOMINAL PAIN	0.00% 0/4 All toxicities will be assessed using the CTEP Active Version of the NCI Common Terminology Criteria for Adverse Events (CTCAE).	3.1% 1/32 • Number of events 1 All toxicities will be assessed using the CTEP Active Version of the NCI Common Terminology Criteria for Adverse Events (CTCAE).
Gastrointestinal disorders ASCITES	0.00% 0/4 All toxicities will be assessed using the CTEP Active Version of the NCI Common Terminology Criteria for Adverse Events (CTCAE).	3.1% 1/32 • Number of events 1 All toxicities will be assessed using the CTEP Active Version of the NCI Common Terminology Criteria for Adverse Events (CTCAE).
General disorders DEATH NOS	0.00% 0/4 All toxicities will be assessed using the CTEP Active Version of the NCI Common Terminology Criteria for Adverse Events (CTCAE).	3.1% 1/32 • Number of events 1 All toxicities will be assessed using the CTEP Active Version of the NCI Common Terminology Criteria for Adverse Events (CTCAE).
General disorders FATIGUE	0.00% 0/4 All toxicities will be assessed using the CTEP Active Version of the NCI Common Terminology Criteria for Adverse Events (CTCAE).	6.2% 2/32 • Number of events 3 All toxicities will be assessed using the CTEP Active Version of the NCI Common Terminology Criteria for Adverse Events (CTCAE).
Infections and infestations CATHETER RELATED INFECTION	0.00% 0/4 All toxicities will be assessed using the CTEP Active Version of the NCI Common Terminology Criteria for Adverse Events (CTCAE).	3.1% 1/32 • Number of events 1 All toxicities will be assessed using the CTEP Active Version of the NCI Common Terminology Criteria for Adverse Events (CTCAE).
Infections and infestations HEPATITIS VIRAL	0.00% 0/4 All toxicities will be assessed using the CTEP Active Version of the NCI Common Terminology Criteria for Adverse Events (CTCAE).	3.1% 1/32 • Number of events 1 All toxicities will be assessed using the CTEP Active Version of the NCI Common Terminology Criteria for Adverse Events (CTCAE).
Infections and infestations LUNG INFECTION	0.00% 0/4 All toxicities will be assessed using the CTEP Active Version of the NCI Common Terminology Criteria for Adverse Events (CTCAE).	12.5% 4/32 • Number of events 5 All toxicities will be assessed using the CTEP Active Version of the NCI Common Terminology Criteria for Adverse Events (CTCAE).
Infections and infestations PLEURAL INFECTION	25.0% 1/4 • Number of events 1 All toxicities will be assessed using the CTEP Active Version of the NCI Common Terminology Criteria for Adverse Events (CTCAE).	0.00% 0/32 All toxicities will be assessed using the CTEP Active Version of the NCI Common Terminology Criteria for Adverse Events (CTCAE).
Infections and infestations SEPSIS	0.00% 0/4 All toxicities will be assessed using the CTEP Active Version of the NCI Common Terminology Criteria for Adverse Events (CTCAE).	9.4% 3/32 • Number of events 3 All toxicities will be assessed using the CTEP Active Version of the NCI Common Terminology Criteria for Adverse Events (CTCAE).
Investigations ALKALINE PHOSPHATASE INCREASED	0.00% 0/4 All toxicities will be assessed using the CTEP Active Version of the NCI Common Terminology Criteria for Adverse Events (CTCAE).	3.1% 1/32 • Number of events 2 All toxicities will be assessed using the CTEP Active Version of the NCI Common Terminology Criteria for Adverse Events (CTCAE).
Investigations EJECTION FRACTION DECREASED	0.00% 0/4 All toxicities will be assessed using the CTEP Active Version of the NCI Common Terminology Criteria for Adverse Events (CTCAE).	3.1% 1/32 • Number of events 1 All toxicities will be assessed using the CTEP Active Version of the NCI Common Terminology Criteria for Adverse Events (CTCAE).
Investigations LYMPHOCYTE COUNT DECREASED	25.0% 1/4 • Number of events 1 All toxicities will be assessed using the CTEP Active Version of the NCI Common Terminology Criteria for Adverse Events (CTCAE).	0.00% 0/32 All toxicities will be assessed using the CTEP Active Version of the NCI Common Terminology Criteria for Adverse Events (CTCAE).
Metabolism and nutrition disorders HYPERCALCEMIA	0.00% 0/4 All toxicities will be assessed using the CTEP Active Version of the NCI Common Terminology Criteria for Adverse Events (CTCAE).	3.1% 1/32 • Number of events 1 All toxicities will be assessed using the CTEP Active Version of the NCI Common Terminology Criteria for Adverse Events (CTCAE).
Metabolism and nutrition disorders HYPERKALEMIA	0.00% 0/4 All toxicities will be assessed using the CTEP Active Version of the NCI Common Terminology Criteria for Adverse Events (CTCAE).	3.1% 1/32 • Number of events 1 All toxicities will be assessed using the CTEP Active Version of the NCI Common Terminology Criteria for Adverse Events (CTCAE).
Metabolism and nutrition disorders HYPOKALEMIA	0.00% 0/4 All toxicities will be assessed using the CTEP Active Version of the NCI Common Terminology Criteria for Adverse Events (CTCAE).	3.1% 1/32 • Number of events 1 All toxicities will be assessed using the CTEP Active Version of the NCI Common Terminology Criteria for Adverse Events (CTCAE).
Metabolism and nutrition disorders HYPOMAGNESEMIA	0.00% 0/4 All toxicities will be assessed using the CTEP Active Version of the NCI Common Terminology Criteria for Adverse Events (CTCAE).	3.1% 1/32 • Number of events 1 All toxicities will be assessed using the CTEP Active Version of the NCI Common Terminology Criteria for Adverse Events (CTCAE).
Metabolism and nutrition disorders HYPOPHOSPHATEMIA	0.00% 0/4 All toxicities will be assessed using the CTEP Active Version of the NCI Common Terminology Criteria for Adverse Events (CTCAE).	37.5% 12/32 • Number of events 14 All toxicities will be assessed using the CTEP Active Version of the NCI Common Terminology Criteria for Adverse Events (CTCAE).
Metabolism and nutrition disorders TUMOR LYSIS SYNDROME	0.00% 0/4 All toxicities will be assessed using the CTEP Active Version of the NCI Common Terminology Criteria for Adverse Events (CTCAE).	3.1% 1/32 • Number of events 1 All toxicities will be assessed using the CTEP Active Version of the NCI Common Terminology Criteria for Adverse Events (CTCAE).
Musculoskeletal and connective tissue disorders ARTHRITIS	0.00% 0/4 All toxicities will be assessed using the CTEP Active Version of the NCI Common Terminology Criteria for Adverse Events (CTCAE).	3.1% 1/32 • Number of events 1 All toxicities will be assessed using the CTEP Active Version of the NCI Common Terminology Criteria for Adverse Events (CTCAE).
Respiratory, thoracic and mediastinal disorders ATELECTASIS	0.00% 0/4 All toxicities will be assessed using the CTEP Active Version of the NCI Common Terminology Criteria for Adverse Events (CTCAE).	3.1% 1/32 • Number of events 1 All toxicities will be assessed using the CTEP Active Version of the NCI Common Terminology Criteria for Adverse Events (CTCAE).
Respiratory, thoracic and mediastinal disorders DYSPNEA	0.00% 0/4 All toxicities will be assessed using the CTEP Active Version of the NCI Common Terminology Criteria for Adverse Events (CTCAE).	3.1% 1/32 • Number of events 1 All toxicities will be assessed using the CTEP Active Version of the NCI Common Terminology Criteria for Adverse Events (CTCAE).
Respiratory, thoracic and mediastinal disorders HYPOXIA	0.00% 0/4 All toxicities will be assessed using the CTEP Active Version of the NCI Common Terminology Criteria for Adverse Events (CTCAE).	3.1% 1/32 • Number of events 1 All toxicities will be assessed using the CTEP Active Version of the NCI Common Terminology Criteria for Adverse Events (CTCAE).
Respiratory, thoracic and mediastinal disorders PLEURAL EFFUSION	0.00% 0/4 All toxicities will be assessed using the CTEP Active Version of the NCI Common Terminology Criteria for Adverse Events (CTCAE).	3.1% 1/32 • Number of events 1 All toxicities will be assessed using the CTEP Active Version of the NCI Common Terminology Criteria for Adverse Events (CTCAE).
Vascular disorders HEMATOMA	0.00% 0/4 All toxicities will be assessed using the CTEP Active Version of the NCI Common Terminology Criteria for Adverse Events (CTCAE).	3.1% 1/32 • Number of events 1 All toxicities will be assessed using the CTEP Active Version of the NCI Common Terminology Criteria for Adverse Events (CTCAE).
Vascular disorders THROMBOEMBOLIC EVENT	0.00% 0/4 All toxicities will be assessed using the CTEP Active Version of the NCI Common Terminology Criteria for Adverse Events (CTCAE).	3.1% 1/32 • Number of events 1 All toxicities will be assessed using the CTEP Active Version of the NCI Common Terminology Criteria for Adverse Events (CTCAE).