Trial Outcomes & Findings for Trial Treating Relapsed Acute Lymphoblastic Leukemia With Venetoclax and Navitoclax (NCT NCT05192889)

NCT ID: NCT05192889

Last Updated: 2025-09-22

Results Overview

The number of participants with end Block 1 minimal residual disease \<0.01% by flow cytometry

Recruitment status

ACTIVE_NOT_RECRUITING

Study phase

PHASE1/PHASE2

Target enrollment

35 participants

Primary outcome timeframe

4 weeks from start of therapy

Results posted on

2025-09-22

Participant Flow

Thirty-five participants enrolled between August 25,2022 and May 3,2024. All participants initially received Block 1 therapy. Twenty-three participants completed Block 1 and met the criteria for Block 2 therapy: 7 participants enrolled on Block 2a and 16 participants enrolled on Block 2b. Ten participants only received Block 1 therapy because they did not meet the criteria for Block 2 or the treating physician recommended other therapy; two participants did not complete Block 1 because of death.

Participants treated on block 2a were all treated at dose level 1. Participants treated on block 2b were all treated at dose level 1. No participants were treated on the other dose levels.

Participant milestones

Participant milestones
Measure	Block 1: All Eligible Patients Receive Common Intervention All eligible patients receive intervention according to the Detailed Description section with the following: Venetoclax, Navitoclax, Dexamethasone, Vincristine, Calaspargase Pegol, Pegaspargase, Erwinia asparaginase, Dasatinib, Leucovorin, Intrathecal (IT) MHA (methotrexate/hydrocortisone/cytarabine) Venetoclax: Given oral (PO). Navitoclax: Given oral (PO). Dexamethasone: Given orally (PO) or intravenously (IV). Vincristine: Given intravenously (IV). Calaspargase Pegol: Given intravenously (IV). Dasatinib: Given oral (PO). Leucovorin: Given oral (PO) or intravenously (IV). Intrathecal Triples: Given Intrathecal (IT). Pegaspargase: May be used in place of Calaspargase Pegol where available. Given intravenously (IV) or intramuscularly (IM). Erwinia asparaginase: To be used in case of hypersensitivity or intolerance to Calaspargase Pegol or Pegaspargase. Given intravenously (IV) or intramuscularly (IM).	Block 2a - Dose Level 1: Cytarabine 3000mg/m^2/Dose Every 12 Hours Therapy for patients with ≥ 5% of leukemic blasts which do not have detectable CD19 on their surface, those with isolated extramedullary relapse, or whose physician determines this therapy arm is in their patient's best interest. All such patients completed Block 1 just prior to treatment with block 2a. These patients are mutually exclusive of patients treated on block 2b.	Block 2b - Dose Level 1: Venetoclax 240mg/m^2 for 21 Doses Therapy for patients with\>95% of leukemic blasts with detectable CD19 on their surface. All such patients completed block 1 just prior to treatment with block 2b. These patients are mutually exclusive of patients treated on block 2a.
Block 1: All Eligible Patients STARTED	35	0	0
Block 1: All Eligible Patients COMPLETED	33	0	0
Block 1: All Eligible Patients NOT COMPLETED	2	0	0
Block 2a - Dose Level 1 STARTED	0	7	0
Block 2a - Dose Level 1 COMPLETED	0	7	0
Block 2a - Dose Level 1 NOT COMPLETED	0	0	0
Block 2b - Dose Level 1 STARTED	0	0	16
Block 2b - Dose Level 1 COMPLETED	0	0	13
Block 2b - Dose Level 1 NOT COMPLETED	0	0	3

Reasons for withdrawal

Reasons for withdrawal
Measure	Block 1: All Eligible Patients Receive Common Intervention All eligible patients receive intervention according to the Detailed Description section with the following: Venetoclax, Navitoclax, Dexamethasone, Vincristine, Calaspargase Pegol, Pegaspargase, Erwinia asparaginase, Dasatinib, Leucovorin, Intrathecal (IT) MHA (methotrexate/hydrocortisone/cytarabine) Venetoclax: Given oral (PO). Navitoclax: Given oral (PO). Dexamethasone: Given orally (PO) or intravenously (IV). Vincristine: Given intravenously (IV). Calaspargase Pegol: Given intravenously (IV). Dasatinib: Given oral (PO). Leucovorin: Given oral (PO) or intravenously (IV). Intrathecal Triples: Given Intrathecal (IT). Pegaspargase: May be used in place of Calaspargase Pegol where available. Given intravenously (IV) or intramuscularly (IM). Erwinia asparaginase: To be used in case of hypersensitivity or intolerance to Calaspargase Pegol or Pegaspargase. Given intravenously (IV) or intramuscularly (IM).	Block 2b - Dose Level 1: Venetoclax 240mg/m^2 for 21 Doses Therapy for patients with\>95% of leukemic blasts with detectable CD19 on their surface. All such patients completed block 1 just prior to treatment with block 2b. These patients are mutually exclusive of patients treated on block 2a.
Block 1: All Eligible Patients Death	2	0
Block 2b - Dose Level 1 Adverse Event	0	1
Block 2b - Dose Level 1 Refused Therapy	0	2

Baseline Characteristics

Trial Treating Relapsed Acute Lymphoblastic Leukemia With Venetoclax and Navitoclax

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Block 1 n=35 Participants All eligible patients receive common intervention according to the Detailed Description section with the following: Venetoclax, Navitoclax, Dexamethasone, Vincristine, Calaspargase Pegol, Pegaspargase, Erwinia asparaginase, Dasatinib, Leucovorin, Intrathecal (IT) MHA (methotrexate/hydrocortisone/cytarabine) Venetoclax: Given oral (PO). Navitoclax: Given oral (PO). Dexamethasone: Given orally (PO) or intravenously (IV). Vincristine: Given intravenously (IV). Calaspargase Pegol: Given intravenously (IV). Dasatinib: Given oral (PO). Leucovorin: Given oral (PO) or intravenously (IV). Intrathecal Triples: Given Intrathecal (IT). Pegaspargase: May be used in place of Calaspargase Pegol where available. Given intravenously (IV) or intramuscularly (IM). Erwinia asparaginase: To be used in case of hypersensitivity or intolerance to Calaspargase Pegol or Pegaspargase. Given intravenously (IV) or intramuscularly (IM).
Age, Continuous	12.99 Years STANDARD_DEVIATION 4.65 • n=5 Participants
Sex: Female, Male Female	19 Participants n=5 Participants
Sex: Female, Male Male	16 Participants n=5 Participants
Race/Ethnicity, Customized White	22 Participants n=5 Participants
Race/Ethnicity, Customized Black	6 Participants n=5 Participants
Race/Ethnicity, Customized Other	7 Participants n=5 Participants

PRIMARY outcome

Timeframe: 4 weeks from start of therapy

Population: Of the 35 patients, 30 Patients had MRD data at the end of Block 1, and 5 patients with no adequate sample.

The number of participants with end Block 1 minimal residual disease \<0.01% by flow cytometry

Outcome measures

Outcome measures
Measure	Block 1 n=30 Participants All eligible patients receive intervention according to the Detailed Description section with the following: Venetoclax, Navitoclax, Dexamethasone, Vincristine, Calaspargase Pegol, Pegaspargase, Erwinia asparaginase, Dasatinib, Leucovorin, Intrathecal (IT) MHA (methotrexate/hydrocortisone/cytarabine) Venetoclax: Given oral (PO). Navitoclax: Given oral (PO). Dexamethasone: Given orally (PO) or intravenously (IV). Vincristine: Given intravenously (IV). Calaspargase Pegol: Given intravenously (IV). Dasatinib: Given oral (PO). Leucovorin: Given oral (PO) or intravenously (IV). Intrathecal Triples: Given Intrathecal (IT). Pegaspargase: May be used in place of Calaspargase Pegol where available. Given intravenously (IV) or intramuscularly (IM). Erwinia asparaginase: To be used in case of hypersensitivity or intolerance to Calaspargase Pegol or Pegaspargase. Given intravenously (IV) or intramuscularly (IM).
Number of Participants With Minimal Residual Disease (MRD)-Negative Response	19 Participants

PRIMARY outcome

Timeframe: 6 weeks from the start of block 2a

Population: Participants treated at Dose Level 1 in Block 2a during dose finding.

The recommended Phase 2 dose (RP2D) of venetoclax in combination with a) high-dose cytarabine and navitoclax will be the dose at which 0 or 1 of 6 treated patients experience a dose limiting toxicity.

Outcome measures

Outcome measures
Measure	Block 1 n=6 Participants All eligible patients receive intervention according to the Detailed Description section with the following: Venetoclax, Navitoclax, Dexamethasone, Vincristine, Calaspargase Pegol, Pegaspargase, Erwinia asparaginase, Dasatinib, Leucovorin, Intrathecal (IT) MHA (methotrexate/hydrocortisone/cytarabine) Venetoclax: Given oral (PO). Navitoclax: Given oral (PO). Dexamethasone: Given orally (PO) or intravenously (IV). Vincristine: Given intravenously (IV). Calaspargase Pegol: Given intravenously (IV). Dasatinib: Given oral (PO). Leucovorin: Given oral (PO) or intravenously (IV). Intrathecal Triples: Given Intrathecal (IT). Pegaspargase: May be used in place of Calaspargase Pegol where available. Given intravenously (IV) or intramuscularly (IM). Erwinia asparaginase: To be used in case of hypersensitivity or intolerance to Calaspargase Pegol or Pegaspargase. Given intravenously (IV) or intramuscularly (IM).
Recommended Phase 2 Dose of Venetoclax in Combination With a) High-dose Cytarabine and Navitoclax	3000 mg/m^2 for cytarabine

PRIMARY outcome

Timeframe: 4 weeks from the start of block 2b

Population: Participants treated at Dose Level 1 in Block 2b during dose finding.

The recommended Phase 2 dose (RP2D) of venetoclax in combination with b) blinatumomab will be the dose at which 0 or 1 of 6 treated patients experience a dose limiting toxicity. RP2D is 240mg/m2 which was delivered for 21 days.

Outcome measures

Outcome measures
Measure	Block 1 n=6 Participants All eligible patients receive intervention according to the Detailed Description section with the following: Venetoclax, Navitoclax, Dexamethasone, Vincristine, Calaspargase Pegol, Pegaspargase, Erwinia asparaginase, Dasatinib, Leucovorin, Intrathecal (IT) MHA (methotrexate/hydrocortisone/cytarabine) Venetoclax: Given oral (PO). Navitoclax: Given oral (PO). Dexamethasone: Given orally (PO) or intravenously (IV). Vincristine: Given intravenously (IV). Calaspargase Pegol: Given intravenously (IV). Dasatinib: Given oral (PO). Leucovorin: Given oral (PO) or intravenously (IV). Intrathecal Triples: Given Intrathecal (IT). Pegaspargase: May be used in place of Calaspargase Pegol where available. Given intravenously (IV) or intramuscularly (IM). Erwinia asparaginase: To be used in case of hypersensitivity or intolerance to Calaspargase Pegol or Pegaspargase. Given intravenously (IV) or intramuscularly (IM).
Recommended Phase 2 Dose of Venetoclax in Combination With b) Blinatumomab	240 240 mg/m^2/day

SECONDARY outcome

Timeframe: 6 weeks from start of block 2a

Population: Among the 7 patients who went to block 2a, 6 of them had Grade\>=3 CTCAE version 5 events.

Occurrence of grade 3 or higher CTCAE version 5 events in patients receiving block 2a therapy estimated as a proportion of patients receiving that therapy

Outcome measures

Outcome measures
Measure	Block 1 n=7 Participants All eligible patients receive intervention according to the Detailed Description section with the following: Venetoclax, Navitoclax, Dexamethasone, Vincristine, Calaspargase Pegol, Pegaspargase, Erwinia asparaginase, Dasatinib, Leucovorin, Intrathecal (IT) MHA (methotrexate/hydrocortisone/cytarabine) Venetoclax: Given oral (PO). Navitoclax: Given oral (PO). Dexamethasone: Given orally (PO) or intravenously (IV). Vincristine: Given intravenously (IV). Calaspargase Pegol: Given intravenously (IV). Dasatinib: Given oral (PO). Leucovorin: Given oral (PO) or intravenously (IV). Intrathecal Triples: Given Intrathecal (IT). Pegaspargase: May be used in place of Calaspargase Pegol where available. Given intravenously (IV) or intramuscularly (IM). Erwinia asparaginase: To be used in case of hypersensitivity or intolerance to Calaspargase Pegol or Pegaspargase. Given intravenously (IV) or intramuscularly (IM).
Number of Participants With Grade 3 or Higher CTCAE Events in Block 2a	6 Participants

SECONDARY outcome

Timeframe: 4 weeks from start of block 2b

Population: Among the 16 patients who went to block 2b, 3 of them had Grade\>=3 CTCAE version 5 events.

Occurrence of grade 3 or higher CTCAE version 5 events in patients receiving block 2b therapy estimated as a proportion of patients receiving that therapy

Outcome measures

Outcome measures
Measure	Block 1 n=16 Participants All eligible patients receive intervention according to the Detailed Description section with the following: Venetoclax, Navitoclax, Dexamethasone, Vincristine, Calaspargase Pegol, Pegaspargase, Erwinia asparaginase, Dasatinib, Leucovorin, Intrathecal (IT) MHA (methotrexate/hydrocortisone/cytarabine) Venetoclax: Given oral (PO). Navitoclax: Given oral (PO). Dexamethasone: Given orally (PO) or intravenously (IV). Vincristine: Given intravenously (IV). Calaspargase Pegol: Given intravenously (IV). Dasatinib: Given oral (PO). Leucovorin: Given oral (PO) or intravenously (IV). Intrathecal Triples: Given Intrathecal (IT). Pegaspargase: May be used in place of Calaspargase Pegol where available. Given intravenously (IV) or intramuscularly (IM). Erwinia asparaginase: To be used in case of hypersensitivity or intolerance to Calaspargase Pegol or Pegaspargase. Given intravenously (IV) or intramuscularly (IM).
Number of Participants With Grade 3 or Higher CTCAE Events in Block 2b	3 Participants

SECONDARY outcome

Timeframe: 1, 3 and 5 years from study entry

EFS will be reported as estimates using the Kaplan-Meier method

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 1, 3 and 5 years from study entry

OS will be reported as estimates using the Kaplan-Meier method

Outcome measures

Outcome data not reported

Adverse Events

Block 1

Serious events: 8 serious events

Other events: 15 other events

Deaths: 2 deaths

Block 2a - Dose Level 1: Cytarabine 3000mg/m^2/Dose Every 12 Hours

Serious events: 2 serious events

Other events: 1 other events

Deaths: 0 deaths

Block 2b - Dose Level 1: Venetoclax 240mg/m^2 for 21 Doses

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Post Therapy Follow-up

Serious events: 0 serious events

Other events: 0 other events

Deaths: 16 deaths

Serious adverse events

Other adverse events

Additional Information

Seth Karol, MD

St. Jude Children's Research Hospital

Phone: (901) 595-1716

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee MSA states Site is unable to publish until all completed case report forms have been delivered to Sponsor, (Study Completion). Site shall have the right to publish after publication of a multi-center publication coordinated by the Sponsor or (12) mths. after Study Completion; provided, that prior to any such publication or public release of such data, Site shall furnish Sponsor with a copy of any proposed publication at least (45)days in advance of the proposed publication or presentation date.
Publication restrictions are in place

Restriction type: OTHER

Serious adverse events
Measure	Block 1 n=35 participants at risk All patients receive common therapy.	Block 2a - Dose Level 1: Cytarabine 3000mg/m^2/Dose Every 12 Hours n=7 participants at risk Therapy for patients with ≥ 5% of leukemic blasts which do not have detectable CD19 on their surface, those with isolated extramedullary relapse, or whose physician determines this therapy arm is in their patient's best interest.	Block 2b - Dose Level 1: Venetoclax 240mg/m^2 for 21 Doses n=16 participants at risk Therapy for patients with \>95% of leukemic blasts with detectable CD19 on their surface.	Post Therapy Follow-up n=33 participants at risk Follow-up after completion of protocol therapy. This is inclusive of all patients treated with block 1 therapy including those who did and did not proceed to block 2a or 2b therapy. Such description enables understanding of the during vs. post therapy toxicity experienced by participants.
Blood and lymphatic system disorders Febrile neutropenia	20.0% 7/35 • Participants will be followed for adverse events from the time the of signed study specific informed consent/assent throughout the time of study drug administration until 30 days following discontinuation of study drug administration, up to 3 years.	28.6% 2/7 • Participants will be followed for adverse events from the time the of signed study specific informed consent/assent throughout the time of study drug administration until 30 days following discontinuation of study drug administration, up to 3 years.	0.00% 0/16 • Participants will be followed for adverse events from the time the of signed study specific informed consent/assent throughout the time of study drug administration until 30 days following discontinuation of study drug administration, up to 3 years.	0.00% 0/33 • Participants will be followed for adverse events from the time the of signed study specific informed consent/assent throughout the time of study drug administration until 30 days following discontinuation of study drug administration, up to 3 years.
Cardiac disorders Pericardial effusion	0.00% 0/35 • Participants will be followed for adverse events from the time the of signed study specific informed consent/assent throughout the time of study drug administration until 30 days following discontinuation of study drug administration, up to 3 years.	14.3% 1/7 • Participants will be followed for adverse events from the time the of signed study specific informed consent/assent throughout the time of study drug administration until 30 days following discontinuation of study drug administration, up to 3 years.	0.00% 0/16 • Participants will be followed for adverse events from the time the of signed study specific informed consent/assent throughout the time of study drug administration until 30 days following discontinuation of study drug administration, up to 3 years.	0.00% 0/33 • Participants will be followed for adverse events from the time the of signed study specific informed consent/assent throughout the time of study drug administration until 30 days following discontinuation of study drug administration, up to 3 years.
Gastrointestinal disorders Abdominal pain	2.9% 1/35 • Participants will be followed for adverse events from the time the of signed study specific informed consent/assent throughout the time of study drug administration until 30 days following discontinuation of study drug administration, up to 3 years.	0.00% 0/7 • Participants will be followed for adverse events from the time the of signed study specific informed consent/assent throughout the time of study drug administration until 30 days following discontinuation of study drug administration, up to 3 years.	0.00% 0/16 • Participants will be followed for adverse events from the time the of signed study specific informed consent/assent throughout the time of study drug administration until 30 days following discontinuation of study drug administration, up to 3 years.	0.00% 0/33 • Participants will be followed for adverse events from the time the of signed study specific informed consent/assent throughout the time of study drug administration until 30 days following discontinuation of study drug administration, up to 3 years.
Gastrointestinal disorders Colitis	2.9% 1/35 • Participants will be followed for adverse events from the time the of signed study specific informed consent/assent throughout the time of study drug administration until 30 days following discontinuation of study drug administration, up to 3 years.	0.00% 0/7 • Participants will be followed for adverse events from the time the of signed study specific informed consent/assent throughout the time of study drug administration until 30 days following discontinuation of study drug administration, up to 3 years.	0.00% 0/16 • Participants will be followed for adverse events from the time the of signed study specific informed consent/assent throughout the time of study drug administration until 30 days following discontinuation of study drug administration, up to 3 years.	0.00% 0/33 • Participants will be followed for adverse events from the time the of signed study specific informed consent/assent throughout the time of study drug administration until 30 days following discontinuation of study drug administration, up to 3 years.
Gastrointestinal disorders Pancreatitis	2.9% 1/35 • Participants will be followed for adverse events from the time the of signed study specific informed consent/assent throughout the time of study drug administration until 30 days following discontinuation of study drug administration, up to 3 years.	14.3% 1/7 • Participants will be followed for adverse events from the time the of signed study specific informed consent/assent throughout the time of study drug administration until 30 days following discontinuation of study drug administration, up to 3 years.	0.00% 0/16 • Participants will be followed for adverse events from the time the of signed study specific informed consent/assent throughout the time of study drug administration until 30 days following discontinuation of study drug administration, up to 3 years.	0.00% 0/33 • Participants will be followed for adverse events from the time the of signed study specific informed consent/assent throughout the time of study drug administration until 30 days following discontinuation of study drug administration, up to 3 years.
Gastrointestinal disorders Typhlitis	5.7% 2/35 • Participants will be followed for adverse events from the time the of signed study specific informed consent/assent throughout the time of study drug administration until 30 days following discontinuation of study drug administration, up to 3 years.	14.3% 1/7 • Participants will be followed for adverse events from the time the of signed study specific informed consent/assent throughout the time of study drug administration until 30 days following discontinuation of study drug administration, up to 3 years.	0.00% 0/16 • Participants will be followed for adverse events from the time the of signed study specific informed consent/assent throughout the time of study drug administration until 30 days following discontinuation of study drug administration, up to 3 years.	0.00% 0/33 • Participants will be followed for adverse events from the time the of signed study specific informed consent/assent throughout the time of study drug administration until 30 days following discontinuation of study drug administration, up to 3 years.
Infections and infestations Appendicitis	2.9% 1/35 • Participants will be followed for adverse events from the time the of signed study specific informed consent/assent throughout the time of study drug administration until 30 days following discontinuation of study drug administration, up to 3 years.	0.00% 0/7 • Participants will be followed for adverse events from the time the of signed study specific informed consent/assent throughout the time of study drug administration until 30 days following discontinuation of study drug administration, up to 3 years.	0.00% 0/16 • Participants will be followed for adverse events from the time the of signed study specific informed consent/assent throughout the time of study drug administration until 30 days following discontinuation of study drug administration, up to 3 years.	0.00% 0/33 • Participants will be followed for adverse events from the time the of signed study specific informed consent/assent throughout the time of study drug administration until 30 days following discontinuation of study drug administration, up to 3 years.
Infections and infestations Infections and infestations - Other, specify	22.9% 8/35 • Participants will be followed for adverse events from the time the of signed study specific informed consent/assent throughout the time of study drug administration until 30 days following discontinuation of study drug administration, up to 3 years.	0.00% 0/7 • Participants will be followed for adverse events from the time the of signed study specific informed consent/assent throughout the time of study drug administration until 30 days following discontinuation of study drug administration, up to 3 years.	0.00% 0/16 • Participants will be followed for adverse events from the time the of signed study specific informed consent/assent throughout the time of study drug administration until 30 days following discontinuation of study drug administration, up to 3 years.	0.00% 0/33 • Participants will be followed for adverse events from the time the of signed study specific informed consent/assent throughout the time of study drug administration until 30 days following discontinuation of study drug administration, up to 3 years.
Infections and infestations Lung infection	0.00% 0/35 • Participants will be followed for adverse events from the time the of signed study specific informed consent/assent throughout the time of study drug administration until 30 days following discontinuation of study drug administration, up to 3 years.	14.3% 1/7 • Participants will be followed for adverse events from the time the of signed study specific informed consent/assent throughout the time of study drug administration until 30 days following discontinuation of study drug administration, up to 3 years.	0.00% 0/16 • Participants will be followed for adverse events from the time the of signed study specific informed consent/assent throughout the time of study drug administration until 30 days following discontinuation of study drug administration, up to 3 years.	0.00% 0/33 • Participants will be followed for adverse events from the time the of signed study specific informed consent/assent throughout the time of study drug administration until 30 days following discontinuation of study drug administration, up to 3 years.
Infections and infestations Meningitis	2.9% 1/35 • Participants will be followed for adverse events from the time the of signed study specific informed consent/assent throughout the time of study drug administration until 30 days following discontinuation of study drug administration, up to 3 years.	0.00% 0/7 • Participants will be followed for adverse events from the time the of signed study specific informed consent/assent throughout the time of study drug administration until 30 days following discontinuation of study drug administration, up to 3 years.	0.00% 0/16 • Participants will be followed for adverse events from the time the of signed study specific informed consent/assent throughout the time of study drug administration until 30 days following discontinuation of study drug administration, up to 3 years.	0.00% 0/33 • Participants will be followed for adverse events from the time the of signed study specific informed consent/assent throughout the time of study drug administration until 30 days following discontinuation of study drug administration, up to 3 years.
Infections and infestations Sepsis	14.3% 5/35 • Participants will be followed for adverse events from the time the of signed study specific informed consent/assent throughout the time of study drug administration until 30 days following discontinuation of study drug administration, up to 3 years.	0.00% 0/7 • Participants will be followed for adverse events from the time the of signed study specific informed consent/assent throughout the time of study drug administration until 30 days following discontinuation of study drug administration, up to 3 years.	0.00% 0/16 • Participants will be followed for adverse events from the time the of signed study specific informed consent/assent throughout the time of study drug administration until 30 days following discontinuation of study drug administration, up to 3 years.	0.00% 0/33 • Participants will be followed for adverse events from the time the of signed study specific informed consent/assent throughout the time of study drug administration until 30 days following discontinuation of study drug administration, up to 3 years.
Infections and infestations Shingles	0.00% 0/35 • Participants will be followed for adverse events from the time the of signed study specific informed consent/assent throughout the time of study drug administration until 30 days following discontinuation of study drug administration, up to 3 years.	14.3% 1/7 • Participants will be followed for adverse events from the time the of signed study specific informed consent/assent throughout the time of study drug administration until 30 days following discontinuation of study drug administration, up to 3 years.	0.00% 0/16 • Participants will be followed for adverse events from the time the of signed study specific informed consent/assent throughout the time of study drug administration until 30 days following discontinuation of study drug administration, up to 3 years.	0.00% 0/33 • Participants will be followed for adverse events from the time the of signed study specific informed consent/assent throughout the time of study drug administration until 30 days following discontinuation of study drug administration, up to 3 years.
Infections and infestations Sinusitis	2.9% 1/35 • Participants will be followed for adverse events from the time the of signed study specific informed consent/assent throughout the time of study drug administration until 30 days following discontinuation of study drug administration, up to 3 years.	0.00% 0/7 • Participants will be followed for adverse events from the time the of signed study specific informed consent/assent throughout the time of study drug administration until 30 days following discontinuation of study drug administration, up to 3 years.	0.00% 0/16 • Participants will be followed for adverse events from the time the of signed study specific informed consent/assent throughout the time of study drug administration until 30 days following discontinuation of study drug administration, up to 3 years.	0.00% 0/33 • Participants will be followed for adverse events from the time the of signed study specific informed consent/assent throughout the time of study drug administration until 30 days following discontinuation of study drug administration, up to 3 years.
Infections and infestations Skin infection	2.9% 1/35 • Participants will be followed for adverse events from the time the of signed study specific informed consent/assent throughout the time of study drug administration until 30 days following discontinuation of study drug administration, up to 3 years.	0.00% 0/7 • Participants will be followed for adverse events from the time the of signed study specific informed consent/assent throughout the time of study drug administration until 30 days following discontinuation of study drug administration, up to 3 years.	0.00% 0/16 • Participants will be followed for adverse events from the time the of signed study specific informed consent/assent throughout the time of study drug administration until 30 days following discontinuation of study drug administration, up to 3 years.	0.00% 0/33 • Participants will be followed for adverse events from the time the of signed study specific informed consent/assent throughout the time of study drug administration until 30 days following discontinuation of study drug administration, up to 3 years.
Metabolism and nutrition disorders Hyperkalemia	2.9% 1/35 • Participants will be followed for adverse events from the time the of signed study specific informed consent/assent throughout the time of study drug administration until 30 days following discontinuation of study drug administration, up to 3 years.	0.00% 0/7 • Participants will be followed for adverse events from the time the of signed study specific informed consent/assent throughout the time of study drug administration until 30 days following discontinuation of study drug administration, up to 3 years.	0.00% 0/16 • Participants will be followed for adverse events from the time the of signed study specific informed consent/assent throughout the time of study drug administration until 30 days following discontinuation of study drug administration, up to 3 years.	0.00% 0/33 • Participants will be followed for adverse events from the time the of signed study specific informed consent/assent throughout the time of study drug administration until 30 days following discontinuation of study drug administration, up to 3 years.
Metabolism and nutrition disorders Hyperphosphatemia	2.9% 1/35 • Participants will be followed for adverse events from the time the of signed study specific informed consent/assent throughout the time of study drug administration until 30 days following discontinuation of study drug administration, up to 3 years.	0.00% 0/7 • Participants will be followed for adverse events from the time the of signed study specific informed consent/assent throughout the time of study drug administration until 30 days following discontinuation of study drug administration, up to 3 years.	0.00% 0/16 • Participants will be followed for adverse events from the time the of signed study specific informed consent/assent throughout the time of study drug administration until 30 days following discontinuation of study drug administration, up to 3 years.	0.00% 0/33 • Participants will be followed for adverse events from the time the of signed study specific informed consent/assent throughout the time of study drug administration until 30 days following discontinuation of study drug administration, up to 3 years.
Metabolism and nutrition disorders Tumor lysis syndrome	2.9% 1/35 • Participants will be followed for adverse events from the time the of signed study specific informed consent/assent throughout the time of study drug administration until 30 days following discontinuation of study drug administration, up to 3 years.	0.00% 0/7 • Participants will be followed for adverse events from the time the of signed study specific informed consent/assent throughout the time of study drug administration until 30 days following discontinuation of study drug administration, up to 3 years.	0.00% 0/16 • Participants will be followed for adverse events from the time the of signed study specific informed consent/assent throughout the time of study drug administration until 30 days following discontinuation of study drug administration, up to 3 years.	0.00% 0/33 • Participants will be followed for adverse events from the time the of signed study specific informed consent/assent throughout the time of study drug administration until 30 days following discontinuation of study drug administration, up to 3 years.
Musculoskeletal and connective tissue disorders Pain in extremity	2.9% 1/35 • Participants will be followed for adverse events from the time the of signed study specific informed consent/assent throughout the time of study drug administration until 30 days following discontinuation of study drug administration, up to 3 years.	0.00% 0/7 • Participants will be followed for adverse events from the time the of signed study specific informed consent/assent throughout the time of study drug administration until 30 days following discontinuation of study drug administration, up to 3 years.	0.00% 0/16 • Participants will be followed for adverse events from the time the of signed study specific informed consent/assent throughout the time of study drug administration until 30 days following discontinuation of study drug administration, up to 3 years.	0.00% 0/33 • Participants will be followed for adverse events from the time the of signed study specific informed consent/assent throughout the time of study drug administration until 30 days following discontinuation of study drug administration, up to 3 years.
Nervous system disorders Seizure	2.9% 1/35 • Participants will be followed for adverse events from the time the of signed study specific informed consent/assent throughout the time of study drug administration until 30 days following discontinuation of study drug administration, up to 3 years.	0.00% 0/7 • Participants will be followed for adverse events from the time the of signed study specific informed consent/assent throughout the time of study drug administration until 30 days following discontinuation of study drug administration, up to 3 years.	0.00% 0/16 • Participants will be followed for adverse events from the time the of signed study specific informed consent/assent throughout the time of study drug administration until 30 days following discontinuation of study drug administration, up to 3 years.	0.00% 0/33 • Participants will be followed for adverse events from the time the of signed study specific informed consent/assent throughout the time of study drug administration until 30 days following discontinuation of study drug administration, up to 3 years.
Nervous system disorders Syncope	2.9% 1/35 • Participants will be followed for adverse events from the time the of signed study specific informed consent/assent throughout the time of study drug administration until 30 days following discontinuation of study drug administration, up to 3 years.	0.00% 0/7 • Participants will be followed for adverse events from the time the of signed study specific informed consent/assent throughout the time of study drug administration until 30 days following discontinuation of study drug administration, up to 3 years.	0.00% 0/16 • Participants will be followed for adverse events from the time the of signed study specific informed consent/assent throughout the time of study drug administration until 30 days following discontinuation of study drug administration, up to 3 years.	0.00% 0/33 • Participants will be followed for adverse events from the time the of signed study specific informed consent/assent throughout the time of study drug administration until 30 days following discontinuation of study drug administration, up to 3 years.
Psychiatric disorders Confusion	2.9% 1/35 • Participants will be followed for adverse events from the time the of signed study specific informed consent/assent throughout the time of study drug administration until 30 days following discontinuation of study drug administration, up to 3 years.	0.00% 0/7 • Participants will be followed for adverse events from the time the of signed study specific informed consent/assent throughout the time of study drug administration until 30 days following discontinuation of study drug administration, up to 3 years.	0.00% 0/16 • Participants will be followed for adverse events from the time the of signed study specific informed consent/assent throughout the time of study drug administration until 30 days following discontinuation of study drug administration, up to 3 years.	0.00% 0/33 • Participants will be followed for adverse events from the time the of signed study specific informed consent/assent throughout the time of study drug administration until 30 days following discontinuation of study drug administration, up to 3 years.
Psychiatric disorders Psychiatric disorders - Other, specify	2.9% 1/35 • Participants will be followed for adverse events from the time the of signed study specific informed consent/assent throughout the time of study drug administration until 30 days following discontinuation of study drug administration, up to 3 years.	0.00% 0/7 • Participants will be followed for adverse events from the time the of signed study specific informed consent/assent throughout the time of study drug administration until 30 days following discontinuation of study drug administration, up to 3 years.	0.00% 0/16 • Participants will be followed for adverse events from the time the of signed study specific informed consent/assent throughout the time of study drug administration until 30 days following discontinuation of study drug administration, up to 3 years.	0.00% 0/33 • Participants will be followed for adverse events from the time the of signed study specific informed consent/assent throughout the time of study drug administration until 30 days following discontinuation of study drug administration, up to 3 years.
Renal and urinary disorders Acute kidney injury	5.7% 2/35 • Participants will be followed for adverse events from the time the of signed study specific informed consent/assent throughout the time of study drug administration until 30 days following discontinuation of study drug administration, up to 3 years.	14.3% 1/7 • Participants will be followed for adverse events from the time the of signed study specific informed consent/assent throughout the time of study drug administration until 30 days following discontinuation of study drug administration, up to 3 years.	0.00% 0/16 • Participants will be followed for adverse events from the time the of signed study specific informed consent/assent throughout the time of study drug administration until 30 days following discontinuation of study drug administration, up to 3 years.	0.00% 0/33 • Participants will be followed for adverse events from the time the of signed study specific informed consent/assent throughout the time of study drug administration until 30 days following discontinuation of study drug administration, up to 3 years.
Respiratory, thoracic and mediastinal disorders Hypoxia	2.9% 1/35 • Participants will be followed for adverse events from the time the of signed study specific informed consent/assent throughout the time of study drug administration until 30 days following discontinuation of study drug administration, up to 3 years.	0.00% 0/7 • Participants will be followed for adverse events from the time the of signed study specific informed consent/assent throughout the time of study drug administration until 30 days following discontinuation of study drug administration, up to 3 years.	0.00% 0/16 • Participants will be followed for adverse events from the time the of signed study specific informed consent/assent throughout the time of study drug administration until 30 days following discontinuation of study drug administration, up to 3 years.	0.00% 0/33 • Participants will be followed for adverse events from the time the of signed study specific informed consent/assent throughout the time of study drug administration until 30 days following discontinuation of study drug administration, up to 3 years.
Respiratory, thoracic and mediastinal disorders Pleural effusion	2.9% 1/35 • Participants will be followed for adverse events from the time the of signed study specific informed consent/assent throughout the time of study drug administration until 30 days following discontinuation of study drug administration, up to 3 years.	0.00% 0/7 • Participants will be followed for adverse events from the time the of signed study specific informed consent/assent throughout the time of study drug administration until 30 days following discontinuation of study drug administration, up to 3 years.	0.00% 0/16 • Participants will be followed for adverse events from the time the of signed study specific informed consent/assent throughout the time of study drug administration until 30 days following discontinuation of study drug administration, up to 3 years.	0.00% 0/33 • Participants will be followed for adverse events from the time the of signed study specific informed consent/assent throughout the time of study drug administration until 30 days following discontinuation of study drug administration, up to 3 years.
Skin and subcutaneous tissue disorders Skin and subcutaneous tissue disorders - Other, specify	2.9% 1/35 • Participants will be followed for adverse events from the time the of signed study specific informed consent/assent throughout the time of study drug administration until 30 days following discontinuation of study drug administration, up to 3 years.	0.00% 0/7 • Participants will be followed for adverse events from the time the of signed study specific informed consent/assent throughout the time of study drug administration until 30 days following discontinuation of study drug administration, up to 3 years.	0.00% 0/16 • Participants will be followed for adverse events from the time the of signed study specific informed consent/assent throughout the time of study drug administration until 30 days following discontinuation of study drug administration, up to 3 years.	0.00% 0/33 • Participants will be followed for adverse events from the time the of signed study specific informed consent/assent throughout the time of study drug administration until 30 days following discontinuation of study drug administration, up to 3 years.

Other adverse events
Measure	Block 1 n=35 participants at risk All patients receive common therapy.	Block 2a - Dose Level 1: Cytarabine 3000mg/m^2/Dose Every 12 Hours n=7 participants at risk Therapy for patients with ≥ 5% of leukemic blasts which do not have detectable CD19 on their surface, those with isolated extramedullary relapse, or whose physician determines this therapy arm is in their patient's best interest.	Block 2b - Dose Level 1: Venetoclax 240mg/m^2 for 21 Doses n=16 participants at risk Therapy for patients with \>95% of leukemic blasts with detectable CD19 on their surface.	Post Therapy Follow-up n=33 participants at risk Follow-up after completion of protocol therapy. This is inclusive of all patients treated with block 1 therapy including those who did and did not proceed to block 2a or 2b therapy. Such description enables understanding of the during vs. post therapy toxicity experienced by participants.
Investigations Aspartate aminotransferase increased	42.9% 15/35 • Participants will be followed for adverse events from the time the of signed study specific informed consent/assent throughout the time of study drug administration until 30 days following discontinuation of study drug administration, up to 3 years.	0.00% 0/7 • Participants will be followed for adverse events from the time the of signed study specific informed consent/assent throughout the time of study drug administration until 30 days following discontinuation of study drug administration, up to 3 years.	0.00% 0/16 • Participants will be followed for adverse events from the time the of signed study specific informed consent/assent throughout the time of study drug administration until 30 days following discontinuation of study drug administration, up to 3 years.	0.00% 0/33 • Participants will be followed for adverse events from the time the of signed study specific informed consent/assent throughout the time of study drug administration until 30 days following discontinuation of study drug administration, up to 3 years.
Investigations Alanine aminotransferase increased	31.4% 11/35 • Participants will be followed for adverse events from the time the of signed study specific informed consent/assent throughout the time of study drug administration until 30 days following discontinuation of study drug administration, up to 3 years.	14.3% 1/7 • Participants will be followed for adverse events from the time the of signed study specific informed consent/assent throughout the time of study drug administration until 30 days following discontinuation of study drug administration, up to 3 years.	6.2% 1/16 • Participants will be followed for adverse events from the time the of signed study specific informed consent/assent throughout the time of study drug administration until 30 days following discontinuation of study drug administration, up to 3 years.	0.00% 0/33 • Participants will be followed for adverse events from the time the of signed study specific informed consent/assent throughout the time of study drug administration until 30 days following discontinuation of study drug administration, up to 3 years.
Metabolism and nutrition disorders Hypocalcemia	28.6% 10/35 • Participants will be followed for adverse events from the time the of signed study specific informed consent/assent throughout the time of study drug administration until 30 days following discontinuation of study drug administration, up to 3 years.	0.00% 0/7 • Participants will be followed for adverse events from the time the of signed study specific informed consent/assent throughout the time of study drug administration until 30 days following discontinuation of study drug administration, up to 3 years.	0.00% 0/16 • Participants will be followed for adverse events from the time the of signed study specific informed consent/assent throughout the time of study drug administration until 30 days following discontinuation of study drug administration, up to 3 years.	0.00% 0/33 • Participants will be followed for adverse events from the time the of signed study specific informed consent/assent throughout the time of study drug administration until 30 days following discontinuation of study drug administration, up to 3 years.
Metabolism and nutrition disorders Hypokalemia	31.4% 11/35 • Participants will be followed for adverse events from the time the of signed study specific informed consent/assent throughout the time of study drug administration until 30 days following discontinuation of study drug administration, up to 3 years.	0.00% 0/7 • Participants will be followed for adverse events from the time the of signed study specific informed consent/assent throughout the time of study drug administration until 30 days following discontinuation of study drug administration, up to 3 years.	0.00% 0/16 • Participants will be followed for adverse events from the time the of signed study specific informed consent/assent throughout the time of study drug administration until 30 days following discontinuation of study drug administration, up to 3 years.	0.00% 0/33 • Participants will be followed for adverse events from the time the of signed study specific informed consent/assent throughout the time of study drug administration until 30 days following discontinuation of study drug administration, up to 3 years.
Metabolism and nutrition disorders Hypoalbuminemia	17.1% 6/35 • Participants will be followed for adverse events from the time the of signed study specific informed consent/assent throughout the time of study drug administration until 30 days following discontinuation of study drug administration, up to 3 years.	0.00% 0/7 • Participants will be followed for adverse events from the time the of signed study specific informed consent/assent throughout the time of study drug administration until 30 days following discontinuation of study drug administration, up to 3 years.	0.00% 0/16 • Participants will be followed for adverse events from the time the of signed study specific informed consent/assent throughout the time of study drug administration until 30 days following discontinuation of study drug administration, up to 3 years.	0.00% 0/33 • Participants will be followed for adverse events from the time the of signed study specific informed consent/assent throughout the time of study drug administration until 30 days following discontinuation of study drug administration, up to 3 years.
Infections and infestations Infections and infestations - Other, specify	17.1% 6/35 • Participants will be followed for adverse events from the time the of signed study specific informed consent/assent throughout the time of study drug administration until 30 days following discontinuation of study drug administration, up to 3 years.	0.00% 0/7 • Participants will be followed for adverse events from the time the of signed study specific informed consent/assent throughout the time of study drug administration until 30 days following discontinuation of study drug administration, up to 3 years.	0.00% 0/16 • Participants will be followed for adverse events from the time the of signed study specific informed consent/assent throughout the time of study drug administration until 30 days following discontinuation of study drug administration, up to 3 years.	0.00% 0/33 • Participants will be followed for adverse events from the time the of signed study specific informed consent/assent throughout the time of study drug administration until 30 days following discontinuation of study drug administration, up to 3 years.
Metabolism and nutrition disorders Hypophosphatemia	8.6% 3/35 • Participants will be followed for adverse events from the time the of signed study specific informed consent/assent throughout the time of study drug administration until 30 days following discontinuation of study drug administration, up to 3 years.	14.3% 1/7 • Participants will be followed for adverse events from the time the of signed study specific informed consent/assent throughout the time of study drug administration until 30 days following discontinuation of study drug administration, up to 3 years.	0.00% 0/16 • Participants will be followed for adverse events from the time the of signed study specific informed consent/assent throughout the time of study drug administration until 30 days following discontinuation of study drug administration, up to 3 years.	0.00% 0/33 • Participants will be followed for adverse events from the time the of signed study specific informed consent/assent throughout the time of study drug administration until 30 days following discontinuation of study drug administration, up to 3 years.
Blood and lymphatic system disorders Febrile neutropenia	11.4% 4/35 • Participants will be followed for adverse events from the time the of signed study specific informed consent/assent throughout the time of study drug administration until 30 days following discontinuation of study drug administration, up to 3 years.	0.00% 0/7 • Participants will be followed for adverse events from the time the of signed study specific informed consent/assent throughout the time of study drug administration until 30 days following discontinuation of study drug administration, up to 3 years.	0.00% 0/16 • Participants will be followed for adverse events from the time the of signed study specific informed consent/assent throughout the time of study drug administration until 30 days following discontinuation of study drug administration, up to 3 years.	0.00% 0/33 • Participants will be followed for adverse events from the time the of signed study specific informed consent/assent throughout the time of study drug administration until 30 days following discontinuation of study drug administration, up to 3 years.
Metabolism and nutrition disorders Hyperkalemia	8.6% 3/35 • Participants will be followed for adverse events from the time the of signed study specific informed consent/assent throughout the time of study drug administration until 30 days following discontinuation of study drug administration, up to 3 years.	0.00% 0/7 • Participants will be followed for adverse events from the time the of signed study specific informed consent/assent throughout the time of study drug administration until 30 days following discontinuation of study drug administration, up to 3 years.	0.00% 0/16 • Participants will be followed for adverse events from the time the of signed study specific informed consent/assent throughout the time of study drug administration until 30 days following discontinuation of study drug administration, up to 3 years.	0.00% 0/33 • Participants will be followed for adverse events from the time the of signed study specific informed consent/assent throughout the time of study drug administration until 30 days following discontinuation of study drug administration, up to 3 years.
Gastrointestinal disorders Nausea	8.6% 3/35 • Participants will be followed for adverse events from the time the of signed study specific informed consent/assent throughout the time of study drug administration until 30 days following discontinuation of study drug administration, up to 3 years.	0.00% 0/7 • Participants will be followed for adverse events from the time the of signed study specific informed consent/assent throughout the time of study drug administration until 30 days following discontinuation of study drug administration, up to 3 years.	0.00% 0/16 • Participants will be followed for adverse events from the time the of signed study specific informed consent/assent throughout the time of study drug administration until 30 days following discontinuation of study drug administration, up to 3 years.	0.00% 0/33 • Participants will be followed for adverse events from the time the of signed study specific informed consent/assent throughout the time of study drug administration until 30 days following discontinuation of study drug administration, up to 3 years.
Gastrointestinal disorders Abdominal pain	5.7% 2/35 • Participants will be followed for adverse events from the time the of signed study specific informed consent/assent throughout the time of study drug administration until 30 days following discontinuation of study drug administration, up to 3 years.	0.00% 0/7 • Participants will be followed for adverse events from the time the of signed study specific informed consent/assent throughout the time of study drug administration until 30 days following discontinuation of study drug administration, up to 3 years.	0.00% 0/16 • Participants will be followed for adverse events from the time the of signed study specific informed consent/assent throughout the time of study drug administration until 30 days following discontinuation of study drug administration, up to 3 years.	0.00% 0/33 • Participants will be followed for adverse events from the time the of signed study specific informed consent/assent throughout the time of study drug administration until 30 days following discontinuation of study drug administration, up to 3 years.
Metabolism and nutrition disorders Hyperglycemia	5.7% 2/35 • Participants will be followed for adverse events from the time the of signed study specific informed consent/assent throughout the time of study drug administration until 30 days following discontinuation of study drug administration, up to 3 years.	0.00% 0/7 • Participants will be followed for adverse events from the time the of signed study specific informed consent/assent throughout the time of study drug administration until 30 days following discontinuation of study drug administration, up to 3 years.	0.00% 0/16 • Participants will be followed for adverse events from the time the of signed study specific informed consent/assent throughout the time of study drug administration until 30 days following discontinuation of study drug administration, up to 3 years.	0.00% 0/33 • Participants will be followed for adverse events from the time the of signed study specific informed consent/assent throughout the time of study drug administration until 30 days following discontinuation of study drug administration, up to 3 years.
Metabolism and nutrition disorders Hypernatremia	5.7% 2/35 • Participants will be followed for adverse events from the time the of signed study specific informed consent/assent throughout the time of study drug administration until 30 days following discontinuation of study drug administration, up to 3 years.	0.00% 0/7 • Participants will be followed for adverse events from the time the of signed study specific informed consent/assent throughout the time of study drug administration until 30 days following discontinuation of study drug administration, up to 3 years.	0.00% 0/16 • Participants will be followed for adverse events from the time the of signed study specific informed consent/assent throughout the time of study drug administration until 30 days following discontinuation of study drug administration, up to 3 years.	0.00% 0/33 • Participants will be followed for adverse events from the time the of signed study specific informed consent/assent throughout the time of study drug administration until 30 days following discontinuation of study drug administration, up to 3 years.
Infections and infestations Sepsis	5.7% 2/35 • Participants will be followed for adverse events from the time the of signed study specific informed consent/assent throughout the time of study drug administration until 30 days following discontinuation of study drug administration, up to 3 years.	0.00% 0/7 • Participants will be followed for adverse events from the time the of signed study specific informed consent/assent throughout the time of study drug administration until 30 days following discontinuation of study drug administration, up to 3 years.	0.00% 0/16 • Participants will be followed for adverse events from the time the of signed study specific informed consent/assent throughout the time of study drug administration until 30 days following discontinuation of study drug administration, up to 3 years.	0.00% 0/33 • Participants will be followed for adverse events from the time the of signed study specific informed consent/assent throughout the time of study drug administration until 30 days following discontinuation of study drug administration, up to 3 years.
Metabolism and nutrition disorders Tumor lysis syndrome	5.7% 2/35 • Participants will be followed for adverse events from the time the of signed study specific informed consent/assent throughout the time of study drug administration until 30 days following discontinuation of study drug administration, up to 3 years.	0.00% 0/7 • Participants will be followed for adverse events from the time the of signed study specific informed consent/assent throughout the time of study drug administration until 30 days following discontinuation of study drug administration, up to 3 years.	0.00% 0/16 • Participants will be followed for adverse events from the time the of signed study specific informed consent/assent throughout the time of study drug administration until 30 days following discontinuation of study drug administration, up to 3 years.	0.00% 0/33 • Participants will be followed for adverse events from the time the of signed study specific informed consent/assent throughout the time of study drug administration until 30 days following discontinuation of study drug administration, up to 3 years.
Metabolism and nutrition disorders Alkaline phosphatase increased	2.9% 1/35 • Participants will be followed for adverse events from the time the of signed study specific informed consent/assent throughout the time of study drug administration until 30 days following discontinuation of study drug administration, up to 3 years.	0.00% 0/7 • Participants will be followed for adverse events from the time the of signed study specific informed consent/assent throughout the time of study drug administration until 30 days following discontinuation of study drug administration, up to 3 years.	0.00% 0/16 • Participants will be followed for adverse events from the time the of signed study specific informed consent/assent throughout the time of study drug administration until 30 days following discontinuation of study drug administration, up to 3 years.	0.00% 0/33 • Participants will be followed for adverse events from the time the of signed study specific informed consent/assent throughout the time of study drug administration until 30 days following discontinuation of study drug administration, up to 3 years.
Immune system disorders Allergic reaction	2.9% 1/35 • Participants will be followed for adverse events from the time the of signed study specific informed consent/assent throughout the time of study drug administration until 30 days following discontinuation of study drug administration, up to 3 years.	0.00% 0/7 • Participants will be followed for adverse events from the time the of signed study specific informed consent/assent throughout the time of study drug administration until 30 days following discontinuation of study drug administration, up to 3 years.	0.00% 0/16 • Participants will be followed for adverse events from the time the of signed study specific informed consent/assent throughout the time of study drug administration until 30 days following discontinuation of study drug administration, up to 3 years.	0.00% 0/33 • Participants will be followed for adverse events from the time the of signed study specific informed consent/assent throughout the time of study drug administration until 30 days following discontinuation of study drug administration, up to 3 years.
Metabolism and nutrition disorders Anorexia	2.9% 1/35 • Participants will be followed for adverse events from the time the of signed study specific informed consent/assent throughout the time of study drug administration until 30 days following discontinuation of study drug administration, up to 3 years.	0.00% 0/7 • Participants will be followed for adverse events from the time the of signed study specific informed consent/assent throughout the time of study drug administration until 30 days following discontinuation of study drug administration, up to 3 years.	0.00% 0/16 • Participants will be followed for adverse events from the time the of signed study specific informed consent/assent throughout the time of study drug administration until 30 days following discontinuation of study drug administration, up to 3 years.	0.00% 0/33 • Participants will be followed for adverse events from the time the of signed study specific informed consent/assent throughout the time of study drug administration until 30 days following discontinuation of study drug administration, up to 3 years.
Investigations Ascites	2.9% 1/35 • Participants will be followed for adverse events from the time the of signed study specific informed consent/assent throughout the time of study drug administration until 30 days following discontinuation of study drug administration, up to 3 years.	0.00% 0/7 • Participants will be followed for adverse events from the time the of signed study specific informed consent/assent throughout the time of study drug administration until 30 days following discontinuation of study drug administration, up to 3 years.	0.00% 0/16 • Participants will be followed for adverse events from the time the of signed study specific informed consent/assent throughout the time of study drug administration until 30 days following discontinuation of study drug administration, up to 3 years.	0.00% 0/33 • Participants will be followed for adverse events from the time the of signed study specific informed consent/assent throughout the time of study drug administration until 30 days following discontinuation of study drug administration, up to 3 years.
Respiratory, thoracic and mediastinal disorders Atelectasis	2.9% 1/35 • Participants will be followed for adverse events from the time the of signed study specific informed consent/assent throughout the time of study drug administration until 30 days following discontinuation of study drug administration, up to 3 years.	0.00% 0/7 • Participants will be followed for adverse events from the time the of signed study specific informed consent/assent throughout the time of study drug administration until 30 days following discontinuation of study drug administration, up to 3 years.	0.00% 0/16 • Participants will be followed for adverse events from the time the of signed study specific informed consent/assent throughout the time of study drug administration until 30 days following discontinuation of study drug administration, up to 3 years.	0.00% 0/33 • Participants will be followed for adverse events from the time the of signed study specific informed consent/assent throughout the time of study drug administration until 30 days following discontinuation of study drug administration, up to 3 years.
Infections and infestations Bacteremia	2.9% 1/35 • Participants will be followed for adverse events from the time the of signed study specific informed consent/assent throughout the time of study drug administration until 30 days following discontinuation of study drug administration, up to 3 years.	0.00% 0/7 • Participants will be followed for adverse events from the time the of signed study specific informed consent/assent throughout the time of study drug administration until 30 days following discontinuation of study drug administration, up to 3 years.	0.00% 0/16 • Participants will be followed for adverse events from the time the of signed study specific informed consent/assent throughout the time of study drug administration until 30 days following discontinuation of study drug administration, up to 3 years.	0.00% 0/33 • Participants will be followed for adverse events from the time the of signed study specific informed consent/assent throughout the time of study drug administration until 30 days following discontinuation of study drug administration, up to 3 years.
Metabolism and nutrition disorders Blood bilirubin increased	2.9% 1/35 • Participants will be followed for adverse events from the time the of signed study specific informed consent/assent throughout the time of study drug administration until 30 days following discontinuation of study drug administration, up to 3 years.	0.00% 0/7 • Participants will be followed for adverse events from the time the of signed study specific informed consent/assent throughout the time of study drug administration until 30 days following discontinuation of study drug administration, up to 3 years.	0.00% 0/16 • Participants will be followed for adverse events from the time the of signed study specific informed consent/assent throughout the time of study drug administration until 30 days following discontinuation of study drug administration, up to 3 years.	0.00% 0/33 • Participants will be followed for adverse events from the time the of signed study specific informed consent/assent throughout the time of study drug administration until 30 days following discontinuation of study drug administration, up to 3 years.
Eye disorders Blurred vision	2.9% 1/35 • Participants will be followed for adverse events from the time the of signed study specific informed consent/assent throughout the time of study drug administration until 30 days following discontinuation of study drug administration, up to 3 years.	0.00% 0/7 • Participants will be followed for adverse events from the time the of signed study specific informed consent/assent throughout the time of study drug administration until 30 days following discontinuation of study drug administration, up to 3 years.	0.00% 0/16 • Participants will be followed for adverse events from the time the of signed study specific informed consent/assent throughout the time of study drug administration until 30 days following discontinuation of study drug administration, up to 3 years.	0.00% 0/33 • Participants will be followed for adverse events from the time the of signed study specific informed consent/assent throughout the time of study drug administration until 30 days following discontinuation of study drug administration, up to 3 years.
Gastrointestinal disorders Constipation	2.9% 1/35 • Participants will be followed for adverse events from the time the of signed study specific informed consent/assent throughout the time of study drug administration until 30 days following discontinuation of study drug administration, up to 3 years.	0.00% 0/7 • Participants will be followed for adverse events from the time the of signed study specific informed consent/assent throughout the time of study drug administration until 30 days following discontinuation of study drug administration, up to 3 years.	0.00% 0/16 • Participants will be followed for adverse events from the time the of signed study specific informed consent/assent throughout the time of study drug administration until 30 days following discontinuation of study drug administration, up to 3 years.	0.00% 0/33 • Participants will be followed for adverse events from the time the of signed study specific informed consent/assent throughout the time of study drug administration until 30 days following discontinuation of study drug administration, up to 3 years.
Infections and infestations Cytomegalovirus infection reactivation	2.9% 1/35 • Participants will be followed for adverse events from the time the of signed study specific informed consent/assent throughout the time of study drug administration until 30 days following discontinuation of study drug administration, up to 3 years.	0.00% 0/7 • Participants will be followed for adverse events from the time the of signed study specific informed consent/assent throughout the time of study drug administration until 30 days following discontinuation of study drug administration, up to 3 years.	0.00% 0/16 • Participants will be followed for adverse events from the time the of signed study specific informed consent/assent throughout the time of study drug administration until 30 days following discontinuation of study drug administration, up to 3 years.	0.00% 0/33 • Participants will be followed for adverse events from the time the of signed study specific informed consent/assent throughout the time of study drug administration until 30 days following discontinuation of study drug administration, up to 3 years.
Gastrointestinal disorders Dyspepsia	2.9% 1/35 • Participants will be followed for adverse events from the time the of signed study specific informed consent/assent throughout the time of study drug administration until 30 days following discontinuation of study drug administration, up to 3 years.	0.00% 0/7 • Participants will be followed for adverse events from the time the of signed study specific informed consent/assent throughout the time of study drug administration until 30 days following discontinuation of study drug administration, up to 3 years.	0.00% 0/16 • Participants will be followed for adverse events from the time the of signed study specific informed consent/assent throughout the time of study drug administration until 30 days following discontinuation of study drug administration, up to 3 years.	0.00% 0/33 • Participants will be followed for adverse events from the time the of signed study specific informed consent/assent throughout the time of study drug administration until 30 days following discontinuation of study drug administration, up to 3 years.
Cardiac disorders Electrocardiogram QT corrected interval prolonged	2.9% 1/35 • Participants will be followed for adverse events from the time the of signed study specific informed consent/assent throughout the time of study drug administration until 30 days following discontinuation of study drug administration, up to 3 years.	0.00% 0/7 • Participants will be followed for adverse events from the time the of signed study specific informed consent/assent throughout the time of study drug administration until 30 days following discontinuation of study drug administration, up to 3 years.	0.00% 0/16 • Participants will be followed for adverse events from the time the of signed study specific informed consent/assent throughout the time of study drug administration until 30 days following discontinuation of study drug administration, up to 3 years.	0.00% 0/33 • Participants will be followed for adverse events from the time the of signed study specific informed consent/assent throughout the time of study drug administration until 30 days following discontinuation of study drug administration, up to 3 years.
Gastrointestinal disorders Gastrointestinal disorders - Other, specify	2.9% 1/35 • Participants will be followed for adverse events from the time the of signed study specific informed consent/assent throughout the time of study drug administration until 30 days following discontinuation of study drug administration, up to 3 years.	0.00% 0/7 • Participants will be followed for adverse events from the time the of signed study specific informed consent/assent throughout the time of study drug administration until 30 days following discontinuation of study drug administration, up to 3 years.	0.00% 0/16 • Participants will be followed for adverse events from the time the of signed study specific informed consent/assent throughout the time of study drug administration until 30 days following discontinuation of study drug administration, up to 3 years.	0.00% 0/33 • Participants will be followed for adverse events from the time the of signed study specific informed consent/assent throughout the time of study drug administration until 30 days following discontinuation of study drug administration, up to 3 years.
Nervous system disorders Headache	2.9% 1/35 • Participants will be followed for adverse events from the time the of signed study specific informed consent/assent throughout the time of study drug administration until 30 days following discontinuation of study drug administration, up to 3 years.	0.00% 0/7 • Participants will be followed for adverse events from the time the of signed study specific informed consent/assent throughout the time of study drug administration until 30 days following discontinuation of study drug administration, up to 3 years.	6.2% 1/16 • Participants will be followed for adverse events from the time the of signed study specific informed consent/assent throughout the time of study drug administration until 30 days following discontinuation of study drug administration, up to 3 years.	0.00% 0/33 • Participants will be followed for adverse events from the time the of signed study specific informed consent/assent throughout the time of study drug administration until 30 days following discontinuation of study drug administration, up to 3 years.
Infections and infestations Herpes simplex reactivation	2.9% 1/35 • Participants will be followed for adverse events from the time the of signed study specific informed consent/assent throughout the time of study drug administration until 30 days following discontinuation of study drug administration, up to 3 years.	0.00% 0/7 • Participants will be followed for adverse events from the time the of signed study specific informed consent/assent throughout the time of study drug administration until 30 days following discontinuation of study drug administration, up to 3 years.	0.00% 0/16 • Participants will be followed for adverse events from the time the of signed study specific informed consent/assent throughout the time of study drug administration until 30 days following discontinuation of study drug administration, up to 3 years.	0.00% 0/33 • Participants will be followed for adverse events from the time the of signed study specific informed consent/assent throughout the time of study drug administration until 30 days following discontinuation of study drug administration, up to 3 years.
Metabolism and nutrition disorders Hyperphosphatemia	2.9% 1/35 • Participants will be followed for adverse events from the time the of signed study specific informed consent/assent throughout the time of study drug administration until 30 days following discontinuation of study drug administration, up to 3 years.	0.00% 0/7 • Participants will be followed for adverse events from the time the of signed study specific informed consent/assent throughout the time of study drug administration until 30 days following discontinuation of study drug administration, up to 3 years.	0.00% 0/16 • Participants will be followed for adverse events from the time the of signed study specific informed consent/assent throughout the time of study drug administration until 30 days following discontinuation of study drug administration, up to 3 years.	0.00% 0/33 • Participants will be followed for adverse events from the time the of signed study specific informed consent/assent throughout the time of study drug administration until 30 days following discontinuation of study drug administration, up to 3 years.
Vascular disorders Hypertension	2.9% 1/35 • Participants will be followed for adverse events from the time the of signed study specific informed consent/assent throughout the time of study drug administration until 30 days following discontinuation of study drug administration, up to 3 years.	0.00% 0/7 • Participants will be followed for adverse events from the time the of signed study specific informed consent/assent throughout the time of study drug administration until 30 days following discontinuation of study drug administration, up to 3 years.	0.00% 0/16 • Participants will be followed for adverse events from the time the of signed study specific informed consent/assent throughout the time of study drug administration until 30 days following discontinuation of study drug administration, up to 3 years.	0.00% 0/33 • Participants will be followed for adverse events from the time the of signed study specific informed consent/assent throughout the time of study drug administration until 30 days following discontinuation of study drug administration, up to 3 years.
Metabolism and nutrition disorders Hyponatremia	2.9% 1/35 • Participants will be followed for adverse events from the time the of signed study specific informed consent/assent throughout the time of study drug administration until 30 days following discontinuation of study drug administration, up to 3 years.	0.00% 0/7 • Participants will be followed for adverse events from the time the of signed study specific informed consent/assent throughout the time of study drug administration until 30 days following discontinuation of study drug administration, up to 3 years.	0.00% 0/16 • Participants will be followed for adverse events from the time the of signed study specific informed consent/assent throughout the time of study drug administration until 30 days following discontinuation of study drug administration, up to 3 years.	0.00% 0/33 • Participants will be followed for adverse events from the time the of signed study specific informed consent/assent throughout the time of study drug administration until 30 days following discontinuation of study drug administration, up to 3 years.
Metabolism and nutrition disorders Lipase increased	2.9% 1/35 • Participants will be followed for adverse events from the time the of signed study specific informed consent/assent throughout the time of study drug administration until 30 days following discontinuation of study drug administration, up to 3 years.	0.00% 0/7 • Participants will be followed for adverse events from the time the of signed study specific informed consent/assent throughout the time of study drug administration until 30 days following discontinuation of study drug administration, up to 3 years.	0.00% 0/16 • Participants will be followed for adverse events from the time the of signed study specific informed consent/assent throughout the time of study drug administration until 30 days following discontinuation of study drug administration, up to 3 years.	0.00% 0/33 • Participants will be followed for adverse events from the time the of signed study specific informed consent/assent throughout the time of study drug administration until 30 days following discontinuation of study drug administration, up to 3 years.
Musculoskeletal and connective tissue disorders Pain	2.9% 1/35 • Participants will be followed for adverse events from the time the of signed study specific informed consent/assent throughout the time of study drug administration until 30 days following discontinuation of study drug administration, up to 3 years.	0.00% 0/7 • Participants will be followed for adverse events from the time the of signed study specific informed consent/assent throughout the time of study drug administration until 30 days following discontinuation of study drug administration, up to 3 years.	0.00% 0/16 • Participants will be followed for adverse events from the time the of signed study specific informed consent/assent throughout the time of study drug administration until 30 days following discontinuation of study drug administration, up to 3 years.	0.00% 0/33 • Participants will be followed for adverse events from the time the of signed study specific informed consent/assent throughout the time of study drug administration until 30 days following discontinuation of study drug administration, up to 3 years.
Musculoskeletal and connective tissue disorders Pain in extremity	2.9% 1/35 • Participants will be followed for adverse events from the time the of signed study specific informed consent/assent throughout the time of study drug administration until 30 days following discontinuation of study drug administration, up to 3 years.	0.00% 0/7 • Participants will be followed for adverse events from the time the of signed study specific informed consent/assent throughout the time of study drug administration until 30 days following discontinuation of study drug administration, up to 3 years.	0.00% 0/16 • Participants will be followed for adverse events from the time the of signed study specific informed consent/assent throughout the time of study drug administration until 30 days following discontinuation of study drug administration, up to 3 years.	0.00% 0/33 • Participants will be followed for adverse events from the time the of signed study specific informed consent/assent throughout the time of study drug administration until 30 days following discontinuation of study drug administration, up to 3 years.
Vascular disorders Peripheral sensory neuropathy	2.9% 1/35 • Participants will be followed for adverse events from the time the of signed study specific informed consent/assent throughout the time of study drug administration until 30 days following discontinuation of study drug administration, up to 3 years.	0.00% 0/7 • Participants will be followed for adverse events from the time the of signed study specific informed consent/assent throughout the time of study drug administration until 30 days following discontinuation of study drug administration, up to 3 years.	0.00% 0/16 • Participants will be followed for adverse events from the time the of signed study specific informed consent/assent throughout the time of study drug administration until 30 days following discontinuation of study drug administration, up to 3 years.	0.00% 0/33 • Participants will be followed for adverse events from the time the of signed study specific informed consent/assent throughout the time of study drug administration until 30 days following discontinuation of study drug administration, up to 3 years.
Infections and infestations Shingles	2.9% 1/35 • Participants will be followed for adverse events from the time the of signed study specific informed consent/assent throughout the time of study drug administration until 30 days following discontinuation of study drug administration, up to 3 years.	0.00% 0/7 • Participants will be followed for adverse events from the time the of signed study specific informed consent/assent throughout the time of study drug administration until 30 days following discontinuation of study drug administration, up to 3 years.	0.00% 0/16 • Participants will be followed for adverse events from the time the of signed study specific informed consent/assent throughout the time of study drug administration until 30 days following discontinuation of study drug administration, up to 3 years.	0.00% 0/33 • Participants will be followed for adverse events from the time the of signed study specific informed consent/assent throughout the time of study drug administration until 30 days following discontinuation of study drug administration, up to 3 years.
Cardiac disorders Sinus tachycardia	2.9% 1/35 • Participants will be followed for adverse events from the time the of signed study specific informed consent/assent throughout the time of study drug administration until 30 days following discontinuation of study drug administration, up to 3 years.	0.00% 0/7 • Participants will be followed for adverse events from the time the of signed study specific informed consent/assent throughout the time of study drug administration until 30 days following discontinuation of study drug administration, up to 3 years.	0.00% 0/16 • Participants will be followed for adverse events from the time the of signed study specific informed consent/assent throughout the time of study drug administration until 30 days following discontinuation of study drug administration, up to 3 years.	0.00% 0/33 • Participants will be followed for adverse events from the time the of signed study specific informed consent/assent throughout the time of study drug administration until 30 days following discontinuation of study drug administration, up to 3 years.
Respiratory, thoracic and mediastinal disorders Sleep apnea	2.9% 1/35 • Participants will be followed for adverse events from the time the of signed study specific informed consent/assent throughout the time of study drug administration until 30 days following discontinuation of study drug administration, up to 3 years.	0.00% 0/7 • Participants will be followed for adverse events from the time the of signed study specific informed consent/assent throughout the time of study drug administration until 30 days following discontinuation of study drug administration, up to 3 years.	0.00% 0/16 • Participants will be followed for adverse events from the time the of signed study specific informed consent/assent throughout the time of study drug administration until 30 days following discontinuation of study drug administration, up to 3 years.	0.00% 0/33 • Participants will be followed for adverse events from the time the of signed study specific informed consent/assent throughout the time of study drug administration until 30 days following discontinuation of study drug administration, up to 3 years.