Trial · NCT05192889

Trial Treating Relapsed Acute Lymphoblastic Leukemia With Venetoclax and Navitoclax

NCT05192889, Phase 1, Phase 2, Active not recruiting, St. Jude Children's Research Hospital; results first posted 2025-09-22

3 sourcestrials-2026-11-12-0.4.0

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ConductScience Library. Trial Treating Relapsed Acute Lymphoblastic Leukemia With Venetoclax and Navitoclax. Trials, record NCT05192889. Release trials-2026-11-12-0.4.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05192889

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Trial Treating Relapsed Acute Lymphoblastic Leukemia With Venetoclax and Navitoclax
NCT number: NCT05192889
Status: Active not recruiting
Phases: Phase 1, Phase 2
Enrollment: 35 participants, actual
Lead sponsor: St. Jude Children's Research Hospital
Conditions: Refractory Acute Lymphoblastic Leukemia, Relapsed Acute Lymphoblastic Leukemia
Interventions: Venetoclax, Navitoclax, Dexamethasone, Vincristine, Calaspargase Pegol, Dasatinib, Cytarabine, Blinatumomab, Methotrexate, Mercaptopurine, Cyclophosphamide, Etoposide, Leucovorin, Intrathecal Triples, Pegaspargase, Erwinia asparaginase, Radiation
First posted: 2022-01-14
Last updated: 2026-10-15
Results first posted: 2025-09-22

Source ClinicalTrials.gov

Registered outcomes7

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Number of Participants With Minimal Residual Disease (MRD)-Negative Response	4 weeks from start of therapy	The number of participants with end Block 1 minimal residual disease \<0.01% by flow cytometry
Primary	Recommended Phase 2 Dose of Venetoclax in Combination With a) High-dose Cytarabine and Navitoclax	6 weeks from the start of block 2a	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.
Primary	Recommended Phase 2 Dose of Venetoclax in Combination With b) Blinatumomab	4 weeks from the start of block 2b	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.
Secondary	Number of Participants With Grade 3 or Higher CTCAE Events in Block 2a	6 weeks from start of block 2a	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
Secondary	Number of Participants With Grade 3 or Higher CTCAE Events in Block 2b	4 weeks from start of block 2b	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
Secondary	Event Free Survival (EFS)	1, 3 and 5 years from study entry	EFS will be reported as estimates using the Kaplan-Meier method
Secondary	Overall Survival (OS)	1, 3 and 5 years from study entry	OS will be reported as estimates using the Kaplan-Meier method

Source ClinicalTrials.gov

Outcomes7

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Number of Participants With Minimal Residual Disease (MRD)-Negative Response	4 weeks from start of therapy	Of the 35 patients, 30 Patients had MRD data at the end of Block 1, and 5 patients with no adequate sample.	Participants	COUNT_OF_PARTICIPANTS
PRIMARY	Recommended Phase 2 Dose of Venetoclax in Combination With a) High-dose Cytarabine and Navitoclax	6 weeks from the start of block 2a	Participants treated at Dose Level 1 in Block 2a during dose finding.	mg/m^2 for cytarabine	NUMBER
PRIMARY	Recommended Phase 2 Dose of Venetoclax in Combination With b) Blinatumomab	4 weeks from the start of block 2b	Participants treated at Dose Level 1 in Block 2b during dose finding.	240 mg/m^2/day	NUMBER
SECONDARY	Number of Participants With Grade 3 or Higher CTCAE Events in Block 2a	6 weeks from start of block 2a	Among the 7 patients who went to block 2a, 6 of them had Grade\>=3 CTCAE version 5 events.	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Number of Participants With Grade 3 or Higher CTCAE Events in Block 2b	4 weeks from start of block 2b	Among the 16 patients who went to block 2b, 3 of them had Grade\>=3 CTCAE version 5 events.	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Event Free Survival (EFS)	1, 3 and 5 years from study entry
SECONDARY	Overall Survival (OS)	1, 3 and 5 years from study entry

Source ClinicalTrials.gov

Results by group5

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Units
Number of Participants With Minimal Residual Disease (MRD)-Negative Response	Block 1	19	Participants
Recommended Phase 2 Dose of Venetoclax in Combination With a) High-dose Cytarabine and Navitoclax	Block 2	3000	mg/m^2 for cytarabine
Recommended Phase 2 Dose of Venetoclax in Combination With b) Blinatumomab	Block 2b	240	240 mg/m^2/day
Number of Participants With Grade 3 or Higher CTCAE Events in Block 2a	Block 2a	6	Participants
Number of Participants With Grade 3 or Higher CTCAE Events in Block 2b	Block 2b	3	Participants

Source ClinicalTrials.gov

Participant flow27

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Block 1: All Eligible Patients	STARTED	Block 1: All Eligible Patients Receive Common Intervention	35
Block 1: All Eligible Patients	STARTED	Block 2a - Dose Level 1: Cytarabine 3000mg/m^2/Dose Every 12 Hours	0
Block 1: All Eligible Patients	STARTED	Block 2b - Dose Level 1: Venetoclax 240mg/m^2 for 21 Doses	0
Block 1: All Eligible Patients	COMPLETED	Block 1: All Eligible Patients Receive Common Intervention	33
Block 1: All Eligible Patients	COMPLETED	Block 2a - Dose Level 1: Cytarabine 3000mg/m^2/Dose Every 12 Hours	0
Block 1: All Eligible Patients	COMPLETED	Block 2b - Dose Level 1: Venetoclax 240mg/m^2 for 21 Doses	0
Block 1: All Eligible Patients	NOT COMPLETED	Block 1: All Eligible Patients Receive Common Intervention	2
Block 1: All Eligible Patients	NOT COMPLETED	Block 2a - Dose Level 1: Cytarabine 3000mg/m^2/Dose Every 12 Hours	0
Block 1: All Eligible Patients	NOT COMPLETED	Block 2b - Dose Level 1: Venetoclax 240mg/m^2 for 21 Doses	0
Block 2a - Dose Level 1	STARTED	Block 1: All Eligible Patients Receive Common Intervention	0

1 to 10 of 27Source ClinicalTrials.gov

See all 27 participant flow

Adverse events304

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk
other	Aspartate aminotransferase increased	Investigations	Block 1	15	35
other	Aspartate aminotransferase increased	Investigations	Block 2a - Dose Level 1: Cytarabine 3000mg/m^2/Dose Every 12 Hours	0	7
other	Aspartate aminotransferase increased	Investigations	Block 2b - Dose Level 1: Venetoclax 240mg/m^2 for 21 Doses	0	16
other	Aspartate aminotransferase increased	Investigations	Post Therapy Follow-up		33
other	Alanine aminotransferase increased	Investigations	Block 1	11	35
other	Alanine aminotransferase increased	Investigations	Block 2a - Dose Level 1: Cytarabine 3000mg/m^2/Dose Every 12 Hours	1	7
other	Alanine aminotransferase increased	Investigations	Block 2b - Dose Level 1: Venetoclax 240mg/m^2 for 21 Doses	1	16
other	Alanine aminotransferase increased	Investigations	Post Therapy Follow-up		33
other	Hypocalcemia	Metabolism and nutrition disorders	Block 1	10	35
other	Hypocalcemia	Metabolism and nutrition disorders	Block 2a - Dose Level 1: Cytarabine 3000mg/m^2/Dose Every 12 Hours	0	7

1 to 10 of 304Source ClinicalTrials.gov

See all 304 adverse events

Adverse event totals12

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Block 1	2	35
Total, all-cause mortality	Block 2a - Dose Level 1: Cytarabine 3000mg/m^2/Dose Every 12 Hours	0	7
Total, all-cause mortality	Block 2b - Dose Level 1: Venetoclax 240mg/m^2 for 21 Doses	0	16
Total, all-cause mortality	Post Therapy Follow-up	16	33
Total, other adverse events	Block 1	15	35
Total, other adverse events	Block 2a - Dose Level 1: Cytarabine 3000mg/m^2/Dose Every 12 Hours	1	7
Total, other adverse events	Block 2b - Dose Level 1: Venetoclax 240mg/m^2 for 21 Doses	2	16
Total, other adverse events	Post Therapy Follow-up	0	33
Total, serious adverse events	Block 1	8	35
Total, serious adverse events	Block 2a - Dose Level 1: Cytarabine 3000mg/m^2/Dose Every 12 Hours	2	7

1 to 10 of 12Source ClinicalTrials.gov

See all 12 adverse event totals

Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Source

Release: trials-2026-11-12-0.4.0
Release manifest SHA-256: 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4
Registry capture: 2026-11-12
Results copy, AACT: 2026-03-23
NIH clinical studies file: 2026-11-13

Source ClinicalTrials.gov

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNone stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

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The record and each of its lists are JSON, twenty rows a page. No key.

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