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A Study of Venetoclax in Combination With Conventional Chemotherapy in Pediatric Patients With Acute Myeloid Leukemia

StatusRecruiting
PhasePhase 2
Started2023-07-25
View on ClinicalTrials.gov ↗

Amendment history

2026-09-18
Recruitment resumed after suspension
2026-07-24
Study Status, Eligibility v15
Eligibility criteria+318 characters
Patients with preexisting conditions that may affect chemotherapy tolerance (e.g., bone marrow failure syndrome, cardiac disease, pulmonary disease, and history of significant hepatic impairment) should be discussed with study PI in detail to enable review of the medical history prior to enrollment [...] Inclusion Criteria: Diagnosis of AML fulfilling the criteria [...]
2026-04-21
Study Status v14
Re-verified, no change to tracked fields
2026-04-07
Study Status, Contacts/Locations v13
Study sites9→10
2025-12-02
Recruiting→Suspended Study Status, Contacts/Locations v12
Trial statusRecruiting→Suspended
Reason stoppednot stated→PI requests voluntary hold
Study sitesdetails revised at 9 of 9 sites
Show 11 earlier versions
2025-07-03
Study Status, Contacts/Locations v11
Study sites6→9
2025-06-23
Study Status v10
Re-verified, no change to tracked fields
2025-01-27
Study Status, Contacts/Locations v9
Study sites5→6
2025-01-07
Study Status, Study Description v8
Study description+15 characters
[...] ng intensification 2. Patients with FLT3 activation receive sorafenibgilteritinib PO QD on days 8-28 during intensification 1 and 2. Intermed [...] nutes QD on days 3-5. Patients with FLT3 activation receive sorafenibgilteritinib PO QD on days 8-28. Intensification: Venetoclax PO QD on da [...] ng intensification 3. Patients with FLT3 activation receive sorafenibgilteritinib PO QD on days 8-28 during intensification 1-3. High Risk In [...] nutes QD on days 3-5. Patients with FLT3 activation receive sorafenibgilteritinib PO QD on days 8-28. Intensification: Patients with MRD < 0. [...] on days 6, 8, and 10. Patients with [...]
2024-12-18
Study Status, Contacts/Locations v7
Study sites2→5
2024-10-01
Study Status, Contacts/Locations v6
Study sites1→2
2024-08-26
Study Status, Eligibility, Contacts/Locations v5
Primary completion date2025-03→2026-12
Eligibility criteria+154 characters
[...] or primary myelodysplastic syndrome (MDS) with ≥ 10% blasts or a complete blood count with the presence of at least 1,000 blasts/μL (e.g., a WBC count ≥ 10,000/μL with ≥ 10% blasts or a WBC count ≥ 5,000/μL with ≥ 20% blasts Age > 28 days and < 22 years No prior therapy for this malignancy except for one dose of intrathecal therapy and the use of hydroxyurea or low-dose cytarabine (≤ 200 mg/m^2 per day fo [...]
Study sitescontacts updated at 1 of 1 site
2024-01-23
Study Status, Eligibility v4
Eligibility criteria-192 characters
Inclusion Criteria: Diagnosis of AML (de novo, MDS-related, or treatment-related) fulfilling the criteria of the WHO classification of myeloi [...] lonal de novo AML genetic abnormality or myeloid sarcoma or primary myelodysplastic syndrome (MDS) with ≥ 10% blasts Age > 28 da [...] and the use of hydroxyurea or low-dose cytarabine (≤ 200 mg/m2m^2 per day for ≤ 7 days) Female patients of childbearing poten [...] hod during the study and for 6 months after study treatment Patient must be fit for protocol therapy Written informed consent from the patient and/or parent/lega [...] onal upper limit of normal Exclusion Criteria [...]
2023-08-22
Study Status v3
Re-verified, no change to tracked fields
2023-08-18
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v2
Trial statusNot Yet Recruiting→Recruiting
Start dateestimated 2023-08→confirmed 2023-07-25
Study sitesdetails revised at 1 of 1 site
2023-07-21
Study Identification, Study Status v1
Study title-8 characters
A Phase 2 Study of Venetoclax in Combination With Conventional Chemotherapy in Pediatric Patients With Acute Myeloid Leukemia
2023-07-12
Original filing
This is a phase 2 study to test the hypothesis that venetoclax in combination with standard chemotherapy will be tolerable and active in pediatric patients with newly diagnosed acute myeloid leukemia (AML). Primary Objectives: * Establish the tolerability adding venetoclax to standard chemotherapy in pediatric patients with AML * Estimate the proportion of patients who become minimal residual disease (MRD) negative by flow cytometry after one course of venetoclax-based induction therapy Secondary Objectives: \- Estimate the rates of complete remission (CR), event-free survival (EFS), and overall survival (OS) in pediatric patients who receive venetoclax-based chemotherapy
Trial Details
NCT Number NCT05955261
Lead Sponsor St. Jude Children's Research Hospital
Collaborators: AbbVie
Conditions Acute Myeloid Leukemia
Enrollment 70 participants
Start Date 2023-07-25
Primary Completion 2026-12 (estimated)
Study Completion 2034-03 (estimated)
Updated on ClinicalTrials.gov 2026-09-17