Clinical trial · Interventional
A Study to Assess Safety and Efficacy of Venetoclax in Combination With Gilteritinib in Participants With Relapsed/Refractory Acute Myeloid Leukemia
A Multicenter, Open-Label Phase 1b Study to Assess Safety and Efficacy of Venetoclax in Combination With Gilteritinib in Subjects With Relapsed/Refractory Acute Myeloid Leukemia
NCT03625505CI-TRIAL-00053881completedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
A dose-escalation study evaluating the safety, tolerability, pharmacokinetics (PK) and efficacy of venetoclax, in combination with gilteritinib, in participants with relapsed or refractory (R/R) acute myeloid leukemia (AML) who have failed to respond to, and/or have relapsed or progressed after at least 1 prior therapy.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Acute Myeloid Leukemia (AML) | Acute Myeloid Leukemia | CURATED_BROADER | 0.80 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Gilteritinib | Drug | Gilteritinib | ALIAS |
| Venetoclax | Drug | Venetoclax | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Dose Escalation Venetoclax + Gilteritinib
- description
- Different combinations of dose levels for venetoclax in combination with gilteritinib will be administered to determine the recommended phase 2 dose (RPTD).
- interventionNames
- Drug: Venetoclax
- Drug: Gilteritinib
- type
- EXPERIMENTAL
- label
- Dose Expansion Venetoclax + Gilteritinib
- description
- Participants will receive venetoclax in combination with gilteritinib at the dose determined in dose escalation portion.
- interventionNames
- Drug: Venetoclax
- Drug: Gilteritinib
Primary outcomes (2)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Should have an established, confirmed diagnosis of Acute Myeloid Leukemia (AML) by World Health Organization (2016). * Should have failed at least 1 line of prior therapy (defined as failure to respond to therapy, and/or progression during or after therapy). * Should have an Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2. * Should have adequate hematologic, kidney and liver function as described in the protocol. * For participants enrolling into the Expansion Cohort only: a documented FMS-like Tyrosine Kinase (FLT3) mutation in bone marrow or peripheral blood, as described in the protocol. Exclusion Criteria: * Has a diagnosis of acute promyelocytic leukemia (APL) or BCR-ABL-positive leukemia. * Has a history of other malignancies within 2 years prior to study entry, with exceptions as described in the protocol. * Has active central nervous system leukemia. * Has a history of chronic New York Heart Association (NYHA) class IV heart failure. * Has a corrected QT interval of \> 450 ms. * Has a chronic respiratory disease that requires continuous oxygen use.
References
Publications (1)
pubmedProvenance
- Source
- PubMed (NLM)
- Dataset
- PubMed E-utilities
- Retrieved
- Sep 30, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
Vanessa E Kennedy, Cheryl A C Peretz, Anushka Walia et al. · Blood · Sep 17, 2026 · PMID 42224378 pubmed
- DERIVEDKennedy VE, Peretz CAC, Walia A, Chyla B, Sun Y, Hill JE, Tran E, Koh AD, Ferng TT, Pintar S, Jones M, Popescu B, Lomeli I, Chehab F, Murad N, John A, Roy RP, Olshen AB, Berryhill CA, Davis C, Angus SP, Rivera JM, Meshulam A, Stieglitz E, Joshi SK, Traer E, Dail M, Hamidi H, Altman JK, Daver NG, Levis MJ, McCloskey J, Perl AE, Smith CC. Dynamic genetic and nongenetic RAS pathway activation drives resistance to FLT3 and BCL2 inhibitor therapy. Blood. 2026 Jun 1:blood.2025032466. doi: 10.1182/blood.2025032466. Online ahead of print. PMID 42224378
- DERIVEDDaver N, Perl AE, Maly J, Levis M, Ritchie E, Litzow M, McCloskey J, Smith CC, Schiller G, Bradley T, Tiu RV, Naqvi K, Dail M, Brackman D, Siddani S, Wang J, Chyla B, Lee P, Altman JK. Venetoclax Plus Gilteritinib for FLT3-Mutated Relapsed/Refractory Acute Myeloid Leukemia. J Clin Oncol. 2022 Dec 10;40(35):4048-4059. doi: 10.1200/JCO.22.00602. Epub 2022 Jul 18.