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| Name | Class |
|---|---|
| Astellas Pharma Inc | INDUSTRY |
| Genentech, Inc. | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dose Escalation Venetoclax + Gilteritinib | Experimental | Different combinations of dose levels for venetoclax in combination with gilteritinib will be administered to determine the recommended phase 2 dose (RPTD). |
|
| Dose Expansion Venetoclax + Gilteritinib | Experimental | Participants will receive venetoclax in combination with gilteritinib at the dose determined in dose escalation portion. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Venetoclax | Drug | tablet, oral |
|
| Measure | Description | Time Frame |
|---|---|---|
| Recommended Phase 2 Dose (RPTD) of Co-administered Study Drugs | The RPTD of co-administered venetoclax and gilteritinib will be determined during the dose escalation phase of the study. RPTD will be determined using available safety and pharmacokinetics data. | Up to approximately 6 months after the last participant is enrolled |
| Modified Composite Complete Remission (CRc) | Modified CRc rate is defined as the proportion of participants with documented complete response (CR) + CR with partial blood count recovery (CRp) + CR with incomplete blood count recovery (CRi) plus Morphologic Leukemia-Free State (MLFS) based on guidelines adapted from the International Working Group (IWG) for Acute Myeloid Leukemia (AML). | Up to approximately 6 months after the last participant is enrolled |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics - Cmax of Venetoclax | Maximum observed plasma concentration (Cmax) of study drug. | Approximately 16 days after first dose of study drug |
| Pharmacokinetics - Cmax of Gilteritinib |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| ABBVIE INC. | AbbVie | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| David Geffen School of Medicin /ID# 200166 | Los Angeles | California | 90095 | United States | ||
| UC San Francisco Medical Center-Parnassus /ID# 200205 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42224378 | Derived | Kennedy 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. | |
| 35849791 |
| Label | URL |
|---|---|
| This clinical study may be evaluating a usage that is not currently FDA approved. Please see US Prescribing Information for approved uses. | View source |
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| Gilteritinib | Drug | tablet, oral |
|
|
Maximum observed plasma concentration (Cmax) of study drug.
| Approximately 16 days after first dose of study drug |
| Pharmacokinetics - Tmax of Venetoclax | Time to maximum plasma concentration (Tmax) of study drug. | Approximately 16 days after first dose of study drug |
| Pharmacokinetics - Tmax of Gilteritinib | Time to maximum plasma concentration (Tmax) of study drug. | Approximately 16 days after first dose of study drug |
| Pharmacokinetics - AUCt of Venetoclax | Area Under the Plasma Concentration-time Curve (AUC) from Time 0 to Time of the Last Measurable Concentration (AUCt) of study drug. | Approximately 16 days after first dose of study drug |
| Pharmacokinetics - AUCt of Gilteritinib | Area Under the Plasma Concentration-time Curve (AUC) from Time 0 to Time of the Last Measurable Concentration (AUCt) of study drug. | Approximately 16 days after first dose of study drug |
| Pharmacokinetics - AUC0-24 Post-dose of Study Drug of Venetoclax | Area under the plasma concentration-time curve from 0 to 24 hours (AUC24) post-dose of study drug. | Approximately 16 days after first dose of study drug |
| Pharmacokinetics - AUC0-24 Post-dose of Study Drug of Gilteritinib | Area under the plasma concentration-time curve from 0 to 24 hours (AUC24) post-dose of study drug. | Approximately 16 days after first dose of study drug |
| Composite Complete Remission (CRc) Rate | CRc is defined as the proportion of participants with documented CR + CRp + CRi based on guidelines adapted from the International Working Group (IWG) for Acute Myeloid Leukemia (AML). | Up to approximately 6 months after the last participant is enrolled |
| Duration of Response (DOR) of Modified Composite Complete Remission (CRc) | DOR of modified CRc will be defined as time from the first date achieving modified CRc to disease progression (including morphologic relapse) or death from any cause whichever is earlier. | Up to approximately 6 months after the last participant is enrolled |
| Complete Remission (CR) + with Partial Hematologic Recovery (CRh) | It is defined as the proportion of participants achieving CR or CRh based on guidelines adapted from the International Working Group (IWG) for Acute Myeloid Leukemia (AML). | Up to approximately 6 months after the last participant is enrolled |
| Duration of Response (DOR) of Complete Remission (CR) + Complete Remission with Partial Hematologic Recovery (CRh) | DOR of CR + CRh will be defined as time from the first date achieving CR and/or CRh to disease progression (including morphologic relapse) or death from any cause whichever is earlier. | Up to approximately 6 months after the last participant is enrolled |
| Number of Participants With Adverse Events | An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. | From first dose of study drug until 30 days or 5 half-lives after discontinuation of study drug administration will be collected (up to approximately 4 years) |
| San Francisco |
| California |
| 94143-2202 |
| United States |
| Sylvester Comprehensive Cancer /ID# 200268 | Miami | Florida | 33136-1002 | United States |
| Northwestern Memorial Hospital /ID# 200230 | Chicago | Illinois | 60611-2927 | United States |
| Norton Cancer Institute /ID# 200623 | Louisville | Kentucky | 40202-3700 | United States |
| Johns Hopkins University /ID# 200349 | Baltimore | Maryland | 21287 | United States |
| Mayo Clinic - Rochester /ID# 200346 | Rochester | Minnesota | 55905-0001 | United States |
| Hackensack Univ Med Ctr /ID# 200229 | Hackensack | New Jersey | 07601 | United States |
| Weill Cornell Medical College /ID# 200109 | New York | New York | 10065 | United States |
| Hosp of the Univ of Penn /ID# 200348 | Philadelphia | Pennsylvania | 19104 | United States |
| MD Anderson Cancer Center at Texas Medical Center /ID# 206686 | Houston | Texas | 77030-4000 | United States |
| Derived |
| Daver 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. |
| ID | Term |
|---|---|
| D015470 | Leukemia, Myeloid, Acute |
| D009369 | Neoplasms |
| D012008 | Recurrence |
| ID | Term |
|---|---|
| D007951 | Leukemia, Myeloid |
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C579720 | venetoclax |
| C000609080 | gilteritinib |
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