[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Jacqueline Garcia, MD\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":75},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,48],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":32,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":37,"lastUpdatePostDateStruct":38,"startDateStruct":41,"completionDateStruct":43,"leadSponsor":45,"locationsCount":5},"100626713","phase-1-assessing-pi3k-gamma-inhibition-with-azacitidine-venetoclax-and-eganelisib-in-patients-with-acute-myeloid-leukemia-100626713",false,"NCT07439211","Assessing PI3K Gamma Inhibition With Azacitidine, Venetoclax and Eganelisib in Patients With Acute Myeloid Leukemia","Safety of Targeting PI3Kgamma Signaling With Azacitidine, Venetoclax and Eganelisib in Acute Myeloid Leukemia: A Phase 1 Study (GAVEL)","GAVEL","Inclusion Criteria:\n\n* Subjects must have histologically confirmed AML that meets one of these categories of disease:\n\n  * Group A: Relapsed or Refractory: Subjects with relapsed or refractory AML or relapsed\u002Frefractory AML, who are not recommended for any approved targeted therapy must meet any one of the following criteria: (1) morphologic relapse (at least 5% blasts), or (2) refractory to intensive chemotherapy (at least one cycle of cytarabine and anthracycline-based intensive regimen) or at least 2 cycles of prior HMA\u002Fvenetoclax-based therapy (without CR\u002FCRh\u002FCRi). No limit to prior lines of AML therapy. OR\n  * (Expansion only) Group B: Untreated AML with ELN 2022 adverse risk disease: Subjects with newly diagnosed or previously untreated AML must be ineligible for intensive chemotherapy based on Ferrara criteria (age ≥75 years or presence of co- morbidity).\n* Evidence of marrow involved AML.\n* Age 18-90 years. Because no dosing or adverse event data are currently available on the use of eganelisib in participants \\\u003C18 years of age, children are excluded from this study, but will be eligible for future pediatric trials.\n* Eastern Cooperative Oncology Group performance status ≤ 3 if 18 to 74 years of age or ECOG 0-2 if ≥ 75 years of age.\n* Subjects must meet the following organ and marrow function as defined below:\n\n  * total serum bilirubin ≤ 1.5 x institutional upper limit of normal (ULN) or\n\n    ≤ 3 x ULN in case of Gilbert's disease\n  * AST(SGOT)\u002FALT(SGPT) ≤ 2.5 x × institutional ULN\n  * Creatinine clearance (CrCl) ≥ 30 L\u002Fmin (Cockcroft-Gault formula)\n* Prior history of CNS leukemia that has been treated, asymptomatic and controlled are eligible. CNS evaluation is not required for screening if asymptomatic.\n* Subjects with a prior or concurrent malignancy (other than MDS, MPN, MDS\u002FMPN, or AML) whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial. Treatment must be at least 12 months from last dose of chemotherapy or immunotherapy (except no window is required for palliative radiation or supportive or hormonal therapies). Concurrent malignancy must be considered not active or requiring therapy.\n* Male subjects and female subjects\u002Fwomen of childbearing potential (WCBP) must agree to the following: The effects of eganelisib on the developing human fetus are unknown. For this reason and because other therapeutic agents used in this trial are known to be teratogenic, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately. When eganelisib is being used alone, the duration of contraception after the last dose should be 3 months for both males and females of childbearing potential. When eganelisib is being used with azacitidine + venetoclax, according to the USPI for azacitidine, females of reproductive potential should use effective contraception during treatment with azacitidine and for 6 months after the last dose and males with female partners of reproductive potential should use effective contraception during treatment with azacitidine and for 3 months after the last dose. WCBP must have negative serum beta human chorionic gonadotropin test measured within 7 days prior to the first dose of eganelisib and consent to ongoing pregnancy testing during the study.\n* Willingness to practice adequate sun protection (i.e. use of sunscreen or sun-protective clothing, limitation of sun and artificial ultraviolet \\[UV\\] exposure) for the study duration and for 30 days after the last dose of eganelisib.\n* Agree to the protocol-required bone marrow biopsies.\n* Ability to understand and the willingness to sign a written informed consent document.\n\nExclusion Criteria:\n\n* Prior systemic cancer therapy is allowed as long as \\>14 days prior to study treatment start. Hormonal therapy may be allowed if approved by Sponsor-Investigator.\n* Major surgery within 28 days prior to study treatment start.\n* Allogeneic stem cell transplant within 100 days prior to study treatment start.\n* Active graft-versus-host disease (GVHD) after allogeneic stem cell transplantation or chronic GVHD requiring systemic steroid administration. Topical therapies are allowed for controlled GVHD.\n* Receiving systemic immunosuppressive therapy such as steroids or calcineurin inhibitors.\n* Participants who have not recovered from adverse events due to prior anti-cancer therapy with the exception of alopecia.\n* Participants who are receiving any other investigational AML directed-agents for this condition.\n* White blood cell count \\> 25x109\u002FL prior to first dose of study treatment.\n* History of allergic reactions attributed to compounds of similar chemical or biologic composition to eganelisib, venetoclax, or azacitidine.\n* Participants receiving any medications or substances within 14 days prior to first dose of study drug and for duration of the study:\n\n  * Moderate or strong inhibitors or inducers of CYP2C8 and CYP3A4, including grapefruit, grapefruit juice, Seville oranges, St. John's wort and herbal supplements, except for antibiotics, antifungals, or antivirals that are moderate or strong inhibitors of CYP3A (preference for moderate CYP3A inhibitors if antifungal therapy is recommended when clinically acceptable).\n  * P-glycoprotein (P-gp) inhibitors except for azole antifungals.\n  * Breast cancer resistance protein (BCRP) inhibitors.\n* Administration of any of the following as of Cycle 1 Day 1 and for the study duration: Substrates with a narrow therapeutic index for P-gp, or Warfarin, phenytoin, or other substrates with a narrow therapeutic index for CYP2C8 or CYP2C9\n* Pregnant women are excluded from this study because eganelisib is an agent without known fertility and developmental toxicity studies. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with eganelisib, breastfeeding should be discontinued if the mother is treated with eganelisib. These potential risks may also apply to other agents used in this study.\n* History or current evidence of any acute or chronic condition, therapy, or laboratory abnormality that may increase the risk associated with study participation or study drug administration, or might confound the results of the trial, interfere with participation for the full duration of the trial, or render trial participation not compatible with the participant's best interest, in the opinion of the Investigator.\n* Participant must be able to swallow pills and not have any known gastrointestinal abnormality that would affect drug absorption (examples include gastric bypass, gastrectomy, chronic diarrhea).","ALL","18 Years","90 Years",{"count":21,"type":22},48,"ESTIMATED","INTERVENTIONAL",[25],"PHASE1","This study is to evaluate the safety and preliminary efficacy of adding the PI3K-gamma inhibitor, eganelisib, to a standard of care treatment option with combination venetoclax and azacitidine in participants with acute myeloid leukemia (AML).\n\nThe names of the study drugs involved in this research study are:\n\n* Venetoclax (a type of BCL-2 inhibitor)\n* Azacitidine (a type of Demethylating Agent)\n* Eganelisib (a type of PI3K-gamma inhibitor)",[28,29,30,31],"Leukemia, Myeloid","Leukemia","Acute Myeloid Leukemia","Refractory Leukemia",[28,29,30,33,34,35],"Refractory Acute Myeloid Leukemia","Relapsed Acute Myeloid Leukemia","AML","NOT_YET_RECRUITING","2026-02-28",{"date":39,"type":40},"2026-03-03","ACTUAL",{"date":42,"type":22},"2026-07",{"date":44,"type":22},"2029-02-01",{"name":46,"class":47},"Jacqueline Garcia, MD","OTHER",{"id":49,"slug":50,"hasResults":11,"nctId":51,"briefTitle":52,"officialTitle":52,"acronym":4,"eligibilityCriteria":53,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":54,"targetDuration":4,"studyType":23,"phases":56,"briefSummary":58,"conditions":59,"keywords":63,"overallStatus":66,"whyStopped":4,"lastUpdateSubmitDate":67,"lastUpdatePostDateStruct":68,"startDateStruct":70,"completionDateStruct":72,"leadSponsor":74,"locationsCount":5},"100604335","phase-1-a-multi-site-break-through-cancer-trial-targeting-measurable-residual-disease-in-patients-with-acute-myeloid-leukemia-a-phase-12-study-of-tagraxofusp-azacitidine-and-venetoclax-100604335","NCT07148180","A Multi-Site Break Through Cancer Trial: Targeting Measurable Residual Disease in Patients With Acute Myeloid Leukemia: A Phase 1\u002F2 Study of Tagraxofusp, Azacitidine, and Venetoclax","Inclusion Criteria:\n\n* Age ≥ 18 years.\n* History of known diagnosis of Acute Myeloid Leukemia (including de novo, secondary or AML arising from MDS).\n* Subjects must be in CR, CRi, or CRh with \\\u003C5% morphologic blasts in bone marrow\n* Any evidence of CD123+ by central assessment.\n* Participants must have measurable disease, defined as ≥ 0.1% by multiparametric flow cytometric assay as assessed by central laboratory\n* ECOG performance status ≤2 (see Appendix A).\n* Subjects must have adequate organ and marrow function as defined below:\n\n  * total bilirubin ≤ 1.5 x institutional upper limit of normal unless due to Gilbert or non-hepatic in origin\n  * AST(SGOT) and ALT(SGPT) ≤ 3.0 × institutional upper limit of normal\n  * Creatinine clearance ≥ 45 ml\u002Fmin GFR by MDRD\n* Albumin ≥ 3.2 g\u002FdL\n* Left ventricular ejection fraction ≥ institutional lower limit of normal by MUGA or echocardiogram within 30 days of first protocol treatment. This can be locally assessed.\n* Pregnancy potential: Female subjects of childbearing potential must have negative results for pregnancy test. Females with reproductive potential are advised to use effective contraception during study treatment and for at least 6 months after last dose. Similarly, males with female partners of reproductive potential are advised to use effective contraception during treatment and for at least 3 months after the last dose. Men must agree to abstain from donating sperm.\n* Subject is able and willing to adhere to the study visit schedule and other protocol requirements\n\nExclusion Criteria:\n\n* Prior treatment with CD123-targeted therapy\n* Known diagnosis of acute promyelocytic leukemia.\n* Subjects who received intensive anti-leukemic chemotherapy within 2 weeks from first dose of study. If on venetoclax, subjects must be off venetoclax for at least 5 days\n* Subjects pre-arranged for SCT are only excluded if it is imminent.\n* History of prior allogeneic stem cell transplant\n* Subject has uncontrolled, clinically significant pulmonary disease (e.g. COPD, pulmonary hypertension, etc.) that in the opinion of the Investigator would put the subject at significant risk for pulmonary complications during the study.\n* Subject has experienced Grade 3 or Grade 4 capillary leak syndrome (CLS) in the past for any reason\n* Subjects with known HBV and\u002For HCV infection must have undetectable viral load during screening (HBV and HCV testing are not required.) Participants with serologic evidence of prior vaccination to HBV (i.e. hepatitis B surface (HBs) antigen negative-, anti-HBs antibody positive and anti-hepatitis B core (HBc) antibody negative) or positive anti-HBc antibody from intravenous immunoglobulins (IVIG) may participate.\n* Subjects with known HIV positivity are permitted provided they have undetectable viral load at the time of screening (HIV testing is not required).\n* Subject has a concurrent malignancy or prior malignancy within the 6-month period before screening. To be eligible, subjects must be in remission from the prior malignancy at least 6 months prior to screening and all treatment-related toxicities must have resolved to ≤ Grade 1 except for alopecia. Exceptions include adequately treated basal or squamous cell skin cancer, superficial bladder cancer, adequately treated carcinoma in situ of the cervix or uterus, or carcinoma in situ of the breast, previous malignancy confined and surgically resected (or successfully treated with other modalities) with curative intent, which are permissible for inclusion. Maintenance therapy, hormonal therapy, or steroid therapy for a well-controlled concurrent malignancy is allowed.\n* Subject has uncontrolled systemic fungal, bacterial, or viral infection, defined as ongoing signs\u002Fsymptoms related to the infection without improvement despite appropriate antibiotics, antivirals, or antifungals, either IV or oral. However, subjects with controlled infection still requiring anti-infectives are eligible.\n* Subjects with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, that have New York Heart Association Functional Class III or IV symptoms.\n* Subject has evidence of ongoing alcohol or drug abuse\n* Subjects with known active\u002Fsymptomatic CNS involvement. CNS prophylaxis allowed\n* Subjects receiving moderate or strong P450 3A (CYP3A) inducers within 7 days of start of study therapy. See Appendix B for examples\n* Subjects with uncontrolled intercurrent illness.\n* Administration or consumption of any of the following within 3 days prior to the first dose of study drug:\n\n  * grapefruit or grapefruit products\n  * Seville oranges (including marmalade containing Seville oranges)\n  * star fruit\n* Pregnant women are excluded from this study because of the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with trial therapy, breastfeeding should be discontinued if the mother is treated on trial.",{"count":55,"type":22},31,[25,57],"PHASE2","The purpose of this research study is to test the safety and efficacy of a new drug combination with three agents, azacitidine, venetoclax and tagraxofusp. Leftover (residual) leukemia disease that is not visible by eye can be increase the chance of disease recurrence. This research study is to determine if the combination therapy can safely help to control residual Acute Myeloid Leukemia (AML) and to prevent disease recurrence.\n\nThe names of the study drugs involved in this study are:\n\n* Tagraxofusp (a type of CD123-directed cytotoxin)\n* Azacitidine (a type of standard of care cytidine nucleoside analog)\n* Venetoclax (a type of standard of care BCL-2 inhibitor)",[60,29,61,62],"Acute Myeloid Leukaemia (AML)","Blood Cancer","Blood Cancers",[30,35,64,65,61,62],"Measurable Residual Disease","Myeloid Neoplasms","RECRUITING","2026-02-03",{"date":69,"type":40},"2026-02-05",{"date":71,"type":40},"2026-02-02",{"date":73,"type":22},"2030-12-31",{"name":46,"class":47},""]