[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"azacitidine\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:azacitidine":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,43],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":4,"eligibilityCriteria":14,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":17,"targetDuration":4,"studyType":20,"phases":21,"briefSummary":24,"conditions":25,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":32,"startDateStruct":35,"completionDateStruct":37,"leadSponsor":39,"locationsCount":42},"100642495","phase-1-a-phase-1b2-study-of-ropeginterferon-alfa-2b-added-to-azacitidine-in-newly-diagnosed-mdsaml--10-blasts-with-tp53-mutations-100642495",false,"NCT07646821","A Phase 1b\u002F2 Study of Ropeginterferon Alfa-2b Added to Azacitidine in Newly Diagnosed MDS\u002FAML (≥ 10% Blasts) With TP53 Mutations","Eligibility Criteria\n\nParticipants with following:\n\ni) Adult participants (≥ 18 years) with newly diagnosed MDS\u002FAML ≥ 10% blasts with TP53 aberration\n\n* TP53 aberration defined by:\n\n  * Single TP53 mutation\\> 10% VAF\n  * ≥ 1 mutation of any VAF, irrespective of cytogenetics or TP53 allele loss\n  * Single TP53 mutation 5-10% with complex karyotype and\u002For TP53 allele loss\n* (TP53 mutation will include any known pathogenic missense, truncating or splicing mutations (defined as Tier 1 or 2 in the UT MD Anderson CLIA lab myeloid NGS panel or validated by molecular pathologist; TP53 allele loss on FISH should be at least \\> 5%) ii) Ineligible for intensive chemotherapy\n\n  * Adult participants ≥ 60 years of age, OR\n  * Adult participants 18 to 60 years of age with at least one of the following relevant clinical situations\u002Fstatus:\n  * Eastern cooperative oncology group (ECOG) performance status ≥2\n  * Clinically significant organ comorbidities, as reflected by at least 1 of:\n\n    * Left ventricular ejection fraction (LVEF) \\\u003C\u002F= 50%\n    * Chronic stable angina or congestive heart failure controlled with medication\n    * Creatinine clearance \\\u003C 45 ml\u002Fmin calculated by the Cockcroft-Gault formula or measured by 24 hours' urine collection\n    * Impaired pulmonary function: Lung diffusing capacity for carbon monoxide (DLCO) ≤65% of expected\n    * Forced expiratory volume in 1 second (FEV1) ≤65% of expected\n    * Other contraindication(s) to anthracycline therapy (must be documented).\n    * Other comorbidity the investigator judges incompatible with intensive remission induction chemotherapy, which must be documented and approved by the PI.\n  * Adequate hepatic function defined by\n\n    * Serum AST\u002FALT ≤ 3 x ULN, unless considered due to leukemic organ involvement.\n    * Serum total bilirubin \\\u003C 2x ULN. Higher levels are acceptable if these can be attributed to ineffective erythropoiesis, leukemia organ involvement or Gilbert's syndrome.\n  * The teratogenic effect of AZA is not well studied. For this reason, 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. (Refer to Pregnancy Assessment Policy UT MD Anderson Institutional Policy # CLN1114). This includes all female participants, between the onset of menses (as early as 8 years of age) and 55 years unless the participants presents with an applicable exclusionary factor which may be one of the following:\n\n    * Postmenopausal (no menses in greater than or equal to 12 consecutive months).\n    * History of hysterectomy or bilateral salpingo-oophorectomy.\n    * Ovarian failure (Follicle Stimulating Hormone and Estradiol in menopausal range, who have received Whole Pelvic Radiation Therapy).\n    * History of bilateral tubal ligation or another surgical sterilization procedure.\n\nApproved methods of birth control are as follows: Hormonal contraception (i.e. birth control pills, injection, implant, transdermal patch, vaginal ring), Intrauterine device (IUD), Tubal Ligation or hysterectomy, Subject\u002FPartner post vasectomy, Implantable or injectable contraceptives, and condoms plus spermicide. Not engaging in sexual activity for the total duration of the trial and the drug washout period is an acceptable practice; however periodic abstinence, the rhythm method, and the withdrawal method are not acceptable methods of birth control. 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.\n\n* Men treated or enrolled on this protocol must also agree to use adequate contraception, for the duration of study participation, and 4 months after completion of AZA administration.\n* For participants with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated.\n* Participants with a history of hepatitis C virus (HCV) infection must have been treated and cured. For participants with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load.\n* Human immunodeficiency virus (HIV)-infected participants on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial.\n* Participants with a prior or concurrent malignancy may be eligible after discussion with the investigator\u002F PI\n* Ability to understand and the willingness to sign a written informed consent document.\n\nExclusion Criteria\n\n* Adult participants with MDS\u002FAML without a known pathogenic TP53 mutation\n* Treated secondary AML (AML developing after prior exposure to hypomethylating agents, chemotherapy or allogeneic HSCT for previous myeloid disorders like MDS, CMML, other MDS\u002FMON overlap syndromes)\n* Post MPN AML (advanced phase MPN)\n* Participants with immediate life-threatening, severe complications of leukemia such as uncontrolled bleeding, pneumonia with hypoxia or shock, and\u002For disseminated intravascular coagulation\n* Participants with active uncontrolled systemic fungal, bacterial, or viral infection (defined as ongoing signs\u002Fsymptoms related to the infection without improvement despite appropriate antibiotics, antiviral therapy, and\u002For other treatment).\n* Participants with known and untreated major depressive disorder\n* Participants with known and active autoimmune disorder\n* Participants with known retinal disease except for known age related macular degeneration\n* Participants with another active cancer warranting therapy. A maintenance therapy for a stable\u002Ftreated prior cancer is acceptable if it does not interfere with the trial therapy. This needs to be discussed with the PI.\n* Participants who are receiving any other leukemia treatment.\n* Participants who are receiving any other investigational agents.\n* History of allergic reactions attributed to compounds of similar chemical or biologic composition to Ropeginterferon alfa-2b, AZA or other agents used in study.\n* Participants with psychiatric illness\u002Fsocial situations that would limit compliance with study requirements.\n* Pregnant women are excluded from this study because AZA and potentially rIFN\\_A has the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infant's secondary to treatment of the mother with the combination, breastfeeding should be discontinued if the mother is treated with combination. These potential risks may also apply to other agents used in this study.","ALL","18 Years",{"count":18,"type":19},30,"ESTIMATED","INTERVENTIONAL",[22,23],"PHASE1","PHASE2","To find the recommended dose of ropeginterferon alfa-2b in combination with azacitidine in patients with newly diagnosed MDS\u002FAML with TP53 mutations. To learn if the recommended dose of ropeinterferon alfa-2b found in Dose Escalation in combination with azacitidine can help to control the disease.",[26,27,28,29],"Ropeginterferon","Alfa-2b","Azacitidine","MDS\u002FAML","NOT_YET_RECRUITING","2026-06-09",{"date":33,"type":34},"2026-06-15","ACTUAL",{"date":36,"type":19},"2026-11-27",{"date":38,"type":19},"2030-12-11",{"name":40,"class":41},"M.D. Anderson Cancer Center","OTHER",1,{"id":44,"slug":45,"hasResults":11,"nctId":46,"briefTitle":47,"officialTitle":48,"acronym":4,"eligibilityCriteria":49,"healthyVolunteers":11,"sex":15,"minAge":50,"maxAge":4,"enrollmentInfo":51,"targetDuration":4,"studyType":20,"phases":53,"briefSummary":55,"conditions":56,"keywords":4,"overallStatus":64,"whyStopped":4,"lastUpdateSubmitDate":65,"lastUpdatePostDateStruct":66,"startDateStruct":68,"completionDateStruct":70,"leadSponsor":72,"locationsCount":42},"100535807","the-maintenance-treatment-of-itiva-in-aml-patients-100535807","NCT06256627","The Maintenance Treatment of \"ITIVA\" in AML Patients","A Multicenter, Single Arm Clinical Study on the Efficacy and Safety of the \"ITIVA\" Protocol in Patients With Complete Remission of AML at Initial Diagnosis","Inclusion Criteria:\n\n1. Male or female, ≥ 14 years old.\n2. According to the WHO (2016) diagnostic criteria, the diagnosis of newly diagnosed AML is met (excluding APL).\n3. After conventional induction and chemotherapy with at least two consolidation schemes (at least one cycle of the scheme containing medium dose or above of Cytarabine, or the scheme of \"vinecla combined with Azacitidine\" gets remission, and continues to use the scheme to consolidate at least 6-8 cycles), CR or CRI can be achieved.\n4. \\\u003C6 months from the last chemotherapy.\n5. Having sufficient organ functions: creatinine clearance rate ≥ 30 mL\u002Fmin; Bilirubin\\\u003C3.0 × Upper limit of normal value (ULN) (sufficient liver function level); Platelets ≥ 50 × 10\\^9\u002FL; Neutrophil count ≥ 1 × 10\\^9\u002FL in granulocyte stimulated hematopoietic therapy\n6. Whole body functional state score (ECOG) 0-2 points\n7. The subjects are willing and able to follow the process required by this protocol.\n\nExclusion Criteria:\n\n1. Have a history of APL.\n2. Morphologically recurrent or refractory AML patients.\n3. Previous history of prodromal hematological diseases or treatment-related AML.\n4. MRD positive patients are scheduled to undergo allogeneic hematopoietic stem cell transplantation within one month. Patients with negative MRD are scheduled to undergo allogeneic hematopoietic stem cell transplantation within 6 months. Patients who have previously received allogeneic hematopoietic stem cell transplantation.\n5. There is a history of AML active central nervous system involvement.\n6. HIV infected patients.\n7. Uncontrolled infection.\n8. Merge New York Heart Association\\>Level 2 Cardiovascular Dysfunction Status. Level 2 is defined as heart disease where the subject feels comfortable during rest, but regular physical activity can lead to fatigue, palpitations, breathing difficulties, or angina.\n9. With chronic Respiratory disease, continuous oxygen inhalation is required, with major medical history of kidney, nerve, spirit, endocrine, metabolism, immunity, liver, cardiovascular disease, or with any other medical condition that the investigator believes will adversely affect his\u002Fher participation in this study.\n10. Complicated with Malabsorption syndrome or other diseases that hinder the administration of drugs through the intestinal route.\n11. Evidence of other clinically significant uncontrollable systemic infections (viruses, bacteria, or fungi) that require treatment.\n12. There are mental illnesses\u002Fsocial situations that may affect research compliance.\n13. History of merging other malignant tumors under treatment\n14. There is a clinically significant medical history or any other reason that the researcher believes will hinder the subject's participation in this study, or make the subject unsuitable for receiving the study drug.\n15. There is a history of allergic reactions or significant sensitivity to the ingredients of the investigational drug (and its excipients) and\u002For other similar products.\n16. The subjects are not allowed to receive other anti AML treatments. Non tumor disease treatment drugs can continue to be used.\n17. Female subjects with Fertility need to take contraceptive measures.\n18. There have been venous or arterial thromboembolic events within the past 6 months.\n19. Other researchers believe that it is not suitable for enrollment.","14 Years",{"count":52,"type":19},130,[54],"NA","We apply for this clinical study to evaluate the efficacy of \"combined recombinant human interference'- α- 1b, interleukin-2, and thalidomide\" regimen in obtaining MRD positive AML patients in CR,as well as the efficacy of the \"Venentoclax and azacitidine\" regimen and the \"combined recombinant human interference'- α- 1b, interleukin-2, and thalidomide\" regimen in alternately maintaining the treatment of MRD negative AML patients. The study included two cohorts. The first cohort consisted of AML patients who obtained CR or CRi but MRD positive after induction chemotherapy and consolidation chemotherapy. They were randomly given two cycles of \"recombinant human interference'- α- 1b, interleukin-2, and thalidomide\" or \"VA\" regimen treatment, and the MRD conversion rates of the two groups were analyzed. In the second cohort , after induction chemotherapy and consolidation chemotherapy, AML patients with CR or CRi and negative MRD were obtained, and were given \"recombinant human interference'- α- 1b, interleukin-2, and thalidomide\", Venentoclax and Azacitidine triple alternative maintenance treatment, to analyze the impact of maintenance treatment scheme on long-term survival of aml patients.",[57,58,59,60,61,62,63,28],"Acute Myeloid Leukemia","Maintenance Treatment","Minor Residue Disease","Interferon-α-1b","Interleukin-2","Thalidomide","Venentoclax","RECRUITING","2024-02-05",{"date":67,"type":34},"2024-02-13",{"date":69,"type":34},"2023-07-11",{"date":71,"type":19},"2027-05-01",{"name":73,"class":74},"Henan Cancer Hospital","OTHER_GOV"]