[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"tp53\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:tp53":32},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,6,0,[8,76,103,124,144,167],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":4,"maxAge":17,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":50,"overallStatus":63,"whyStopped":4,"lastUpdateSubmitDate":64,"lastUpdatePostDateStruct":65,"startDateStruct":68,"completionDateStruct":70,"leadSponsor":72,"locationsCount":75},"100495785","phase-2-mt2021-08t-cell-receptor-alphabeta-depletion-pbsc-transplantation-for-heme-malignancies-100495785",false,"NCT05735717","MT2021-08T Cell Receptor Alpha\u002FBeta Depletion PBSC Transplantation for Heme Malignancies","Phase II, Open-Label, Prospective Study of T Cell Receptor Alpha\u002FBeta Depletion (A\u002FB TCD) Peripheral Blood Stem Cell (PBSC) Transplantation for Children and Adults With Hematological Malignancies","Inclusion Criteria:\n\n* Histological confirmation of hematological malignancies\n* Acute leukemias\n* Acute Myeloid Leukemia (AML) and related precursor neoplasms\n* Favorable risk AML is defined as having one of the following:\n* Acute lymphoblastic leukemia (ALL)\u002Flymphoma\n* Myelodysplasia (MDS) IPSS INT-2 or High Risk (i.e. RAEB, RAEBt) or Refractory Anemia with severe pancytopenia, transfusion dependence, or high risk cytogenetics or molecular features.\n* Age 60 years of age or younger at the time of consent\n* Karnofsky performance status ≥ 70% or Lansky play score 50% for ≤16 years of age.\n* Adequate organ function\n\nExclusion Criteria:\n\n* Pregnant or breastfeeding.\n* Active uncontrolled infection within 1 week of starting preparative therapy\n* Known seropositive for HIV or known active Hepatitis B or C infection with detectable viral load by PCR.\n* Any prior autologous or allogeneic transplant\n* CML blast crisis\n* Active central nervous system malignancy","ALL","60 Years",{"count":19,"type":20},70,"ESTIMATED","INTERVENTIONAL",[23],"PHASE2","This is a phase II, open-label, prospective study of T cell receptor alpha\u002Fbeta depletion (TCR α\u002Fβ TCD) peripheral blood stem cell (PBSC) transplantation for children and adults with hematological malignancies. This is a safety\u002Ffeasibility study of the investigational procedure\u002Fproduct.",[26,27,28,29,30,31,32,33,34,35,36,37,38,39,40,41,42,43,44,45,46,47,48,49],"Hematologic Malignancy","Acute Leukemia","Remission","Acute Myeloid Leukemia","Acute Lymphoblastic Leukemia","AML","TP53","Intrachromosomal Amplification of Chromosome 21","Cytogenetic Abnormality","CNS Leukemia","Minimal Residual Disease","Myelodysplasia","Juvenile Myelomonocytic Leukemia","Somatic Mutation","PTPN11 Gene Mutation","N-RAS Gene Amplification","Neurofibromatosis 1","NF1 Mutation","CBL Gene Mutation","Monosomy 7","Chromosome Abnormality","Fetal Hemoglobin","Lymphoblastic Lymphoma","High Grade Non-Hodgkin's Lymphoma, Adult",[51,52,53,54,55,56,57,58,59,60,61,62],"Bu","Flu","G-CSF","GFSR","aGVHD","HCT","MAC","Mel","PBSCT","PTLD","RECIST","TCR","RECRUITING","2026-03-31",{"date":66,"type":67},"2026-04-06","ACTUAL",{"date":69,"type":67},"2023-05-11",{"date":71,"type":20},"2030-11-30",{"name":73,"class":74},"Masonic Cancer Center, University of Minnesota","OTHER",1,{"id":77,"slug":78,"hasResults":11,"nctId":79,"briefTitle":80,"officialTitle":81,"acronym":4,"eligibilityCriteria":82,"healthyVolunteers":11,"sex":16,"minAge":83,"maxAge":4,"enrollmentInfo":84,"targetDuration":4,"studyType":21,"phases":86,"briefSummary":87,"conditions":88,"keywords":91,"overallStatus":63,"whyStopped":4,"lastUpdateSubmitDate":94,"lastUpdatePostDateStruct":95,"startDateStruct":97,"completionDateStruct":99,"leadSponsor":101,"locationsCount":5},"100544243","phase-2-alpine-maintenance-letrozoleabemaciclib-100544243","NCT06366347","ALPINE: Maintenance Letrozole\u002FAbemaciclib","A Phase 2 Trial of Maintenance Abemaciclib\u002FLetrozole After Systemic Therapy in Patients With Advanced or Recurrent Estrogen Receptor Positive, Mismatch Repair Proficient, TP53 Wildtype Endometrial Cancer","Inclusion Criteria:\n\n* Participants must have histologically confirmed either i) endometrioid endometrial cancer or ii) endometrial carcinosarcoma with endometrioid epithelial component.\n* Participants must have ER-positive disease, defined as ≥ 1 percent of tumor cell nuclei being immunoreactive by immunohistochemistry (IHC). If multiple analyses have been performed, judgment should be based on the most recent biopsy or pathology specimen analyzed in a CLIA (Clinical Laboratory Improvement Amendments)-certified laboratory.\n* Tumor must be TP53 wild-type as determined by immunohistochemistry (IHC) or via CLIA-certified targeted Next-Generation Sequencing (NGS); IHC assessment of p53 status is included in the NCCN guidelines of uterine neoplasms for the molecular analysis of endometrial carcinoma.\n* Participants must have mismatch repair proficient (MMRP) endometrial cancer as determined by immunohistochemistry (IHC) or polymerase chain reaction (PCR) or any CLIA-certified next generation sequencing assay.\n* No known tumor mutational burden ≥ 10 mutations\u002Fmegabase (Mb).\n* No known RB1 mutations or two-copy RB1 deletion.\n* Participants must have just completed a minimum of 4 cycles and a maximum of 10 cycles of a combination of carboplatin and taxane or a combination of taxane and anti-PD-(L)1 inhibitor therapy (e.g., pembrolizumab, or dostarlimab, or durvalumab).\n* Participants must have had measurable stage III, measurable stage IVA, stage IVB (with or without measurable disease) or recurrent (with or without measurable disease) endometrial cancer.\n* Participants are permitted to have received:\n\n  * a. Prior adjuvant chemotherapy (e.g., paclitaxel\u002Fcarboplatin alone or as a component of concurrent chemotherapy and radiation therapy \\[with or without cisplatin\\])\n  * b. Prior radiation therapy for treatment of endometrial cancer. Prior radiation therapy may have included pelvic radiation therapy, extended field pelvic\u002Fparaaortic radiation therapy, intravaginal brachytherapy, and\u002For palliative radiation therapy. All radiation therapy must have been completed at least 4 weeks prior to registration.\n  * c. Prior hormonal therapy for treatment of endometrial cancer.\n* Must be able to initiate study drug between 3 to 8 weeks (or 21 to 56 days) after completion of their final dose of chemotherapy and anti-PD-(L)1 blockade (if they were receiving anti-PD-(L)1 blockade).\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0-2 (see Appendix A)\n* Age ≥ 18 years\n* Participants must have normal organ and bone marrow function within 2 weeks before starting protocol therapy as defined below:\n\n  * System Laboratory Value\n  * Hematologic\n\n    * ANC ≥1.5 × 109 \u002FL\n    * Platelets ≥100 × 109 \u002FL\n    * Hemoglobin ≥8 g\u002FdL Patients may receive erythrocyte transfusions to achieve this hemoglobin level at the discretion of the investigator. Initial treatment must not begin earlier than the day after the erythrocyte transfusion.\n  * Hepatic\n\n    * Total bilirubin ≤1.5 × ULN Patients with Gilbert's syndrome with a total bilirubin ≤2.0 times ULN and direct bilirubin within normal limits are permitted.\n    * ALT and AST ≤3 × ULN\n    * Creatinine ≤ 1.5 × institutional ULN, OR\n    * Creatinine clearance ≥ 60 mL\u002Fmin\u002F1.73 m2 for participants with creatinine levels above 1.5 x institutional ULN.\n    * Abbreviations: ALT = alanine aminotransferase; ANC = absolute neutrophil count; AST = aspartate aminotransferase; ULN = upper limit of normal.\n* Ability to understand and the willingness to sign a written informed consent document.\n* Ability to swallow and retain oral medication.\n* Participants must be willing to release archival tissue if available. Please see section 9.1.2 and the laboratory manual for tissue requirements.\n\nExclusion Criteria:\n\n* Participants who have received previous treatment with CDK4\u002F6 inhibitors, including but not limited to previous abemaciclib therapy.\n* Any gastrointestinal dysfunctions that could interfere with the absorption of study drugs (e.g., bowel obstruction, inability to swallow tablets, malabsorption syndrome, unresolved nausea, vomiting, diarrhea CTCAE v 5.0 \\> grade 1).\n* Patients who received chemotherapy must have recovered (Common Terminology Criteria for Adverse Events \\[CTCAE\\] Grade ≤1) from the acute effects of chemotherapy except for residual alopecia or Grade 2 peripheral neuropathy prior to starting study treatment.\n* The patient has active systemic bacterial infection (requiring intravenous \\[IV\\] antibiotics at time of initiating study treatment), fungal infection, or detectable viral infection (such as known human immunodeficiency virus positivity or with known active hepatitis B or C \\[for example, hepatitis B surface antigen positive\\]. Screening is not required for enrollment.\n* Major injuries or surgery within 14 days prior to start of study treatment and\u002For planned major surgery during the on-treatment study period. Patients who received radiotherapy must have completed and fully recovered from the acute effects of radiotherapy. A washout period of at least 14 days is required between end of radiotherapy and starting study treatment.\n* Other malignant disease with disease-free ≤ 3 years except: curatively treated carcinoma in situ of the cervix, basal cell carcinoma of the skin, or ductal carcinoma in situ (DCIS) of the breast or any other cancer deemed by the investigator to be at low risk for recurrence of that malignancy.\n* Active brain metastases (e.g., stable for \\\u003C 8 weeks, no adequate previous treatment with radiotherapy and\u002For surgery, symptomatic, requiring treatment with anti-convulsant therapy. Corticoid therapy is allowed if administered as stable dose for at least 1 month before starting study treatment).\n* Females who are pregnant or lactating. The effects of the study agents on the developing human fetus are unknown. For this reason, women of child-bearing potential must agree to use a medically approved contraceptive method during the treatment period and for 3 months following the last dose of study agent. Contraceptive methods may include an intrauterine device (IUD) or barrier method. If condoms are used as a barrier method, a spermicidal agent should be added as a double barrier protection. Should a woman become pregnant or suspect she is pregnant while she is participating in this study, she should inform her treating physician immediately. A negative serum pregnancy test is required for study entry from women of childbearing potential.\n* The patient has serious and\u002For uncontrolled preexisting medical condition(s) that, in the judgment of the investigator, would preclude participation in this study (for example, interstitial lung disease\u002Fpneumonitis, severe dyspnea at rest or requiring oxygen therapy, severe renal impairment \\[e.g. estimated creatinine clearance \\\u003C30ml\u002Fmin\\], history of major surgical resection involving the stomach or small bowel, or preexisting Crohn's disease or ulcerative colitis or a preexisting chronic condition resulting in baseline Grade 2 or higher diarrhea).\n* Participants who at the time of study enrollment are known to require concomitant therapy with strong CYP3A4 inducers, or strong inhibitors of CYP3A4. Due to potential drug interactions, concomitant use of these medications is not permitted for the duration of treatment on trial. Participants are eligible for study entry if an appropriate substitution is made prior to the first dose of study medication.\n* Participants with personal history of any of the following conditions: syncope of cardiovascular etiology, ventricular arrhythmia of pathological origin (including, but not limited to, ventricular tachycardia and ventricular fibrillation), or sudden cardiac arrest.\n* Individuals with a history of a different malignancy are ineligible with the following exceptions: individuals who have been treated and are disease-free for a minimum of 3 years prior to study enrollment, or individuals who are deemed by the treating investigator to be at low risk for disease recurrence.","18 Years",{"count":85,"type":20},32,[23],"The purpose of this research study is to see if the study drugs abemaciclib and letrozole are effective and safe for participants with estrogen-receptor positive (ER+), mismatch repair proficient, tumor protein p53 (TP53) wild-type endometrial cancer.\n\nThe names of the study drugs involved in this study are:\n\n* Abemaciclib (a type of cyclin-dependent kinase (CDK) inhibitor)\n* Letrozole (a type of aromatase inhibitor)",[89,90,32],"Endometrial Cancer","Recurrent Endometrial Cancer",[92,89,93],"TP53 wild-type endometrial cancer","Recurrent endometrial cancer","2026-02-09",{"date":96,"type":67},"2026-02-11",{"date":98,"type":67},"2024-09-25",{"date":100,"type":20},"2029-03-01",{"name":102,"class":74},"Dana-Farber Cancer Institute",{"id":104,"slug":105,"hasResults":11,"nctId":106,"briefTitle":107,"officialTitle":107,"acronym":4,"eligibilityCriteria":108,"healthyVolunteers":11,"sex":16,"minAge":83,"maxAge":4,"enrollmentInfo":109,"targetDuration":4,"studyType":21,"phases":111,"briefSummary":112,"conditions":113,"keywords":4,"overallStatus":63,"whyStopped":4,"lastUpdateSubmitDate":115,"lastUpdatePostDateStruct":116,"startDateStruct":118,"completionDateStruct":120,"leadSponsor":122,"locationsCount":75},"100611408","phase-2-the-efficacy-and-safety-of-glofitamab-in-combination-with-pd-1-antibody-and-lenalidomide-in-patients-with-relapsedrefractory-large-b-cell-lymphoma-lbcl-with-tp53-aberrations-a-prospective-multicenter-phase-ii-clinical-study-100611408","NCT07240194","The Efficacy and Safety of Glofitamab in Combination With PD-1 Antibody and Lenalidomide in Patients With Relapsed\u002FRefractory Large B-cell Lymphoma (LBCL) With TP53 Aberrations: A Prospective, Multicenter, Phase II Clinical Study","Inclusion Criteria:\n\n* Signed informed consent form before any study-specific procedures.\n* Age ≥ 18 years at the time of consent.\n* Histologically confirmed large B-cell lymphoma (LBCL) with CD20 expression, including but not limited to:Diffuse large B-cell lymphoma not otherwise specified (DLBCL-NOS),Transformed follicular lymphoma (tFL),Grade 3B follicular lymphoma (3B FL),High-grade B-cell lymphoma (HGBCL),Intravascular large B-cell lymphoma (IVLBCL),Primary mediastinal large B-cell lymphoma (PMBCL),Epstein-Barr virus-positive LBCL (EBV+ LBCL).\n* Relapsed or refractory (R\u002FR) LBCL defined as:\n\nRelapsed: Disease recurrence after achieving remission for longer than 6 months after completing the last line of therapy.\n\nRefractory: Failure to achieve remission or progression within 6 months after completing the last line of therapy.\n\n* Confirmed TP53 deletion or mutation via FISH or NGS.\n* Not eligible for autologous stem cell transplantation (ASCT) per any of the following criteria: Age ≥ 70 years, End-stage organ dysfunction, ECOG performance status of ≥ 2,Patient decision to decline ASCT, Other investigator-determined comorbidities (e.g., severe heart or lung disease, active infections) per local clinical practice standards.\n* Measurable disease at baseline, with at least:\n\nOne lymph node lesion ≥ 1.5 cm (in the longest diameter), or One extranodal lesion ≥ 1.0 cm (in the longest diameter).\n\n* ECOG performance status of 0, 1, or 2.\n* Life expectancy of ≥ 12 weeks, as assessed by the investigator.\n* Adequate hematologic function unless due to extensive bone marrow involvement or spleen-related complications caused by lymphoma, defined as:\n\nAbsolute neutrophil count (ANC) ≥ 1.0 × 10⁹\u002FL,Platelets ≥ 50 × 10⁹\u002FL,Hemoglobin ≥ 80 g\u002FL.\n\n-Willingness to adhere to the study procedures, including contraception requirements during the trial for participants of reproductive potential.\n\nExclusion Criteria:\n\n* Prior allogeneic stem cell transplantation or organ transplantation. Active central nervous system involvement by lymphoma. Active autoimmune diseases requiring immune suppressive therapy. Uncontrolled systemic infections, including active hepatitis B, hepatitis C, or HIV infection.\n\nPrevious treatment with Glofitamab, another bispecific antibody targeting CD20 and CD3, or PD-1 inhibitors combined with Lenalidomide.\n\nHistory of severe hypersensitivity to monoclonal antibodies or any components of the study drugs.\n\nConcurrent participation in another investigational study. Use of systemic immunosuppressive therapy within 14 days prior to enrollment (excluding corticosteroids for lymphoma treatment or prevention of adverse effects).\n\nPregnant or breastfeeding women. Any psychological, social, or medical condition that, in the investigator's opinion, could interfere with study compliance or compromise the participants' safety or outcome.",{"count":110,"type":20},24,[23],"This is a Phase II, open-label, single-arm, multicenter study designed to evaluate the safety and efficacy of a novel combination therapy-Glofitamab, a PD-1 inhibitor, and Lenalidomide (Glofit-PD-1-Len)-in patients with TP53-aberrant relapsed or refractory large B-cell lymphoma (R\u002FR LBCL). The study will enroll 24 participants and utilize a Simon two-stage design to assess the best complete response rate (BCR), defined as achieving complete remission (CR) per 2014 Lugano criteria during the treatment period. Secondary endpoints include overall response rate (ORR), progression-free survival (PFS), overall survival (OS), duration of response (DoR), and MRD negativity rate at the end of treatment. Safety and tolerability will also be evaluated. This study addresses a critical unmet need for patients with TP53-mutant R\u002FR LBCL, who typically have a poor prognosis under current treatment options.",[114,32],"Large B-cell Lymphoma","2025-11-19",{"date":117,"type":67},"2025-11-20",{"date":119,"type":67},"2025-09-01",{"date":121,"type":20},"2028-12-30",{"name":123,"class":74},"The First Affiliated Hospital with Nanjing Medical University",{"id":125,"slug":126,"hasResults":11,"nctId":127,"briefTitle":128,"officialTitle":129,"acronym":4,"eligibilityCriteria":130,"healthyVolunteers":11,"sex":16,"minAge":83,"maxAge":4,"enrollmentInfo":131,"targetDuration":4,"studyType":21,"phases":132,"briefSummary":134,"conditions":135,"keywords":4,"overallStatus":63,"whyStopped":4,"lastUpdateSubmitDate":136,"lastUpdatePostDateStruct":137,"startDateStruct":139,"completionDateStruct":141,"leadSponsor":143,"locationsCount":75},"100593607","phase-1-phase-iii-clinical-trial-of-proteasome-inhibitor-in-combination-with-cpx-351-for-the-treatment-of-newly-diagnosed-tp53-mutated-acute-myeloid-leukemia-aml-100593607","NCT07008638","Phase I\u002FII Clinical Trial of Proteasome Inhibitor in Combination With CPX-351 for the Treatment of Newly-Diagnosed TP53-mutated Acute Myeloid Leukemia (AML)","HM2024-29: Phase I\u002FII Clinical Trial of Proteasome Inhibitor in Combination With CPX-351 for the Treatment of Newly-Diagnosed TP53-mutated Acute Myeloid Leukemia (AML)","Inclusion Criteria:\n\n* Adult (age ≥ 18 years at time of consent)\n* Have not received any systemic chemotherapy for the treatment of AML. Use of hydroxyurea and leukapheresis to control excess peripheral blasts is permissible. WBC \\\u003C 25,000 to initiate bortezomib, must reach this threshold by day 7 of CPX-351.\n* Karnofsky performance status (KPS) ≥ 70\n* Adequate renal, hepatic and cardiac function defined as\n* Renal: An estimated glomerular filtration rate ≥ 30 mL\u002Fmin\u002F1.73 m2\n* Hepatic: AST and ALT ≤3 x ULN, ALP ≤2.5 x ULN, and total bilirubin ≤1.5 x ULN. (exception for Gilbert's syndrome or leukemic infiltration of liver)\n* Cardiac: New York Heart Association (NYHA) Class I or II, left ventricular ejection fraction \\> 50% by echocardiogram, MUGA or cardiac MRI\n* Sexually active couples of childbearing potential must agree to use effective contraception or abstinence during treatment and for at least 7 months after the final dose of study drug\n* Provides voluntary written consent before the performance of any study related activities not part of standard of care.\n\nExclusion Criteria:\n\n* Received systemic chemotherapy for the treatment of AML\n* Bi-phenotypic acute leukemia or mixed lineage leukemia, acute promyelocytic leukemia\n* Active central nervous system malignancy or symptoms of CNS involvement\n* Symptomatic extramedullary disease\n* Known history of uncontrolled HIV or active hepatitis B or active hepatitis C infection\n* Has any of the following cardiac abnormalities\n* Symptomatic congestive heart failure\n* Myocardial infarction less than or equal to 6 months prior to enrollment\n* Unstable angina pectoris\n* Serious uncontrolled cardiac arrhythmia\n* Concomitant malignancies or previous malignancies with less than a 1-year disease free interval at the time of signing consent. Potential participants with adequately resected basal or squamous cell carcinoma of the skin, or adequately resected carcinoma in situ (e.g., cervix) may enroll irrespective of the time of diagnosis\n* Participants for whom administration of CPX-351 would exceed their lifetime cumulative daunorubicin exposure limit of 550 mg\u002Fm2 (or 400 mg\u002Fm2 in patients with prior chest radiation) or equivalent anthracycline dose.\n* Pregnant or breastfeeding, or planning pregnancy within 3 months after the treatment completion",{"count":85,"type":20},[133,23],"PHASE1","This is a Phase I\u002FII study evaluating safety and efficacy of proteasome inhibitor (bortezomib) in combination with CPX-351 (liposomal daunorubicin and cytarabine) for the treatment of newly-diagnosed TP53-mutated acute myeloid leukemia (TP53m AML).\n\nThe primary endpoint of the study is to define safety\u002Ftolerability (phase I) and preliminary efficacy profile (phase II) of the treatment. The secondary endpoints of interest are complete remission (CR) rate, detectable minimal residual disease (MRD) status, overall response rate (ORR), rate of allogeneic hematopoietic cell transplantation (allo-HCT), treatment-related mortality (TRM), overall survival (OS), achievement of complete remission anytime in 1 year, and disease-free survival (DFS) at 1 year and 2 years. All the patient outcomes assessments will be performed as part of standard-of-care AML management.\n\nThe hypothesis is the combination of bortezomib and CPX-351 will have an acceptable safety profile in this patient population based on the data from previous studies. The treatment will attenuate Nuclear Factor kB pathway activation in these cells and eradicate TP53m leukemia stem cells (LSC) leading to increased response rate and survival in these patients.",[29,32],"2025-07-08",{"date":138,"type":67},"2025-07-09",{"date":140,"type":67},"2025-07-07",{"date":142,"type":20},"2028-01-27",{"name":73,"class":74},{"id":145,"slug":146,"hasResults":11,"nctId":147,"briefTitle":148,"officialTitle":149,"acronym":4,"eligibilityCriteria":150,"healthyVolunteers":11,"sex":16,"minAge":83,"maxAge":151,"enrollmentInfo":152,"targetDuration":4,"studyType":21,"phases":154,"briefSummary":155,"conditions":156,"keywords":4,"overallStatus":63,"whyStopped":4,"lastUpdateSubmitDate":158,"lastUpdatePostDateStruct":159,"startDateStruct":161,"completionDateStruct":163,"leadSponsor":165,"locationsCount":75},"100528256","phase-2-aza-combined-with-rchop-in-p53-mutated-dlbcl-100528256","NCT06158399","AZA Combined With RCHOP in P53-mutated DLBCL.","A Single-arm Clinical Study of Azacitidine in Combination With R-CHOP (ARCHOP) for the Treatment of TP53-mutated Previously Untreated Diffuse Large B-cell Lymphoma","Inclusion Criteria:\n\n(1)18-70 years old; 2) New-onset TP53 mutant DLBCL; 3) ECOG 0-2; 4) LVEF \\>45%; 5) HBV-positive serology (occult carriers: anti-HBeAg +, HbsAg-, anti-HBsAg +\u002F-) only if HBV-DNA test is negative before enrollment; (6) Liver function: serum bilirubin ≤ 2.0 × ULN, serum ALT and AST ≤ 2.5 × ULN. Renal function: serum Cr ≤ 2.0 × ULN; (unless due to lymphoma); 7) Life expectancy ≥ 6 months; 8) Informed consent.\n\nExclusion Criteria:\n\n1. Primary and secondary central DLBCL;\n2. HIV-positive patients and or HCV active infection; (3) Clinically significant secondary cardiovascular disease;\n\n4\\) Combined hypoxemia severe chronic obstructive pulmonary disease; 5) Active bacterial, fungal, and, or viral infections not controlled by systemic therapy; 6) Apart from cured basal cell carcinoma of the skin or cervical cancer in situ or early prostate cancer not requiring systemic therapy or early breast cancer requiring only surgery alone. Within the last 3 years or concurrently with other malignant tumors; 7) Known hypersensitivity or allergic reaction to antibodies or proteins of the murine family","70 Years",{"count":153,"type":20},52,[23],"To evaluate the efficacy and adverse effects of Azacitidine in combination with R-CHOP (ARCHOP) for the treatment of TP53-mutated previously untreated Diffuse large B-cell lymphoma",[157,32],"DLBCL - Diffuse Large B Cell Lymphoma","2025-02-18",{"date":160,"type":67},"2025-02-19",{"date":162,"type":67},"2023-11-22",{"date":164,"type":20},"2026-05-31",{"name":166,"class":74},"The First Affiliated Hospital of Xiamen University",{"id":168,"slug":169,"hasResults":11,"nctId":170,"briefTitle":171,"officialTitle":171,"acronym":4,"eligibilityCriteria":172,"healthyVolunteers":11,"sex":16,"minAge":83,"maxAge":173,"enrollmentInfo":174,"targetDuration":4,"studyType":21,"phases":176,"briefSummary":177,"conditions":178,"keywords":4,"overallStatus":183,"whyStopped":4,"lastUpdateSubmitDate":184,"lastUpdatePostDateStruct":185,"startDateStruct":187,"completionDateStruct":189,"leadSponsor":191,"locationsCount":4},"100499045","phase-2-safety-and-efficacy-of-aumolertinib-combined-with-anlotinib-as-1st-line-treatment-in-advanced-lung-cancer-egfr-mutation-with-tp53-co-mutation-100499045","NCT05778149","Safety and Efficacy of Aumolertinib Combined With Anlotinib as 1st Line Treatment in Advanced Lung Cancer EGFR Mutation With TP53 Co-Mutation","Inclusion Criteria:\n\n1. Locally advanced or metastatic NSCLC EGFR sensitive mutations (19del and L858R) and TP53 co-mutation;\n2. Age 18-85 years, male or female;\n3. Have not received systematic treatment; If the subject has received adjuvant therapy after completing radical treatment for early gastric cancer and the subject has relapsed disease, ensure that the end of adjuvant therapy is more than 6 months from the first dose of the study and that various toxicities due to the adjuvant therapy have recovered;\n4. ECOG 0-1, The expected survival is more than 6 months;\n5. At least one assessable lesion (RECIST 1.1 );\n6. If the main organs function normally, they meet the following standards:\n\n   1. Absolute value of neutrophils (ANC) ≥ 1.5 × 10 \\^ 9 \u002FL;\n   2. platelet count ≥ 100 × 10 \\^ 9 \u002FL\n   3. hemoglobin ≥ 90g \u002FL;\n   4. white blood cell ≥ 3.0 × 10\\^9\\\\\u002FL；\n   5. Liver function: total bilirubin\\\u003C1.5 times the upper limit of normal value, aspartate aminotransferase (AST \u002FSGOT), alanine aminotransferase (ALT \u002FSGPT) and alkaline phosphatase (ALP) ≤ 2.5 times the upper limit of normal value; In case of liver metastasis, AST and ALT ≤ 5.0 times the upper limit of normal value; In case of liver metastasis and\u002For bone metastasis, ALP ≤ 5.0 times the upper limit of normal value.\n   6. Renal function: serum creatinine (Scr) ≤ 1.5 times the upper limit of normal value; Urine routine test: urine protein\\\u003C2 (+); If the urine protein at baseline is ≥ 2 (+), the 24-hour urine protein quantity must be ≤ 1.0g;\n   7. Coagulation function: international normalized ratio (INR) ≤ 1.5, and activated partial thromboplastin time (APTT) ≤ 1.5 times the upper limit of normal value;\n\nExclusion Criteria:\n\n1. Squamous cell carcinoma (including adenosquamous carcinoma and undifferentiated carcinoma); Small cell lung cancer (including small cell and non-small cell mixed lung cancer); Patients who have received systemic therapy in the past (allow to receive adjuvant or neoadjuvant therapy in the past);\n2. Patients with symptomatic brain metastasis at the beginning of treatment (patients with brain metastasis who have received treatment in the past are eligible if asymptomatic brain metastasis lasts for at least 4 weeks when receiving stable dose of drug treatment);\n3. . Patients who participated in the intervention tumor clinical trial during the first-line treatment or within the last 30 days before the first-line treatment;\n4. History of tracheoesophageal fistula, gastrointestinal perforation or gastrointestinal fistula and intra-abdominal abscess within 6 months before treatment;\n5. Suffer from serious cardio-cerebrovascular disease;\n6. Subjects who received chest radiotherapy in the lung field within the first 4 weeks, or who have not recovered from radiotherapy-related toxicity. Subjects who received radiotherapy or did not recover from radiotherapy-related toxicity within 2 weeks before randomization for all other anatomical sites;\n7. Major surgical treatment was performed within 4 weeks before treatment or planned during the trial period (the researcher judged that there was bleeding risk or wound healing complications);\n8. . Have bleeding tendency, high bleeding risk or coagulation dysfunction, including thrombotic disease within 6 months before randomization and\u002For hemoptysis history within 3 months before randomization (single cough bleeding ≥ 2.5mL)\n9. Subjects with high suspicion of idiopathic pulmonary fibrosis, organic pneumonia, drug-related pneumonia, idiopathic pneumonia or active pneumonia on chest CT scan during screening period;\n10. Imaging examination showed that there was evidence of tumor invasion into large vessels, and the tumor had completely approached, surrounded or invaded the lumen of large vessels (such as pulmonary artery or superior vena cava);\n11. Subjects with hypertension (systolic blood pressure\\>160mmHg or diastolic blood pressure\\>100mmHg) that are still poorly controlled after treatment with two or more antihypertensive drugs in the screening period, and who have a history of hypertensive crisis or hypertensive brain disease in the past;\n12. Those with unhealed wounds, active digestive ulcer, fractures (excluding old healed fractures);\n13. Known or suspected to be allergic to aumolertinib and Anlotinib and\u002For other components of their preparations;\n14. Pregnant or lactating women;\n15. Women or male subjects of childbearing age who are unwilling to take effective contraceptive measures during the study period or within 6 months after the last administration of the study drug\n16. In addition to the above conditions, the researcher believes that there are other conditions that are not suitable for selection","75 Years",{"count":175,"type":20},47,[23],"The goal of this open, single-arm, exploratory phase II clinical study is to exploratory safety and efficacy in 1st line treatment in advanced lung cancer EGFR mutation with TP53 co-mutation. 47 patients are scheduled to be enrolled. Treatment regimen is aumolertinib 110mg p.o QD and Anlotinib 12mg oral for 2 weeks, three weeks a cycle, until disease progression or intolerable adverse reactions or death.",[179,180,32,181,182],"Aumolertinib","Anlotinib","NSCLC","EGFR Activating Mutation","NOT_YET_RECRUITING","2023-03-08",{"date":186,"type":67},"2023-03-21",{"date":188,"type":20},"2023-03-31",{"date":190,"type":20},"2027-03-31",{"name":192,"class":74},"Tianjin Medical University Cancer Institute and Hospital"]