[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"hematologic-disorder\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:hematologic-disorder":23},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,49,59],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":4,"maxAge":4,"enrollmentInfo":17,"targetDuration":4,"studyType":20,"phases":4,"briefSummary":21,"conditions":22,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":37,"lastUpdatePostDateStruct":38,"startDateStruct":41,"completionDateStruct":43,"leadSponsor":45,"locationsCount":48},"100054158","athn-transcends-a-natural-history-study-of-non-neoplastic-hematologic-disorders-100054158",false,"NCT04398628","ATHN Transcends: A Natural History Study of Non-Neoplastic Hematologic Disorders","ATHN Transcends: A Natural History Cohort Study of the Safety, Effectiveness, and Practice of Treatment in People With Non-Neoplastic Hematologic Disorders","Participants who meet the following inclusion criteria and none of the exclusion criteria are eligible for enrollment in one of the open disease-specific arms.\n\nInclusion Criteria:\n\n1. Any age\n2. Having a congenital or acquired blood disorder; or\n3. Having a bleeding phenotype as indicated by an age adjusted abnormal ISTH Bleeding Assessment Tool score with an unknown diagnosis; or\n4. Connective tissue disorder with bleeding tendency as indicated by an age adjusted abnormal ISTH Bleeding Assessment Tool score.\n5. Eligible for a currently active disease-specific arm.\n6. Concurrent enrollment in the ATHNdataset or current ATHNdataset participant.\n\nExclusion Criteria:\n\n1\\. Does not qualify for inclusion in a currently activedisease-specific arm; participants may be eligible to enroll as future cohorts and arms are activated; 2. Unable to give informed consent or assent 3. Unwilling to perform study procedures\n\nCohort Participant Selection\n\nEach participant is to be enrolled in the cohort for which they qualify as defined below.\n\nHemophilia Cohort\n\nInclusion Criteria:\n\nParticipants who meet any of the following inclusion criteria are eligible for enrollment into this cohort:\n\n1. Factor VIII or factor IX activity \\\u003C50%, without another explanation for low clotting factor other than congenital hemophilia or being a known carrier for congenital hemophilia; OR\n2. Carrier for congenital hemophilia with a factor VIII \\>=50% or factor IX activity \\>=50% with or without a bleeding phenotype as indicated by an ISTH Bleeding Assessment Tool score of ≥4 for adult males, ≥6 for adult females, or ≥3 for children younger than 18 years OR\n3. Known congenital hemophilia that have a factor level \\>50% after receiving vector, OR 4. Acquired hemophilia.\n\nExclusion Criteria:\n\nNone\n\nVon Willebrand Disease Cohort\n\nInclusion Criteria:\n\nParticipants who meet the following inclusion criteria are eligible for enrollment into this cohort:\n\n1\\. Meeting the definition of VWD or low VWF per most recent international guidelines\n\nExclusion Criteria:\n\nNone\n\nCongenital Platelet Disorders Cohort\n\nInclusion Criteria:\n\nParticipants who meet the following inclusion criteria are eligible for enrollment into this cohort:\n\n1. Abnormalities of platelet function a. Glanzmann thrombasthenia (GPIIb or GPIIIa) b. Bernard-Soulier syndrome (GPIbalpha, GPIbbeta, or GPIX)\n2. Abnormalities of platelet granules\n3. Abnormalities of platelet signal transduction\n4. Abnormalities of platelet secretion\n5. Collagen Receptor Defect\n6. ADP Receptor Defect\n7. Thromboxane Receptor Defect\n8. Giant Platelet Disorder\n9. Abnormalities in platelet aggregation testing due to another or unknown cause (not drug related)\n\nExclusion Criteria:\n\n1\\. Platelet disorders secondary to medications or other substances\n\nRare Disorders Cohort\n\nInclusion Criteria:\n\nParticipants who meet the following inclusion criteria are eligible for enrollment into this cohort:\n\n1\\. Have an established Rare Coagulation Disorder (RCD) diagnosis of one of the following:\n\n1. PAI-1 deficiency\n2. Factor I, II, V, VII, X, XI, XIII deficiencies\n3. Combined FV and FVIII deficiency\n4. Plasminogen deficiency\n5. Decreased tissue plasminogen activator\n6. Afibrinogenemia\u002Fhypofibrinogenemia\u002Fdysfibrinogenemia\n7. Thrombotic Thrombocytopenia Purpura or Congenital Hemolytic Uremic Syndrome\n8. Wiskott-Aldrich\n9. Methylenetetrahydrofolate Reductase Deficiency\n\nExclusion Criteria:\n\nNone\n\nBleeding NOS Cohort\n\nInclusion Criteria:\n\nParticipants who meet the following inclusion criteria are eligible for enrollment into this cohort:\n\n1. Have a bleeding phenotype as indicated by an ISTH Bleeding Assessment Tool score of ≥4 for adult males, ≥6 for adult females, or ≥3 for children younger than 18 years with an unknown diagnosis, OR\n2. Connective tissue disorder with bleeding tendency as indicated by an ISTH Bleeding Assessment Tool score of ≥4 for adult males, ≥6 for adult females, or ≥3 for children younger than 18 years.\n\nExclusion Criteria:\n\nNone\n\nThrombosis\u002FThrombophilia Cohort\n\nInclusion Criteria\n\nParticipants who meet the following inclusion criteria are eligible for enrollment into this cohort:\n\n1\\. Have a prior history of arterial or venous thrombosis. 2. Participants with a known congenital or acquired thrombophilia with or without thrombosis.\n\na. Common congenital thrombophilias: i. Protein C deficiency ii. Protein S deficiency iii. Antithrombin deficiency iv. Factor V Leiden v. Prothrombin gene mutation b. Rare genetic factors i. Hyperhomocysteinemia c. Indeterminate genetic factors i. Elevated factor VIII ii. Elevated factor IX iii. Elevated factor XI iv. Elevated lipoprotein (a) d. Acquired thrombophilias i. Lupus anticoagulant ii. Anti-cardiolipin antibodies\u002FBeta2 glycoprotein antibodies iii. Antiphospholipid syndrome\n\nExclusion Criteria Acquired thrombophilia secondary to medications (birth control pills or hormone replacement therapy), overweight or obesity, smoking, cancer, pregnancy, surgery, injury, prolonged inactivity\u002Fbedrest, heart failure, inflammatory bowel disease, or kidney disease\n\nNon-Neoplastic Hematologic Conditions Cohort\n\nInclusion Criteria\n\nParticipants who meet the following inclusion criteria are eligible for enrollment into this cohort:\n\n1\\. Having any congenital or acquired non-neoplastic hematologic disorder not included in any other cohort\n\nExclusion Criteria None\n\nArm\u002FModule Participant Selection\n\nPreviously Untreated Patients Arm\n\nInclusion Criteria:\n\n1. Diagnosis of congenital hemophilia A (FVIII \\\u003C40%) or hemophilia B (FIX \\\u003C40% or below lower limit for age)\n2. Age \\\u003C18 years at time of enrollment\n3. Parent or authorized guardian or legally authorized representative (LAR) can provide informed consent\n4. Care established at one of the ATHN Transcends participating HTCs\n5. Clotting Factor Concentrate (CFC) exposure, fresh frozen plasma (FFP), cryoprecipitate, and single donor platelets \\\u003C3 exposure days (ED)\n\nExclusion Criteria\n\n1. Concomitant diagnosis with another bleeding disorder\n2. History of a confirmed, positive inhibitor\n\nINHIBIT Module\n\nInclusion Criteria:\n\n1\\. Diagnosis of severe factor VIII deficiency with baseline factor VIII level \\\u003C1% 2. Initiating or plan to initiate prophylaxis with emicizumab or factor replacement 3. Factor concentrate exposure, Fresh Frozen Plasma (FFP), cryoprecipitate, and single donor platelets ≤3 EDs 4. ≤5 years of age\n\nExclusion Criteria\n\n1. Concomitant diagnosis with bleeding disorder other than hemophilia A\n2. Immune disorder\n3. Previous history or presence of factor VIII inhibitor. A confirmed, positive inhibitor is defined as two consecutive positive inhibitor titers (≥ 0.6 BU) that result in changes in treatment recommendations.\n\nEfanesoctocog alfa (ALTUVIIIO®) Module\n\nInclusion criteria:\n\n1. Ability of the potential participant's legally authorized representative (e.g., their parent or legal guardian) to understand the purpose and risks of the study and provide signed and dated informed consent and authorization to use confidential health information in accordance with national and local participant privacy regulation.\n2. People with severe HA with a baseline FVIII activity of less than 1%. (While inclusion for participation in ATHN Transcends lists \\\u003C5% FVIII activity, this proposed module will limit enrollment to people with FVIII activity levels of \\\u003C1%.) Other severities may be included per ATHN Transcends PI approval.\n3. \\\u003C18 years of age.\n4. No history of a confirmed, positive FVIII inhibitor.\n5. Sex assigned at birth of male, female, or intersex.\n6. Participants should have no more than three (3) exposure days of blood products (fresh frozen plasma, cryoprecipitate, or platelets), no more than three (3) doses of any FVIII concentrate other than efanesoctocog alfa, and up to three (3) doses of efanesoctocog alfa prior to enrollment.\n7. Site PI confirmed all inclusion criteria has been met.\n\nExclusion criteria:\n\n1. Not meeting all the inclusion criteria; confirmed by site PI.\n2. Any exposure to blood products or FVIII replacement products except as described in the inclusion criteria.\n3. History of positive inhibitor testing.\n4. History of hypersensitivity reactions associated with efanesoctocog alfa administration.\n5. Other coagulation disorder(s) in addition to Hemophilia A.\n6. Any concurrent clinically significant major disease such as cancer that, in the opinion of the investigator, would make the participant unsuitable for enrollment.\n7. Concurrent systemic treatment with chemotherapy and\u002For other immunosuppressant medications. Use of corticosteroids for the treatment of asthma or management of acute allergic or otherwise life-threatening episodes is allowed except for systemic corticosteroid treatment given to children daily or on an alternate day schedule at \\> 2 mg\u002Fkg\u002Fday of prednisone or its equivalent or \\> 20 mg\u002Fday if the duration is longer than 14 days.\n8. Enrollment in a concurrent clinical interventional drug study.\n9. Intake of an Investigational Medicinal Product within three (3) months prior to inclusion in this study.\n10. Inability to comply with study requirements.\n11. Other, unspecified reasons that, in the investigator's opinion, make the participant unsuitable for enrollment.\n\nHemophilia Natural History Arm\n\nInclusion Criteria\n\n1. Congenital or acquired hemophilia A or B of any severity with or without inhibitors receiving a current therapy, a non-factor product, or for whom use of a non-factor product is a possibility, OR\n2. Females of any age, with confirmed congenital hemophilia A or B carrier status with genetic mutational analysis and any factor level.\n\nExclusion Criteria\n\n1. Presence of any known bleeding disorder other than congenital hemophilia A or B\n2. Presence of concurrent hemophilia and a second hemostatic defect (low von Willebrand Factor (vWF) without vWD diagnosis is not excluded)\n3. Unable or unwilling to comply with the study arm protocol.\n\nNonacog beta pegol (Rebinyn®) Module\n\nInclusion Criteria:\n\n1. Has provided signed written consent for the nonacog beta pegol (Rebinyn®)Module before any study-related activities.\n2. Male participants, at any age with hemophilia B, naïve or minimally exposed (up to 3 EDs) to nonacog beta pegol treatment at time of study enrollment. Additional doses may be allowable per ATHN Transcends PI approval.\n3. Decision to initiate continuous prophylaxis treatment with commercially available nonacog beta pegol has been made by the participant(s)\u002FLegally Authorized Representative(s) (LAR(s)) and the treating physician before and independently from the decision to include the participant in this study.\n\nExclusion Criteria:\n\n1. Previous participation in this study. Participation is defined as having given informed consent in this study.\n2. Mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation, including a diagnosis or suspicion of attention deficit hyperactivity disorder (ADHD) or autism spectrum disorder (ASD) per the discretion of the Principal Investigator.\n3. Known or suspected hypersensitivity to nonacog beta pegol or related products.\n4. Clinical suspicion or presence of FIX inhibitor at time of inclusion.\n5. Inability or unwillingness to undergo neurological assessment\u002Fstructured developmental history.\n\nEmicizumab (Hemlibra®) Module\n\nInclusion Criteria:\n\n1. Participant currently treated with emicizumab (Hemlibra®)\n2. Currently enrolled in the Hemophilia Natural History Arm of ATHN Transcends\n\nExclusion Criteria:\n\n1\\. Unable or unwilling to comply with the protocol\n\nDistress Module\n\nInclusion Criteria:\n\n1. Congenital hemophilia A or B of any severity with or without inhibitors receiving a current therapy, a non-factor product, or for whom use of a non-factor product is a possibility\n2. Age 18 years of age or older\n3. English speaking\n\nExclusion Criteria:\n\n1. Presence of any known bleeding disorder other than congenital hemophilia A or B;\n2. Presence of concurrent hemophilia and a second hemostatic defect (low von Willebrand Factor (vWF) without vWD diagnosis is not excluded); and\n3. Unable or unwilling to comply with the study arm protocol\n\nHemophilia Gene Therapy Outcomes Arm\n\nInclusion Criteria\n\n1. Hemophilia A or B of any severity with or without inhibitors having received or will receive a hemophilia gene transfer product in the next 6 months.\n2. Age 18 years and older.\n3. Able to give informed consent.\n\nExclusion Criteria None\n\nEtranacogene dezaparvovec (HEMGENIX®) Module\n\nInclusion Criteria:\n\nEtranacogene dezaparvovec (HEMGENIX®) Cohort\n\n1. Age 18 years of age or older\n2. Treatment with commercial etranacogene dezaparvovec (HEMGENIX®)\n3. Have provided signed written informed consent within 3 months before or within 6 months after etranacogene dezaparvovec (HEMGENIX®) treatment, or within 6 months of when the study is initiated at the treating site.\n\nFIX Prophylaxis Cohort\n\n1. Age 18 years of age or older\n2. Treatment with FIX prophylaxis therapy\n3. Has provided signed written consent at any time for ATHN Transcends Study\n\nExclusion Criteria, both cohorts:\n\n1\\. Have been treated with etranacogene dezaparvovec in a clinical trial prior to commercial availability. These patients are still eligible for enrollment in the Gene Therapy Outcomes Arm, and their data may be collected for separate analysis.\n\nCongenital Platelet Disorders Arm\n\nInclusion Criteria\n\n1. Platelet adhesion defect\n\n   1. Bernard Soulier syndrome (Defective GPIb-IX-V receptor, impaired adhesion to vWF)\n   2. Velocardio-facial syndrome\u002FDiGeorge syndrome (Defective GPIb-IX-V receptor)\n   3. Platelet type vWD (Defective GPIb-IX-V, gain of function interaction between vWF-GP1bα)\n2. Platelet aggregation defect\n\n   1. Glanzmann thrombasthenia (Defective integrin αIIbβ3 (GPIIb\u002FIIIa)\n   2. Platelet aggregation defect, NOS\n3. Agonist receptor defects\n\n   1. Epinephrine\n   2. ADP\n   3. Collagen\n   4. Thromboxane A2\n4. Platelet signaling defects\n\n   1. Cyclooxygenase deficiency (PTGS1 mutation)\n   2. Phospholipase A2 deficiency\n   3. Thromboxane synthase deficiency (TBXAS1 mutation)\n   4. G protein activation defect (GNAS mutation)\n   5. Scott syndrome (defect in phosphatidyl serine translocation)\n5. Platelet Granule disorders\n\n   1. Dense granule storage pool disorder\n\n      * Hermansky Pudlak syndrome\n      * Chediak Higashi syndrome\n      * Griscelli syndrome\n   2. Alpha granule storage pool disorder\n\n      * Grey platelet syndrome\n      * Arthrogryposis-Renal Dysfunction-Cholestasis (ARC) syndrome\n      * Quebec platelet disorder\n      * Paris-Trousseau syndrome\n   3. Combined alpha delta granule deficiency\n6. Platelet cytoskeletal structure defects\n\n   1. Wiskott Aldrich syndrome\n   2. MYH9 associated disorders (myosin heavy chain)\n\n      * May Hegglin syndrome\n      * Fechtner syndrome\n      * Sebastian syndrome\n      * Epstein syndrome\n   3. Other mutations\n\n      * FLNA mutations (Filamin)\n      * DIAPH1 (Actin and microtubules)\n      * ACTN1 (alpha actinin)\n      * TPM4 (tropomyosin)\n      * TUBB1 (beta tubulin)\n7. Other Congenital thrombocytopenias\n\n   1. Familial platelet disorders and predisposition to AML (RUNX1)\n   2. X linked thrombocytopenia with dyserythropoiesis (GATA1)\n   3. Congenital amegakaryocytic thrombocytopenia (MPL)\n\nExclusion Criteria\n\n1. Diagnosis of von Willebrand Disease (Meeting the definition of vWD or low vWF per most recent international guidelines)\n2. Diagnosis of Hemophilia A or Hemophilia B (Factor VIII or IX ≤ 40%)\n\nGlanzmann Thrombasthenia (GT) Module\n\nInclusion Criteria\n\n1. Participant has signed the informed consent\u002Fassent form\n2. Participant has flow cytometry or aggregometry or genetics confirmed GT\n3. Participant is willing to perform study procedures, including daily bleed tracking for 3 months and further if requested\n4. Participants are 2 years or older at time of consent\n\nExclusion Criteria None","ALL",{"count":18,"type":19},3000,"ESTIMATED","OBSERVATIONAL","In parallel with the growth of ATHN's clinical studies, the number of new therapies for all blood disorders is increasing significantly. Some of the recently FDA-approved therapies for congenital and acquired hematologic conditions have not yet demonstrated long-term safety and effectiveness beyond the pivotal trials that led to their approval. In addition, results from well controlled, pivotal studies often cannot be replicated once a therapy has been approved for general use.2,3,4,5\n\nIn 2019 alone, the FDA has issued approvals for 24 new therapies for congenital and acquired hematologic conditions.6 In addition, almost 10,000 new studies for hematologic diseases are currently registered on www.clinicaltrials.gov.7\n\nWith this increase in potential new therapies possible, it is imperative that clinicians and clinical researchers in the field of non-neoplastic hematology have a uniform, secure, unbiased, and enduring method to collect long-term safety and efficacy data. As emphasized in a recently published review, accurate, uniform and quality national data collection is critical in clinical research, particularly for longitudinal cohort studies covering a lifetime of biologic risk.8",[23,24,25,26,27,28,29,30,31,32,33,34,35],"Hematologic Disorder","Bleeding Disorder","Connective Tissue Disorder","Hemophilia","Thrombosis","Von Willebrand Diseases","Thrombophilia","Rare Bleeding Disorder","Platelet Disorder","Factor IX Deficiency","Factor VIII Deficiency","Thalassemia","Sickle Cell Disease","RECRUITING","2026-07-10",{"date":39,"type":40},"2026-07-13","ACTUAL",{"date":42,"type":40},"2020-09-30",{"date":44,"type":19},"2035-12",{"name":46,"class":47},"American Thrombosis and Hemostasis Network","NETWORK",71,{"id":50,"slug":4,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":4,"maxAge":4,"enrollmentInfo":51,"targetDuration":4,"studyType":20,"phases":4,"briefSummary":21,"conditions":52,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":53,"lastUpdatePostDateStruct":54,"startDateStruct":56,"completionDateStruct":57,"leadSponsor":58,"locationsCount":48},"100393100",{"count":18,"type":19},[23,24,25,26,27,28,29,30,31,32,33,34,35],"2026-01-09",{"date":55,"type":40},"2026-01-12",{"date":42,"type":40},{"date":44,"type":19},{"name":46,"class":47},{"id":60,"slug":61,"hasResults":11,"nctId":62,"briefTitle":63,"officialTitle":64,"acronym":65,"eligibilityCriteria":66,"healthyVolunteers":11,"sex":16,"minAge":67,"maxAge":4,"enrollmentInfo":68,"targetDuration":4,"studyType":70,"phases":71,"briefSummary":73,"conditions":74,"keywords":77,"overallStatus":81,"whyStopped":4,"lastUpdateSubmitDate":82,"lastUpdatePostDateStruct":83,"startDateStruct":85,"completionDateStruct":87,"leadSponsor":89,"locationsCount":92},"100616305","phase-2-golidocitinib-for-refractory-immune-related-hematologic-toxicities-of-advanced-lung-cancer-100616305","NCT07303881","Golidocitinib for Refractory Immune-related Hematologic Toxicities of Advanced Lung Cancer","A Clinical Study Evaluating the Safety and Efficacy of Golidocitinib in Patients With Refractory Immune-related Hematologic Toxicities of Advanced Lung Cancer","JACKPOT22","Inclusion Criteria:\n\n1. Able to provide a signed and dated informed consent form, including compliance with the Informed Consent Form (ICF) and the requirements and limitations listed in this protocol.\n2. The subject is ≥18 years of age at the time of signing the ICF.\n3. Has not experienced disease progression in the past two weeks and has a Eastern Cooperative Oncology Group (ECOG) score of 0-2, with a predicted survival of ≥12 weeks.\n4. Pathologically or cytologically confirmed locally advanced (American Joint Committee on Cancer, AJCC 8th edition IIIB and IIIC stages) or metastatic (stage IV) non-small cell lung cancer, or extensive-stage small cell lung cancer (AJCC 8th edition TNM staging of lung cancer stage IV, or T3-4 disease caused by multiple pulmonary nodules with excessive disease spread, or tumor\u002Fnodule size too large for a tolerable radiation therapy plan).\n5. Patients confirmed by an accredited local laboratory to lack any therapeutically targeted driver gene mutations, i.e., driver gene-negative subjects.\n6. Patients experiencing grade ≥3 refractory hematologic toxicity (white blood cell count \\\u003C2.0 × 10⁹\u002FL or\u002Fand absolute neutrophil count \\\u003C1.0 × 10⁹\u002FL or\u002Fand platelet count \\\u003C50 × 10⁹\u002FL or\u002Fand hemoglobin \\\u003C8.0 g\u002FdL, specific hematologic parameters are detailed in Appendix D), during treatment with immune checkpoint inhibitors (including monotherapy or combination therapy), and the toxicity is considered to be immune-related. Refractory toxicity is defined in two main ways: ① Resistance to conventional treatment: No significant improvement in hematologic toxicity after at least 3 days of supportive care including the use of hormones (e.g., methylprednisolone ≥1 mg\u002Fkg\u002Fd), hematopoietic growth factors (e.g., G-CSF, TPO), and\u002For blood transfusions; ② Positive antinuclear antibody profile indicating anti-SSA antibodies and\u002For Ro52 antibodies, suggesting an immune-mediated mechanism.\n7. Patients with brain metastases must be asymptomatic or have been treated and have stable disease after discontinuation of steroids and anticonvulsants. Patients suspected of having brain metastases at screening should undergo brain CT\u002FMRI before study enrollment.\n8. At least one measurable lesion (as defined in RECIST 1.1): a lesion that has not undergone radiotherapy, has a long diameter ≥10 mm (short diameter ≥15 mm for lymph node lesions), and can be accurately and repeatedly measured from baseline on CT or MRI; and a measurable lesion outside the central nervous system.\n9. Adequate organ system functional reserve, summarized as follows:\n\n   * Total bilirubin ≤1.5×ULN; if Gilbert's syndrome (unconjugated hyperbilirubinemia) is present, total bilirubin should be ≤3×ULN.\n   * ALT and AST ≤2.5×ULN. For patients with documented liver metastases, AST and ALT levels ≤5×ULN.\n   * Creatinine clearance, calculated using the Cockcroft-Gault method, \\>60 ml\u002Fmin for patients treated with cisplatin and \\>45 ml\u002Fmin for patients treated with carboplatin.\n   * Urinalysis shows less than 2+ protein in urine, or 24-hour urine protein quantification \\\u003C1g.\n   * Good coagulation function, defined as International Normalized Ratio (INR) and\u002For Prothrombin Time (PT) ≤1.5 times the ULN and\u002For Activated Partial Thromboplastin Time (APTT) ≤1.5 of the upper limit of normal; if the subject is receiving anticoagulation therapy, PT is acceptable as long as it is within the range intended for use with the anticoagulant.\n   * Serum amylase ≤1.5 times the ULN and\u002For serum lipase ≤1.5 times the ULN.\n   * Echocardiography (ECHO) shows a left ventricular ejection fraction (LVEF) ≥55%.\n10. Women of Childbearing Potential (WOCBP) must undergo a urine and\u002For serum pregnancy test (if the urine test cannot confirm a negative result) within 7 days prior to the first dose of the study drug, and the result must be negative; WOCBP or male subjects and their WOCBP partners should agree to use effective contraception from the signing of the ICF until 6 months after the last dose of the study drug. k. Participants should be able to understand the study protocol and voluntarily comply with the study and follow-up.\n\nExclusion Criteria:\n\na. An active autoimmune disease requiring systemic treatment (e.g., use of disease-modifying medications, corticosteroids, or immunosuppressants) within 2 years prior to the first dose. Replacement therapies (e.g., thyroxine, insulin, or physiological corticosteroids for adrenal or pituitary insufficiency) are not considered systemic treatment.\n\nb. Prior to the first dose, any other form of immunosuppressive therapy other than corticosteroids (e.g., TNF-α inhibitors, mycophenolate mofetil, gamma globulin, rituximab, other JAK inhibitors, etc.) was received for hematologic toxicity.\n\nc. Spinal cord compression or meningeal metastases are present. d. Any of the following medical histories:\n\n* Currently participating in an interventional clinical trial, or having received other investigational drugs or used investigational devices within 4 weeks prior to the first dose; any drug still in development requires a 5-half-life washout (or discussion with the research team);\n* Underwent major surgery (excluding diagnostic or biopsy, excluding vascular access) within 4 weeks prior to the first dose, or is expected to undergo major surgery during the study;\n* Received palliative radiation therapy within 2 weeks prior to the first dose;\n* Have experienced a serious arterial\u002Fvenous thrombotic event within 6 months prior to the first dose, including cerebrovascular accidents (e.g., history of stroke or intracranial hemorrhage), deep vein thrombosis, and pulmonary embolism;\n* Currently receiving (or unable to discontinue at least 1 week prior to the first dose) any known potent inducer or inhibitor of CYP3A, herbal supplements, or foods;\n* Have experienced a grade CTCAE \\> 1 adverse event (excluding any degree of alopecia and hematologic toxicity) due to prior treatment prior to the first dose. e. Has received a solid organ or blood system transplant (e.g., a previous allogeneic bone marrow transplant).\n\n  f. Has a history of interstitial lung disease, drug-induced interstitial lung disease, radiation pneumonitis requiring corticosteroid therapy, or currently has active interstitial lung disease (including interstitial lung changes), or immune-mediated pneumonitis caused by immunotherapy.\n\n  g. Has been diagnosed with another malignancy within 5 years prior to the first dose, excluding clinically cured basal cell carcinoma, squamous cell carcinoma, and\u002For radically resected carcinoma in situ.\n\n  h. Has received a live vaccine, including attenuated live vaccines, excluding inactivated vaccines, within 30 days prior to the first dose.\n\n  i. Has known active tuberculosis, such as a positive tuberculin (PPD) test (induration diameter \\> 10 mm), a positive T-SPOT test, tuberculous lesions on chest X-ray\u002FCT, or other positive results found according to routine clinical screening (excluding those cured by investigator assessment after standard anti-tuberculosis treatment).\n\n  j. Subjects with pre-existing, uncontrollable severe infectious diseases must be excluded. If an infectious disease occurred within two months prior to the first dose, its control must be assessed by the research team to determine eligibility for enrollment.\n\n  k. Subjects with active infections, including but not limited to hepatitis B virus (HBV), hepatitis C virus (HCV), human immunodeficiency virus (HIV) (see table below), and active COVID-19 infection (determined by the investigator to be clinically significant, with signs or symptoms). COVID-19 testing will be based on local practice.\n\n  l. Meeting any of the following cardiac criteria:\n* Congestive heart failure (CHF) classified as \\>II by the New York Heart Association (NYHA);\n* Clinically significant valvular heart disease, hypertrophic or constrictive cardiomyopathy;\n* Any clinically significant abnormality on resting ECG, such as complete left bundle branch block, second\u002Fthird-degree atrioventricular block, or PR interval \\>250 msec;\n* Average calibrated QTcF \\>470 msec on three resting ECGs during the screening period;\n* Any factor that could increase the risk of QT interval prolongation or arrhythmic events (e.g., heart failure, hypokalemia, congenital long QT syndrome, or a first-degree relative with long QT syndrome or a family history of unexplained sudden death under 40 years of age, or any concomitant medication known to prolong the QT interval);\n* Ventricular arrhythmias requiring treatment;\n* An acute myocardial infarction (AMI), the onset of unstable angina, or a new onset of angina within 6 months prior to administration.\n\n  m. Hypersensitivity to the study drug or any component thereof. n. Intractable nausea and vomiting, chronic gastrointestinal disease, difficulty swallowing medication, intestinal obstruction, or a history of bowel resection that may prevent adequate absorption of the study drug.\n\n  o. Pregnancy or lactation. p. Known bleeding diathesis, i.e., hemophilia or von Willebrand disease. q. Investigator assessment indicating a serious or uncontrolled systemic disease (including poorly controlled hypertension and bleeding disorders) that precludes participation in the clinical study or may lead to poor adherence.","18 Years",{"count":69,"type":19},16,"INTERVENTIONAL",[72],"PHASE2","This study is a single-arm clinical trial designed to evaluate the safety and efficacy of golidocitinib in patients with refractory, immune-related hematologic toxicity in advanced lung cancer.",[75,23,76],"IrAE","Lung Cancer (Locally Advanced or Metastatic)",[78,79,80],"Immune-related hematologic toxicities","irAE","Lung cancer","NOT_YET_RECRUITING","2025-12-12",{"date":84,"type":40},"2025-12-26",{"date":86,"type":19},"2026-02",{"date":88,"type":19},"2028-12",{"name":90,"class":91},"The First Affiliated Hospital of Guangzhou Medical University","OTHER",1]