[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"recurrent-blastic-plasmacytoid-dendritic-cell-neoplasm\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:recurrent-blastic-plasmacytoid-dendritic-cell-neoplasm":34},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,72],{"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":55,"overallStatus":59,"whyStopped":4,"lastUpdateSubmitDate":60,"lastUpdatePostDateStruct":61,"startDateStruct":64,"completionDateStruct":66,"leadSponsor":68,"locationsCount":71},"100310864","phase-1-ha-1-t-tcr-t-cell-immunotherapy-for-the-treatment-of-patients-with-relapsed-or-refractory-acute-leukemia-after-donor-stem-cell-transplant-100310864",false,"NCT03326921","HA-1 T TCR T Cell Immunotherapy for the Treatment of Patients With Relapsed or Refractory Acute Leukemia After Donor Stem Cell Transplant","Phase I Study of Adoptive Immunotherapy With CD8+ and CD4+ Memory T Cells Transduced to Express an HA-1-Specific T Cell Receptor (TCR) for Children and Adults With Recurrent Acute Leukemia After Allogeneic Hematopoietic Stem Cell Transplantation (HCT)","Inclusion Criteria:\n\n* Subject age 0-80 years at the time of enrollment.\n* Subject must express HLA-A\\*0201\n* Subject must have the HA-1(H) genotype (RS\\_1801284: A\u002FG, A\u002FA)\n* Subject must have an adult donor for HCT who is adequately HLA matched by institutional standards (includes HLA-matched related or unrelated donors, and HLA-mismatched family donors, including haploidentical donors) and is either:\n\n  * HLA-A\\*0201 positive and HA-1(H) negative (RS\\_1801284: G\u002FG) or\n  * HLA-A\\*0201 negative\n* Subjects who are currently undergoing or who previously underwent allogeneic HCT for\n\n  * Acute myeloid leukemia (AML) of any subtype\n  * Acute lymphoid leukemia (ALL) of any subtype\n  * Mixed phenotype\u002Fundifferentiated\u002Fany other type of acute leukemia, including blastic plasmacytoid dendritic cell neoplasm\n  * Chronic myeloid leukemia with a history of blast crisis and:\n\n    * With relapse or refractory disease (\\>= 5% marrow blasts, or circulating blasts) at any time after HCT\n    * With persistent rising minimal residual disease (defined as detectable disease by morphology, flow cytometry, molecular or cytogenetic testing but \\\u003C 5% marrow blasts by morphology, no circulating blasts on \\>= 2 of two consecutive tests), refractory or ineligible for treatment with tyrosine kinase inhibitors at any time after HCT\n  * Myelodysplastic syndrome (MDS) of any subtype\n  * Chronic myelomonocytic leukemia (CMML)\n  * Juvenile myelomonocytic leukemia (JMML)\n* Subjects must be able to understand and be willing to give informed consent; decision-impaired adults may consent with their legally authorized representative; parent or legal representative will be asked to consent for subjects younger than 18 years old\n* Subjects must agree to participate in long-term follow-up for up to 15 years if they are enrolled in the study and receive T cell infusion\n* Subjects who have relapsed or have MRD after HCT may receive other agents for treatment of disease and remain eligible for the protocol\n* A specific performance status score is not required for enrolling on the protocol; a delay in infusion of the HA-1 TCR T cells may be required for subjects with low performance status\n\nDONOR SELECTION INCLUSION\n\n* Donor age \\>= 18 years\n* Donors must be able to give informed consent\n\nExclusion Criteria:\n\n* Medical or psychological conditions that would make the subject unsuitable candidate for cell therapy at the discretion of the principal investigator (PI)\n* Fertile subjects unwilling to use contraception during and for 12 months after treatment\n* Subjects with a life expectancy of \\\u003C 3 months of enrollment from coexisting disease other than leukemia\n* Subjects who have ongoing grade IV acute GVHD or severe chronic GVHD following most recent transplant. Exception: the principal investigator (PI) may make an exception on a case-by-case basis to include such a subject if there is doubt surrounding the GVHD diagnosis and\u002For sustained significant improvement in GVHD severity\n* The presence of organ toxicities will not necessarily exclude subjects from enrolling on the protocol at the discretion of the PI; however, a delay in the infusion of HA-1 TCR T cells may be required\n\nDONOR SELECTION EXCLUSION\n\n* Donors who are human immunodeficiency virus (HIV)-1, HIV-2, human T-lymphotropic virus (HTLV)-1, HTLV-2 seropositive or with active hepatitis B or hepatitis C virus infection\n* Unrelated donor residing outside of the United States of America (USA) unless the donor screening, testing and leukapheresis occur at an National Marrow Donor Program (NMDP)-affiliated and qualified donor center and are facilitated by the NMDP","ALL","80 Years",{"count":19,"type":20},24,"ESTIMATED","INTERVENTIONAL",[23],"PHASE1","This phase I trial studies the side effects and best dose of CD4+ and CD8+ HA-1 T cell receptor (TCR) (HA-1 T TCR) T cells in treating patients with acute leukemia that persists, has come back (recurrent) or does not respond to treatment (refractory) following donor stem cell transplant. T cell receptor is a special protein on T cells that helps them recognize proteins on other cells including leukemia. HA-1 is a protein that is present on the surface of some peoples' blood cells, including leukemia. HA-1 T cell immunotherapy enables genes to be added to the donor cells to make them recognize HA-1 markers on leukemia cells.",[26,27,28,29,30,31,32,33,34,35,36,37,38,39,40,41,42,43,44,45,46,47,48,49,50,51,52,53,54],"Juvenile Myelomonocytic Leukemia","Recurrent Acute Biphenotypic Leukemia","Recurrent Acute Undifferentiated Leukemia","Recurrent Childhood Acute Lymphoblastic Leukemia","Recurrent Childhood Acute Myeloid Leukemia","Refractory Acute Lymphoblastic Leukemia","Refractory Adult Acute Lymphoblastic Leukemia","Blast Phase Chronic Myeloid Leukemia, BCR-ABL1 Positive","Recurrent Blastic Plasmacytoid Dendritic Cell Neoplasm","Recurrent Myelodysplastic Syndrome","Refractory Blastic Plasmacytoid Dendritic Cell Neoplasm","Refractory Myelodysplastic Syndrome","Acute Undifferentiated Leukemia","Mixed Phenotype Acute Leukemia","Recurrent Chronic Myeloid Leukemia, BCR-ABL1 Positive","Refractory Chronic Myeloid Leukemia, BCR-ABL1 Positive","Recurrent Acute Lymphoblastic Leukemia","Recurrent Acute Myeloid Leukemia","Myelodysplastic Syndrome","Acute Myeloid Leukemia","Acute Lymphoblastic Leukemia","Acute Biphenotypic Leukemia","Chronic Myeloid Leukemia","Chronic Myelomonocytic Leukemia","Minimal Residual Disease","Recurrent Chronic Myelomonocytic Leukemia","Recurrent Mixed Phenotype Acute Leukemia","Leukemia","Chronic Myeloid Leukemia, BCR-ABL1 Positive",[56,57,58,53],"HA-1","TCR","Immunotherapy","RECRUITING","2026-05-15",{"date":62,"type":63},"2026-05-18","ACTUAL",{"date":65,"type":63},"2018-02-23",{"date":67,"type":20},"2028-07-16",{"name":69,"class":70},"Fred Hutchinson Cancer Center","OTHER",1,{"id":73,"slug":74,"hasResults":11,"nctId":75,"briefTitle":76,"officialTitle":77,"acronym":4,"eligibilityCriteria":78,"healthyVolunteers":11,"sex":16,"minAge":79,"maxAge":4,"enrollmentInfo":80,"targetDuration":4,"studyType":21,"phases":82,"briefSummary":83,"conditions":84,"keywords":4,"overallStatus":59,"whyStopped":4,"lastUpdateSubmitDate":117,"lastUpdatePostDateStruct":118,"startDateStruct":120,"completionDateStruct":122,"leadSponsor":124,"locationsCount":5},"100570866","phase-1-q702-for-the-treatment-of-patients-with-hematologic-malignancies-100570866","NCT06712810","Q702 for the Treatment of Patients With Hematologic Malignancies","MC220806: Phase I Study Evaluating the Efficacy of CSF1R and TAM Receptor or Inhibition in Hematologic Malignancies With Q702, a Small Molecular Inhibitor","Inclusion Criteria:\n\n* PRE-REGISTRATION: Age ≥ 18 years\n* PRE-REGISTRATION: Not eligible for or have failed therapies with established benefits, at the discretion of the treating physician\n* PRE-REGISTRATION: Patients must meet one of the following criteria:\n\n  * Relapsed\u002Frefractory patients with Erdheim-Chester disease, Langerhans histiocytosis, histiocytic sarcoma, or other malignant histiocytosis without activating alterations in v-Raf murine sarcoma viral oncogene homolog B (BRAF) or Mitogen-activated protein kinase kinase (MAP2K) oncogenes who have progressed after first line of therapy.\n\n    * Note: Relapsed is defined as a relapse that occurred after having a response to the last therapy at any point during the treatment. Refractory is no response (stable disease or progressive disease while on therapy) to a given treatment at least after 1 month of being on the given treatment.\n  * Newly diagnosed patients with Rosai-Dorfman disease without activating alterations in MAP2K oncogenes.\n  * Relapsed\u002Frefractory patients with Rosai-Dorfman disease and an activating mitogen-activated protein kinase (MAPK) pathway alteration who have failed prior treatment with cobimetinib.\n  * Relapsed\u002Frefractory patients with Erdheim-Chester disease or Langerhans histiocytosis who have received vemurafenib for BRAF V600E mutated disease or cobimetinib for disease with activating MAP2K alterations.\n  * Patients with Erdheim-Chester disease, Rosai-Dorfman disease, Langerhans histiocytosis, histiocytic sarcoma, or another malignant histiocytosis who cannot tolerate or have a contraindication to BRAF or MEK inhibitors or those who cannot have reliable access to these inhibitors due to financial restraints or geographic location or initiation of BRAF or mitogen-activated protein kinase kinase (MEK) inhibitors is futile based on the genomic alterations or the discretion of treating physician.\n  * Relapsed\u002Frefractory higher risk myelodysplastic syndromes (MDS), chronic myelomonocytic leukemia (CMML) or myelofibrosis (MF).\n\n    * Note: MF patients must have failed ≥ 1 of the 4 Food and Drug Administration (FDA)-approved Janus kinase (JAK) Inhibitors for MF (i.e. ruxolitinib, fedratinib, pacritinib, momelotinib) to be eligible. MDS and CMML patients must have failed hypomethylating agent-based therapy, if eligible.\n    * Note: Higher risk is defined as intermediate or higher risk by international prognostic scoring system (IPSS-R) or moderate high or higher risk as per molecular internal prognostic scoring system (IPSS-M).\n  * T cell lymphoma (peripheral and cutaneous), or mantle cell lymphomas. Patients must have failed ≥ 2 lines of therapy.\n  * Primary central nervous system (CNS) lymphoma who has failed ≥ 2 lines of therapy.\n  * Relapsed or refractory follicular lymphoma; or Waldenstrom macroglobulinemia\u002Flymphoplasmacytic lymphoma. Must have failed ≥ 2 lines of therapy.\n  * Patients with Waldenström macroglobulinemia who have received or are not eligible for a Bruton tyrosine kinase (BTK)-inhibitor therapy.\n  * Relapsed or refractory chronic lymphocytic leukemia (CLL)\u002Fsmall lymphocytic lymphoma (SLL) who have failed ≥ 2 lines of therapy and have been treated with at least one prior line of a BTK inhibitor and\u002For a B-cell lymphoma 2 (BCL2) inhibitor. Need documented CLL\u002FSLL requiring treatment according to International Workshop on Chronic Lymphocytic Leukemia (iwCLL) guidelines 2018.\n\n    * NOTE: Use of oral steroids up to 20 mg of daily will be allowed for patients who are discontinuing BTK inhibitors just prior to the registration. This is not mandatory and should be done at the discretion of patient's treating physician.\n\n      * Note: All patients in the above disease groups may be on corticosteroids at the investigator's discretion\n* PRE-REGISTRATION: Histopathological or cytological confirmation of diseases\n* PRE-REGISTRATION: Willingness to provide mandatory blood, bone marrow aspirate, saliva, and tissue specimens for correlative research, as applicable to the disease site\n* PRE-REGISTRATION: Ability to swallow pills\n* REGISTRATION: Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0, 1, or 2\n* REGISTRATION: Life expectancy of ≥ 3 months\n* REGISTRATION: Measurable or assessable disease:\n\n  * For histiocytic neoplasms and lymphoma-measurable disease is defined as measurable by CT (dedicated CT or the CT portion of a PET\u002FCT) or MRI: To be considered measurable, there must be at least one lesion that has a single diameter of ≥ 1.5 cm for non-CNS disease. For CNS involved disease, MRI confirmation with any size would be appropriate.\n\n    * NOTE: Skin lesions can be used if the area is ≥ 1.5 cm in at least one diameter and photographed with a ruler. Patients with assessable disease by PET\u002FCT are also eligible as long as the assessable disease is biopsy proven lymphoma or histiocytic\u002Fdendritic cell neoplasms.\n  * For all other eligible diseases listed-N\u002FA\n* REGISTRATION: Hemoglobin ≥ 8.0 g\u002FdL (obtained ≤ 14 days prior to registration)\n* REGISTRATION: Absolute neutrophil count (ANC) ≥ 1.0 x 10\\^9\u002FL (obtained ≤ 14 days prior to registration)\n* REGISTRATION: Platelet count ≥ 80 x 10\\^9\u002FL (obtained ≤ 14 days prior to registration)\n* REGISTRATION: White blood cell (WBC) ≥ 2.5 x 10\\^9\u002FL (obtained ≤ 14 days prior to registration)\n* REGISTRATION: Total bilirubin ≤ 1.5 x upper limit of normal (ULN) (obtained ≤ 14 days prior to registration)\n* REGISTRATION: Alanine aminotransferase (ALT), aspartate transaminase (AST), and alkaline phosphatase (ALP) ≤ 2.5 x ULN (≤ 5 x ULN for patients with liver involvement) (obtained ≤ 14 days prior to registration)\n* REGISTRATION: Serum creatinine of ≤ 1.5 x ULN and calculated creatinine clearance of ≥ 50 mL\u002Fmin using the Cockcroft-Gault formula (obtained ≤ 14 days prior to registration)\n* REGISTRATION: Negative urine or serum pregnancy test done ≤ 7 days prior to registration, for persons of childbearing potential only\n* REGISTRATION: Sexually active patients and their partners must use an effective method of contraception associated with a low failure rate prior to study entry and for the duration of study participation and for at least 3 months after the last dose of study drug.\n\n  * Note: The following are considered effective contraceptives: oral contraceptive pill; condom plus spermicide; diaphragm plus spermicide; patient or partner surgically sterile; patient or partner more than 2 years postmenopausal; or injectable or implantable agent\u002Fdevice\n* REGISTRATION: Provide written informed consent\n* REGISTRATION: Ability to complete questionnaire(s) by themselves or with assistance\n* REGISTRATION: Willing to return to the enrolling institution for follow-up (during the Active Monitoring Phase of the study).\n\nExclusion Criteria:\n\n* PRE-REGISTRATION: Myeloproliferative neoplasm (MPN) patients with known active CNS metastases and\u002For carcinomatous meningitis.\n\n  * Note: Histiocytosis and lymphoma patients who are on steroids are allowed to enroll\n* REGISTRATION: Any of the following because this study involves an investigational agent whose genotoxic, mutagenic and teratogenic effect on the developing fetus and newborn are unknown:\n\n  * Pregnant persons\n  * Nursing persons\n  * Persons of childbearing potential (and persons able to father a child) who are unwilling to employ adequate contraception\n* REGISTRATION: New York Heart Association Class III or IV cardiac disease, or myocardial infarction, severe unstable angina, coronary\u002Fperipheral artery bypass graft, congestive heart failure ≤ 6 months prior to registration\n* REGISTRATION: Corrected QT interval (using Fridericia's correction formula) (QTcF) of \\> 470 msec\n* REGISTRATION: Known active infection with human immunodeficiency virus (HIV), Human T-lymphotropic virus 1 (HTLV-1), hepatitis B virus (HBV), or hepatitis C virus (HCV):\n\n  * Active infection with (HIV) and CD4+ T-cell count \\\u003C 350 μL.\n  * Patients with a detectable HIV viral load and not on antiretroviral therapy (ART) for ≥ 4 weeks.\n  * Exceptions:\n\n    * Patients with a history of hepatitis B or C are allowed if HBV deoxyribonucleic acid (DNA) or HCV ribonucleic acid (RNA) are undetectable.\n    * Patients with active HIV infection and CD4+ T-cell count ≥ 350 μL who are on active antiretroviral treatment\n* REGISTRATION: Active, uncontrolled bacterial, viral, or fungal infections, requiring systemic therapy\n* REGISTRATION: Concomitant use of strong inhibitors and inducers of CYP1A2, CYP2C19, CYP2D6, and strong inhibitors and inducers of CYP3A4 within five half-lives of the active drug prior to registration and throughout the trial.\n\n  * Note: Strong inhibitors and inducers of CYP3A4 should be discontinued for five half-lives of the active drug prior to starting study drug and avoided throughout the trial\n* REGISTRATION: Concomitant use of any herbal supplements.\n\n  * Note: Supplements taken prior to starting study drug should be discussed with the Principal Investigator as varied washout periods may be clinically indicated and necessary\n* REGISTRATION: Any of the following prior therapies used as primary cancer treatment:\n\n  * Targeted therapeutics other than monoclonal antibodies (e.g., kinases inhibitors) ≤ 2 weeks prior to registration.\n  * Monoclonal antibodies ≤ 6 weeks, or ≥ 5 half-life, whichever is shorter, prior to registration.\n  * Chemotherapy ≤ 4 weeks prior to registration (6 weeks for nitrosoureas or Mitomycin C.\n  * Surgery ≤ 4 weeks prior to registration\n  * Any investigational therapy ≤ 4 weeks prior to registration\n  * Radiation therapy ≤ 4 weeks prior to registration\n\n    * Exceptions:\n\n      * Palliative radiation therapy ≥ 2 weeks prior to registration for control of tumor mass related symptoms (e.g., pain control from a discrete bone metastasis) allowed, unless the radiation field includes organs for which the radiation therapy could result in certain direct organ toxicities (e.g., radiation induced esophagitis), which could complicate the interpretation of the Q702 safety profile.\n      * Radiation induced toxicities which could interfere with the interpretation of the Q702 safety profile should recover to ≤ grade 1 before registration.\n      * Patients receiving palliative radiation intended to reduce the risk of a potential pathological fracture should be allowed ≥ 4 weeks from the last radiation therapy treatment to recover from any radiation induced toxicity and to allow for an adequate period of observation relative to the potential risk of a pathological fracture\n* REGISTRATION: Failure to recover from acute, reversible effects of prior therapy to ≤ grade 1 or patient baseline prior to registration.\n\n  * NOTE: Patient with chronic effects such as neuropathy, fatigue, keratitis\u002Fkeratopathy, anorexia, etc. are allowed\n* REGISTRATION: Co-morbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens\n* REGISTRATION: Active retinal pigment epithelium (RPE)\u002Fphotoreceptor disorders such as retinitis pigmentosa, cone-rod dystrophies, Bests dystrophy, Stargardt disease (STGD), macular degeneration, retinal detachment, and opaque cornea. Exceptions:\n\n  * Mild blurry vision, either age-related or due to ocular or systemic disorder (e.g., diabetes, dry eyes, cataracts, uncorrected refraction abnormality) may be allowed at the discretion of the ophthalmologist if deemed as not constituting evidence of pre-existing retinopathy (e.g., severe nonproliferative or proliferative diabetes retinopathy) or a condition with the potential to cause a predisposition to drug-induced retinopathy. \\[e.g., severe retinal vascular disease with scattered intraretinal hemorrhages, cotton wool-spots and intraretinal microvascular abnormalities (IRMA)\\]\n  * Patients with only one assessable eye and no evidence of pre-existing retinopathy may be allowed at the discretion of the principal investigator\n* REGISTRATION: Active second malignancy requiring treatment that would interfere with the assessment of the response of the primary cancer or interpretation of the safety of this protocol therapy","18 Years",{"count":81,"type":20},46,[23],"This phase I trial tests the safety, side effects, and best dose of Q702 in treating patients with hematologic malignancies. Q702 is in a class of medications called immunomodulatory agents. It works by helping the immune system kill cancer cells and by helping the bone marrow to produce normal blood cells. Giving Q702 may be safe, tolerable and\u002For effective in treating patients with hematologic malignancies.",[85,86,87,88,89,90,51,91,92,93,35,94,95,96,97,98,99,100,101,102,37,103,104,105,106,107,34,108,109,110,111,112,36,113,114,115,116],"Hematopoietic and Lymphatic System Neoplasm","Histiocytic Sarcoma","Malignant Histiocytosis","Peripheral T-Cell Lymphoma, Not Otherwise Specified","Primary Cutaneous T-Cell Non-Hodgkin Lymphoma","Recurrent Chronic Lymphocytic Leukemia","Recurrent Follicular Lymphoma","Recurrent Langerhans Cell Histiocytosis","Recurrent Lymphoplasmacytic Lymphoma","Recurrent Myelofibrosis","Recurrent Small Lymphocytic Lymphoma","Recurrent Waldenstrom Macroglobulinemia","Refractory Chronic Lymphocytic Leukemia","Refractory Chronic Myelomonocytic Leukemia","Refractory Erdheim-Chester Disease","Refractory Follicular Lymphoma","Refractory Langerhans Cell Histiocytosis","Refractory Lymphoplasmacytic Lymphoma","Refractory Myelofibrosis","Refractory Small Lymphocytic Lymphoma","Refractory Waldenstrom Macroglobulinemia","Rosai-Dorfman-Destombes Disease","Primary Central Nervous System Lymphoma","Recurrent Erdheim-Chester Disease","Recurrent Fibroblastic Reticular Cell Sarcoma","Recurrent Histiocytic Sarcoma","Recurrent Interdigitating Dendritic Cell Sarcoma","Recurrent Rosai-Dorfman-Destombes Disease","Refractory Fibroblastic Reticular Cell Sarcoma","Refractory Histiocytic Sarcoma","Refractory Interdigitating Dendritic Cell Sarcoma","Refractory Rosai-Dorfman-Destombes Disease","2025-10-08",{"date":119,"type":63},"2025-10-10",{"date":121,"type":63},"2025-08-27",{"date":123,"type":20},"2030-09-15",{"name":125,"class":70},"Mayo Clinic"]