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Apotheek KGO","Utrecht","3584 CW","Netherlands","NL",{"type":79,"coordinates":455},[456,457],5.12222,52.09083,{"lat":457,"lon":456},{"facility":460,"status":97,"city":450,"state":46,"zip":461,"country":452,"countryCode":453,"cosmosGeoPoint":462,"geoPoint":464,"contacts":46},"University Medical Center (UMC) Utrecht","3584 CX",{"type":79,"coordinates":463},[456,457],{"lat":457,"lon":456},{"type":466,"investigatorFullName":46,"investigatorTitle":46,"investigatorAffiliation":46,"oldNameTitle":46,"oldOrganization":46},"SPONSOR","100379997","phase-1-a-safety-study-of-sea-cd70-in-patients-with-myeloid-malignancies-100379997",false,"NCT04227847","A Safety Study of SEA-CD70 in Patients With Myeloid Malignancies","A Phase 1 Study of SEA-CD70 in Myeloid Malignancies","Part A Inclusion Criteria\n\n* Participants with cytologically\u002Fhistologically confirmed MDS (2016 World Health Organization (WHO) classification) with\n\n  * Measurable disease per WHO MDS with excess blasts criteria\n  * MDS that is relapsed or refractory and must not have other therapeutic options\n  * Treatment failure after prior hypomethylating agent (HMA) therapy for MDS\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0-1\n\nPart B Inclusion Criteria\n\n* Participants with cytologically\u002Fhistologically confirmed MDS (WHO classification) with:\n\n  * Measurable disease per WHO MDS with excess blasts (MDS-EB) criteria\n  * MDS that is relapsed or refractory and must not have other therapeutic options\n  * Treatment failure after prior HMA therapy for MDS\n* ECOG Performance Status of 0-2\n\nPart C Inclusion Criteria\n\n* Participants with relapsed or refractory AML (ICC 2022) (except for acute promyelocytic leukemia \\[APL\\]):\n\n  * Who have received either 2 or 3 previous regimens\n  * Who have received 1 previous regimen to treat active disease and have at least one of the following:\n\n    * Age \\> 60 and ≤75 years.\n    * Primary resistant AML or secondary AML\n    * First CR duration \\\u003C6 months\n    * Adverse-risk per European Leukemia Network genetic risk stratification\n* Age 18-75 years\n* ECOG performance status of 0-2\n\nParts D and F Inclusion Criteria\n\n* Participants with diagnosis of MDS or MDS\u002FAML (ICC 2022 criteria)\n* Disease which has relapsed, failed to respond after minimum of 6 cycles, or progressed following an HMA in the immediately preceding line of therapy.\n* Eligible for continued therapy with azacitidine\n* ECOG Performance Status 0-2\n\nParts D and E Inclusion Criteria\n\n* Participants with diagnosis of MDS or MDS\u002FAML (ICC 2022 criteria), previously untreated.\n* Participants with higher-risk per IPSS-M MDS and MDS\u002FAML\n* ECOG Performance Status 0-2\n\nPart G Inclusion Criteria\n\n* Participants with diagnosis of AML (ICC 2022 criteria), previously untreated and ineligible for standard induction chemotherapy.\n* Age ≥18 years.\n* ECOG Performance Status of 0-2.\n\nExclusion Criteria (All Parts)\n\n* Previous exposure to CD70-targeted agents\n* Prior allogeneic hematopoietic stem cell transplant, for any condition\n* Central nervous system leukemia\n* History of clinically significant sickle cell anemia, autoimmune hemolytic anemia, or idiopathic thrombocytopenic purpura\n* Parts D, F and G only: Prior oral HMA or oral HMA-combinations\n* Part G: conditions that preclude enteral route of administration; concomitant use of strong\u002Fmoderate CYP3A inducers; history of myeloproliferative neoplasm","ALL","18 Years",{"count":477,"type":478},178,"ESTIMATED","INTERVENTIONAL",[481],"PHASE1","This trial will look at a drug called SEA-CD70 with and without azacitidine, to find out if it is safe for participants with myelodysplastic syndrome (MDS) and acute myeloid leukemia (AML). It will study SEA-CD70 to find out what its side effects are and if it works for AML and MDS. A side effect is anything the drug does besides treating cancer.\n\nThis study will have seven groups or \"parts.\"\n\n* Part A will find out how much SEA-CD70 should be given to participants\n* Part B will use the dose found in Part A to find out how safe SEA-CD70 is and if it works to treat participants with MDS.\n* Part C will use the dose found in Part A to find out how safe SEA-CD70 is and if it works to treat participants with AML.\n* Part D will find out how much SEA-CD70 with azacitidine should be given to participants\n* Part E will use the dose found in Part D to find out how safe SEA-CD70 with azacitidine is and if it works to treat participants with MDS or MDS\u002FAML that has not been treated.\n* Part F will use the dose found in Part D to find out how safe SEA-CD70 with azacitidine is and if it works to treat participants with MDS or MDS\u002FAML.\n* Part G will find out how much SEA-CD70 with azacitidine and with venetoclax should be given to participants with AML. Also, to evaluate safety and tolerability of PF-08046040 in combination with azacitidine and venetoclax in participants with previously untreated AML who are unfit for standard induction chemotherapy.",[484,485],"Myelodysplastic Syndrome","Acute Myeloid Leukemia",[487],"Seattle Genetics","2026-04-06",{"date":490,"type":491},"2026-04-07","ACTUAL",{"date":493,"type":491},"2020-08-07",{"date":495,"type":478},"2028-07-03",{"name":497,"class":6},"Seagen, a wholly owned subsidiary of Pfizer",54]