[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07511062":3,"trial-entities:NCT07511062":220,"trial-summary:NCT07511062":225},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":21,"study_type":22,"primary_purpose":23,"phases":24,"enrollment_info":26,"interventions":29,"primary_outcomes":44,"secondary_outcomes":53,"sex":66,"minimum_age":67,"maximum_age":17,"healthy_volunteers":68,"eligibility_criteria":69,"std_ages":90,"locations":93,"central_contacts":108,"overall_officials":114,"references":115,"see_also_links":219},"NCT07511062","NSH 1436","Axatilimab Combined With Decitabine\u002FVenetoclax for the Treatment of TP53-mutated AML","Axatilimab Combined With Decitabine\u002FVenetoclax for the Treatment of TP53-mutated\u002FDeleted AML Patients","NOT_YET_RECRUITING","2030-08-01","2026-03","2026-04-06","2026-08-01","Northside Hospital, Inc.","OTHER",true,"Axatilimab combined with Decitabine\u002FVenetoclax for the treatment of TP53-mutated\u002Fdeleted AML patients",null,[19,20],"Acute Myeloid Leukemia","TP53 Gene Mutation",[],"INTERVENTIONAL","TREATMENT",[25],"PHASE1",{"count":27,"type":28},32,"ESTIMATED",[30,36,40],{"type":31,"name":32,"description":33,"armGroupLabels":34},"DRUG","Decitabine","20mg\u002Fm2\u002Fd x5 days (induction \\& consolidation)",[35],"Axatilimab+Decitabine+Venetoclax",{"type":31,"name":37,"description":38,"armGroupLabels":39},"Venetoclax","400mg\u002Fd x14 days (induction); 400mg\u002Fd x7 days (consolidation)",[35],{"type":31,"name":41,"description":42,"armGroupLabels":43},"Axatilimab","Dose escalation, given on Days 1 and 15 of each cycle",[35],[45,49],{"measure":46,"description":47,"timeFrame":48},"Phase 2 Dose Level determination","To find the recommended phase 2 dose (RP2D) of axatilimab when combined with decitabine and venetoclax by recording adverse events based on the CTCAE v.5.","1 year",{"measure":50,"description":51,"timeFrame":52},"Estimation of MRD-negative complete remission","To estimate the MRD-negative complete remission rate after 1-2 cycles of induction chemotherapy with decitabine and venetoclax by conducing bone marrow biopsies and disease response assessments after induction","2 months",[54,57,60,63],{"measure":55,"description":56,"timeFrame":48},"Estimation of Response Rates, Overall Survival","To estimate the complete response rate by evaluating bone marrow biopsies that occur after induction and every 3 months during consolidation",{"measure":58,"description":59,"timeFrame":48},"Evaluation of Safety of the Regimen","To evaluate the safety and tolerability of axatilimab when combined with decitabine and venetoclax by recording all adverse events according to the CTCAE v5.0",{"measure":61,"description":62,"timeFrame":48},"Estimation of Progression Free Survival","To estimate the progression free survival rate by evaluating bone marrow biopsies that occur after induction and every 3 months during consolidation",{"measure":64,"description":65,"timeFrame":48},"Estimation of Overall Survival","To estimate the overall survival rates by contacting patients 1 year after completion of therapy for survival data","ALL","18 Years",false,{"inclusion":70,"exclusion":77,"raw_text":89},[71,72,73,74,75,76],"MDS\u002FAML or AML with a TP53 mutation or deletion, defined as:","greater than or equal to 10% AND (one of the following):","presence of a TP53 mutation","presence of a TP53 deletion by FISH","positive TP53 staining on IHC of diagnostic bone marrow","Either untreated or first salvage (primary refractory or first relapse)",[78,79,80,81,82,83,84,85,86,87,88],"KPS \\\u003C60","active uncontrolled infection","history of HIV or active HBV or HBC infection","currently active second malignancy","calculated CrCl \\\u003C40mL\u002Fmin","AST and\u002For ALT and\u002For direct bilirubin \\>3x ULN","cardiac ejection fraction \\\u003C40% or history of uncontrolled cardiac arrhythmias","history of acute or chronic pancreatitis, history of myositis","known leukemia involvement of CNS","hematopoietic stem cell transplantation within 3 months of treatment start and\u002For persistent non-hematologic toxicities of Grade 2+ related to the transplant","active acute or chronic GVHD requiring immunosuppressive treatment","Inclusion Criteria:\n\n* MDS\u002FAML or AML with a TP53 mutation or deletion, defined as:\n* greater than or equal to 10% AND (one of the following):\n* presence of a TP53 mutation\n* presence of a TP53 deletion by FISH\n* positive TP53 staining on IHC of diagnostic bone marrow\n* Either untreated or first salvage (primary refractory or first relapse)\n\nExclusion Criteria:\n\n* KPS \\\u003C60\n* active uncontrolled infection\n* history of HIV or active HBV or HBC infection\n* currently active second malignancy\n* calculated CrCl \\\u003C40mL\u002Fmin\n* AST and\u002For ALT and\u002For direct bilirubin \\>3x ULN\n* cardiac ejection fraction \\\u003C40% or history of uncontrolled cardiac arrhythmias\n* history of acute or chronic pancreatitis, history of myositis\n* known leukemia involvement of CNS\n* hematopoietic stem cell transplantation within 3 months of treatment start and\u002For persistent non-hematologic toxicities of Grade 2+ related to the transplant\n* active acute or chronic GVHD requiring immunosuppressive treatment",[91,92],"ADULT","OLDER_ADULT",[94],{"facility":13,"city":95,"state":96,"zip":97,"country":98,"contacts":99,"geoPoint":105},"Atlanta","Georgia","30342","United States",[100],{"name":101,"role":102,"phone":103,"email":104},"Caitlin Guzowski","CONTACT","404-851-8523","caitlin.guzowski@northside.com",{"lat":106,"lon":107},33.749,-84.38798,[109,113],{"name":110,"role":102,"phone":111,"email":112},"Scott R Solomon, MD","404-255-1930","ssolomon@bmtga.com",{"name":101,"role":102,"phone":103,"email":104},[],[116,120,123,126,129,132,135,138,141,144,147,150,153,156,159,162,165,168,171,174,177,180,183,186,189,192,195,198,201,204,207,210,213,216],{"pmid":117,"type":118,"citation":119},"39292927","RESULT","Wolff D, Cutler C, Lee SJ, Pusic I, Bittencourt H, White J, Hamadani M, Arai S, Salhotra A, Perez-Simon JA, Alousi A, Choe H, Kwon M, Bermudez A, Kim I, Socie G, Chhabra S, Radojcic V, O'Toole T, Tian C, Ordentlich P, DeFilipp Z, Kitko CL; AGAVE-201 Investigators. Axatilimab in Recurrent or Refractory Chronic Graft-versus-Host Disease. N Engl J Med. 2024 Sep 19;391(11):1002-1014. doi: 10.1056\u002FNEJMoa2401537.",{"pmid":121,"type":118,"citation":122},"36459673","Kitko CL, Arora M, DeFilipp Z, Zaid MA, Di Stasi A, Radojcic V, Betts CB, Coussens LM, Meyers ML, Qamoos H, Ordentlich P, Kumar V, Quaranto C, Schmitt A, Gu Y, Blazar BR, Wang TP, Salhotra A, Pusic I, Jagasia M, Lee SJ. Axatilimab for Chronic Graft-Versus-Host Disease After Failure of at Least Two Prior Systemic Therapies: Results of a Phase I\u002FII Study. J Clin Oncol. 2023 Apr 1;41(10):1864-1875. doi: 10.1200\u002FJCO.22.00958. Epub 2022 Dec 2.",{"pmid":124,"type":118,"citation":125},"25157821","Alexander KA, Flynn R, Lineburg KE, Kuns RD, Teal BE, Olver SD, Lor M, Raffelt NC, Koyama M, Leveque L, Le Texier L, Melino M, Markey KA, Varelias A, Engwerda C, Serody JS, Janela B, Ginhoux F, Clouston AD, Blazar BR, Hill GR, MacDonald KP. CSF-1-dependant donor-derived macrophages mediate chronic graft-versus-host disease. J Clin Invest. 2014 Oct;124(10):4266-80. doi: 10.1172\u002FJCI75935. Epub 2014 Aug 26.",{"pmid":127,"type":118,"citation":128},"20602996","Lemmon MA, Schlessinger J. Cell signaling by receptor tyrosine kinases. Cell. 2010 Jun 25;141(7):1117-34. doi: 10.1016\u002Fj.cell.2010.06.011.",{"pmid":130,"type":118,"citation":131},"7506935","Rosnet O, Birnbaum D. Hematopoietic receptors of class III receptor-type tyrosine kinases. Crit Rev Oncog. 1993;4(6):595-613.",{"pmid":133,"type":118,"citation":134},"35030341","Xu L, Xie X, Li X, Duan W, Qiu L, Liu H, Luo Y. Inflammatory level under different p53 mutation status and the regulation role of curcumin in tumor microenvironment. Immunobiology. 2022 Mar;227(2):152177. doi: 10.1016\u002Fj.imbio.2022.152177. Epub 2022 Jan 7.",{"pmid":136,"type":118,"citation":137},"31940491","Blagih J, Zani F, Chakravarty P, Hennequart M, Pilley S, Hobor S, Hock AK, Walton JB, Morton JP, Gronroos E, Mason S, Yang M, McNeish I, Swanton C, Blyth K, Vousden KH. Cancer-Specific Loss of p53 Leads to a Modulation of Myeloid and T Cell Responses. Cell Rep. 2020 Jan 14;30(2):481-496.e6. doi: 10.1016\u002Fj.celrep.2019.12.028.",{"pmid":139,"type":118,"citation":140},"33057635","Vadakekolathu J, Lai C, Reeder S, Church SE, Hood T, Lourdusamy A, Rettig MP, Aldoss I, Advani AS, Godwin J, Wieduwilt MJ, Arellano M, Muth J, Yau TO, Ravandi F, Sweet K, Altmann H, Foulds GA, Stolzel F, Middeke JM, Ciciarello M, Curti A, Valk PJM, Lowenberg B, Gojo I, Bornhauser M, DiPersio JF, Davidson-Moncada JK, Rutella S. TP53 abnormalities correlate with immune infiltration and associate with response to flotetuzumab immunotherapy in AML. Blood Adv. 2020 Oct 27;4(20):5011-5024. doi: 10.1182\u002Fbloodadvances.2020002512.",{"pmid":142,"type":118,"citation":143},"23733335","Mussai F, De Santo C, Abu-Dayyeh I, Booth S, Quek L, McEwen-Smith RM, Qureshi A, Dazzi F, Vyas P, Cerundolo V. Acute myeloid leukemia creates an arginase-dependent immunosuppressive microenvironment. Blood. 2013 Aug 1;122(5):749-58. doi: 10.1182\u002Fblood-2013-01-480129. Epub 2013 Jun 3.",{"pmid":145,"type":118,"citation":146},"24639350","Sierra-Filardi E, Nieto C, Dominguez-Soto A, Barroso R, Sanchez-Mateos P, Puig-Kroger A, Lopez-Bravo M, Joven J, Ardavin C, Rodriguez-Fernandez JL, Sanchez-Torres C, Mellado M, Corbi AL. CCL2 shapes macrophage polarization by GM-CSF and M-CSF: identification of CCL2\u002FCCR2-dependent gene expression profile. J Immunol. 2014 Apr 15;192(8):3858-67. doi: 10.4049\u002Fjimmunol.1302821. Epub 2014 Mar 17.",{"pmid":148,"type":118,"citation":149},"28212753","Hartwig T, Montinaro A, von Karstedt S, Sevko A, Surinova S, Chakravarthy A, Taraborrelli L, Draber P, Lafont E, Arce Vargas F, El-Bahrawy MA, Quezada SA, Walczak H. The TRAIL-Induced Cancer Secretome Promotes a Tumor-Supportive Immune Microenvironment via CCR2. Mol Cell. 2017 Feb 16;65(4):730-742.e5. doi: 10.1016\u002Fj.molcel.2017.01.021.",{"pmid":151,"type":118,"citation":152},"21654748","Qian BZ, Li J, Zhang H, Kitamura T, Zhang J, Campion LR, Kaiser EA, Snyder LA, Pollard JW. CCL2 recruits inflammatory monocytes to facilitate breast-tumour metastasis. Nature. 2011 Jun 8;475(7355):222-5. doi: 10.1038\u002Fnature10138.",{"pmid":154,"type":118,"citation":155},"20876310","Corzo CA, Condamine T, Lu L, Cotter MJ, Youn JI, Cheng P, Cho HI, Celis E, Quiceno DG, Padhya T, McCaffrey TV, McCaffrey JC, Gabrilovich DI. HIF-1alpha regulates function and differentiation of myeloid-derived suppressor cells in the tumor microenvironment. J Exp Med. 2010 Oct 25;207(11):2439-53. doi: 10.1084\u002Fjem.20100587. Epub 2010 Sep 27.",{"pmid":157,"type":118,"citation":158},"25047706","Stromnes IM, Greenberg PD, Hingorani SR. Molecular pathways: myeloid complicity in cancer. Clin Cancer Res. 2014 Oct 15;20(20):5157-70. doi: 10.1158\u002F1078-0432.CCR-13-0866. Epub 2014 Jul 21.",{"pmid":160,"type":118,"citation":161},"32730593","Sallman DA, McLemore AF, Aldrich AL, Komrokji RS, McGraw KL, Dhawan A, Geyer S, Hou HA, Eksioglu EA, Sullivan A, Warren S, MacBeth KJ, Meggendorfer M, Haferlach T, Boettcher S, Ebert BL, Al Ali NH, Lancet JE, Cleveland JL, Padron E, List AF. TP53 mutations in myelodysplastic syndromes and secondary AML confer an immunosuppressive phenotype. Blood. 2020 Dec 10;136(24):2812-2823. doi: 10.1182\u002Fblood.2020006158.",{"pmid":163,"type":118,"citation":164},"32605996","Tohumeken S, Baur R, Bottcher M, Stoll A, Loschinski R, Panagiotidis K, Braun M, Saul D, Volkl S, Baur AS, Bruns H, Mackensen A, Jitschin R, Mougiakakos D. Palmitoylated Proteins on AML-Derived Extracellular Vesicles Promote Myeloid-Derived Suppressor Cell Differentiation via TLR2\u002FAkt\u002FmTOR Signaling. Cancer Res. 2020 Sep 1;80(17):3663-3676. doi: 10.1158\u002F0008-5472.CAN-20-0024. Epub 2020 Jun 30.",{"pmid":166,"type":118,"citation":167},"28126925","Pyzer AR, Stroopinsky D, Rajabi H, Washington A, Tagde A, Coll M, Fung J, Bryant MP, Cole L, Palmer K, Somaiya P, Karp Leaf R, Nahas M, Apel A, Jain S, McMasters M, Mendez L, Levine J, Joyce R, Arnason J, Pandolfi PP, Kufe D, Rosenblatt J, Avigan D. MUC1-mediated induction of myeloid-derived suppressor cells in patients with acute myeloid leukemia. Blood. 2017 Mar 30;129(13):1791-1801. doi: 10.1182\u002Fblood-2016-07-730614. Epub 2017 Jan 26.",{"pmid":169,"type":118,"citation":170},"33415170","Wang H, Tao Q, Wang Z, Zhang Q, Xiao H, Zhou M, Dong Y, Zhai Z. Circulating Monocytic Myeloid-Derived Suppressor Cells Are Elevated and Associated with Poor Prognosis in Acute Myeloid Leukemia. J Immunol Res. 2020 Dec 21;2020:7363084. doi: 10.1155\u002F2020\u002F7363084. eCollection 2020.",{"pmid":172,"type":118,"citation":173},"26358057","Sun H, Li Y, Zhang ZF, Ju Y, Li L, Zhang BC, Liu B. Increase in myeloid-derived suppressor cells (MDSCs) associated with minimal residual disease (MRD) detection in adult acute myeloid leukemia. Int J Hematol. 2015 Nov;102(5):579-86. doi: 10.1007\u002Fs12185-015-1865-2. Epub 2015 Sep 10.",{"pmid":175,"type":118,"citation":176},"35965420","Ren X, Tao Q, Wang H, Zhang Q, Zhou M, Liu L, Zhai Z. Monocytic Myeloid-Derived Suppressor Cells But Not Monocytes Predict Poor Prognosis of Acute Myeloid Leukemia. Turk J Haematol. 2022 Dec 1;39(4):230-236. doi: 10.4274\u002Ftjh.galenos.2022.2022.0137. Epub 2022 Aug 15.",{"pmid":178,"type":118,"citation":179},"36226545","Peterlin P, Debord C, Eveillard M, Garnier A, Le Bourgeois A, Guillaume T, Jullien M, Bene MC, Chevallier P. Peripheral levels of monocytic myeloid-derived suppressive cells before and after first induction predict relapse and survivals in AML patients. J Cell Mol Med. 2022 Nov;26(21):5486-5492. doi: 10.1111\u002Fjcmm.17576. Epub 2022 Oct 13.",{"pmid":181,"type":118,"citation":182},"25484881","Hamilton TA, Zhao C, Pavicic PG Jr, Datta S. Myeloid colony-stimulating factors as regulators of macrophage polarization. Front Immunol. 2014 Nov 21;5:554. doi: 10.3389\u002Ffimmu.2014.00554. eCollection 2014.",{"pmid":184,"type":118,"citation":185},"30425048","Edwards DK 5th, Watanabe-Smith K, Rofelty A, Damnernsawad A, Laderas T, Lamble A, Lind EF, Kaempf A, Mori M, Rosenberg M, d'Almeida A, Long N, Agarwal A, Sweeney DT, Loriaux M, McWeeney SK, Tyner JW. CSF1R inhibitors exhibit antitumor activity in acute myeloid leukemia by blocking paracrine signals from support cells. Blood. 2019 Feb 7;133(6):588-599. doi: 10.1182\u002Fblood-2018-03-838946. Epub 2018 Nov 13.",{"pmid":187,"type":118,"citation":188},"29632729","Yang X, Feng W, Wang R, Yang F, Wang L, Chen S, Ru Y, Cheng T, Zheng G. Repolarizing heterogeneous leukemia-associated macrophages with more M1 characteristics eliminates their pro-leukemic effects. Oncoimmunology. 2017 Dec 26;7(4):e1412910. doi: 10.1080\u002F2162402X.2017.1412910. eCollection 2018.",{"pmid":190,"type":118,"citation":191},"32002295","Xu ZJ, Gu Y, Wang CZ, Jin Y, Wen XM, Ma JC, Tang LJ, Mao ZW, Qian J, Lin J. The M2 macrophage marker CD206: a novel prognostic indicator for acute myeloid leukemia. Oncoimmunology. 2019 Nov 3;9(1):1683347. doi: 10.1080\u002F2162402X.2019.1683347. eCollection 2020.",{"pmid":193,"type":118,"citation":194},"34771453","Smirnova T, Spertini C, Spertini O. CSF1R Inhibition Combined with GM-CSF Reprograms Macrophages and Disrupts Protumoral Interplays with AML Cells. Cancers (Basel). 2021 Oct 21;13(21):5289. doi: 10.3390\u002Fcancers13215289.",{"pmid":196,"type":118,"citation":197},"36549780","Brauneck F, Fischer B, Witt M, Muschhammer J, Oelrich J, da Costa Avelar PH, Tsoka S, Bullinger L, Seubert E, Smit DJ, Bokemeyer C, Ackermann C, Wellbrock J, Haag F, Fiedler W. TIGIT blockade repolarizes AML-associated TIGIT+ M2 macrophages to an M1 phenotype and increases CD47-mediated phagocytosis. J Immunother Cancer. 2022 Dec;10(12):e004794. doi: 10.1136\u002Fjitc-2022-004794.",{"pmid":199,"type":118,"citation":200},"34249942","Miari KE, Guzman ML, Wheadon H, Williams MTS. Macrophages in Acute Myeloid Leukaemia: Significant Players in Therapy Resistance and Patient Outcomes. Front Cell Dev Biol. 2021 Jun 24;9:692800. doi: 10.3389\u002Ffcell.2021.692800. eCollection 2021.",{"pmid":202,"type":118,"citation":203},"39457618","Mesaros O, Onciul M, Matei E, Joldes C, Jimbu L, Neaga A, Serban O, Zdrenghea M, Nanut AM. Macrophages as Potential Therapeutic Targets in Acute Myeloid Leukemia. Biomedicines. 2024 Oct 11;12(10):2306. doi: 10.3390\u002Fbiomedicines12102306.",{"pmid":205,"type":118,"citation":206},"34298810","Cencini E, Fabbri A, Sicuranza A, Gozzetti A, Bocchia M. The Role of Tumor-Associated Macrophages in Hematologic Malignancies. Cancers (Basel). 2021 Jul 18;13(14):3597. doi: 10.3390\u002Fcancers13143597.",{"pmid":208,"type":118,"citation":209},"32499238","Maiti A, Rausch CR, Cortes JE, Pemmaraju N, Daver NG, Ravandi F, Garcia-Manero G, Borthakur G, Naqvi K, Ohanian M, Short NJ, Alvarado Y, Kadia TM, Takahashi K, Yilmaz M, Jain N, Kornblau S, Montalban Bravo G, Sasaki K, Andreeff M, Bose P, Ferrajoli A, Issa GC, Jabbour EJ, Masarova L, Thompson PA, Wang S, Konoplev S, Pierce SA, Ning J, Qiao W, Welch JS, Kantarjian HM, DiNardo CD, Konopleva MY. Outcomes of relapsed or refractory acute myeloid leukemia after frontline hypomethylating agent and venetoclax regimens. Haematologica. 2021 Mar 1;106(3):894-898. doi: 10.3324\u002Fhaematol.2020.252569. No abstract available.",{"pmid":211,"type":118,"citation":212},"34255353","Kim K, Maiti A, Loghavi S, Pourebrahim R, Kadia TM, Rausch CR, Furudate K, Daver NG, Alvarado Y, Ohanian M, Sasaki K, Short NJ, Takahashi K, Yilmaz M, Tang G, Ravandi F, Kantarjian HM, DiNardo CD, Konopleva MY. Outcomes of TP53-mutant acute myeloid leukemia with decitabine and venetoclax. Cancer. 2021 Oct 15;127(20):3772-3781. doi: 10.1002\u002Fcncr.33689. Epub 2021 Jul 13.",{"pmid":214,"type":118,"citation":215},"39133921","Dohner H, Pratz KW, DiNardo CD, Wei AH, Jonas BA, Pullarkat VA, Thirman MJ, Recher C, Schuh AC, Babu S, Li X, Ku G, Liu Z, Sun Y, Potluri J, Dail M, Chyla B, Pollyea DA. Genetic risk stratification and outcomes among treatment-naive patients with AML treated with venetoclax and azacitidine. Blood. 2024 Nov 21;144(21):2211-2222. doi: 10.1182\u002Fblood.2024024944.",{"pmid":217,"type":118,"citation":218},"37370821","Zhao D, Zarif M, Zhou Q, Capo-Chichi JM, Schuh A, Minden MD, Atenafu EG, Kumar R, Chang H. TP53 Mutations in AML Patients Are Associated with Dismal Clinical Outcome Irrespective of Frontline Induction Regimen and Allogeneic Hematopoietic Cell Transplantation. Cancers (Basel). 2023 Jun 16;15(12):3210. doi: 10.3390\u002Fcancers15123210.",[],{"nct_id":4,"conditions":221,"biomarkers":223},[19,222],"Myelodysplastic Syndrome",[224],"TP53 Gene",{"nct_id":4,"found":15,"summary":226,"prompt_version":236},{"design":227,"status":228,"heading":229,"summary":230,"follow_up":231,"word_count":232,"commitments":233,"compensation":234,"drugs_mentioned":235},"This is an interventional study, meaning participants will receive specific treatments. It aims to determine the best dose level for a later Phase 2 study and will involve about 32 participants.","completed","Axatilimab with Decitabine\u002FVenetoclax for TP53-mutated AML","This study is testing a combination of three drugs: Axatilimab, Decitabine, and Venetoclax, for people with Acute Myeloid Leukemia (AML) that has a specific change in the TP53 gene (TP53-mutated AML). You might be able to join if you have AML with this TP53 mutation or deletion, and you are either newly diagnosed or have had one previous treatment. The researchers want to find the best dose of Axatilimab and see how many people achieve a complete remission without measurable residual disease (MRD-negative complete remission). This study plans to enroll 32 participants, but its current recruitment status is unclear.","The study will measure outcomes like the Phase 2 dose level at 1 year and MRD-negative complete remission at 2 months.",99,"Not specified in the trial record.","Not stated in the trial record.",[32,37,41],"v2"]