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Myeloablative regimens used for disease control are associated with acute and long-term adverse effects. We used a CD45RA-depleted haploidentical graft for adoptive transfer of memory T cells combined with NK-cell addback and hypothesized that maximizing the graft-versus-leukemia (GVL) effect might allow for reduction in intensity of conditioning regimen.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>In this phase II clinical trial (NCT01807611), 72 patients with hematological malignancies (complete remission (CR)1: 25,\u2009\u2265\u2009CR2: 28, refractory disease: 19) received haploidentical CD34\u2009+\u2009enriched and CD45RA-depleted hematopoietic progenitor cell grafts followed by NK-cell infusion. Conditioning included fludarabine, thiotepa, melphalan, cyclophosphamide, total lymphoid irradiation, and graft-versus-host disease (GVHD) prophylaxis consisted of a short-course sirolimus or mycophenolate mofetil without serotherapy.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>\n                      The 3-year overall survival (OS) and event-free-survival (EFS) for patients in CR1 were 92% (95% CI:72\u201398) and 88% (95% CI: 67\u201396);\u2009\u2265\u2009CR2 were 81% (95% CI: 61\u201392) and 68% (95% CI: 47\u201382) and refractory disease were 32% (95% CI: 11\u201354) and 20% (95% CI: 6\u201340). The 3-year EFS for all patients in morphological CR was 77% (95% CI: 64\u201387) with no difference amongst recipients with or without minimal residual disease (\n                      <jats:italic>P<\/jats:italic>\n                      \u2009=\u20090.2992). Immune reconstitution was rapid, with mean CD3 and CD4 T-cell counts of 410\/\u03bcL and 140\/\u03bcL at day\u2009+\u200930. Cumulative incidence of acute GVHD and chronic GVHD was 36% and 26% but most patients with acute GVHD recovered rapidly with therapy. Lower rates of grade III-IV acute GVHD were observed with NK-cell alloreactive donors (\n                      <jats:italic>P<\/jats:italic>\n                      \u2009=\u20090.004), and higher rates of moderate\/severe chronic GVHD occurred with maternal donors (\n                      <jats:italic>P<\/jats:italic>\n                      \u2009=\u20090.035).\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusion<\/jats:title>\n                    <jats:p>The combination of a CD45RA-depleted graft and NK-cell addback led to robust immune reconstitution maximizing the GVL effect and allowed for use of a submyeloablative, TBI-free conditioning regimen that was associated with excellent EFS resulting in promising long-term outcomes in this high-risk population.<\/jats:p>\n                    <jats:p>The trial is registered at ClinicalTrials.gov (NCT01807611).<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1186\/s13045-024-01567-0","type":"journal-article","created":{"date-parts":[[2024,6,27]],"date-time":"2024-06-27T09:05:23Z","timestamp":1719479123000},"update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":18,"title":["Memory T-cell enriched haploidentical transplantation with NK cell addback results in promising long-term outcomes: a phase II trial"],"prefix":"10.1186","volume":"17","author":[{"given":"Swati","family":"Naik","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ying","family":"Li","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Aimee C.","family":"Talleur","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Subodh","family":"Selukar","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Emily","family":"Ashcraft","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Cheng","family":"Cheng","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Renee M.","family":"Madden","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ewelina","family":"Mamcarz","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Amr","family":"Qudeimat","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Akshay","family":"Sharma","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ashok","family":"Srinivasan","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ali Y.","family":"Suliman","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Rebecca","family":"Epperly","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Esther A.","family":"Obeng","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"M. 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GM conducts sponsored research for Astellas Inc and SymBio Pharmaceutical. SG is a co-inventor on patent applications in the fields of cell or gene therapy for cancer, a member of the Scientific Advisory Board of Be Biopharma and CARGO, and the Data and Safety Monitoring Board (DSMB) of Immatics and has received honoraria from TESSA Therapeutics within the last year. BMT has received travel support from Miltenyi Biotech to present published data. The remaining authors declare no competing interests.","order":4,"name":"Ethics","group":{"name":"EthicsHeading","label":"Competing interests"}}],"article-number":"50"}}