Citations 2
Gilteritinib as Post-Transplant Maintenance for AML With Internal Tandem Duplication Mutation of FLT3
Levis, Mark J. , Hamadani, Mehdi , Logan, Brent R. , Jones, Richard J. , Singh, Anurag K. , Litzow, Mark R. , Wingard, John R. , Papadopoulos, Esperanza B. , Perl, Alexander E. , Soiffer, Robert J. , Üstün, Celalettin , Uy, Geoffrey L. , Vasu, Sumithra, Solh, Melhem , Mishra, Asmita , Muffly, Lori , Mikesch, Jan‐Henrik , Onozawa, Masahiro , Thomson, Kirsty , Nagler, Arnon , Marcucci, Guido , Geller, Nancy L. , Hasabou, Nahla, Delgado, David, Rosales, Matt, Hill, Jason E. , Gill, Stanley C. , Nuthethi, Rishita, King, Denise , Wittsack, Heather, Mendizabal, Adam , Horowitz, Mary M. , Chen, Yi‐Bin , Investigators, on behalf of the BMT-CTN 1506/MORPHO Study, Agura, Ed, Altman, Jessica K. , Anagnostopoulos, Achiles, Aulitzky, Walter E. , Balderman, Sophia , Ballen, Karen K. , Béguin, Yves , Berkahn, Leanne, Bilmon, Ian , Briggs, Adrienne, Brunstein, Claudio G. , Byrne, Michael , Carrum, George, Černý, Jan , Ciceri, Fabio , Colorado, Mercedes , Cook, Rachel J. , Couriel, Daniel R. , Damon, Lloyd E. , Deol, Abhinav , Desbrosses, Yohan, Devine, Steve, Grazia, Carmela Di, Stasi, Antonio Di , Dias, Ajoy , Dorritie, Kathy, Essell, James , Eto, Tetsuya , Forcade, Édouard , Frankfurt, Olga, Fukuda, Takahiro , Fürst, Sabine , Goto, Tatsunori , Hall, Aric C. , Hatta, Shunsuke , Hicheri, Yosr , Horwitz, Mitchell E. , How, Jonathan, Howard, Dianna S. , Hsu, Wei‐Hsun , Huynh, Anne , Irvine, David, Ishikawa, Takayuki , Jamieson, Katarzyna , Wiktor-Jędrzejczak, W , Karakasis, Dimitrios, Kato, Jun , Kekre, Natasha , Khera, Nandita , Klein, A. , Kobbe, Guido , Kornblit, Brian, Lachance, Silvy , Levis, Mark J., Lin, Tung‐Liang , Litzow, Mark, Liu, Ta‐Chih, Martelli, Maurizio , Matsuoka, Ken‐ichi , McCarty, John M. , Mendez, Lourdes , Michelis, Fotios V. , Mikesch, Jan-Henrik, Mineishi, Shin , Moors, Ine , Motyckova, Gabriela, Mueller, Lutz Peter , Muffly, Lori, Nakamae, Hirohisa , Nathan, Sunita , Norkin, Maxim , Ogawa, Yoshiaki, Olesen, G., Onozawa, Masahiro, Paulson, Kristjan, Pemberton, Lucy, Perera, Travis, Perl, Alexander E., Piątkowska‐Jakubas, Beata, Protheroe, Rachel, Ross, Kelly , Santarone, Stella , Sawa, Masashi , Schaar, Dale , Scheid, Christoph, Schriber, Jeffrey, Seropian, Stuart , Shah, Nilay , Shah, Nirav N. , Gil, Jorge Sierra, Sobecks, Ronald , Sprague, Kellie , Spyridonidis, Alexandros , Stelljes, Matthias , Stiff, Patrick J. , Tandra, Anand, Tholouli, Eleni , Thomas, Xavier , Tomlinson, Benjamin , Ustun, Celalettin, Uy, Geoffrey L., Ferreiras, David Valcarcel, Wagner, Eva , Watson, Anne-Marie, Wolschke, Christine, Yamauchi, Takuji , Yeh, Su‐Peng , Logan, Brent , Litzow, Mark R. , Ueda Oshima, Masumi , Uy, Geoffrey , Waller, Edmund K , Solh, Melham M , Mishra, Asmita , Muffly, Lori , Kim, Hee-Je , Najima, Yuho , Onozawa, Masahiro , Nagler, Arnon , Wei, Andrew H , Geller, Nancy , Hill, Jason , Gill, Stanley C , King, Denise , Devine, Steven , Horowitz, Mary , Chen, Yi-Bin , Hamadani, Mehdi , Ueda, Masumi , Waller, Edmund K. , Wei, Andrew H. , Devine, Steven M. , Investigators, on behalf of the BMT-CTN 1506/MORPHO Study, Anagnostopoulos, Achiles, Anand, Sarah , Artz, Andrew , Becker, Michael W. , Berneman, Zwi Nisan , Bhatt, Vijaya Raj , Bonifazi, Francesca , Bruno, Benedetto , Byrne, Jenny , Cabrero, Mónica , Cairoli, Roberto , Cheong, June‐Won , Colorado, Mercedes , Craddock, Charles , Grazia, Carmela Di, Farag, Sherif Shafik , Fujiwara, Shin‐ichiro , Fukushima, Kentaro , Hou, Hsin‐An , Jethava, Yogesh S. , Jiménez, Antonio , Jung, Chul Won , Kanda, Junya , Klein, Andreas, Kota, Vamsi , Leber, Brian F. , Lee, Catherine J , Lee, Je‐Hwan , Levis, Mark J., Litzow, Mark, Martínez, Carmen , Mikesch, Jan-Henrik, Mohty, Mohamad , Mueller, Lutz, Muffly, Lori, Nakano, Nobuaki , Nicholson, Emma , Oluwole, Olalekan O. , Onozawa, Masahiro, Pantin, Jeremy , Perl, Alexander E., Poiré, Xavier , Rambaldi, Alessandro , Ritchie, David , Rubio, Marie‐Thérèse , Sanz, Jaime , Shore, Tsiporah B. , Socié, Gèrard , Stuart, Robert K. , Tanaka, Masatsugu , Tiribelli, Mario , Tsirigotis, Panagiotis D. , Tzachanis, Dimitrios , Uchida, Naoyuki , Ustun, Celalettin, Uy, Geoffrey L., Ferreiras, David Valcarcel, Weisdorf, Daniel J. , Wróbel, Tomasz , Yakoub‐Agha, Ibrahim , Yared, Jean A. , Yoon, Sung‐Soo , Yoshihara, Satoshi
Journal of Clinical Oncology | March 12, 2024 | Volume: 42 | Issue: 15 | Pages: 1766-1775
PURPOSE Allogeneic hematopoietic cell transplantation (HCT) improves outcomes for patients with AML harboring an internal tandem duplication mutation of FLT3 ( FLT3-ITD) AML. These patients are routinely treated with a FLT3 inhibitor after HCT, but there is limited evidence to support this. Accordingly, we conducted a randomized trial of post-HCT maintenance with the FLT3 inhibitor gilteritinib (ClinicalTrials.gov identifier: NCT02997202 ) to determine if all such patients benefit or if detection of measurable residual disease (MRD) could identify those who might benefit. METHODS Adults with FLT3-ITD AML in first remission underwent HCT and were randomly assigned to placebo or 120 mg once daily gilteritinib for 24 months after HCT. The primary end point was relapse-free survival (RFS). Secondary end points included overall survival (OS) and the effect of MRD pre- and post-HCT on RFS and OS. RESULTS Three hundred fifty-six participants were randomly assigned post-HCT to receive gilteritinib or placebo. Although RFS was higher in the gilteritinib arm, the difference was not statistically significant (hazard ratio [HR], 0.679 [95% CI, 0.459 to 1.005]; two-sided P = .0518). However, 50.5% of participants had MRD detectable pre- or post-HCT, and, in a prespecified subgroup analysis, gilteritinib was beneficial in this population (HR, 0.515 [95% CI, 0.316 to 0.838]; P = .0065). Those without detectable MRD showed no benefit (HR, 1.213 [95% CI, 0.616 to 2.387]; P = .575). CONCLUSION Although the overall improvement in RFS was not statistically significant, RFS was higher for participants with detectable FLT3-ITD MRD pre- or post-HCT who received gilteritinib treatment. To our knowledge, these data are among the first to support the effectiveness of MRD-based post-HCT therapy.
Incorporation of extracorporeal photopheresis into a reduced intensity conditioning regimen in myelodysplastic syndrome and aggressive lymphoma: results from ECOG 1402 and 1902
Foss, Francine M. , Wang, Victoria , Luger, Selina M. , Miller, Kenneth B., Stadtmauer, Edward A. , Avigan, David , Gascoyne, Randall D., Wagner, Henry, Strair, Roger , Sprague, Kellie , Litzow, Mark R. , Tallman, Martin S. , Horning, Sandra J., Foss, Francine , Jegede, Opeyemi A. , Whiteside, Theresa L , Arber, Daniel A. , Hogan, William J. , Lazarus, Hillard M.
Transfusion | July 12, 2020 | Volume: 60 | Issue: 8 | Pages: 1867-1872
BackgroundExtracorporeal photopheresis (ECP) is an immunomodulatory cellular therapy which has been shown to induce a tolerogenic state in patients with acute and chronic graft‐vs‐host disease. ECOG‐ACRIN explored the activity of ECP as a part of a reduced intensity conditioning regimen in two multicenter trials in patients with MDS (E1902) and lymphomas (E1402). While both studies closed before completing accrual, we report results in 23 patients (17 MDS and 6 lymphoma).Study Design and MethodsPatients received 2 days of ECP followed by pentostatin 4 mg/m2 /day for two consecutive days, followed by 600 cGy of total body irradiation prior to stem cell infusion. Immunosuppression for aGVHD was infusional cyclosporine A or tacrolimus and methotrexate on day +1, +3, with mycophenolate mofetil starting on day 100 for chronic GVHD prophylaxis.ResultsAll patients engrafted, with median time to neutrophil and platelet engraftment of 15‐18 days and 10‐18 days respectively. Grade 3 or 4 aGVHD occurred in 13% and chronic extensive GVHD in 30%.ConclusionsThese studies demonstrate that ECP/pentostatin/TBI is well tolerated and associated with adequate engraftment of neutrophils and platelets in patients with lymphomas and MDS.