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Schroeder, Thomas [Author]; Stelljes, Matthias [Author]; Christopeit, Maximilian [Author]; Esseling, Eva [Author]; Scheid, Christoph [Author]; Mikesch, Jan-Henrik [Author]; Rautenberg, Christina [Author]; Jäger, Paul [Author]; Cadeddu, Ron-Patrick [Author]; Drusenheimer, Nadja [Author]; Holtick, Udo [Author]; Klein, Stefan [Author]; Trenschel, Rudolf [Author]; Haas, Rainer [Author]; Germing, Ulrich [Author]; Kröger, Nicolaus [Author]; Kobbe, Guido [Author]

Azacitidine, lenalidomide and donor lymphocyte infusions for relapse of myelodysplastic syndrome, acute myeloid leukemia and chronic myelomonocytic leukemia after allogeneic transplant

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  • Media type: E-Article
  • Title: Azacitidine, lenalidomide and donor lymphocyte infusions for relapse of myelodysplastic syndrome, acute myeloid leukemia and chronic myelomonocytic leukemia after allogeneic transplant : the Azalena-Trial
  • Contributor: Schroeder, Thomas [Author]; Stelljes, Matthias [Author]; Christopeit, Maximilian [Author]; Esseling, Eva [Author]; Scheid, Christoph [Author]; Mikesch, Jan-Henrik [Author]; Rautenberg, Christina [Author]; Jäger, Paul [Author]; Cadeddu, Ron-Patrick [Author]; Drusenheimer, Nadja [Author]; Holtick, Udo [Author]; Klein, Stefan [Author]; Trenschel, Rudolf [Author]; Haas, Rainer [Author]; Germing, Ulrich [Author]; Kröger, Nicolaus [Author]; Kobbe, Guido [Author]
  • Published: November, 2023
  • Published in: Haematologica ; 108(2023), 11, Seite 3001-3010
  • Language: English
  • DOI: 10.3324/haematol.2022.282570
  • Identifier:
  • Origination:
  • Footnote:
  • Description: Azacitidine (Aza) combined with donor lymphocyte infusions (DLI) is an established treatment for relapse of myeloid malignancies after allogeneic transplantation. Based on its immunomodulatory and anti-leukemic properties we considered Lenalidomide (Lena) to act synergistically with Aza/DLI to improve outcome. We, therefore, prospectively investigated tolerability and efficacy of this combination as first salvage therapy for adults with post-transplant relapse of acute myeloid leukemia, myelodysplastic syndromes and chronic myelomonocytic leukemia. Patients were scheduled for eight cycles Aza (75 mg/m2 day 1-7), Lena (2.5 or 5 mg, days 1-21) and up to three DLI with increasing T-cell dosages (0.5×106-1.5×107 cells/kg). Primary endpoint was safety, while secondary endpoints included response, graft-versus-host disease (GvHD) and overall survival (OS). Fifty patients with molecular (52%) or hematological (48%) relapse of myelodysplastic syndromes (n=24), acute myeloid leukemia (n=23) or chronic myelomonocytic leukemia (n=3) received a median of seven (range, 1-8) cycles including 14 patients with 2.5 mg and 36 with 5 mg Lena daily dosage. Concomitantly, 34 patients (68%) received at least one DLI. Overall response rate was 56% and 25 patients (50%) achieved complete remission being durable in 80%. Median OS was 21 months and 1-year OS rate 65% with no impact of type of or time to relapse and Lena dosages. Treatment was well tolerated indicated by febrile neutropenia being the only grade ≥3 non-hematologic adverse event in >10% of patients and modest acute (grade 2-4 24%) and chronic (moderate/severe 28%) GvHD incidences. In summary, Lena can be safely added to Aza/DLI without excess of GvHD and toxicity. Its significant anti-leukemic activity suggests that this combination is a novel salvage option for post-transplant relapse (clinicaltrials gov. Identifier: NCT02472691).
  • Access State: Open Access