Immunomodulation with pomalidomide at early lymphocyte recovery after induction chemotherapy in newly diagnosed AML and high-risk MDS

Leukemia. 2020 Jun;34(6):1563-1576. doi: 10.1038/s41375-019-0693-4. Epub 2020 Jan 3.

Abstract

An immunosuppressive microenvironment promoting leukemia cell immune escape plays an important role in the pathogenesis of AML. Through its interaction with cereblon, a substrate receptor for the E3 ubiquitin ligase complex, pomalidomide leads to selective ubiquitination of transcription factors Aiolos and Ikaros thereby promoting immune modulation. In this phase I trial, 51 newly diagnosed non-favorable risk AML and high-risk MDS patients were enrolled and treated with AcDVP16 (cytarabine 667 mg/m2/day IV continuous infusion days 1-3, daunorubicin 45 mg/m2 IV days 1-3, etoposide 400 mg/m2 IV days 8-10) induction therapy followed by dose- and duration-escalation pomalidomide beginning at early lymphocyte recovery. Forty-three patients (AML: n = 39, MDS: n = 4) received pomalidomide. The maximum tolerated dose of pomalidomide was 4 mg for 21 consecutive days. The overall complete remission (CR + CRi) rate, median overall survival, and disease-free survival were 75%, 27.1 and 20.6 months, respectively. Subset analyses revealed 86% CR/CRi rate in AML patients with unfavorable-risk karyotype treated with pomalidomide. Pomalidomide significantly decreased Aiolos expression in both CD4+ and CD8+ peripheral blood and bone marrow T cells, promoted T cell differentiation, proliferation, and heightened their cytokine production. Finally, pomalidomide induced distinct gene expression changes in immune function-related ontologies in CD4+ and CD8+ T cells.

Publication types

  • Clinical Trial, Phase I
  • Research Support, N.I.H., Extramural
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adult
  • Aged
  • Antineoplastic Combined Chemotherapy Protocols / therapeutic use*
  • Cytarabine / administration & dosage
  • Disease-Free Survival
  • Etoposide / administration & dosage
  • Female
  • Hexosamines / administration & dosage
  • Humans
  • Immunologic Factors / administration & dosage*
  • Immunomodulation / drug effects
  • Induction Chemotherapy / methods
  • Leukemia, Myeloid, Acute / drug therapy*
  • Male
  • Maximum Tolerated Dose
  • Middle Aged
  • Myelodysplastic Syndromes / drug therapy*
  • Remission Induction
  • Thalidomide / administration & dosage
  • Thalidomide / analogs & derivatives*
  • Treatment Outcome
  • Young Adult

Substances

  • Hexosamines
  • Immunologic Factors
  • Cytarabine
  • daunosamine
  • Thalidomide
  • Etoposide
  • pomalidomide