Phase 2 study of lenalidomide maintenance for patients with high-risk acute myeloid leukemia in remission

Iman Abou Dalle, Hagop M. Kantarjian, Farhad Ravandi, Naval Daver, Xuemei Wang, Elias Jabbour, Zeev Estrov, Courtney D. DiNardo, Naveen Pemmaraju, Alessandra Ferrajoli, Nitin Jain, Sa A. Wang, Nadya Jammal, Gautam Borthakur, Kiran Naqvi, Sarah Pelletier, Sherry Pierce, Michael Andreeff, Guillermo Garcia-Manero, Jorge E. CortesTapan M. Kadia

Research output: Contribution to journalArticlepeer-review

7 Scopus citations


Background: New drug combinations have led to significant improvements in remission rates for patients with acute myeloid leukemia (AML). However, many patients with high-risk AML who respond to their initial treatment and are not candidates for allogeneic stem cell transplantation (ASCT) will eventually relapse with poor outcomes. Methods: In this phase 2 trial, the efficacy of lenalidomide maintenance was evaluated in patients with high-risk AML who had achieved their first or second remission after induction chemotherapy and at least 1 consolidation cycle and who were not candidates for immediate ASCT. Lenalidomide was given orally at 10 to 20 mg daily on days 1 to 28 of a 28-day cycle for up to 24 cycles. Results: A total of 28 patients were enrolled in this study with a median age of 61 years (range, 24-87 years). The median number of cycles was 8 (range, 1-24 cycles). Ten patients (36%) completed 24 months of maintenance treatment. With a median follow-up of 22.5 months (range, 2.6-55 months), 12 patients (43%) relapsed after a median of 3 months (range, 0.7-23 months). The median duration of remission for all patients was 18.7 months (range, 0.7-55.1 months). The 2-year overall survival and relapse-free survival rates from the time of enrollment were 63% and 50%, respectively. Overall, lenalidomide was well tolerated; serious adverse events of grade 3 or 4, including rash (n = 5), thrombocytopenia (n = 4), neutropenia (n = 4), and fatigue (n = 2), were observed in 13 patients (46%). Conclusions: Lenalidomide is a safe and feasible maintenance strategy in patients with high-risk AML who are not candidates for ASCT, and it has beneficial effects for patients with negative measurable residual disease.

Original languageEnglish (US)
Pages (from-to)1894-1900
Number of pages7
Issue number11
StatePublished - Jun 1 2021


  • acute myeloid leukemia (AML)
  • immunomodulation
  • lenalidomide
  • maintenance

ASJC Scopus subject areas

  • Oncology
  • Cancer Research


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