Bendamustine and rituximab in relapsed and refractory hairy cell leukemia

Mauricio Burotto, Maryalice Stetler-Stevenson, Evgeny Arons, Hong Zhou, Wyndham Wilson, Robert J. Kreitman*

*Corresponding author for this work

Research output: Contribution to journalArticlepeer-review

67 Scopus citations


Purpose: To determine tolerability and for the first time explore efficacy of bendamustine-rituximab (BR) in multiply relapsed/refractory hairy cell leukemia (HCL), using two different dose levels of bendamustine. Experimental Design: Patients with HCL with ≥ 2 prior therapies requiring treatment received rituximab 375 mg/m2 days 1 and 15 plus bendamustine 70 (n = 6) or 90 (n = 6) mg/m2, days 1 and 2, for six cycles at 4-week intervals. Results: At 70 and 90 mg/m2/dose of bendamustine, overall response rate was 100%, with three (50%) and four (67%) complete remissions (CR) in each respective group. Minimal residual disease (MRD) was absent in 67% and 100% of CRs, respectively. All six without MRD remain in CRat 30 to 35 (median, 31) months of follow-up. Soluble CD22 and CD25 levels decreased with all responses, with median values decreasing from 17.7 and 42 ng/mL at baseline to undetectable and 2 ng/mL after CR, respectively (P < 0.001). Of 12 patients receiving 72 cycles of BR, the most common toxicities were hematologic, including thrombocytopenia (83%), lymphopenia (75%), leukopenia (58%), and neutropenia (42%). Grade III and IV hematologic toxicity included lymphopenia and thrombocytopenia (each 75%), leukopenia (58%), and neutropenia (25%). No significant dose-related differences were detected in response or toxicity. Conclusion: BR has significant activity in HCL. Bendamustine at either 70 or 90 mg/m2/dose was highly effective in multiply relapsed/refractory HCL and could be considered for achieving durable CRs without MRD in patients after failure of standard therapies. As it was not dose-limiting, 90 mg/m 2/dose was chosen for future testing.

Original languageEnglish
Pages (from-to)6313-6321
Number of pages9
JournalClinical Cancer Research
Issue number22
StatePublished - 15 Nov 2013
Externally publishedYes


  • Aged
  • Antibodies, Monoclonal, Murine-Derived
  • Antineoplastic Agents, Alkylating
  • Antineoplastic Combined Chemotherapy Protocols
  • Blood Platelets
  • CD4-Positive T-Lymphocytes
  • CD8-Positive T-Lymphocytes
  • Drug Administration Schedule
  • Female
  • Humans
  • Immunologic Factors
  • Leukemia, Hairy Cell
  • Lymphocyte Count
  • Male
  • Middle Aged
  • Nitrogen Mustard Compounds
  • Pilot Projects
  • Platelet Count
  • Remission Induction
  • Treatment outcome


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