Pentostatin, Cyclophosphamide, and Rituximab Followed by Alemtuzumab for Relapsed or Refractory Chronic Lymphocytic Leukemia: A Phase 2 Trial of the ECOG-Acrin Cancer Research Group (E2903)

Sanford Kempin, Zhuoxin Sun, Neil E. Kay, Elisabeth M. Paietta, Joseph J. Mazza, Rhett P. Ketterling, Olga Frankfurt, David F. Claxton, Joel N. Saltzman, Gordan Srkalovic, Natalie S. Callander, Gerald Gross, Martin S. Tallman

Research output: Contribution to journalArticle

Abstract

Patients with relapsed/refractory (R/R) chronic lymphocytic leukemia (CLL) may benefit from salvage chemoimmunotherapy (CIT). To explore further the use of CIT in the pre-novel agent era, ECOG-ACRIN undertook a phase 2 trial (E2903) for R/R CLL utilizing pentostatin, cyclophosphamide, and rituximab (PCR) followed by a consolidation course of alemtuzumab. This trial enrolled 102 patients with a median age of 64 years. Treatment consisted of 6 cycles of PCR followed by alemtuzumab for either 4 or 18 weeks depending on the initial response to PCR. The overall response after PCR (complete remission, CR, nodular partial remission, nPR, and partial remission, PR) was 55%. Major responses (CR or nPR) were achieved in 6%. The median overall survival (OS) and the median progression-free survival were 28 and 12 months, respectively. The most serious nonlethal adverse events were myelosuppression, febrile neutropenia, fatigue, nausea, and hyponatremia. PCR is an effective and well-tolerated nucleoside-based regimen for heavily pretreated CLL patients with R/R disease. The addition of alemtuzumab to CLL patients with a minor response (PR) or stable disease did not result in a significant number of higher responses (CR or nPR) nor an improvement in OS.

Original languageEnglish (US)
Pages (from-to)224-232
Number of pages9
JournalActa Haematologica
Volume142
Issue number4
DOIs
StatePublished - Nov 1 2019

All Science Journal Classification (ASJC) codes

  • Hematology

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    Kempin, S., Sun, Z., Kay, N. E., Paietta, E. M., Mazza, J. J., Ketterling, R. P., Frankfurt, O., Claxton, D. F., Saltzman, J. N., Srkalovic, G., Callander, N. S., Gross, G., & Tallman, M. S. (2019). Pentostatin, Cyclophosphamide, and Rituximab Followed by Alemtuzumab for Relapsed or Refractory Chronic Lymphocytic Leukemia: A Phase 2 Trial of the ECOG-Acrin Cancer Research Group (E2903). Acta Haematologica, 142(4), 224-232. https://doi.org/10.1159/000500164