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)
JournalActa Haematologica
DOIs
StatePublished - Jan 1 2019

Fingerprint

Pentostatin
B-Cell Chronic Lymphocytic Leukemia
Cyclophosphamide
Research
Neoplasms
Febrile Neutropenia
Survival
Hyponatremia
Nucleosides
Nausea
Disease-Free Survival
Fatigue
alemtuzumab
Rituximab

ASJC Scopus subject areas

  • Hematology

Cite this

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

In: Acta Haematologica, 01.01.2019.

Research output: Contribution to journalArticle

Kempin, Sanford ; Sun, Zhuoxin ; Kay, Neil E. ; Paietta, Elisabeth M. ; Mazza, Joseph J. ; Ketterling, Rhett P. ; Frankfurt, Olga ; Claxton, David F. ; Saltzman, Joel N. ; Srkalovic, Gordan ; Callander, Natalie S. ; Gross, Gerald ; Tallman, Martin S. / 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). In: Acta Haematologica. 2019.
@article{e25cefcd94454f81a1e168a8d25ef001,
title = "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)",
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.",
author = "Sanford Kempin and Zhuoxin Sun and Kay, {Neil E.} and Paietta, {Elisabeth M.} and Mazza, {Joseph J.} and Ketterling, {Rhett P.} and Olga Frankfurt and Claxton, {David F.} and Saltzman, {Joel N.} and Gordan Srkalovic and Callander, {Natalie S.} and Gerald Gross and Tallman, {Martin S.}",
year = "2019",
month = "1",
day = "1",
doi = "10.1159/000500164",
language = "English (US)",
journal = "Acta Haematologica",
issn = "0001-5792",
publisher = "S. Karger AG",

}

TY - JOUR

T1 - Pentostatin, Cyclophosphamide, and Rituximab Followed by Alemtuzumab for Relapsed or Refractory Chronic Lymphocytic Leukemia

T2 - A Phase 2 Trial of the ECOG-Acrin Cancer Research Group (E2903)

AU - Kempin, Sanford

AU - Sun, Zhuoxin

AU - Kay, Neil E.

AU - Paietta, Elisabeth M.

AU - Mazza, Joseph J.

AU - Ketterling, Rhett P.

AU - Frankfurt, Olga

AU - Claxton, David F.

AU - Saltzman, Joel N.

AU - Srkalovic, Gordan

AU - Callander, Natalie S.

AU - Gross, Gerald

AU - Tallman, Martin S.

PY - 2019/1/1

Y1 - 2019/1/1

N2 - 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.

AB - 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.

UR - http://www.scopus.com/inward/record.url?scp=85069698001&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=85069698001&partnerID=8YFLogxK

U2 - 10.1159/000500164

DO - 10.1159/000500164

M3 - Article

JO - Acta Haematologica

JF - Acta Haematologica

SN - 0001-5792

ER -