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) Journal Article
| Authors: | 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. |
| Article 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. © 2019 S. Karger AG, Basel. |
| Keywords: | adult; treatment response; aged; major clinical study; overall survival; fludarabine; fatigue; neutropenia; cancer growth; diarrhea; side effect; treatment duration; cancer patient; rituximab; cancer immunotherapy; progression free survival; multiple cycle treatment; neutrophil count; phase 2 clinical trial; anemia; bone marrow suppression; nausea; thrombocytopenia; vomiting; myalgia; relapse; aciclovir; cyclophosphamide; hemoglobin; hemoglobin blood level; kidney failure; febrile neutropenia; fever; injection site reaction; lymphocytopenia; pneumonia; tumor lysis syndrome; hyponatremia; death; urinary tract infection; colitis; injection site pain; clostridium difficile infection; leukemia relapse; lung infection; chronic lymphatic leukemia; cotrimoxazole; granulocyte colony stimulating factor; cytomegalovirus infection; respiratory tract infection; alemtuzumab; pentostatin; eye infection; multiple organ failure; respiratory tract disease; platelet count; adult respiratory distress syndrome; leukemia remission; filgrastim; chronic lymphocytic leukemia; septicemia; pegfilgrastim; chemoimmunotherapy; consolidation chemotherapy; refractory disease; human; male; female; priority journal; article; median survival time; refractory chronic lymphocytic leukemia |
| Journal Title: | Acta Haematologica |
| Volume: | 142 |
| Issue: | 4 |
| ISSN: | 0001-5792 |
| Publisher: | S. Karger AG |
| Date Published: | 2019-11-01 |
| Start Page: | 224 |
| End Page: | 232 |
| Language: | English |
| DOI: | 10.1159/000500164 |
| PUBMED: | 31336367 |
| PROVIDER: | scopus |
| PMCID: | PMC6834875 |
| DOI/URL: | |
| Notes: | Article -- Export Date: 2 December 2019 -- Source: Scopus |
