Fludarabine, Cyclophosphamide, and Rituximab or Alemtuzumab in Treating CLL2007 CLL 2007 FMP

Summary

RATIONALE: Drugs used in chemotherapy, such as fludarabine and cyclophosphamide, work in different ways to kill cancer cells or stop them from growing. Monoclonal antibodies, such as rituximab and alemtuzumab, can block cancer growth in different ways. Some find cancer cells and help kill them or carry cancer-killing substances to them. Others interfere with the ability of cancer cells to grow and spread. It is not yet known whether giving fludarabine and cyclophosphamide together with rituximab is more effective than giving fludarabine and cyclophosphamide together with alemtuzumab in treating B-cell chronic lymphocytic leukemia. PURPOSE: This randomized phase III trial is studying giving fludarabine together with cyclophosphamide and rituximab to see how well it works as first-line therapy compared with giving fludarabine together with cyclophosphamide and alemtuzumab in treating patients with B-cell chronic lymphocytic leukemia.

Timeline

Start

2007-11

Primary completion

2009-01

Completion

2013-07

Publications

• Grgurevic S, Montilla-Perez P, Bradbury A, Gilhodes J, Queille S, Pelofy S, Bancaud A, Filleron T, Ysebaert L, Recher C, Laurent G, Fournie JJ, Cazaux C, Quillet-Mary A, Hoffmann JS. DNA polymerase nu gene expression influences fludarabine resistance in chronic lymphocytic leukemia independently of p53 status. Haematologica. 2018 Jun;103(6):1038-1046. doi: 10.3324/haematol.2017.174243. Epub 2018 Mar 22.
• Lepretre S, Aurran T, Mahe B, Cazin B, Tournilhac O, Maisonneuve H, Casasnovas O, Delmer A, Leblond V, Royer B, Corront B, Chevret S, Delepine R, Vaudaux S, Van Den Neste E, Bene MC, Letestu R, Cymbalista F, Feugier P. Excess mortality after treatment with fludarabine and cyclophosphamide in combination with alemtuzumab in previously untreated patients with chronic lymphocytic leukemia in a randomized phase 3 trial. Blood. 2012 May 31;119(22):5104-10. doi: 10.1182/blood-2011-07-365437. Epub 2012 Feb 14.

Drugs

Indications