Pentostatin, Cyclophosphamide, and Rituximab Followed By Lenalidomide in Treating Patients With Relapsed or Refractory B-Cell Chronic Lymphocytic Leukemia
RATIONALE: Drugs used in chemotherapy, such as pentostatin, cyclophosphamide, and lenalidomide work in different ways to stop cancer cells from dividing so they stop growing or die. Monoclonal antibodies, such as rituximab can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells. Combining chemotherapy with monoclonal antibody therapy may kill more tumor cells.
PURPOSE: This phase II trial is studying how well pentostatin, cyclophosphamide, rituximab, and lenalidomide work in treating patients with relapsed or refractory B-cell chronic lymphocytic leukemia.
|Study Design:||Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase II Trial of Pentostatin, Cyclophosphamide and Rituximab (PCR) Followed by Lenalidomide for Previously Treated Relapsed or Refractory Patients With Chronic Lymphocytic Leukemia|
- Response (CR, nPR, PR) rate in all patients treated with PCR [ Designated as safety issue: No ]
- Minimal-residual disease (MRD) as assessed by both flow cytometry and real-time allele-specific oligonucleotide polymerase chain reaction (RT-PCR) [ Designated as safety issue: No ]
- Toxicity as measured by CTCAE criteria every month [ Designated as safety issue: Yes ]
- Overall survival and progression-free survival as measured by Kaplan-Meier method during study treatment [ Designated as safety issue: No ]
- Rate of molecular complete remission (MCR) after the treatment of PCR and alemtuzumab (before May 2011) or lenalidomide after May 2011) in patients who achieve a CR or nPR [ Designated as safety issue: No ]
|Study Start Date:||December 2004|
|Estimated Primary Completion Date:||October 2014 (Final data collection date for primary outcome measure)|
Show 145 Study Locations
|Study Chair:||Sanford J. Kempin, MD||Beth Israel Medical Center|
|Investigator:||Neil E. Kay, MD||Mayo Clinic|