Pentostatin, Cyclophosphamide, and Rituximab Followed By Lenalidomide in Treating Patients With Relapsed or Refractory B-Cell Chronic Lymphocytic Leukemia
|ClinicalTrials.gov Identifier: NCT00074282|
Recruitment Status : Unknown
Verified November 2012 by National Cancer Institute (NCI).
Recruitment status was: Recruiting
First Posted : December 11, 2003
Last Update Posted : November 12, 2012
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.
|Condition or disease||Intervention/treatment||Phase|
|Leukemia||Biological: filgrastim Biological: pegfilgrastim Biological: rituximab Drug: cyclophosphamide Drug: lenalidomide Drug: pentostatin||Phase 2|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||110 participants|
|Masking:||None (Open Label)|
|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|
|Study Start Date :||December 2004|
|Estimated Primary Completion Date :||October 2014|
- Response (CR, nPR, PR) rate in all patients treated with PCR
- Minimal-residual disease (MRD) as assessed by both flow cytometry and real-time allele-specific oligonucleotide polymerase chain reaction (RT-PCR)
- Toxicity as measured by CTCAE criteria every month
- Overall survival and progression-free survival as measured by Kaplan-Meier method during study treatment
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00074282
Show 145 Study Locations
|Study Chair:||Sanford J. Kempin, MD||Beth Israel Medical Center|
|OverallOfficial:||Neil E. Kay, MD||Mayo Clinic|