SWOG clinical trial number
E2997
Phase III Randomized Trial of Fludarabine and Cyclophosphamide versus Fludarabine for Previously Untreated Chronic Lymphocytic Leukemia.
Treatment
Cyclophosphamide
Fludarabine Phosphate
Pts. must have CLL of any stage. Pts. must require chemotherapy as described in the protocol. Pts. with autoimmune anemia or thrombocytopenia are not eligible. Serum creatinine must not be greater than 2.0 mg/dl w/in 2 weeks prior to randomization. Bilirubin must be less than or equal 2.0 mg/dl w/in 2 weeks prior to randomization. Pts. must be 18 years of age or older. Pts. w/active infections reequiring oral or intravenous antibiotics are not eligible until resolutionof the infection and completion of therapeutic antibiotics. Pts. must not be pregnant or breastfeeding. Women of childbearing age and sexually active men are strongly advised to use an accepted and effective method of contraception. Pts. must have an ECOG PS of 0-2. Pts. w/second malignancy other than basal cell carcinoma of the skin in situ carcinoma of the cervix are not eligible unless the tumor was treated w/curative intent at least 2 years prevously.
2011
Incidence of therapy-related myeloid neoplasia after initial for CLL with fludarabine-cyclophosphamide versus fludarabine: long-term follow-up of US intergroup study E2997 [PMID21803850; PMC3186330]
MR Smith;D Neuberg;IW Flynn;MR Grever;HM Lazarus;JM Rowe;G Dewald;JM Bennett;E Paietta;JC Byrd;MA Hussein;FR Appelbaum;RA Larson;MR Litzow;MS Tallman Blood 118(13):3525-3527
2007
Phase III trial of fludarabine plus cyclophosphamide compared with fludarabine for patients with previously untreated chronic lymphocytic leukemia: US Intergroup Trial E2997
IW Flinn;DS Neuberg;MR Grever;GW Dewald;JM Bennett;EM Paietta;MA Hussein;FR Appelbaum;RA Larson;DF Moore;MS Tallman Journal of Clinical Oncology 25(7):793-798
PMid: PMID17283364
Comprehensive assessment of genetic and molecular features predicting outcome in patients with chronic lymphocytic leukemia: results from the US Intergroup Phase III Trial E2997
MR Grever;DM Lucas;GW Dewald;JC Reed;S Kitada;IW Flinn;MS Tallman;FR Appelbaum;RA Larson;E Paietta;DF Jelinek;JG Gribben;JC Byrd Journal of Clinical Oncology 25(7):799-804
PMid: PMID17283363
2005
Cytogenetic studies of 539 chronic lymphocytic leukemia (CLL) patients
NA Heerema;G Lozanski;TS Lin;M Moran;MR Grever;JC Byrd Blood 106(11):#1192
Expression of T cell co-stimulator (ICOS) and its ligand and disease progression in B-cell chronic lymphocytic leukemia.
T Fukuda;DS Neuberg;L Huynh;LZ Rassenti;TL Toy;KR Rai;MJ Keating;JG Gribben;IW Flinn;JC Byrd;NE Kay;TJ Kipps Blood 106(11):#2943
2004
Fludarabine and cyclophosphamide produces a higher complete response rate and more durable remissions than fludarabine in patients with previously untreated CLL: Intergroup trial E2997
IW Flinn;E Kumm;MR Grever;D Neuberg;GW Dewald;JM Bennett;EM Paietta;FR Appelbaum;RA Larson;MA Hussein;DF Moore Jr;MS Tallman Blood 104(11): #475
Clinical, laboratory, and treatment outcome characteristics of chronic lymphocytic leukemia (CLL) patients with p53 mutations or del(17p) enrolled on a prospective phase III clinical trial: short progression free survival, irrespective of fludarabine-based treatment used
DM Lucas;GW Dewald;DS Neuberg;JC Byrd;G Lozanski;J Harbison;KD Cunningham;IW Flinn;MS Tallman;MR Grever Blood 104(11): #949
Critical molecular studies to strategically plan therapy in chronic lymphocytic leukemia (CLL): correlating cellular proteins with defined prognostic patient subsets and their response to treatment
S Kitada;JC Reed;DM Lucas;DS Neuberg;JG Gribben;GW Dewald;IW Flinn;MS Tallman;JC Byrd;MR Grever Blood 104(11):956
Outcome of treatment with fludarabine versus fludarabine and cyclophosphamide in chronic lymphocytic leukemia (CLL) is adversely impacted by high risk genetic features: results from ECOG 2997
MR Grever;DM Lucas;GW Dewald;DS Neuberg;IW Flinn;MS Tallman;JG Gribben;JC Byrd Blood 104(11):#3487
