study assessing the safety and efficacy of abt-263 in subjects with b-cell chronic lymphocytic leukemia (cll) who have failed at least one prior fludarabine-containing regimen

Conditions: B-cell Chronic Lymphocytic Leukemia

Summary: this is a phase 2b, open-label, multicenter, global study assessing the safety and efficacy of abt-263 in subjects with b-cell cll who have failed at least one prior fludarabine-containing regimen.


Eligibility criteria:
inclusion criteria: * \>= 18 yrs of age, have b-cell cll, failed at least 1 prior fludarabine-containing regimen. * refractory to 1 fludarabine-containing regimen is defined as failure to achieve at least pr to the last fludarabine-containing regimen received, or disease progression while receiving the last fludarabine-containing regimen, or disease progression in responders (i.e., achieved a pr or cr) within 6 mos of the last cycle of the last fludarabine-containing regimen received (e.g., fludarabine monotherapy, fr, or fc) or in responders (i.e., achieved a pr or cr ) within 24 mos of the last cycle of fcr. * intolerant to fludarabine is defined as discontinuation of therapy within 2 cycles due to side effects/toxicity from the last fludarabine-containing regimen. * ecog score of \<=1. * adequate coagulation, renal, \& hepatic function at screening as follows: * serum creatinine \ = 50 ml/min; * ast \& alt \<= 3.0 x uln; * bilirubin \<= 1.5 x uln. * gilbert's syndrome may have a bilirubin \> 1.5 x uln; aptt, pt, not to exceed 1.2 x uln. * adequate bone marrow (bm) independent of any growth factor support (with the exception of subjects with bm heavily infiltrated with underlying disease \[80% or more\] who may use growth factor support to achieve adequate bm) at screening as follows: * anc \>= 1000/µl; * platelets \>= 75,000/mm3 (entry platelet count must be independent of transfusion within 14 days of screening); * hemoglobin \>= 9.0 g/dl. * history of autologous bm transplant must be \> 6 mos post transplant (prior to the 1st dose of study drug) \& have adequate bm independent of any growth factor support (with the exception of subjects with bm that is heavily infiltrated with underlying disease \[80% or more\] who may use growth factor support to achieve adequate bm) at screening as follows: * anc \>= 1500/µl; * platelets \>= 125,000/mm3; * hemoglobin \>= 10.0 g/dl. * female subjects must be surgically sterile, postmenopausal (at least 1 year), or have negative results on a pregnancy test. * all female subjects not surgically sterile or postmenopausal (at least 1 year) \& non-vasectomized male subjects must practice birth control. exclusion criteria: * history/clinically suspicious for cancer-related cns disease. * undergone allogeneic stem cell transplant. * undergone autologous stem cell transplant w/i 6 mos prior to 1st dose. * history/predisposing condition of bleeding or currently exhibits signs of bleeding. * recent history of non-chemotherapy induced thrombocytopenic associated bleeding w/i 6 mos prior to 1st dose. * active peptic ulcer disease or other hemorrhagic esophagitis/gastritis. * active immune thrombocytopenic purpura or history of being refractory to platelet transfusions w/i 1 yr prior to 1st dose. * currently receiving/requires anticoagulation therapy or any drugs or herbal supplements that affect platelet function, with the exception of low-dose anticoagulation medications used to maintain the patency of a central iv catheter. * significant history of cardiovascular disease, renal, neurologic, psychiatric, endocrinologic, metabolic, immunologic, or hepatic disease. * positive for hiv, hepatitis b, or hepatitis c. * previous or current malignancies w/i the last 3 yrs: * except adequately treated in situ carcinoma of the cervix uteri; * basal or squamous cell carcinoma; * in situ carcinoma of the bladder; * or previous malignancy confined and surgically resected with curative intent. * has prolymphocytic leukemia or richter's transformation to an aggressive b-cell malignancy. * exhibits evidence of other clinically significant uncontrolled condition(s) including, but not limited to uncontrolled systemic infection or diagnosis of fever and neutropenia w/i 1 week prior to study drug. * prior exposure to abt-263. * received antibody therapy w/i 30 days prior to 1st dose. * received any anti-cancer therapy including chemotherapy, immunotherapy, radiotherapy, hormonal, or any investigational therapy w/i 14 days prior to the 1st dose, or has not recovered to \<gr2 clinically significant ae(s) /toxicity(s) of the previous therapy. * received steroid therapy for anti-neoplastic intent, w/i 7 days prior to the 1st dose with the exception of inhaled steroids for asthma, topical steroids, or replacement/stress corticosteroids. * received aspirin w/i 7 days prior to the 1st dose. * consumed grapefruit or grapefruit products w/i 3 days prior to 1st dose. * females pregnant or breast-feeding.