Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 5:09 PM
Ignite Modification Date:
2025-12-24 @ 5:09 PM
NCT ID:
NCT00918450
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 \<= 2.0 mg/dL or calculated creatinine clearance \>= 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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00918450
Study Brief:
Protocol Section:
NCT00918450