B-cell Chronic Lymphocytic Leukemia Clinical Trial
Official title:
A Phase 2b Monotherapy Study of ABT-263 in Subjects With Relapsed or Refractory B-Cell Chronic Lymphocytic Leukemia
NCT number | NCT00918450 |
Other study ID # | M10-738 |
Secondary ID | |
Status | Withdrawn |
Phase | Phase 2 |
First received | May 22, 2009 |
Last updated | February 25, 2010 |
Start date | March 2010 |
Verified date | February 2010 |
Source | Abbott |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Food and Drug Administration |
Study type | Interventional |
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.
Status | Withdrawn |
Enrollment | 150 |
Est. completion date | |
Est. primary completion date | December 2012 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
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. |
Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Abbott | Genentech, Inc. |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Assess the safety of ABT-263 by evaluating study drug exposure, adverse events, serious adverse events, all deaths, as well as changes in laboratory determinations and vital sign parameters. | monthly (at a minimum) | Yes | |
Primary | Assess the objective response rate (partial response [PR] and confirmed complete response [CR]) of B-cell CLL subjects treated with ABT-263. | Every 3 months | No | |
Secondary | Assess the effects of ABT-263 on duration of overall response, PFS and overall survival in subjects with B-cell CLL. | Every 3 months | No | |
Secondary | Assess the effects of ABT-263 on time to response, 12-month survival rate, time to disease progression (TTP), and disease control rate in subjects with B-cell CLL . | Every 3 months | No | |
Secondary | Investigate the effects of ABT-263 on quality of life (FACT-Leu and EQ-5D), ECOG performance status, and biomarkers in subject with B-cell CLL. | Every 3 months | No |
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