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
This study has been withdrawn prior to enrollment.
(Sponsor has decided to not proceed with this study.)
Information provided by:
First received: May 22, 2009
Last updated: February 25, 2010
Last verified: February 2010
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.
B-cell Chronic Lymphocytic Leukemia
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
||A Phase 2b Monotherapy Study of ABT-263 in Subjects With Relapsed or Refractory B-Cell Chronic Lymphocytic Leukemia
Primary Outcome Measures:
- 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. [ Time Frame: monthly (at a minimum) ] [ Designated as safety issue: Yes ]
- Assess the objective response rate (partial response [PR] and confirmed complete response [CR]) of B-cell CLL subjects treated with ABT-263. [ Time Frame: Every 3 months ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Assess the effects of ABT-263 on duration of overall response, PFS and overall survival in subjects with B-cell CLL. [ Time Frame: Every 3 months ] [ Designated as safety issue: No ]
- 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 . [ Time Frame: Every 3 months ] [ Designated as safety issue: No ]
- 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. [ Time Frame: Every 3 months ] [ Designated as safety issue: No ]
| Estimated Enrollment:
| Study Start Date:
| Estimated Primary Completion Date:
||December 2012 (Final data collection date for primary outcome measure)
Continuous dosing until disease progression using one of the following formulations:
25 mg/mL oral solution OR 50 mg/mL oral solution OR 2.0 grams/bottle powder for oral solution of 25 mg/mL when mixed OR 2.0 grams/bottle powder for oral solution of 50 mg/mL when mixed
|Ages Eligible for Study:
||18 Years and older (Adult, Senior)
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- >= 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.
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||Sari Enschede, MD, Abbott Laboratories
History of Changes
|Other Study ID Numbers:
|Study First Received:
||May 22, 2009
||February 25, 2010
||United States: Food and Drug Administration
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on July 27, 2016
Leukemia, Lymphocytic, Chronic, B-Cell
Neoplasms by Histologic Type
Immune System Diseases