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This study has been withdrawn prior to enrollment.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.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
No Contacts or Locations Provided
||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 August 28, 2016
Leukemia, Lymphocytic, Chronic, B-Cell
Neoplasms by Histologic Type
Immune System Diseases