Status:
COMPLETED
Study of ABT-263 When Administered in Combination With Either Fludarabine/Cyclophosphamide/Rituximab or Bendamustine/Rituximab in Relapsed or Refractory Chronic Lymphocytic Leukemia
Lead Sponsor:
AbbVie (prior sponsor, Abbott)
Collaborating Sponsors:
Genentech, Inc.
Conditions:
Chronic Lymphocytic Leukemia
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
This is a Phase 1 study evaluating the safety of ABT-263 administered in combination with either FCR or BR in subjects with relapsed or refractory chronic lymphocytic leukemia.
Eligibility Criteria
Inclusion
- Must have relapsed or refractory Chronic Lymphocytic Leukemia (CLL), received no more than 5 prior myelosuppressive/chemotherapy regimens and must be a candidate for treatment with either Fludarabine/Cyclophosphamide/Rituximab (FCR) or Bendamustine/Rituximab (BR);
- Subject has an Eastern Cooperative Oncology Group (ECOG) performance score of \</=1;
- Must have adequate bone marrow independent of growth factor support (with the exception of subjects with bone marrow heavily infiltrated with underlying disease \[80% or more\] who may use growth factor support to achieve Absolute Neutrophil Count (ANC) eligibility criteria), per local laboratory reference range at Screening as follows: ANC \>/=1000/mcL, Platelets\>/= 100,000/mm3 (entry platelet count must be independent of transfusion within 14 days of Screening),Hemoglobin \>/= 9.0 g/dL.
Exclusion
- Subject has history or is clinically suspicious for cancer-related Central Nervous System disease;
- Has history of severe allergic or anaphylactic reactions to human, humanized, chimeric or murine monoclonal antibodies;
- Has undergone an allogeneic stem cell transplant; Exhibits evidence of other uncontrolled condition(s) including, but not limited to: uncontrolled systemic infection, diagnosis of fever and neutropenia within 1 week prior to study drug administration;
- Has underlying, predisposing condition of bleeding or currently exhibits signs of bleeding; Has a recent history of non-chemotherapy induced thrombocytopenic associated bleeding;
- Currently receiving or requires anticoagulation therapy;
- Has active immune thrombocytopenic purpura (ITP) or a history of being refractory to platelet transfusions (within 1 year prior to 1st dose of study drug);
- Has active peptic ulcer disease or other hemorrhagic esophagitis/gastritis.
Key Trial Info
Start Date :
November 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2013
Estimated Enrollment :
32 Patients enrolled
Trial Details
Trial ID
NCT00868413
Start Date
November 1 2009
End Date
May 1 2013
Last Update
June 7 2013
Active Locations (6)
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1
Site Reference ID/Investigator# 17841
La Jolla, California, United States, 92093
2
Site Reference ID/Investigator# 25899
Stanford, California, United States, 94305-5821
3
Site Reference ID/Investigator# 21622
Baltimore, Maryland, United States, 21231-1000
4
Site Reference ID/Investigator# 21621
Columbus, Ohio, United States, 43210