Study of ABT-263 When Administered in Combination With Either Fludarabine/Cyclophosphamide/Rituximab or Bendamustine/Rituximab in Relapsed or Refractory Chronic Lymphocytic Leukemia
Completed · Phase 1
Conditions studied: Chronic Lymphocytic Leukemia
In brief
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.
Key facts
- Study ID
- NCT00868413
- Run by
- AbbVie (prior sponsor, Abbott)
- People needed
- 32
- Starts
- 2009-11-01
- Expected to finish
- 2013-05-01
- Last updated by the study team
- 2013-06-07
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- Site Reference ID/Investigator# 17841 — La Jolla, California, United States
- Site Reference ID/Investigator# 25899 — Stanford, California, United States
- Site Reference ID/Investigator# 21622 — Baltimore, Maryland, United States
- Site Reference ID/Investigator# 21621 — Columbus, Ohio, United States
- Site Reference ID/Investigator# 39613 — Philadelphia, Pennsylvania, United States
- Site Reference ID/Investigator# 17943 — Houston, Texas, United States
Full record on ClinicalTrials.gov
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