Study of ABT-263 When Administered in Combination With Either Fludarabine/Cyclophosphamide/Rituximab or Bendamustine/Rituximab in Relapsed or Refractory Chronic Lymphocytic Leukemia
- Registration Number
- NCT00868413
- Lead Sponsor
- AbbVie (prior sponsor, Abbott)
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 32
Inclusion Criteria
- 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 Criteria
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description A ABT-263 FCR+ABT-263 A FCR FCR+ABT-263 B ABT-263 BR+ABT-263 B BR BR+ABT-263
- Primary Outcome Measures
Name Time Method Assess the safety profile, characterize pharmacokinetics, and determine the MTD and recommended Phase 2 dose (RPTD) of ABT-263 when administered in combination with either FCR or BR in subjects with relapsed or refractory CLL. Safety assessments = 1 wk, Pharmacokinetic (PK) Sampling = 1 wk for 1st 2 cycles, then, every other cycle starting Cycle 3 to Cycle 9, Determination of MTD & RPTD = Every 60 days
- Secondary Outcome Measures
Name Time Method Evaluate preliminary data regarding progression-free survival (PFS), tumor response rate and overall survival (OS) when ABT-263 is administered in combination with either FCR or BR. Every 2 months Tumor assessments
Trial Locations
- Locations (6)
Site Reference ID/Investigator# 21622
🇺🇸Baltimore, Maryland, United States
Site Reference ID/Investigator# 17841
🇺🇸La Jolla, California, United States
Site Reference ID/Investigator# 25899
🇺🇸Stanford, California, 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