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Study of ABT-263 When Administered in Combination With Either Fludarabine/Cyclophosphamide/Rituximab or Bendamustine/Rituximab in Relapsed or Refractory Chronic Lymphocytic Leukemia
Not Recruiting
Trial ID: NCT00868413
Purpose
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.
Official Title
A Phase 1 Study Evaluating the Safety of ABT-263 in Combination With Either Fludarabine/Cyclophosphamide/Rituximab (FCR) or Bendamustine/Rituximab (BR) in Subjects With Relapsed or Refractory Chronic Lymphocytic Leukemia
Eligibility
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
- 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.
Intervention(s):
drug: ABT-263
drug: FCR
drug: BR
Not Recruiting
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
Cancer Clinical Trials Office
650-498-7061