Gene Therapy Clinical Trials
Study of ABT-263 When Administered in Combination With Either Fludarabine/Cyclophosphamide/Rituximab or Bendamustine/Rituximab in Relapsed or Refractory Chronic Lymphocytic Leukemia
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.
Stanford is currently not accepting patients for this trial.
Intervention(s):
- drug: ABT-263
- drug: FCR
- drug: BR
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 =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.
Ages Eligible for Study
18 Years - N/A
Genders Eligible for Study
All
Not currently accepting new patients for this trial
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
Cancer Clinical Trials Office
650-498-7061
Not Recruiting