Status:
COMPLETED
Phase II Eltrombopag in Chronic Lymphocytic Leukemia (CLL)
Lead Sponsor:
M.D. Anderson Cancer Center
Collaborating Sponsors:
GlaxoSmithKline
Conditions:
CLL
Leukemia
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
The goal of this clinical research study is to learn if eltrombopag can help to increase the number of platelets in patients with CLL. The safety of this drug will also be studied.
Detailed Description
The Study Drug: When the number of platelets in your body gets too low, it can cause bleeding, which may cause serious health problems and/or prevent you from receiving chemotherapy. Eltrombopag is d...
Eligibility Criteria
Inclusion
- Diagnosis of chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL)
- Age \>/= 18 years
- PLT transfusion-dependent, defined as need for transfusion to maintain PLT count \>/=20K/µL, or the average of two (non-transfused) PLT counts taken within 2 weeks of the screening period \</=50K/µL, with no individual count \>55K/µL
- Patients with ITP must have failed at least 1 prior treatment for ITP including one of the following: corticosteroids, rituximab, splenectomy, cyclosporine
- At least 3 weeks must have elapsed since the last chemotherapy treatment for CLL
- ECOG performance status (PS) \</=2
- Adequate liver function (total bilirubin \</=2\* upper limit normal (ULN); ALT \</=2.5\* ULN)
- Adequate renal function (serum creatinine Cr \</=2.2 mg/dL)
- For patients with ITP on corticosteroids or cyclosporine, dose of corticosteroids or cyclosporine must be stable for 2 weeks prior to enrollment and planned to be tapered in patients responding to eltrombopag
- Able to provide informed consent
Exclusion
- Concurrent chemotherapy for CLL
- Diagnosis of Richter's transformation
- Uncontrolled autoimmune hemolytic anemia i.e. patients with AIHA that is not controlled with treatment such as corticosteroids or cyclosporine. This would include patients who require PBRC transfusions or who do not have a stable hemoglobin (HGB) due to ongoing hemolysis.
- Concurrent treatment for ITP (except for corticosteroids and cyclosporine)
- Diagnosis of myelodysplastic syndrome or acute myeloid leukemia
- Active infection or significant medical illness as determined by the treating physician
- Treatment with thrombomimetic agents in the past 3 months (rTPO, PEG-rHuMGDF, Nplate or Promacta)
- Pregnant or breast feeding subjects and subjects not willing to use adequate contraceptive precautions
Key Trial Info
Start Date :
November 3 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 7 2022
Estimated Enrollment :
23 Patients enrolled
Trial Details
Trial ID
NCT01168921
Start Date
November 3 2010
End Date
March 7 2022
Last Update
March 23 2023
Active Locations (1)
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1
University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030