Overview

Phase II Eltrombopag in Chronic Lymphocytic Leukemia (CLL)

Status:
Active, not recruiting

Trial end date:
2022-08-01

Target enrollment:
0

Participant gender:
All

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.

Phase:

Phase 2

Accepts Healthy Volunteers?

Details

Lead Sponsor:

M.D. Anderson Cancer Center

Collaborator:

GlaxoSmithKline

Criteria

Inclusion Criteria:

1. Diagnosis of chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL)

2. Age >/= 18 years

3. 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 55K/µL

4. Patients with ITP must have failed at least 1 prior treatment for ITP including one of
the following: corticosteroids, rituximab, splenectomy, cyclosporine

5. At least 3 weeks must have elapsed since the last chemotherapy treatment for CLL

6. ECOG performance status (PS)
7. Adequate liver function (total bilirubin ULN)

8. Adequate renal function (serum creatinine Cr
9. 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

10. Able to provide informed consent

Exclusion Criteria:

1. Concurrent chemotherapy for CLL

2. Diagnosis of Richter's transformation

3. 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.

4. Concurrent treatment for ITP (except for corticosteroids and cyclosporine)

5. Diagnosis of myelodysplastic syndrome or acute myeloid leukemia

6. Active infection or significant medical illness as determined by the treating
physician

7. Treatment with thrombomimetic agents in the past 3 months (rTPO, PEG-rHuMGDF, Nplate
or Promacta)

8. Pregnant or breast feeding subjects and subjects not willing to use adequate
contraceptive precautions