Clinical trial · Interventional
Phase II Eltrombopag in Chronic Lymphocytic Leukemia (CLL)
A Phase II Trial of Eltrombopag for Patients With Chronic Lymphocytic Leukemia (CLL) and Thrombocytopenia
NCT01168921CI-TRIAL-00064944completedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| CLL | Chronic Lymphocytic Leukemia | ALIAS | 0.90 |
| Leukemia | Leukemia | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Eltrombopag | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Eltrombopag
- description
- Starting dose 75 mg by mouth (PO) daily for 28 day cycle.
- interventionNames
- Drug: Eltrombopag
Primary outcomes (1)
- measure
- Number of Participants With a Response
- timeFrame
- Up to 4 years
- description
- Response is Complete Response (CR) + Major Response (MR). Complete response was defined as an increase in platelet count to ≥100K/µL for at least 4 weeks. Major response was defined as an increase in platelet count from \<20K/µL to ≥20K/μL and by at least 100% for at least 8 weeks; or for pts starting with \>20K/μL platelet count, absolute increase in platelet count of ≥30K/μL for at least 4 weeks.
Secondary outcomes (1)
- measure
- Time to CLL Progression Requiring Leukemia Treatment
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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 \</=50K/µL, with no individual count \>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) \</=2 7. Adequate liver function (total bilirubin \</=2\* upper limit normal (ULN); ALT \</=2.5\* ULN) 8. Adequate renal function (serum creatinine Cr \</=2.2 mg/dL) 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
References
Publications (0)
Data not yet available
No reference posted for this study.