Clinical trial · Interventional
Eltrombopag Olamine in Treating Thrombocytopenia in Patients With Chronic Myeloid Leukemia or Myelofibrosis Receiving Tyrosine Kinase Therapy
Eltrombopag for the Management of Thrombocytopenia Associated With Tyrosine Kinase Therapy in Patients With Chronic Myeloid Leukemia (CML) and Myelofibrosis (MF)
- 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)
This phase II/III trial studies how well eltrombopag olamine works in treating thrombocytopenia in patients with chronic myeloid leukemia or myelofibrosis receiving tyrosine kinase inhibitor therapy. Eltrombopag olamine may cause the body to make platelets after receiving treatment for chronic myeloid leukemia or myelofibrosis.
Conditions
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Accelerated Phase Chronic Myelogenous Leukemia, BCR-ABL1 Positive | Accelerated Phase Chronic Myeloid Leukemia, BCR-ABL1 Positive | ALIAS | 0.90 |
| Blast Phase Chronic Myelogenous Leukemia, BCR-ABL1 Positive | Blast Phase Chronic Myeloid Leukemia, BCR-ABL1 Positive | ALIAS | 0.90 |
| Chronic Phase Chronic Myelogenous Leukemia, BCR-ABL1 Positive | Chronic Phase Chronic Myeloid Leukemia, BCR-ABL1 Positive | ALIAS | 0.90 |
| Primary Myelofibrosis | Primary Myelofibrosis | ONTOLOGY_EXACT | 0.98 |
| Thrombocytopenia | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Eltrombopag Olamine | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Supportive care (eltrombopag olamine)
- description
- Patients receive eltrombopag olamine PO QD in the absence of disease progression or unacceptable toxicity.
- interventionNames
- Drug: Eltrombopag Olamine
Primary outcomes (1)
- measure
- Number of Participants With a Platelet Response
- timeFrame
- Up to 9 years
- description
- The primary endpoint is complete (platelet) response (yes/no). A complete (platelet) response will be defined as a sustained (3 months) platelet count of \> 50 x 109/L for patients with CML and \> 100 x 109/L for patients with MF and at least a 20% increase in platelet count from baseline.
Secondary outcomes (1)
- measure
- Number of Participants With a Response to TKI Therapy After Eltrombopag
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * CML patients in chronic phase receiving treatment with any Food and Drug Administration (FDA) approved TKI; or CML patients in accelerated or blastic phase who are considered to be in this phase because of thrombocytopenia or because of clonal evolution and with no other criteria for accelerated/blastic phase or patients with myelofibrosis receiving treatment with FDA approved TKI and with peripheral blood and/or bone marrow blasts =\< 10% * Grade \>= 3 thrombocytopenia (platelets \< 50 x 10\^9/L) after the first 3 months of therapy with the TKI for patients with CML and platelets \< 100 x 10\^9/L for patients with MF after the first 3 months of therapy; thrombocytopenia must be either recurrent (i.e., second or greater episode of thrombocytopenia) or having required dose reductions of the TKI * Subject is anticipated to have therapy with TKI continued for \>= 3 months * Total bilirubin =\< 1.5 x upper limit of normal (ULN) (except for Gilbert's syndrome) * Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) \< 3 x ULN * Creatinine =\< 2 x ULN Exclusion Criteria: * CML patients in accelerated or blastic phase except for those who are considered to be in this phase because of thrombocytopenia or because of clonal evolution and with no other criteria for accelerated/blastic phase; or myelofibrosis patients who have transformed to acute leukemia or have \>= 10% blasts in peripheral blood and/or in bone marrow * Thrombocytopenia that is considered to be unrelated to treatment with TKI or accelerated phase as defined above * Stem cell transplantation within preceding 60 days prior to registration * Patients with documented active hepatitis B or C infection * Patients with known bone marrow reticulin fibrosis (\>= grade 2) (only applicable to patients with CML) * Patients with palpable splenomegaly \>= 16 cm below coastal margin (only applicable to patients with CML) * Female subjects who are pregnant or breastfeeding * Women of childbearing potential are required to have a beta human chorionic gonadotropin (BHCG) serum or urine pregnancy test performed within 7 days prior to first study drug dose; a female of childbearing potential is a sexually mature woman who: * Has not undergone a hysterectomy or bilateral oophorectomy * Has not been naturally postmenopausal for at least 12 consecutive months (i.e., has had menses at any time in the preceding 12 consecutive months) * Women of child-bearing potential and men must agree to use contraception prior to study entry and for the duration of study participation * Patients with known risk factors for thromboembolism (e.g. Factor V Leiden mutation, antithrombin III (ATIII) deficiency, Protein C and S deficiency, antiphospholipid syndrome, portal hypertension, etc.)
References
Publications (0)
Data not yet available