This phase II trial studies how well eltrombopag olamine works in improving the recovery of platelet counts in older patients with Acute Myeloid Leukemia (AML) undergoing induction (the first treatment given for a disease) chemotherapy. Platelet counts recover more slowly in older patients, leading to risk of complications and the delay of post-remission therapy. Eltrombopag olamine may cause the body to make platelets after chemotherapy.
PRIMARY OBJECTIVES: I.To determine whether eltrombopag leads to early platelet recovery in older AML patients (≥ 60years) who attain morphologic remission on day 14 (range, day 14-17) bone marrow assessment following remission induction chemotherapy (IC). SECONDARY OBJECTIVES: I. To determine the effect of eltrombopag on megakaryopoiesis - median time to reach platelet count ≥50,000 /μL and ≥100,000 /μL, number of days of platelet transfusion, rates of platelet transfusion-independence and the median time to reach platelet transfusion independence. II. To determine the effect of eltrombopag on the rates of clinically significant bleeding events (CSBE). III. To determine the effect of eltrombopag on erythropoiesis the median time to red blood cell transfusion independence. IV. To determine the effect of eltrombopag on granulopoiesis- the time taken to reach an absolute neutrophil count of ≥ 500 /μL. V. To determine the safety and tolerability of eltrombopag in AML patients undergoing remission IC - incidence and severity of eltrombopag-related adverse events. VI. To determine rates of complete remission (CR), rates of partial complete remission (CRp), time to attain CR, and time to initiation of post-remission consolidation therapy. OUTLINE: Participants receive eltrombopag olamine orally (PO) once daily (QD) until platelet counts reach ≥50,000/uL or for 8 weeks, whichever comes earlier. Treatment continues in the absence of unacceptable toxicity. After completion of study treatment, participants are followed up for 2 years.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
31
Given PO
Case Comprehensive Cancer Center
Cleveland, Ohio, United States
Number of Participants With a Median Platelet Count >= 50,000/uL
Number of participants with a median platelet count \>= 50,000/uL
Time frame: Day 24 of Treatment
Median Time Needed to Reach Platelet Count >= 50,000 /µL in Days
Defined as the average number of days from the first day of eltrombopag until the first of five consecutive days with platelet counts \>= 50,000 /µL without a platelet transfusion. The time will be summarized using the Kaplan-Meier method and will use the logrank test and proportional hazards models.
Time frame: up to 12 weeks
Median Days of Platelet Transfusions
Defined as the median number of days from the first day of eltrombopag until the patient stopped treatment. The time will be summarized using the Kaplan-Meier method and will use the log-rank test and proportional hazards models.
Time frame: Up to 12 weeks
Rates of Clinically Significant Bleeding Events
The number of bleeding events experienced by patients during treatment including hematuria, gastrointestinal bleed (with or without requiring intervention, retroperitoneal bleeding, intra-cranial bleed, epistaxis not controlled by conservative measures and muscle or soft tissue hematomas.
Time frame: Up to 12 weeks
Median Time to Absolute Neutrophil Recovery, Defined as > 500/uL
The average number of days patients take to reach a neutrophil count \>500/ul as summarized using the Kaplan-Meier method and modeled using logrank test and proportional hazards.
Time frame: Up to 12 weeks
Median Rise in Hemoglobin Level in Patients With Pretreatment Hemoglobin of < 8 g/dL
The median increase in hemoglobin levels in g/dL among patients with a starting hemoglobin level \<8g/dL
Time frame: Up to 12 weeks
Complete Response Rate
The percent of participants with a sustained improvement of platelet counts (independent of platelet transfusions) to ≥ 50,000 /µL lasting for at least 2 weeks.
Time frame: Up to 12 weeks
Median Days to Attain Complete Response
The median number of days participants take to achieve a complete response as defined as a sustained improvement of platelet counts (independent of platelet transfusions) to ≥ 50,000 /µL lasting for at least 2 weeks.
Time frame: Up to 12 weeks
Partial Complete Response Rate
The number of participants with a sustained improvement of platelet counts (independent of platelet transfusions) seen by at least a doubling of platelet count from the pretreatment thrombocytopenic level (defined as \< 10000 /µL, ) or an absolute increase in platelet counts to between 30000 /µL and 50000 /µL, whichever is higher but not achieving complete response. Or if there is a need to restart eltrombopag due to drop in platelet count to below 50000 /µL following interruption of eltrombopag therapy after achieving platelet counts of \> 100000 /µL on the drug.
Time frame: Up to 12 weeks
Time to Initiation of Post-remission Therapy
The average number of days from the the beginning of treatment to the onset of post-remission therapy as summarized using the Kaplan-Meier method and calculated using the logrank test and proportional hazards models.
Time frame: Up to 12 weeks
Rate of Refractory or Persistent Disease
The number of participants with presence of morphologic evidence of disease
Time frame: Up to 12 weeks
Overall Survival (OS) - Percent of Participants Alive at Follow-up
OS is defined from the day of study registration until the last follow-up or death
Time frame: at 28 days, at 6 months and up to 5 years
Number of Participants With 3/4 Adverse Events Adverse Events, Determined According to the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0
Incidence of grade 3/4 adverse events (AE), determined according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0. For full list, see AE/serious adverse event (SAE) section
Time frame: Up to 4 weeks after last dose of eltrombopag olamine
Disease-Free Survival
Calculated from the date of complete remission until relapse, the date of last follow-up, or other protocol-defined event
Time frame: At 5 year follow-up
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.