A Phase 2 interventional study of eltrombopag olamine in Acute Myeloid Leukemia With Multilineage Dysplasia Following Myelodysplastic Syndrome, Adult Acute Basophilic Leukemia and Adult Acute Eosinophilic Leukemia, sponsored by Case Comprehensive Cancer Center. Completed at 1 site in United States. Open to participants aged 60 Years and older. Per ClinicalTrials.gov, last updated 2026-08-07.
Sponsored by Case Comprehensive Cancer Center · Phase 2, Interventional, and Supportive care
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.
55 studies on the registry are indexed under Leukemia, Basophilic, Acute; none are open to participants now.
This study's enrollment of 31 is below the median of 60 across 45 interventional studies indexed under Leukemia, Basophilic, Acute.
Browse Leukemia, Basophilic, Acute studies →Case Comprehensive Cancer Center is the lead sponsor of 494 studies on the registry; 61 are open to participants now.
Of its 75 completed or terminated interventional studies of FDA-regulated products, 46 (61%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Women of should be advised to avoid becoming pregnant and men should be advised to not father a child while receiving treatment. All men and women of childbearing potential must use acceptable methods of throughout the study as described below:
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Stem cell (bone marrow) transplants. Allogeneic uses cells from a donor; autologous uses your own cells, collected earlier and given back.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.
Stroke symptoms need emergency care at once, even if they go away.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Allogeneic and autologous transplant
Stem cell (bone marrow) transplants. Allogeneic uses cells from a donor; autologous uses your own cells, collected earlier and given back.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Relapsed and refractory
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
TIA (transient ischaemic attack)
A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.
Stroke symptoms need emergency care at once, even if they go away.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Bilirubin
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Excipients
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients receive eltrombopag olamine by mouth (PO) daily (QD) until platelet counts reach \>= 50,000/uL or for 8 weeks, whichever comes earlier. Treatment continues in the absence of unacceptable toxicity.
Drug: eltrombopag olamine
Given PO
Also known as: Promacta, SB 497115, SB-497115, SB497115
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
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: Up to 52 months
| Milestone | Supportive Care (Eltrombopag Olamine) |
|---|---|
| Started | 31 |
| Completed | 31 |
| Not completed | 0 |
Number of participants with a median platelet count \>= 50,000/uL
| Participants | Supportive Care (Eltrombopag Olamine) |
|---|---|
| Number of Participants With a Median Platelet Count >= 50,000/uL | 30 |
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.
| days | Supportive Care (Eltrombopag Olamine) |
|---|---|
| Median Time Needed to Reach Platelet Count >= 50,000 /µL in Days | 7 (6 to 8) |
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.
| days | Supportive Care (Eltrombopag Olamine) |
|---|---|
| Median Days of Platelet Transfusions | 10 (8 to 11) |
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.
| events | Supportive Care (Eltrombopag Olamine) |
|---|---|
| Rates of Clinically Significant Bleeding Events | 0 |
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.
No measurements were reported for this outcome.
The median increase in hemoglobin levels in g/dL among patients with a starting hemoglobin level \<8g/dL
No measurements were reported for this outcome.
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.
| Percent of participants | Supportive Care (Eltrombopag Olamine) |
|---|---|
| Complete Response Rate | 90 |
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.
| days | Supportive Care (Eltrombopag Olamine) |
|---|---|
| Median Days to Attain Complete Response | 30 (25 to 34) |
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.
| Participants | Supportive Care (Eltrombopag Olamine) |
|---|---|
| Partial Complete Response Rate | 0 |
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.
No measurements were reported for this outcome.
The number of participants with presence of morphologic evidence of disease
| Participants | Supportive Care (Eltrombopag Olamine) |
|---|---|
| Rate of Refractory or Persistent Disease | 0 |
OS is defined from the day of study registration until the last follow-up or death
| percent of participants | Supportive Care (Eltrombopag Olamine) |
|---|---|
| 28 days from start of treatment | 100 |
| 6 months from start of treatment | 74.2 |
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
| Participants | Supportive Care (Eltrombopag Olamine) |
|---|---|
| febrile neutropenia | 1 |
| thromboembolic event | 1 |
| rash | 1 |
| generalized myalgias | 1 |
| hypokalemia & hypocalhypokalemia & hypocalcemia | 1 |
Calculated from the date of complete remission until relapse, the date of last follow-up, or other protocol-defined event
| Months | Supportive Care (Eltrombopag Olamine) |
|---|---|
| Disease-Free Survival | 34.89 (1.77 to 52.00) |
Collected over Adverse events are collected for 4 weeks post intervention and mortality is monitored for up to 52 months of follow-up. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Supportive Care (Eltrombopag Olamine) | 8/31 (25.8%) | 14/31 (45.2%) | 25/31 (80.6%) |
| Event | Supportive Care (Eltrombopag Olamine) |
|---|---|
| Respiratory failureRespiratory, thoracic and mediastinal disorders | 6/31 |
| Acute kidney injuryRespiratory, thoracic and mediastinal disorders | 2/31 |
| HypoxiaRespiratory, thoracic and mediastinal disorders | 2/31 |
| Febrile neutropeniaBlood and lymphatic system disorders | 1/31 |
| Cardiac arrestCardiac disorders | 1/31 |
| Supraventricular tachycardiaCardiac disorders | 1/31 |
| DiarrheaGastrointestinal disorders | 1/31 |
| IleusGastrointestinal disorders | 1/31 |
| PainGeneral disorders | 1/31 |
| SepsisInfections and infestations | 1/31 |
| Event | Supportive Care (Eltrombopag Olamine) |
|---|---|
| AnemiaBlood and lymphatic system disorders | 12/31 |
| Febrile neutropeniaBlood and lymphatic system disorders | 9/31 |
| Edema limbsGeneral disorders | 9/31 |
| DiarrheaGastrointestinal disorders | 8/31 |
| HypokalemiaMetabolism and nutrition disorders | 8/31 |
| NauseaGastrointestinal disorders | 6/31 |
| AnorexiaMetabolism and nutrition disorders | 6/31 |
| HypocalcemiaMetabolism and nutrition disorders | 6/31 |
| Rash maculo-papularSkin and subcutaneous tissue disorders | 6/31 |
| FeverGeneral disorders | 5/31 |
Participants who went on study
| Age, Continuous(Years) | Supportive Care (Eltrombopag Olamine) |
|---|---|
| Median | 67 (60 to 78) |
| Sex: Female, Male(Participants) | Supportive Care (Eltrombopag Olamine) |
|---|---|
| Female | 12 |
| Male | 19 |
| Ethnicity (NIH/OMB)(Participants) | Supportive Care (Eltrombopag Olamine) |
|---|---|
| Hispanic or Latino | 0 |
| Not Hispanic or Latino | 31 |
| Unknown or Not Reported | 0 |
| Race (NIH/OMB)(Participants) | Supportive Care (Eltrombopag Olamine) |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 0 |
| Native Hawaiian or Other Pacific Islander | 1 |
| Black or African American | 1 |
| White | 29 |
| More than one race | 0 |
| Unknown or Not Reported | 0 |
| Region of Enrollment(participants) | Supportive Care (Eltrombopag Olamine) |
|---|---|
| United States | 31 |
PDFs hosted by the registry, ClinicalTrials.gov.
Ran from Aug 2014 to primary completion in Oct 2018, 50 months.
Results were first posted in Nov 2020, 2 years 1 month after primary completion.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Apr 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Eltrombopag
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