Eltrombopag Olamine in Improving Platelet Recovery in Older Patients With Acute Myeloid Leukemia Undergoing Chemotherapy

Sponsor
Case Comprehensive Cancer Center (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT02071901
Collaborator
(none)
31
Enrollment
1
Location
1
Arm
109.4
Anticipated Duration (Months)
0.3
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Detailed Description

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:
  1. 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.

  2. To determine the effect of eltrombopag on the rates of clinically significant bleeding events (CSBE).

  3. To determine the effect of eltrombopag on erythropoiesis the median time to red blood cell transfusion independence.

  4. 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 Design

Study Type:
Interventional
Actual Enrollment :
31 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Supportive Care
Official Title:
A Single Arm, Phase II Study of Eltrombopag to Enhance Platelet Count Recovery in Elderly Patients With Acute Myeloid Leukemia Undergoing Remission Induction Therapy
Actual Study Start Date :
Aug 14, 2014
Actual Primary Completion Date :
Oct 20, 2018
Anticipated Study Completion Date :
Sep 26, 2023

Arms and Interventions

ArmIntervention/Treatment
Experimental: Supportive care (eltrombopag olamine)

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
Other Names:
  • Promacta
  • SB 497115
  • SB-497115
  • SB497115
  • Outcome Measures

    Primary Outcome Measures

    1. Number of Participants With a Median Platelet Count >= 50,000/uL [Day 24 of Treatment]

      Number of participants with a median platelet count >= 50,000/uL

    Secondary Outcome Measures

    1. Median Time Needed to Reach Platelet Count >= 50,000 /µL in Days [up to 12 weeks]

      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.

    2. Median Days of Platelet Transfusions [Up to 12 weeks]

      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.

    3. Rates of Clinically Significant Bleeding Events [Up to 12 weeks]

      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.

    4. Median Time to Absolute Neutrophil Recovery, Defined as > 500/uL [Up to 12 weeks]

      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.

    5. Median Rise in Hemoglobin Level in Patients With Pretreatment Hemoglobin of < 8 g/dL [Up to 12 weeks]

      The median increase in hemoglobin levels in g/dL among patients with a starting hemoglobin level <8g/dL

    6. Complete Response Rate [Up to 12 weeks]

      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.

    7. Median Days to Attain Complete Response [Up to 12 weeks]

      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.

    8. Partial Complete Response Rate [Up to 12 weeks]

      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.

    9. Time to Initiation of Post-remission Therapy [Up to 12 weeks]

      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.

    10. Rate of Refractory or Persistent Disease [Up to 12 weeks]

      The number of participants with presence of morphologic evidence of disease

    11. Overall Survival (OS) - Percent of Participants Alive at Follow-up [at 28 days, at 6 months and up to 5 years]

      OS is defined from the day of study registration until the last follow-up or death

    12. 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 [Up to 4 weeks after last dose of eltrombopag olamine]

      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

    13. Disease-Free Survival [At 5 year follow-up]

      Calculated from the date of complete remission until relapse, the date of last follow-up, or other protocol-defined event

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    60 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • All categories of AML will be included except for acute promyelocytic leukemia (APL), acute megakaryocytic leukemia, and acute leukemias of ambiguous lineage undergoing 7 + 3 remission IC with cytarabine and an anthracycline (daunorubicin or idarubicin). All cases have to be histopathologically confirmed by a diagnostic bone marrow biopsy. Use of granulocyte colony-stimulating factor (G-CSF) for any indication must have been discontinued at least 7 days prior to entry into the study.

    • Patients with secondary AML arising out of Myelodysplastic syndrome (MDS) (all subtypes under WHO [World Health Organization] classification), chronic myelomonocytic leukemia (CMML); therapy-related AML and those with a prior autologous hematopoietic cell transplantation are eligible.

    • No morphological evidence of disease on day 14 bone marrow examination following IC

    • Must be able to give voluntary informed written consent to participate in the study; informed consent will be obtained prior to initiation of remission IC and before any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudice to future medical care

    • Women of childbearing potential 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 birth control throughout the study as described below:

    1. Females of childbearing potential: Recommendation is for 2 effective contraceptive methods during the study. Adequate forms of contraception are double-barrier methods (condoms with spermicidal jelly or foam and diaphragm with spermicidal jelly or foam), oral, depo provera, or injectable contraceptives, intrauterine devices, and tubal ligation.

    2. Male patients with female partners who are of childbearing potential: Recommendation is for male and partner to use at least 2 effective contraceptive methods, as described above, during the study or to abstain.

    • Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2
    Exclusion Criteria:
    • Any serious medical condition, laboratory abnormality, or psychiatric illness that, in the view of the treating physician, would place the participant at an unacceptable risk if he or she were to participate in the study or would prevent that person from giving informed consent

    • Any active malignancy (unrelated, non-hematological malignancy) diagnosed within the past 12 months of starting the study drug (other than curatively treated carcinoma-in-situ of the cervix or non-melanoma skin cancer).

    • Secondary AML arising out of myeloproliferative neoplasms [as per the revised 2008 WHO classification of myeloid neoplasms and acute leukemias] and MDS/myeloproliferative disease (MPD) neoplasms other than CMML [as per the revised 2008 WHO classification of myeloid neoplasms and acute leukemias]. Refractory Anemia with Ringed Sideroblasts with thrombocytosis (RARS-T) classified as MDS/MPN neoplasm, unclassifiable will be excluded. AML patients with presenting features suspicious of underlying unrecognized MPD such as marked splenomegaly (> 20 cm) and thrombocytosis (>400,000 per microliter) will be excluded. Patients with relapsed or refractory AML will be excluded.

    • Radiation therapy, cytotoxic chemotherapy, and combined modality (both radiation and chemotherapy) used to treat other cancers or medical conditions and administered within 12 months prior to signing informed consent. Use of hydroxyurea or emergent leukapheresis (for cytoreduction of highly elevated white blood cell counts) is permissible. Those AML patients who initially receive treatment with all-trans retinoic acid (ATRA) for presumptive diagnosis of APL but if APL is ruled out in final pathology will be eligible for the study.

    • Prior history of treatment with recombinant thrombopoietin (TPO) or TPO-receptor (R) agonists

    • History of arterial or venous thrombosis [excluding line-thrombosis] within the last 1 year, or those with known inherited coagulopathies. Arterial or venous thrombosis includes pulmonary embolism, deep vein thrombosis of both upper [excluding line-thrombosis] and lower extremities, coronary artery disease managed medically or requiring intervention (percutaneous stent placement or coronary bypass surgery), cerebrovascular accident (for transient ischemic attacks clinical documentation is required), or involvement of other organs (such as hepatic, renal, spleen or other sites).

    • Evidence of fibrosis on bone marrow examination at the time of diagnosis

    • Active participation in any other investigational treatment study

    • Uncontrolled intercurrent illness including, but not limited to uncontrolled infection, symptomatic congestive heart failure, cardiac arrhythmia, unstable angina or renal insufficiency (acute or chronic) on hemodialysis

    • Liver enzymes (aspartate aminotransferase [AST] and alanine aminotransferase [ALT]) can not be greater than or equal to 2.5 times the upper limits of normal (ULN)

    • Total bilirubin ≥ 1.5 x ULN within 14 days of enrollment.

    • Serum creatinine should be ≥ 2.5 x ULN within 14 days of enrollment

    • A known immediate or delayed hypersensitivity reaction or idiosyncrasy that, in the opinion of the Medical Monitor is due to drugs chemically related to eltrombopag or excipients (e.g. mannitol)

    • Known history of human immunodeficiency virus (HIV) or active hepatitis B or C

    • No major surgery within 2 weeks prior to trial enrollment

    • Female subject is pregnant or breast-feeding

    • Male and female patients who are fertile who do not agree to use an effective barrier methods of birth control (i.e. abstinence) to avoid pregnancy while receiving study treatment.

    Contacts and Locations

    Locations

    SiteCityStateCountryPostal Code
    1Case Comprehensive Cancer CenterClevelandOhioUnited States44106-5065

    Sponsors and Collaborators

    • Case Comprehensive Cancer Center

    Investigators

    • Principal Investigator: Sudipto Mukherjee, MD, PhD, MPH, Case Comprehensive Cancer Center

    Study Documents (Full-Text)

    More Information

    Publications

    None provided.
    Responsible Party:
    Case Comprehensive Cancer Center
    ClinicalTrials.gov Identifier:
    NCT02071901
    Other Study ID Numbers:
    • CASE4913
    • NCI-2014-00252
    First Posted:
    Feb 26, 2014
    Last Update Posted:
    Dec 1, 2021
    Last Verified:
    Nov 1, 2021

    Study Results

    Participant Flow

    Recruitment Details
    Pre-assignment Detail
    Arm/Group TitleSupportive Care (Eltrombopag Olamine)
    Arm/Group DescriptionPatients receive eltrombopag olamine PO QD until platelet counts reach >= 50,000/uL or for 8 weeks, whichever comes earlier. Treatment continues in the absence of unacceptable toxicity. eltrombopag olamine: Given PO
    Period Title: Overall Study
    STARTED31
    COMPLETED31
    NOT COMPLETED0

    Baseline Characteristics

    Arm/Group TitleSupportive Care (Eltrombopag Olamine)
    Arm/Group DescriptionPatients receive eltrombopag olamine PO QD until platelet counts reach >= 50,000/uL or for 8 weeks, whichever comes earlier. Treatment continues in the absence of unacceptable toxicity. eltrombopag olamine: Given PO
    Overall Participants31
    Age (Years) [Median (Full Range) ]
    Median (Full Range) [Years]
    67
    Sex: Female, Male (Count of Participants)
    Female
    12
    38.7%
    Male
    19
    61.3%
    Ethnicity (NIH/OMB) (Count of Participants)
    Hispanic or Latino
    0
    0%
    Not Hispanic or Latino
    31
    100%
    Unknown or Not Reported
    0
    0%
    Race (NIH/OMB) (Count of Participants)
    American Indian or Alaska Native
    0
    0%
    Asian
    0
    0%
    Native Hawaiian or Other Pacific Islander
    1
    3.2%
    Black or African American
    1
    3.2%
    White
    29
    93.5%
    More than one race
    0
    0%
    Unknown or Not Reported
    0
    0%
    Region of Enrollment (participants) [Number]
    United States
    31
    100%

    Outcome Measures

    1. Primary Outcome
    TitleNumber of Participants With a Median Platelet Count >= 50,000/uL
    DescriptionNumber of participants with a median platelet count >= 50,000/uL
    Time FrameDay 24 of Treatment

    Outcome Measure Data

    Analysis Population Description
    Participants who completed study
    Arm/Group TitleSupportive Care (Eltrombopag Olamine)
    Arm/Group DescriptionPatients receive eltrombopag olamine PO QD until platelet counts reach >= 50,000/uL or for 8 weeks, whichever comes earlier. Treatment continues in the absence of unacceptable toxicity. eltrombopag olamine: Given PO
    Measure Participants31
    Count of Participants [Participants]
    30
    96.8%
    2. Secondary Outcome
    TitleMedian Time Needed to Reach Platelet Count >= 50,000 /µL in Days
    DescriptionDefined 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 Frameup to 12 weeks

    Outcome Measure Data

    Analysis Population Description
    Participants who completed study. Statistical tests were not completed because a) Difficulty in obtaining accurate information on the reasons for platelet transfusion in the historical cohort and b) Several participants had platelet counts higher than threshold for starting transfusion, making comparisons not meaningful
    Arm/Group TitleSupportive Care (Eltrombopag Olamine)
    Arm/Group DescriptionPatients receive eltrombopag olamine PO QD until platelet counts reach >= 50,000/uL or for 8 weeks, whichever comes earlier. Treatment continues in the absence of unacceptable toxicity. eltrombopag olamine: Given PO
    Measure Participants31
    Median (Full Range) [days]
    7
    3. Secondary Outcome
    TitleMedian Days of Platelet Transfusions
    DescriptionDefined 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 FrameUp to 12 weeks

    Outcome Measure Data

    Analysis Population Description
    Participants who completed study. Statistical tests were not completed because a) Difficulty in obtaining accurate information on the reasons for platelet transfusion in the historical cohort and b) Several participants had platelet counts higher than threshold for starting transfusion, making comparisons not meaningful
    Arm/Group TitleSupportive Care (Eltrombopag Olamine)
    Arm/Group DescriptionPatients receive eltrombopag olamine PO QD until platelet counts reach >= 50,000/uL or for 8 weeks, whichever comes earlier. Treatment continues in the absence of unacceptable toxicity. eltrombopag olamine: Given PO
    Measure Participants31
    Median (Full Range) [days]
    10
    4. Secondary Outcome
    TitleRates of Clinically Significant Bleeding Events
    DescriptionThe 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 FrameUp to 12 weeks

    Outcome Measure Data

    Analysis Population Description
    Participants who completed study
    Arm/Group TitleSupportive Care (Eltrombopag Olamine)
    Arm/Group DescriptionPatients receive eltrombopag olamine PO QD until platelet counts reach >= 50,000/uL or for 8 weeks, whichever comes earlier. Treatment continues in the absence of unacceptable toxicity. eltrombopag olamine: Given PO
    Measure Participants31
    Number [events]
    0
    5. Secondary Outcome
    TitleMedian Time to Absolute Neutrophil Recovery, Defined as > 500/uL
    DescriptionThe 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 FrameUp to 12 weeks

    Outcome Measure Data

    Analysis Population Description
    Data not collected - daily blood counts were not checked once participants were discharged or received post-remission therapy and subsequent follow ups locally
    Arm/Group TitleSupportive Care (Eltrombopag Olamine)
    Arm/Group DescriptionPatients receive eltrombopag olamine PO QD until platelet counts reach >= 50,000/uL or for 8 weeks, whichever comes earlier. Treatment continues in the absence of unacceptable toxicity. eltrombopag olamine: Given PO
    Measure Participants0
    6. Secondary Outcome
    TitleMedian Rise in Hemoglobin Level in Patients With Pretreatment Hemoglobin of < 8 g/dL
    DescriptionThe median increase in hemoglobin levels in g/dL among patients with a starting hemoglobin level <8g/dL
    Time FrameUp to 12 weeks

    Outcome Measure Data

    Analysis Population Description
    Data not collected - daily blood counts were not checked once participants were discharged or received post-remission therapy and subsequent follow ups locally
    Arm/Group TitleSupportive Care (Eltrombopag Olamine)
    Arm/Group DescriptionPatients receive eltrombopag olamine PO QD until platelet counts reach >= 50,000/uL or for 8 weeks, whichever comes earlier. Treatment continues in the absence of unacceptable toxicity. eltrombopag olamine: Given PO
    Measure Participants0
    7. Secondary Outcome
    TitleComplete Response Rate
    DescriptionThe 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 FrameUp to 12 weeks

    Outcome Measure Data

    Analysis Population Description
    Participants who completed study
    Arm/Group TitleSupportive Care (Eltrombopag Olamine)
    Arm/Group DescriptionPatients receive eltrombopag olamine PO QD until platelet counts reach >= 50,000/uL or for 8 weeks, whichever comes earlier. Treatment continues in the absence of unacceptable toxicity. eltrombopag olamine: Given PO
    Measure Participants31
    Number [Percent of participants]
    90
    290.3%
    8. Secondary Outcome
    TitleMedian Days to Attain Complete Response
    DescriptionThe 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 FrameUp to 12 weeks

    Outcome Measure Data

    Analysis Population Description
    Participants who completed study
    Arm/Group TitleSupportive Care (Eltrombopag Olamine)
    Arm/Group DescriptionPatients receive eltrombopag olamine PO QD until platelet counts reach >= 50,000/uL or for 8 weeks, whichever comes earlier. Treatment continues in the absence of unacceptable toxicity. eltrombopag olamine: Given PO
    Measure Participants31
    Median (95% Confidence Interval) [days]
    30
    9. Secondary Outcome
    TitlePartial Complete Response Rate
    DescriptionThe 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 FrameUp to 12 weeks

    Outcome Measure Data

    Analysis Population Description
    Participants who completed study
    Arm/Group TitleSupportive Care (Eltrombopag Olamine)
    Arm/Group DescriptionPatients receive eltrombopag olamine PO QD until platelet counts reach >= 50,000/uL or for 8 weeks, whichever comes earlier. Treatment continues in the absence of unacceptable toxicity. eltrombopag olamine: Given PO
    Measure Participants31
    Count of Participants [Participants]
    0
    0%
    10. Secondary Outcome
    TitleTime to Initiation of Post-remission Therapy
    DescriptionThe 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 FrameUp to 12 weeks

    Outcome Measure Data

    Analysis Population Description
    Data not collected - daily blood counts were not checked once participants were discharged or received post-remission therapy and subsequent follow ups locally
    Arm/Group TitleSupportive Care (Eltrombopag Olamine)
    Arm/Group DescriptionPatients receive eltrombopag olamine PO QD until platelet counts reach >= 50,000/uL or for 8 weeks, whichever comes earlier. Treatment continues in the absence of unacceptable toxicity. eltrombopag olamine: Given PO
    Measure Participants0
    11. Secondary Outcome
    TitleRate of Refractory or Persistent Disease
    DescriptionThe number of participants with presence of morphologic evidence of disease
    Time FrameUp to 12 weeks

    Outcome Measure Data

    Analysis Population Description
    Participants who completed study
    Arm/Group TitleSupportive Care (Eltrombopag Olamine)
    Arm/Group DescriptionPatients receive eltrombopag olamine PO QD until platelet counts reach >= 50,000/uL or for 8 weeks, whichever comes earlier. Treatment continues in the absence of unacceptable toxicity. eltrombopag olamine: Given PO
    Measure Participants31
    Count of Participants [Participants]
    0
    0%
    12. Secondary Outcome
    TitleOverall Survival (OS) - Percent of Participants Alive at Follow-up
    DescriptionOS is defined from the day of study registration until the last follow-up or death
    Time Frameat 28 days, at 6 months and up to 5 years

    Outcome Measure Data

    Analysis Population Description
    Participants who went on study
    Arm/Group TitleSupportive Care (Eltrombopag Olamine)
    Arm/Group DescriptionPatients receive eltrombopag olamine PO QD until platelet counts reach >= 50,000/uL or for 8 weeks, whichever comes earlier. Treatment continues in the absence of unacceptable toxicity. eltrombopag olamine: Given PO
    Measure Participants31
    28 days from start of treatment
    100
    322.6%
    6 months from start of treatment
    74.2
    239.4%
    13. Secondary Outcome
    TitleNumber 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
    DescriptionIncidence 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 FrameUp to 4 weeks after last dose of eltrombopag olamine

    Outcome Measure Data

    Analysis Population Description
    Participants enrolled in study
    Arm/Group TitleSupportive Care (Eltrombopag Olamine)
    Arm/Group DescriptionPatients receive eltrombopag olamine PO QD until platelet counts reach >= 50,000/uL or for 8 weeks, whichever comes earlier. Treatment continues in the absence of unacceptable toxicity. eltrombopag olamine: Given PO
    Measure Participants31
    febrile neutropenia
    1
    3.2%
    thromboembolic event
    1
    3.2%
    rash
    1
    3.2%
    generalized myalgias
    1
    3.2%
    hypokalemia & hypocalhypokalemia & hypocalcemia
    1
    3.2%
    14. Secondary Outcome
    TitleDisease-Free Survival
    DescriptionCalculated from the date of complete remission until relapse, the date of last follow-up, or other protocol-defined event
    Time FrameAt 5 year follow-up

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title
    Arm/Group Description

    Adverse Events

    Time FrameAdverse events are collected for 4 weeks post intervention and mortality is monitored for up to 5 years of follow-up
    Adverse Event Reporting Description
    Arm/Group TitleSupportive Care (Eltrombopag Olamine)
    Arm/Group DescriptionPatients receive eltrombopag olamine PO QD until platelet counts reach >= 50,000/uL or for 8 weeks, whichever comes earlier. Treatment continues in the absence of unacceptable toxicity. eltrombopag olamine: Given PO
    All Cause Mortality
    Supportive Care (Eltrombopag Olamine)
    Affected / at Risk (%)# Events
    Total8/31 (25.8%)
    Serious Adverse Events
    Supportive Care (Eltrombopag Olamine)
    Affected / at Risk (%)# Events
    Total14/31 (45.2%)
    Blood and lymphatic system disorders
    Febrile neutropenia1/31 (3.2%) 1
    Cardiac disorders
    Cardiac arrest1/31 (3.2%) 1
    Supraventricular tachycardia1/31 (3.2%) 1
    Gastrointestinal disorders
    Diarrhea1/31 (3.2%) 1
    Ileus1/31 (3.2%) 1
    General disorders
    Pain1/31 (3.2%) 1
    Infections and infestations
    Sepsis1/31 (3.2%) 1
    Sinusitis1/31 (3.2%) 1
    Investigations
    Alkaline phosphatase increased1/31 (3.2%) 1
    Cardiac troponin T increased1/31 (3.2%) 1
    White blood cell decreased1/31 (3.2%) 1
    Metabolism and nutrition disorders
    Hypermagnesemia1/31 (3.2%) 1
    Hypoalbuminemia1/31 (3.2%) 1
    Hypokalemia1/31 (3.2%) 1
    Tumor lysis syndrome1/31 (3.2%) 1
    Respiratory, thoracic and mediastinal disorders
    Acute kidney injury2/31 (6.5%) 2
    Hematuria1/31 (3.2%) 1
    Adult respiratory distress syndrome1/31 (3.2%) 1
    Dyspnea1/31 (3.2%) 1
    Hypoxia2/31 (6.5%) 2
    Lung infection1/31 (3.2%) 1
    Pleural effusion1/31 (3.2%) 1
    Pulmonary edema1/31 (3.2%) 1
    Respiratory failure6/31 (19.4%) 6
    Skin and subcutaneous tissue disorders
    Skin ulceration1/31 (3.2%) 1
    Vascular disorders
    Hypotension1/31 (3.2%) 1
    Other (Not Including Serious) Adverse Events
    Supportive Care (Eltrombopag Olamine)
    Affected / at Risk (%)# Events
    Total25/31 (80.6%)
    Blood and lymphatic system disorders
    Anemia12/31 (38.7%) 14
    Febrile neutropenia9/31 (29%) 11
    Cardiac disorders
    Atrial fibrillation2/31 (6.5%) 2
    Ear and labyrinth disorders
    Ear pain2/31 (6.5%) 2
    Gastrointestinal disorders
    Constipation3/31 (9.7%) 3
    Diarrhea8/31 (25.8%) 8
    Ileus2/31 (6.5%) 2
    Nausea6/31 (19.4%) 7
    Vomiting4/31 (12.9%) 4
    General disorders
    Chills2/31 (6.5%) 2
    Edema limbs9/31 (29%) 11
    Fatigue3/31 (9.7%) 4
    Fever5/31 (16.1%) 5
    Non-cardiac chest pain2/31 (6.5%) 2
    Infections and infestations
    Blood infections2/31 (6.5%) 2
    Metabolism and nutrition disorders
    Anorexia6/31 (19.4%) 8
    Hypoalbuminemia3/31 (9.7%) 3
    Hypocalcemia6/31 (19.4%) 6
    Hypokalemia8/31 (25.8%) 9
    Hypomagnesemia4/31 (12.9%) 4
    Hyponatremia2/31 (6.5%) 2
    Hypophosphatemia4/31 (12.9%) 5
    Musculoskeletal and connective tissue disorders
    Pain in extremity2/31 (6.5%) 2
    Nervous system disorders
    Headache5/31 (16.1%) 7
    Psychiatric disorders
    Confusion2/31 (6.5%) 2
    Respiratory, thoracic and mediastinal disorders
    Cough3/31 (9.7%) 3
    Dyspnea5/31 (16.1%) 5
    Epistaxis3/31 (9.7%) 3
    Hypoxia3/31 (9.7%) 3
    Nasal congestion2/31 (6.5%) 2
    Sore throat3/31 (9.7%) 3
    Skin and subcutaneous tissue disorders
    Rash maculo-papular6/31 (19.4%) 7
    Vascular disorders
    Hypotension3/31 (9.7%) 3

    Limitations/Caveats

    [Not Specified]

    More Information

    Certain Agreements

    All Principal Investigators ARE employed by the organization sponsoring the study.

    There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

    Results Point of Contact

    Name/TitleDr. Sudipto Mukherjee
    OrganizationCleveland Clinic, Case Comprehensive Cancer Center
    Phone1-866-223-8100
    EmailTaussigResearch@ccf.org
    Responsible Party:
    Case Comprehensive Cancer Center
    ClinicalTrials.gov Identifier:
    NCT02071901
    Other Study ID Numbers:
    • CASE4913
    • NCI-2014-00252
    First Posted:
    Feb 26, 2014
    Last Update Posted:
    Dec 1, 2021
    Last Verified:
    Nov 1, 2021