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)
• Enrollment: 31
• Location: 1
• Arm: 1
• Anticipated Duration (Months): 109.4
• Patients Per Site Per Month: 0.3

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.

Condition or Disease	Intervention/Treatment	Phase
Acute Myeloid Leukemia With Multilineage Dysplasia Following Myelodysplastic Syndrome; Adult Acute Basophilic Leukemia; Adult Acute Eosinophilic Leukemia; Adult Acute Megakaryoblastic Leukemia (M7); Adult Acute Minimally Differentiated Myeloid Leukemia (M0); Adult Acute Monoblastic Leukemia (M5a); Adult Acute Monocytic Leukemia (M5b); Adult Acute Myeloblastic Leukemia With Maturation (M2); Adult Acute Myeloblastic Leukemia Without Maturation (M1); Adult Acute Myeloid Leukemia in Remission; Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities; Adult Acute Myeloid Leukemia With Del(5q); Adult Acute Myeloid Leukemia With Inv(16)(p13;q22); Adult Acute Myeloid Leukemia With t(16;16)(p13;q22); Adult Acute Myeloid Leukemia With t(8;21)(q22;q22); Adult Acute Myelomonocytic Leukemia (M4); Adult Erythroleukemia (M6a); Adult Pure Erythroid Leukemia (M6b); Secondary Acute Myeloid Leukemia	Drug: eltrombopag olamine	Phase 2

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

Arm	Intervention/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

	Site	City	State	Country	Postal Code
1	Case Comprehensive Cancer Center	Cleveland	Ohio	United States	44106-5065

Sponsors and Collaborators

• Case Comprehensive Cancer Center

Investigators

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

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - May 14, 2018
• Informed Consent Form - Aug 11, 2017

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

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: No
• Additional relevant MeSH terms: Leukemia; Leukemia, Myeloid; Leukemia, Myeloid, Acute; Leukemia, Monocytic, Acute; Leukemia, Myelomonocytic, Acute; Leukemia, Megakaryoblastic, Acute; Leukemia, Erythroblastic, Acute; Leukemia, Basophilic, Acute; Leukemia, Eosinophilic, Acute; Myelodysplastic Syndromes; Hypereosinophilic Syndrome

Study Results

Participant Flow

Arm/Group Title	Supportive Care (Eltrombopag Olamine)
Arm/Group Description	Patients 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
STARTED	31
COMPLETED	31
NOT COMPLETED	0

Baseline Characteristics

Arm/Group Title	Supportive Care (Eltrombopag Olamine)
Arm/Group Description	Patients 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 Participants	31
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

Title	Number of Participants With a Median Platelet Count >= 50,000/uL
Description	Number of participants with a median platelet count >= 50,000/uL
Time Frame	Day 24 of Treatment

Outcome Measure Data

Analysis Population Description

Participants who completed study

Arm/Group Title	Supportive Care (Eltrombopag Olamine)
Arm/Group Description	Patients 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 Participants	31
Count of Participants [Participants]	30 96.8%

2. Secondary Outcome

Title	Median Time Needed to Reach Platelet Count >= 50,000 /µL in Days
Description	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

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 Title	Supportive Care (Eltrombopag Olamine)
Arm/Group Description	Patients 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 Participants	31
Median (Full Range) [days]	7

3. Secondary Outcome

Title	Median Days of Platelet Transfusions
Description	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

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 Title	Supportive Care (Eltrombopag Olamine)
Arm/Group Description	Patients 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 Participants	31
Median (Full Range) [days]	10

4. Secondary Outcome

Title	Rates of Clinically Significant Bleeding Events
Description	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

Outcome Measure Data

Analysis Population Description

Participants who completed study

Arm/Group Title	Supportive Care (Eltrombopag Olamine)
Arm/Group Description	Patients 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 Participants	31
Number [events]	0

5. Secondary Outcome

Title	Median Time to Absolute Neutrophil Recovery, Defined as > 500/uL
Description	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

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 Title	Supportive Care (Eltrombopag Olamine)
Arm/Group Description	Patients 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 Participants	0

6. Secondary Outcome

Title	Median Rise in Hemoglobin Level in Patients With Pretreatment Hemoglobin of < 8 g/dL
Description	The median increase in hemoglobin levels in g/dL among patients with a starting hemoglobin level <8g/dL
Time Frame	Up 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 Title	Supportive Care (Eltrombopag Olamine)
Arm/Group Description	Patients 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 Participants	0

7. Secondary Outcome

Title	Complete Response Rate
Description	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

Outcome Measure Data

Analysis Population Description

Participants who completed study

Arm/Group Title	Supportive Care (Eltrombopag Olamine)
Arm/Group Description	Patients 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 Participants	31
Number [Percent of participants]	90 290.3%

8. Secondary Outcome

Title	Median Days to Attain Complete Response
Description	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

Outcome Measure Data

Analysis Population Description

Participants who completed study

Arm/Group Title	Supportive Care (Eltrombopag Olamine)
Arm/Group Description	Patients 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 Participants	31
Median (95% Confidence Interval) [days]	30

9. Secondary Outcome

Title	Partial Complete Response Rate
Description	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

Outcome Measure Data

Analysis Population Description

Participants who completed study

Arm/Group Title	Supportive Care (Eltrombopag Olamine)
Arm/Group Description	Patients 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 Participants	31
Count of Participants [Participants]	0 0%

10. Secondary Outcome

Title	Time to Initiation of Post-remission Therapy
Description	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

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 Title	Supportive Care (Eltrombopag Olamine)
Arm/Group Description	Patients 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 Participants	0

11. Secondary Outcome

Title	Rate of Refractory or Persistent Disease
Description	The number of participants with presence of morphologic evidence of disease
Time Frame	Up to 12 weeks

Outcome Measure Data

Analysis Population Description

Participants who completed study

Arm/Group Title	Supportive Care (Eltrombopag Olamine)
Arm/Group Description	Patients 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 Participants	31
Count of Participants [Participants]	0 0%

12. Secondary Outcome

Title	Overall Survival (OS) - Percent of Participants Alive at Follow-up
Description	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

Outcome Measure Data

Analysis Population Description

Participants who went on study

Arm/Group Title	Supportive Care (Eltrombopag Olamine)
Arm/Group Description	Patients 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 Participants	31
28 days from start of treatment	100 322.6%
6 months from start of treatment	74.2 239.4%

13. Secondary Outcome

Title	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
Description	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

Outcome Measure Data

Analysis Population Description

Participants enrolled in study

Arm/Group Title	Supportive Care (Eltrombopag Olamine)
Arm/Group Description	Patients 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 Participants	31
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

Title	Disease-Free Survival
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

Adverse Events

Time Frame	Adverse events are collected for 4 weeks post intervention and mortality is monitored for up to 5 years of follow-up
Arm/Group Title	Supportive Care (Eltrombopag Olamine)
Arm/Group Description	Patients 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
Total	8/31 (25.8%)
Serious Adverse Events
	Supportive Care (Eltrombopag Olamine)
	Affected / at Risk (%)	# Events
Total	14/31 (45.2%)
Blood and lymphatic system disorders
Febrile neutropenia	1/31 (3.2%)	1
Cardiac disorders
Cardiac arrest	1/31 (3.2%)	1
Supraventricular tachycardia	1/31 (3.2%)	1
Gastrointestinal disorders
Diarrhea	1/31 (3.2%)	1
Ileus	1/31 (3.2%)	1
General disorders
Pain	1/31 (3.2%)	1
Infections and infestations
Sepsis	1/31 (3.2%)	1
Sinusitis	1/31 (3.2%)	1
Investigations
Alkaline phosphatase increased	1/31 (3.2%)	1
Cardiac troponin T increased	1/31 (3.2%)	1
White blood cell decreased	1/31 (3.2%)	1
Metabolism and nutrition disorders
Hypermagnesemia	1/31 (3.2%)	1
Hypoalbuminemia	1/31 (3.2%)	1
Hypokalemia	1/31 (3.2%)	1
Tumor lysis syndrome	1/31 (3.2%)	1
Respiratory, thoracic and mediastinal disorders
Acute kidney injury	2/31 (6.5%)	2
Hematuria	1/31 (3.2%)	1
Adult respiratory distress syndrome	1/31 (3.2%)	1
Dyspnea	1/31 (3.2%)	1
Hypoxia	2/31 (6.5%)	2
Lung infection	1/31 (3.2%)	1
Pleural effusion	1/31 (3.2%)	1
Pulmonary edema	1/31 (3.2%)	1
Respiratory failure	6/31 (19.4%)	6
Skin and subcutaneous tissue disorders
Skin ulceration	1/31 (3.2%)	1
Vascular disorders
Hypotension	1/31 (3.2%)	1
Other (Not Including Serious) Adverse Events
	Supportive Care (Eltrombopag Olamine)
	Affected / at Risk (%)	# Events
Total	25/31 (80.6%)
Blood and lymphatic system disorders
Anemia	12/31 (38.7%)	14
Febrile neutropenia	9/31 (29%)	11
Cardiac disorders
Atrial fibrillation	2/31 (6.5%)	2
Ear and labyrinth disorders
Ear pain	2/31 (6.5%)	2
Gastrointestinal disorders
Constipation	3/31 (9.7%)	3
Diarrhea	8/31 (25.8%)	8
Ileus	2/31 (6.5%)	2
Nausea	6/31 (19.4%)	7
Vomiting	4/31 (12.9%)	4
General disorders
Chills	2/31 (6.5%)	2
Edema limbs	9/31 (29%)	11
Fatigue	3/31 (9.7%)	4
Fever	5/31 (16.1%)	5
Non-cardiac chest pain	2/31 (6.5%)	2
Infections and infestations
Blood infections	2/31 (6.5%)	2
Metabolism and nutrition disorders
Anorexia	6/31 (19.4%)	8
Hypoalbuminemia	3/31 (9.7%)	3
Hypocalcemia	6/31 (19.4%)	6
Hypokalemia	8/31 (25.8%)	9
Hypomagnesemia	4/31 (12.9%)	4
Hyponatremia	2/31 (6.5%)	2
Hypophosphatemia	4/31 (12.9%)	5
Musculoskeletal and connective tissue disorders
Pain in extremity	2/31 (6.5%)	2
Nervous system disorders
Headache	5/31 (16.1%)	7
Psychiatric disorders
Confusion	2/31 (6.5%)	2
Respiratory, thoracic and mediastinal disorders
Cough	3/31 (9.7%)	3
Dyspnea	5/31 (16.1%)	5
Epistaxis	3/31 (9.7%)	3
Hypoxia	3/31 (9.7%)	3
Nasal congestion	2/31 (6.5%)	2
Sore throat	3/31 (9.7%)	3
Skin and subcutaneous tissue disorders
Rash maculo-papular	6/31 (19.4%)	7
Vascular disorders
Hypotension	3/31 (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.