Eltrombopag Olamine in Treating Patients With Relapsed/Refractory Acute Myeloid Leukemia
|ClinicalTrials.gov Identifier: NCT01550185|
Recruitment Status : Terminated (Sponsor wanted study rewritten)
First Posted : March 9, 2012
Last Update Posted : April 6, 2016
|Condition or disease||Intervention/treatment||Phase|
|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 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) Recurrent Adult Acute Myeloid Leukemia||Drug: eltrombopag olamine Procedure: standard follow-up care||Phase 1|
I. To estimate the maximum tolerated dose (MTD) and examine the tolerability of daily oral eltrombopag (eltrombopag olamine) (14 days +/- 2 days after initiation of cytarabine) in patients receiving high dose cytarabine and mitoxantrone for the treatment of acute myeloid leukemia patients with hypoplastic bone marrow 14 days +/- 2 days from initiation of cytarabine.
II. To examine platelet count recovery to >= 100 x 10^9/L when eltrombopag is administered following high dose cytarabine and mitoxantrone for the treatment of acute myeloid leukemic patients.
OUTLINE: This is a dose-escalation study.
Patients receive eltrombopag olamine orally (PO) once daily (QD) from day 1 up to day 62. Treatment continues for up to 9 weeks in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up at 30 days.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||10 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase I Dose-Finding Study of Eltrombopag Following High Dose Cytarabine and Mitoxantrone in Relapsed/Refractory Patients With Acute Myeloid Leukemia|
|Study Start Date :||May 2012|
|Actual Primary Completion Date :||December 2014|
|Actual Study Completion Date :||December 2014|
Experimental: Treatment (eltrombopag olamine)
Patients receive eltrombopag olamine PO QD from day 1 up to day 62. Treatment continues for up to 9 weeks in the absence of disease progression or unacceptable toxicity.
Drug: eltrombopag olamine
Procedure: standard follow-up care
Receive standard care
- MTD and tolerability of eltrombopag olamine in patients with AML, determined according to incidence of dose-limiting toxicity (DLT) graded using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4 [ Time Frame: Up to day 15 ]
- Platelet count recovery to >= 100 x 10^9/L when eltrombopag olamine is administered following high dose cytarabine and mitoxantrone for the treatment of AML patients [ Time Frame: Up to 9 weeks ]
- Platelet recovery to >= 100 x 10^9/L and platelet response, assessed based on a modified International Working Group Consensus Criteria for hematologic improvement [ Time Frame: Up to 9 weeks ]Number of platelet transfusions and duration of time without platelet transfusions from the first dose of eltrombopag olamine will be measured.
- Platelet response based on a modified International Working Group Consensus Criteria for hematologic improvement [ Time Frame: Up to 9 weeks ]
- Platelet transfusion requirements [ Time Frame: Up to 9 weeks ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01550185
|United States, Georgia|
|Emory University, Winship Cancer Institute|
|Atlanta, Georgia, United States, 30322|
|United States, New York|
|Roswell Park Cancer Institute|
|Buffalo, New York, United States, 14263|
|Principal Investigator:||Wetzler Meir||Roswell Park Cancer Institute|