Can a Platelet-Boosting drug speed recovery for older leukemia patients?
NCT ID NCT02071901
First seen Jul 17, 2026 · Last updated Aug 07, 2026 · Updated 1 time
Summary
This phase II trial investigates whether eltrombopag, a drug that stimulates platelet production, can help older adults with acute myeloid leukemia (AML) recover their platelet counts faster after initial chemotherapy. Older patients often experience slow platelet recovery, which raises the risk of bleeding and can delay necessary follow-up treatments. The study enrolls adults aged 60 and older with AML who are receiving standard induction chemotherapy, and measures how many achieve a safe platelet level and how quickly.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- eltrombopag olamine, a drug that stimulates platelet production
- What this could lead to
- If successful, this approach could help older AML patients recover platelets faster after chemotherapy, reducing bleeding risks and allowing timely follow-up treatment.
- What could go wrong
- This is a small, early-phase study without a placebo group, so results may not be definitive. Eltrombopag may also carry risks like liver problems or blood clots.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
-
31 people
The number who actually took part.
- Started
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Aug 2014
- Finished
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Jan 2019
- Lead sponsor
-
Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
60 years and older
- Sex
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Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Case Comprehensive Cancer Center
Cleveland, Ohio, 44106-5065, United States
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