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eltrombopag olamine for Acute Myeloid Leukemia
Phase 2
Waitlist Available
Led By Sudipto Mukherjee, MD, PhD, MPH
Research Sponsored by Case Comprehensive Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at 5 year follow-up
Awards & highlights
Summary
This trial looks at how well a drug works in improving the recovery of platelet counts in older patients with Acute Myeloid Leukemia undergoing induction chemotherapy.
Eligible Conditions
- Acute Myeloid Leukemia
- Acute Basophilic Leukemia
- Megakaryoblastic Leukemia
- Monoblastic Leukemia
- Monocytic Leukemia
- Adult Acute Myeloid Leukemia
- Acute Myelomonocytic Leukemia
- Erythroleukemia
- Acute Myeloblastic Leukemia
- Leukemia
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ at 5 year follow-up
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at 5 year follow-up
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Number of Participants With a Median Platelet Count >= 50,000/uL
Secondary study objectives
Complete Response Rate
Disease-Free Survival
Median Days of Platelet Transfusions
+10 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: Supportive care (eltrombopag olamine)Experimental Treatment1 Intervention
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
eltrombopag olamine
2009
Completed Phase 1
~100
Find a Location
Who is running the clinical trial?
Case Comprehensive Cancer CenterLead Sponsor
462 Previous Clinical Trials
32,532 Total Patients Enrolled
Sudipto Mukherjee, MD, PhD, MPHPrincipal InvestigatorCase Comprehensive Cancer Center
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You are currently involved in another study testing a new treatment.You have received previous treatment with certain medications called recombinant thrombopoietin or TPO-receptor agonists.You have had a bad allergic reaction to drugs similar to eltrombopag or its ingredients.You have received radiation therapy, strong chemotherapy, or a combination of both to treat another cancer or medical condition within the past year. However, the use of hydroxyurea or leukapheresis for certain situations is allowed. If you were treated with all-trans retinoic acid (ATRA) for a suspected diagnosis of acute promyelocytic leukemia (APL), but it was later confirmed that you do not have APL, you may still be eligible for the study.In the past year, you have had a blood clot in an artery or vein, except for clots related to medical lines. This includes clots in the lungs, legs, heart, brain, liver, kidneys, spleen, or other organs.
Research Study Groups:
This trial has the following groups:- Group 1: Supportive care (eltrombopag olamine)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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