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Thrombopoietin Receptor Agonist

Eltrombopag Olamine for Bone Marrow Transplant Recipient

Phase 2

Waitlist Available

Led By Uday Popat

Research Sponsored by M.D. Anderson 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 up to 1 year

Awards & highlights

Study Summary

This trial looks at whether a drug can help increase platelet counts in people undergoing a blood or bone marrow transplant.

Eligible Conditions

Bone Marrow Transplant Recipient
Cord Blood Transplant Recipient

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 1 year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Rate of platelet engraftment, evaluated as the number of patients experiencing platelet engraftment of greater than 50K/ul

Secondary outcome measures

Cumulative incidence of acute graft-versus-host disease

Cumulative incidence of chronic graft-versus-host disease

Incidence of neutrophil engraftment defined as the first of three consecutive days that the absolute neutrophil count is greater than 0.5 k/ul

+7 more

Side effects data

From 2022 Phase 2 & 3 trial • 21 Patients • NCT01428635

53%

Alanine aminotransferase increased

47%

Aspartate aminotransferase increased

40%

Fatigue

20%

Thrombocytopenia

20%

Edema

20%

Diarrhea

20%

Insomnia

20%

Nausea

13%

Neoplasms benign

13%

Cholesterol high

13%

Abdominal pain

13%

Hypertension

13%

Infection

13%

Anemia

13%

Eye Disorders

13%

Pain Extremity

13%

Rash acneiform

Cystitis noninfective

Respiratory failure

Skin and subcutaneous tissue disorders

Upper respiratory infection

Stroke

Pleural Effusion

Sepsis

Gastroesophageal reflux disease

Sinus tachycardia

Flu Like Symptoms

Gastritis

Thrombotic thrombocytopenic purpura

Gastric Hemorrhage

Pancreatitis

Cardiac Arrest

Chest Pain

Edema Limbs

Lung Infection

Back pain

Blood bilirubin increased

Blurred vision

Bruising

Conjunctivitis

Cough

Creatinine increased

Dehydration

Depression

Dysphagia

Dyspnea

Encephalopathy

Eye Infection

Fever

Gastroparesis

Hallucinations

Headache

Hearing Impaired

Hyperglycemia

Hypocalcemia

Hypomagnesemia

Thrombosis

Memory Impairment

Tendonitis

Neutropenia

Periodontal Disease

Periorbital edema

Peripheral Motor Neuropathy

Pruritis

100%

80%

60%

40%

20%

Study treatment Arm

Supportive Care (Eltrombopag Olamine) CML Participants

Supportive Care (Eltrombopag Olamine) Myelofibrosis Participants

Trial Design

2Treatment groups

Experimental Treatment

Group I: Arm II (haploidentical donor stem cell transplant patients)Experimental Treatment2 Interventions

Patients receive eltrombopag olamine PO QD for 60 days beginning on day 5.

Group II: Arm I (cord blood transplant patients)Experimental Treatment2 Interventions

Patients receive eltrombopag olamine PO QD for 60 days beginning on day -1.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Eltrombopag Olamine

2012

Completed Phase 3

~140

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)NIH

13,654 Previous Clinical Trials

40,933,105 Total Patients Enrolled

M.D. Anderson Cancer CenterLead Sponsor

2,966 Previous Clinical Trials

1,804,733 Total Patients Enrolled

Uday PopatPrincipal InvestigatorM.D. Anderson Cancer Center

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are we currently enrolling new participants for this research project?

"According to the information available on clinicaltrials.gov, this trial is not recruiting patients at this time. The study was first posted on October 14th, 2013 and was last updated on October 6th, 2022. Although this particular trial is no longer looking for participants, there are 35 other similar trials that have open recruitment periods."

Answered by AI

Is Eltrombopag Olamine safe for human use?

"Eltrombopag Olamine is classified as a Phase 2 drug, meaning that while there is evidence of its safety, there is none yet to support claims of efficacy. Our team at Power rates it as a 2 on our scale."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Eltrombopag Olamine in Increasing Platelet Counts in Patients Undergoing Transplant

2013. "Eltrombopag Olamine in Increasing Platelet Counts in Patients Undergoing Transplant". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT01927731.