Skip to main content
Clinical Trials/NCT01927731
NCT01927731CompletedPhase 2

Safety and Efficacy of Eltrombopag in Patients Undergoing Cord Blood or Haploidentical Bone Marrow Transplantation

M.D. Anderson Cancer Center1 site in 1 country48 target enrollmentStarted: October 14, 2013Last updated:
Conditions
Interventions
Drugs

Trial Snapshot

Phase
Phase 2
Status
Completed
Enrollment
48
Locations
1
Primary Endpoint
Number of Participants That Achieved Platelet Engraftment Greater Than 50K/ul

Study Overview

Brief Summary

This phase II trial studies how well eltrombopag olamine works in increasing platelet counts in patients undergoing transplant. Eltrombopag olamine may help platelet counts and the immune system recover from blood or bone marrow transplant.

Detailed Description

PRIMARY OBJECTIVES:

I. To estimate the rate of platelet engraftment by day 60 in patients undergoing cord blood transplant (CBT) or haploidentical donor stem cell transplantation treated with eltrombopag (eltrombopag olamine).

SECONDARY OBJECTIVES:

I. To assess safety of eltrombopag in this population. II. To assess neutrophil engraftment with eltrombopag in this population. III. To characterize immune reconstitution. IV. To assess overall survival (OS). V. To assess progression free survival (PFS). VI. To assess incidence of acute graft-versus-host disease (GVHD).

OUTLINE: Patients are assigned to 1 of 2 arms.

Study Design

Study Type
Interventional
Allocation
Non Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Patients undergoing a cord blood or haploidentical transplantation on any protocol or standard of care treatment plan.
  • Females of child bearing potential defined as not post-menopausal for 12 months or no previous surgical sterilization or breast-feeding must be willing to use an effective contraceptive measure until 30 days after the last dose of eltrombopag. Males who have had sexual contact with female of child-bearing potential must be willing to use contraceptive techniques until 30 days after the last dose of eltrombopag.
  • Patient or patient's legal representative(s) is/are able to provide written informed consent to participate.

Exclusion Criteria

  • ALT and AST >/= 2.5 ULN.
  • Serum direct bilirubin >/= 1 mg/dl (except Gilbert's syndrome or hemolysis).
  • Patients of east Asian ancestry (Chinese, Japanese, or Korean Origin).
  • Calculated creatinine clearance < 30ml./min. Creatinine clearance will be calculated using the MDRD method.
  • Arterial or venous thrombosis in the last year except for line-related venous thrombosis more than 3 months ago.
  • Positive beta HCG within 7 days prior to consent in female of child-bearing potential defined as not post-menopausal for 12 months or no previous surgical sterilization or breast-feeding.

Arms & Interventions

Arm I (cord blood transplant patients)

Experimental

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

Intervention: Eltrombopag Olamine (Drug)

Arm I (cord blood transplant patients)

Experimental

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

Intervention: Laboratory Biomarker Analysis (Other)

Arm II (haploidentical donor stem cell transplant patients)

Experimental

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

Intervention: Eltrombopag Olamine (Drug)

Arm II (haploidentical donor stem cell transplant patients)

Experimental

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

Intervention: Laboratory Biomarker Analysis (Other)

Outcomes

Primary Outcomes

Number of Participants That Achieved Platelet Engraftment Greater Than 50K/ul

Time Frame: Up to day 60

Number of participants that achieved platelet engraftment greater than 50K/ul 60 days post transplant.

Secondary Outcomes

  • Progression Free Survival(Up to 1 year)
  • Overall Survival(Up to 1 year)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

Loading locations...

Similar Trials

Completed
Phase 2
Eltrombopag Olamine in Improving Platelet Recovery in Older Patients With Acute Myeloid Leukemia Undergoing ChemotherapyAcute Myeloid Leukemia With Multilineage Dysplasia Following Myelodysplastic SyndromeAdult Acute Basophilic LeukemiaAdult Acute Eosinophilic LeukemiaAdult 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 RemissionAdult Acute Myeloid Leukemia With 11q23 (MLL) AbnormalitiesAdult 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
NCT02071901Case Comprehensive Cancer Center31
Terminated
Phase 2
Eltrombopag for Thrombocytopenia in Patients With Relapsed Multiple MyelomaMultiple MyelomaThrombocytopenia
NCT01484314Dana-Farber Cancer Institute1
Completed
Phase 2
Eltrombopag Olamine in Treating Thrombocytopenia in Patients With Chronic Myeloid Leukemia or Myelofibrosis Receiving Tyrosine Kinase TherapyAccelerated Phase Chronic Myelogenous Leukemia, BCR-ABL1 PositiveBlast Phase Chronic Myelogenous Leukemia, BCR-ABL1 PositiveChronic Phase Chronic Myelogenous Leukemia, BCR-ABL1 PositiveThrombocytopeniaPrimary Myelofibrosis
NCT01428635M.D. Anderson Cancer Center21
Terminated
Phase 3
Eltrombopag To Reduce The Need For Platelet Transfusion In Subjects With Chronic Liver Disease And Thrombocytopenia Undergoing Elective Invasive ProceduresChronic Liver DiseaseHCVNASH - Nonalcoholic SteatohepatitisHIV InfectionHepatitis C VirusHBVHuman Immunodeficiency VirusLiver DiseasesHepatitis B VirusNon-alcoholic SteatohepatitisThrombocytopenia
NCT00678587GlaxoSmithKline292
Withdrawn
Phase 2
Study of Eltrombopag in Platelet Refractory ThrombocytopeniaThrombocytopenia
NCT01194167University of Cincinnati