Eltrombopag Olamine in Increasing Platelet Counts in Patients Undergoing Transplant

Hematopoietic Cell Transplantation Recipient Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01927731
• Other study ID #: 2012-0920
• Secondary ID: NCI-2013-0234820
• Status: Completed
• Phase: Phase 2
• Start date: October 14, 2013
• Est. completion date: June 6, 2023

Study information

• Verified date: March 2024
• Source: M.D. Anderson Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

ARM I (CORD BLOOD TRANSPLANT): Patients receive eltrombopag olamine orally (PO) once daily (QD) for 60 days beginning on day -1.

ARM II (HAPLOIDENTICAL DONOR STEM CELL TRANSPLANT): Patients receive eltrombopag olamine PO QD for 60 days beginning on day 5.

After completion of study treatment, patients are followed up at 1, 2, 3, 6, and 12 months.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: June 6, 2023
• Est. primary completion date: June 6, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients undergoing a cord blood or haploidentical transplantation on any protocol or standard of care treatment plan.

• Age >/= 18.

• 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.

Related Conditions & MeSH terms

• Bone Marrow Transplantation Recipient
• Cord Blood Transplant Recipient
• Hematopoietic Cell Transplantation Recipient

Intervention

Drug:
• Eltrombopag Olamine
Given PO

Other:
• Laboratory Biomarker Analysis
Correlative studies

Locations

Country	Name	City	State
United States	M D Anderson Cancer Center	Houston	Texas

Sponsors (2)

Lead Sponsor	Collaborator
M.D. Anderson Cancer Center	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants That Achieved Platelet Engraftment Greater Than 50K/ul	Number of participants that achieved platelet engraftment greater than 50K/ul 60 days post transplant.	Up to day 60
Secondary	Overall Survival	Number of participants that survived at one year post transplant.	Up to 1 year
Secondary	Progression Free Survival	Number of participants without disease progression at 1 year post transplant.	Up to 1 year

External Links

•   MD Anderson Cancer Center Website