Eltrombopag Olamine in Increasing Platelet Counts in Patients Undergoing Transplant

NCT ID: NCT01927731

Last Updated: 2024-04-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 48 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-10-14
• Study Completion Date: 2023-06-06

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.

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.

Conditions

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

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Arm I (cord blood transplant patients)

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

Group Type: EXPERIMENTAL

Eltrombopag Olamine

Intervention Type: DRUG

Given PO

Laboratory Biomarker Analysis

Intervention Type: OTHER

Correlative studies

Arm II (haploidentical donor stem cell transplant patients)

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

Group Type: EXPERIMENTAL

Eltrombopag Olamine

Intervention Type: DRUG

Given PO

Laboratory Biomarker Analysis

Intervention Type: OTHER

Correlative studies

Interventions

Eltrombopag Olamine

Given PO

Intervention Type: DRUG

Laboratory Biomarker Analysis

Correlative studies

Intervention Type: OTHER

Other Intervention Names

Promacta; SB-497115-GR

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

M.D. Anderson Cancer Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Uday Popat

Role: PRINCIPAL_INVESTIGATOR

M.D. Anderson Cancer Center

Locations

M D Anderson Cancer Center

Houston, Texas, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Related Links

http://www.mdanderson.org

MD Anderson Cancer Center Website

Other Identifiers

NCI-2013-02348

Identifier Type: REGISTRY

Identifier Source: secondary_id

2012-0920

Identifier Type: OTHER

Identifier Source: secondary_id

2012-0920

Identifier Type: -

Identifier Source: org_study_id