Eltrombopag Olamine in Increasing Platelet Counts in Patients Undergoing Transplant

NCT01927731 | Completed Phase 2 Results FDA Drug

• 2 other identifiers: 2012-0920NCI-2013-02348
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Overall Survival

  Up to 1 year

• Progression Free Survival

  Up to 1 year

Study Arms (2)

Arm I (cord blood transplant patients)

EXPERIMENTAL

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

Drug: Eltrombopag Olamine; Other: Laboratory Biomarker Analysis

Arm II (haploidentical donor stem cell transplant patients)

EXPERIMENTAL

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

Drug: Eltrombopag Olamine; Other: Laboratory Biomarker Analysis

Interventions

Eltrombopag Olamine DRUG

Given PO

Also known as: Promacta, SB-497115-GR

Arm I (cord blood transplant patients); Arm II (haploidentical donor stem cell transplant patients)

Laboratory Biomarker Analysis OTHER

Correlative studies

Arm I (cord blood transplant patients); Arm II (haploidentical donor stem cell transplant patients)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

M D Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

• MD Anderson Cancer Center Website

MeSH Terms

Interventions

eltrombopag

Results Point of Contact

• Title: Uday Popat, M.D. / Stem Cell Transplantation
• Organization: The University of Texas MD Anderson Cancer Center

upopat@mdanderson.org

713-792-8750

Study Officials

• Uday Popat

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 20, 2013
• First Posted: August 23, 2013
• Study Start: October 14, 2013
• Primary Completion: June 6, 2023
• Study Completion: June 6, 2023
• Last Updated: April 23, 2024
• Results First Posted: April 23, 2024

Record last verified: 2024-03

Locations

US (1)