Safety and Efficacy of Eltrombopag in Patients Undergoing Cord Blood or Haploidentical Bone Marrow Transplantation
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- M.D. Anderson Cancer Center
- 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)
Patients receive eltrombopag olamine PO QD for 60 days beginning on day -1.
Intervention: Eltrombopag Olamine (Drug)
Arm I (cord blood transplant patients)
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)
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)
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)