Eltrombopag Olamine in Increasing Platelet Counts in Patients Undergoing Transplant

• Status: Active, not recruiting
• Trial end date: 2022-10-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: M.D. Anderson Cancer Center
• Collaborators: National Cancer Institute (NCI); Novartis Pharmaceuticals

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.