Eltrombopag for Enhancing Platelet Engraftment in Adult Patients Undergoing Cord Blood Transplantation

• Status: Unknown status
• Trial end date: 2016-06-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to determine whether Eltrombopag may shorten time to platelet engraftment after allogeneic cord blood transplantation.

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

Details

• Lead Sponsor: Rabin Medical Center

Criteria

Inclusion Criteria:

1. Patient ≥ 18 year old.

2. Patients receiving unmanipulated single or double umbilical cord blood allogeneic grafts.

3. Malignant and non malignant indications for transplantation.

4. Myeloablative and reduced intensity conditioning regimens.

5. Patients must meet all other pre-transplantation criteria of the transplantation center including acceptable tests of heart, liver, kidney, and lung function (standard screening for transplantation per PI, and co-investigators).

6. Able to give written informed consent for a clinical trial.

7. Able to comply with study protocol.

Exclusion Criteria:

1. Indications for transplantation

1. Patients with primary myelofibrosis.

2. M7 (French-American-British classification) acute myeloid leukemia. Acute leukemia secondary to a myeloproliferative neoplasm.

3. Patients with persistent acute leukemia (>5% bone marrow blasts) at the time of transplantation.

2. Patients with prior thromboembolic event. Patients with previous catheter related thrombosis will be eligible if more than 3 months elapsed.

3. Hypersensitivity to eltrombopag.

4. Liver enzymes abnormalities:

Alanine transaminase (ALT) levels > 3 times the upper limit of normal (ULN) or serum bilirubin > 1.5 ULN (unless due to Gilbert's syndrome or hemolytic bilirubin).

5. Pregnancy: Women of child-bearing potential and men must agree to use contraception prior to study entry and for the duration of study participation. A woman of child-bearing potential is defined as a woman who has not been naturally post-menopausal for at least 12 consecutive months or with no previous surgical sterilization.