Eltrombopag for Enhancing Platelet Engraftment in Adult Patients Undergoing Cord Blood Transplantation
Hematological Malignancy, Bone Marrow Failure Syndrome
About this trial
This is an interventional treatment trial for Hematological Malignancy focused on measuring Cord blood transplantation, Eltrombopag, Platelet engraftment
Eligibility Criteria
Inclusion Criteria:
- Patient ≥ 18 year old.
- Patients receiving unmanipulated single or double umbilical cord blood allogeneic grafts.
- Malignant and non malignant indications for transplantation.
- Myeloablative and reduced intensity conditioning regimens.
- 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).
- Able to give written informed consent for a clinical trial.
- Able to comply with study protocol.
Exclusion Criteria:
Indications for transplantation
- Patients with primary myelofibrosis.
- M7 (French-American-British classification) acute myeloid leukemia. Acute leukemia secondary to a myeloproliferative neoplasm.
- Patients with persistent acute leukemia (>5% bone marrow blasts) at the time of transplantation.
- Patients with prior thromboembolic event. Patients with previous catheter related thrombosis will be eligible if more than 3 months elapsed.
- Hypersensitivity to eltrombopag.
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).
- 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.
Sites / Locations
- Hadassah hospitalRecruiting
- Davidof Cancer Center, Beilinson hospital, Rabin medical centerRecruiting
Arms of the Study
Arm 1
Experimental
Eltrombopag
Eltrombopag will be given orally as a single daily dose. From day +1 after cord blood transplantation, start eltrombopag 100 mg/d. If primary end point not reached on day +14,then from day +15 - 150 mg/d. If primary end point not reached on day +28 then from day +29 - 200 mg/d. If primary end point not reached on day +42 then from day +43 and on - 300 mg/d (maximal dose). If dose not tolerated, return to last tolerated dose. Eltrombopag will be discontinued after platelet count has exceeded 50,000/microliter for 14 consecutive days without administration of platelets. In case of decline of platelet count < 30,000/microliter within 15 days from eltrombopag discontinuation, it will be resumed for additional 4 weeks. After 4 weeks we will re-attempt to hold the drug.