Eltrombopag for Post Transplant Thrombocytopenia

• Status: Completed
• Trial end date: 2018-04-04
• Target enrollment: 0
• Participant gender: All

Summary

The goal of this clinical research study is to learn if eltrombopag can help to improve platelet counts in patients with low platelets after they have had a stem cell transplant. The safety of this drug will also be studied.

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

Details

• Lead Sponsor: M.D. Anderson Cancer Center
• Collaborator: Novartis Pharmaceuticals

Criteria

Inclusion Criteria:

1. Patients >/= 35 days post HCT with Platelet countor patients are platelet transfusion dependent, and

2. Neutrophil count >/= 1.5 x 10^9/l anytime within the last seven days before enrollment. Patients can be on myeloid or erythroid growth factors for example filgrastim), and

3. Age >/= 18

Exclusion Criteria:

1. Recurrence or progression of primary malignancy after HCT

2. ALT >/= 2.5 times the ULN

3. Serum bilirubin >2mg/dl (unless due to Gilbert's syndrome)

4. Documented deep vein thrombosis within 1 year before enrollment on the study, except if upper arm thrombosis related to central venous catheters, within 3 months before enrollment on the study.

5. ECOG Performance status >2

6. 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. A negative pregnancy test result will be required before any study drug is given.