Eltrombopag for Post Transplant Thrombocytopenia

This study is currently recruiting participants.
Verified April 2014 by M.D. Anderson Cancer Center
Sponsor:
Collaborator:
GlaxoSmithKline
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT01000051
First received: October 20, 2009
Last updated: April 8, 2014
Last verified: April 2014
  Purpose

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.


Condition Intervention Phase
Thrombocytopenia
Drug: Eltrombopag
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: Eltrombopag for Post Transplant Thrombocytopenia

Resource links provided by NLM:


Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:
  • Number of Participants with Platelet Count >/= 50 X 10^9/l at day 57 without platelet transfusion [ Time Frame: Baseline to Day 57 ] [ Designated as safety issue: No ]
    Development of a platelet count >/= 30 X 10^9/l at day 57 without platelet transfusion within 7 days, and participants who drop out of the trial before completion of day 57 with a platelet count >/= 30 X 10^9/l at the time of discontinuation are considered successes with respect to outcome (primary endpoint).


Estimated Enrollment: 60
Study Start Date: February 2010
Estimated Primary Completion Date: February 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Eltrombopag
Starting dose 50 mg/day orally for 8 weeks
Drug: Eltrombopag
Starting daily dose 50 mg orally on empty stomach (1 hour before or 2 hours after a meal) for 8 weeks. East Asians start at 25 mg daily.
Other Name: Promacta
Placebo Comparator: Placebo
Once a day orally for 8 weeks
Drug: Placebo
Once a day, orally for 8 weeks.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patients >/= 35 days post Hematopoietic cell transplantation (HCT) with Platelet count </= 20 x 10^9/l sustained for 7 days or 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. alanine aminotransferase (ALT) >/= 2.5 times the upper limit of normal (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. Eastern Cooperative Oncology Group (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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01000051

Contacts
Contact: Uday Popat, MD 713-792-8750

Locations
United States, Texas
UT MD Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Principal Investigator: Uday Popat, MD         
Sponsors and Collaborators
M.D. Anderson Cancer Center
GlaxoSmithKline
Investigators
Study Chair: Uday Popat, MD UT MD Anderson Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT01000051     History of Changes
Other Study ID Numbers: 2009-0106, NCI-2011-01099
Study First Received: October 20, 2009
Last Updated: April 8, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by M.D. Anderson Cancer Center:
Transplant Thrombocytopenia
Hematopoietic cell transplantation
HCT
Low platelet count
Bleeding
Blood clot
Stem Cell Transplant
Blood And Marrow Transplantation
Eltrombopag
Promacta

Additional relevant MeSH terms:
Thrombocytopenia
Blood Platelet Disorders
Hematologic Diseases

ClinicalTrials.gov processed this record on April 16, 2014