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Eltrombopag for Post Transplant Thrombocytopenia

This study is currently recruiting participants.
Verified January 2013 by M.D. Anderson Cancer Center
Sponsor:
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT01000051
First received: October 20, 2009
Last updated: January 23, 2013
Last verified: January 2013
History of Changes
  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:

Drug Information available for: Eltrombopag
U.S. FDA Resources

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

Primary Outcome Measures:
  • Number of Patients 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 ]

Estimated Enrollment: 60
Study Start Date: February 2010
Estimated Primary Completion Date: February 2015 (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 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 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. M7 AML
  2. Primary or secondary myelofibrosis
  3. Recurrence or progression of primary malignancy after HCT
  4. Patients with persistent acute myeloid leukemia (>5% bone marrow blasts) at the time of transplant
  5. ALT >/= 2.5 times the ULN
  6. Serum bilirubin >2mg/dl (unless due to Gilbert's syndrome)
  7. 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.
  8. ECOG Performance status >2
  9. 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
Investigators
Study Chair: Uday Popat, MD UT MD Anderson Cancer Center
  More Information

Additional Information:
UT MD Anderson Cancer Center website  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT01000051     History of Changes
Other Study ID Numbers: 2009-0106
Study First Received: October 20, 2009
Last Updated: January 23, 2013
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 May 19, 2013