Trial record 17 of 2633 for:    Open Studies | "Blood"

Eltrombopag in Cord Blood or Haploidentical Bone Marrow Transplantation

This study is currently recruiting participants. (see Contacts and Locations)
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:
NCT01927731
First received: August 20, 2013
Last updated: April 29, 2014
Last verified: April 2014
  Purpose

The goal of this clinical research study is to learn if taking Promacta (eltrombopag) will help your platelet count improve faster after your stem cell transplant. The safety of this drug will also be studied.


Condition Intervention Phase
Blood And Marrow Transplantation
Drug: Eltrombopag
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Safety and Efficacy of Eltrombopag in Patients Undergoing Cord Blood or Haploidentical Bone Marrow Transplantation

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Rate of Platelet Engraftment [ Time Frame: 60 days ] [ Designated as safety issue: No ]
    Primary objective of the trial will be to estimate the rate of platelet engraftment by Day 60 in patients undergoing cord blood transplant (CBT) or haploidentical donor stem cell transplantation treated with eltrombopag.


Estimated Enrollment: 60
Study Start Date: October 2013
Estimated Study Completion Date: October 2017
Estimated Primary Completion Date: October 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Cord Blood Transplant (CBT) Group
Eltrombopag given as a single daily dose of 300 mg orally on an empty stomach (1 hour before or 2 hours after a meal) for 60 total days. Eltrombopag started on Day -1 (the day prior to stem cell infusion in cord blood patients).
Drug: Eltrombopag
300 mg orally for 60 total days. Eltrombopag started on Day -1 (the day prior to stem cell infusion in cord blood patients) and on Day +5 in patients receiving haploidentical transplant.
Other Name: Promacta
Active Comparator: Haploidentical Transplant Group
Eltrombopag given as a single daily dose of 300 mg orally on an empty stomach (1 hour before or 2 hours after a meal) for 60 total days. Eltrombopag started on Day +5 in patients receiving haploidentical transplant.
Drug: Eltrombopag
300 mg orally for 60 total days. Eltrombopag started on Day -1 (the day prior to stem cell infusion in cord blood patients) and on Day +5 in patients receiving haploidentical transplant.
Other Name: Promacta

Detailed Description:

Study Drug Administration:

If you agree to take part in this study, you will take eltrombopag by mouth 1 time each day for up to 60 days. The study drug should be taken on an empty stomach (1 hour before or 2 hours after food/drink). You may drink water, coffee, and/or tea with the study drug. Do not use any milk or cream in your coffee or tea. If you vomit the drug within 30 minutes of taking, the dose should be repeated.

If you will have a cord blood transplant, you will start taking eltrombopag 1 day before your transplant (Day -1).

If you will have (or have had) a haploidentical transplant, you will start taking eltrombopag 5 days after your transplant (Day +5).

Study Visits:

You will be admitted to the hospital as part of your transplant and during your stay blood will be drawn daily as standard transplant care to check your blood counts, kidney and liver functions. Once you are discharged, you will be seen as an outpatient 1-3 times per week as standard post-transplant care.

Blood (about 1 tablespoon) will be drawn once a week while you are taking eltrombopag, and then once a week for 4 weeks after the last dose of eltrombopag to check your blood counts, kidney, and liver function.

About 1, 2, 3, 6, and 12 months after your transplant, blood (about 5 tablespoons) will be drawn to check your immune system.

If you have a blood and/or platelet transfusion, research staff will record the number of transfusions you receive during the study.

Length of Study:

You will be on study for about 1 year. You will be taken off study early if your platelet count becomes too high, if you have any intolerable side effects, if you are unable to follow study directions, if your doctor thinks it is in your best interest, or if you choose to leave the study early.

This is an investigational study. Eltrombopag is FDA approved and commercially available for the treatment of low platelet counts in patients with idiopathic thrombocytopenic purpura (ITP -- a severe bleeding disease). Its use in patients with low platelet counts after a stem cell transplant is investigational.

Up to 60 patients will take part in this study. All will be enrolled at MD Anderson.

  Eligibility

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

Inclusion Criteria:

  1. Patients undergoing a cord blood or haploidentical transplantation on any protocol or standard of care treatment plan.
  2. Age >/= 18.
  3. Females of child bearing potential defined as not post-menopausal for 12 months or no previous surgical sterilization or breast-feeding must be willing to use an effective contraceptive measure until 30 days after the last dose of eltrombopag. Males who have had sexual contact with female of child-bearing potential must be willing to use contraceptive techniques until 30 days after the last dose of eltrombopag.
  4. Patient or patient's legal representative(s) is/are able to provide written informed consent to participate.

Exclusion Criteria:

  1. ALT and AST >/= 2.5 ULN.
  2. Serum direct bilirubin >/= 1 mg/dl (except Gilbert's syndrome or hemolysis).
  3. Patients of east Asian ancestry (Chinese, Japanese, or Korean Origin).
  4. Calculated creatinine clearance < 30ml./min. Creatinine clearance will be calculated using the MDRD method.
  5. Arterial or venous thrombosis in the last year.
  6. Positive beta HCG within 7 days prior to consent in female of child-bearing potential defined as not post-menopausal for 12 months or no previous surgical sterilization or breast-feeding.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01927731

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

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

Additional Information:
No publications provided

Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT01927731     History of Changes
Other Study ID Numbers: 2012-0920, NCI-2013-02348
Study First Received: August 20, 2013
Last Updated: April 29, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by M.D. Anderson Cancer Center:
Blood And Marrow Transplantation
Cord blood transplantation
CBT
Platelet count
Haploidentical donor stem cell transplant
Eltrombopag
Promacta

ClinicalTrials.gov processed this record on October 19, 2014