NCT01757145

Brief Summary

The purpose of this study is to determine whether Eltrombopag may shorten time to platelet engraftment after allogeneic cord blood transplantation.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Jan 2013

Typical duration for phase_2

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 6, 2012

Completed
22 days until next milestone

First Posted

Study publicly available on registry

December 28, 2012

Completed
4 days until next milestone

Study Start

First participant enrolled

January 1, 2013

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2016

Completed
Last Updated

June 19, 2015

Status Verified

February 1, 2013

Enrollment Period

3.4 years

First QC Date

December 6, 2012

Last Update Submit

June 18, 2015

Conditions

Hematological MalignancyBone Marrow Failure Syndrome

Keywords

Cord blood transplantationEltrombopagPlatelet engraftment

Outcome Measures

Primary Outcomes (1)

  • Platelet engraftment rate up to 50 days post transplantation, defined as the first of 7 consecutive days of an unsupported platelet count of at least 20,000/microliter.

    50 days

Secondary Outcomes (4)

  • Time to partial platelet engraftment, defined as the first of 7 consecutive days of an unsupported platelet count of at least 20,000/microliter.

    180 days

  • Time to sustained complete platelet engraftment defined as the first of 7 consecutive days of an unsupported platelet count of at least 50,000/microliter.

    180 days

  • Complete platelet engraftment rates up to 50 days post transplantation defined as the first of 7 consecutive days of an unsupported platelet count of at least 50,000/microliter.

    50 days

  • Time to neutrophil engraftment defined as the first of 3 consecutive days to achieve an absolute neutrophil count ≥ 500/microliter.

    60 days

Other Outcomes (2)

  • Any grade 3/4 adverse event

    12 months

  • Thromboembolic events

    12 months

Study Arms (1)

Eltrombopag

EXPERIMENTAL

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.

Drug: Eltrombopag

Interventions

EltrombopagDRUG

From day +1, 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 present 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 (if the threshold of platelet count \>50,000/microliter will be reached again).

Also known as: Revolade
Eltrombopag

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Hadassah hospital

Jerusalem, Israel

RECRUITING

Davidof Cancer Center, Beilinson hospital, Rabin medical center

Petah Tikva, Israel

RECRUITING

MeSH Terms

Conditions

Hematologic NeoplasmsBone Marrow Failure Disorders

Interventions

eltrombopag

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsHematologic DiseasesHemic and Lymphatic DiseasesBone Marrow Diseases

Study Officials

  • Moshe Yeshurun, MD

    Rabin Medical Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Moshe Yeshurun, MD

CONTACT

972-50-4065543moshey@clalit.org.il

Ron Ram, MD

CONTACT

972-50-4065621RonRa@clalit.org.il

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 6, 2012

First Posted

December 28, 2012

Study Start

January 1, 2013

Primary Completion

June 1, 2016

Study Completion

June 1, 2016

Last Updated

June 19, 2015

Record last verified: 2013-02

Locations

IL(2)