Safety of Romiplostim (Nplate®) Following UCBT
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02046291|
Recruitment Status : Recruiting
First Posted : January 27, 2014
Last Update Posted : December 5, 2017
|Condition or disease||Intervention/treatment||Phase|
|Hematologic Malignancies||Drug: Romiplostim||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Supportive Care|
|Official Title:||Safety of Romiplostim (Nplate®) in Patients Who Have Failed to Achieve Platelet Engraftment Following Umbilical Cord Blood Transplant|
|Actual Study Start Date :||April 10, 2015|
|Estimated Primary Completion Date :||March 2018|
|Estimated Study Completion Date :||June 2018|
Experimental: Romiplostim treatment
Romiplostim at the assigned dose will be administered subcutaneously (SQ) once a week for 6 weeks (i.e. 6 doses) unless platelet count exceeds 100 x 10^9/L and at least 4 doses of therapy were given.After the initial dose, subsequent doses will be administered within a window of +/- 3 days.
Romiplostim at the assigned dose will be administered subcutaneously (SQ) once a week for 6 weeks. The dose will be assigned at the time of subject registration. This is a dose escalation to determine the maximum tolerated dose. The doses include 4 mcg/kg/dose, 6 mcg/kg/dose, 8 mcg/kg/dose, and 10 mcg/kg/dose.
Other Name: Nplate
- Maximum tolerated dose of romiplostim [ Time Frame: Day +28 blood transplant (UCBT) ]Measured by number of patients who have failed to achieve platelet engraftment by day +28 after a myeloablative or nonmyeloablative umbilical cord blood transplant (UCBT)
- Platelet recovery [ Time Frame: Day +28 ]Average speed of platelet recovery in patients who have failed to achieve platelet engraftment.
- Thrombocytopenia [ Time Frame: Day +28 ]Incidence of clinically significant bleeding episodes and number of platelet transfusions.
- Bone marrow fibrosis [ Time Frame: Day 100 post transplant ]Incidence of bone marrow fibrosis.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02046291
|Contact: Angela Smith, MDemail@example.com|
|United States, Minnesota|
|University of Minnesota Masonic Cancer Center||Recruiting|
|Minneapolis, Minnesota, United States, 55455|
|Contact: Angela Smith, MD 612-626-2778 firstname.lastname@example.org|
|Principal Investigator: Angela Smith, MD|
|Principal Investigator:||Angela Smith, MD||University of Minnesota - Clinical and Translational Science Institute|