ClinicalTrials.gov
ClinicalTrials.gov Menu

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 : September 26, 2018
Sponsor:
Information provided by (Responsible Party):
Masonic Cancer Center, University of Minnesota

Brief Summary:
This is a single institution, phase I dose escalation study of weekly romiplostim post umbilical cord blood transplantation in patients who fail to achieve platelet engraftment by day +30. Engraftment is defined as a platelet count ≥ 20 x 109/L on 3 consecutive measurements without transfusion for 7 days. Romiplostim is administered at the assigned dose as 6 weekly injections beginning by day +42 post transplant. Up to 4 dose levels (4, 6, 8, and 10 mcg/kg/dose) will be evaluated with the maximum tolerated dose (MTD) of romiplostim determined by using the Continual Reassessment Method (CRM). The goal of this CRM will be to identify 1 of the 4 dose levels which corresponds to the desired maximum toxicity rate of 20% or less.

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 2019
Estimated Study Completion Date : June 2019

Resource links provided by the National Library of Medicine

Drug Information available for: Romiplostim

Arm Intervention/treatment
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.
Drug: Romiplostim
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




Primary Outcome Measures :
  1. 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)


Secondary Outcome Measures :
  1. Platelet recovery [ Time Frame: Day +28 ]
    Average speed of platelet recovery in patients who have failed to achieve platelet engraftment.

  2. Thrombocytopenia [ Time Frame: Day +28 ]
    Incidence of clinically significant bleeding episodes and number of platelet transfusions.

  3. Bone marrow fibrosis [ Time Frame: Day 100 post transplant ]
    Incidence of bone marrow fibrosis.



Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Any patient who has undergone a single or double umbilical cord blood transplant (UCBT) except those with primary myelofibrosis.

    • Those with acute leukemia must be in remission at the time of transplant
  • Must have achieved neutrophil engraftment (defined as an ANC >500 for three consecutive days) and be off daily G-CSF prior to starting romiplostim. Intermittent G-CSF is allowed.
  • Failure to achieve platelet engraftment (defined as platelet count ≥20x10^9/L on 3 consecutive measurements without transfusion for 7 days) by day +28 post UCBT
  • Between day +28 and day +42 status post myeloablative or nonmyeloablative UCBT (single or double cord blood transplant)
  • Age ≥ 18 years
  • Adequate organ function within 7 days of enrollment defined as:

    • Creatinine: ≤ 2.0 mg/dL
    • Hepatic: SGOT and SGPT < 5 x upper limit of institutional normal (ULN)
  • Women of child bearing potential agree to use effective contraception during therapy and for 4 months after completion of therapy
  • Voluntary written consent

Exclusion Criteria:

  • Known pregnancy - Pregnancy Category C: there are no adequate and well-controlled studies of romiplostim in pregnancy
  • Recurrence of AML or myelodysplastic syndrome on bone marrow evaluation done within 21 days of enrollment
  • Presence of clinically significant bone marrow fibrosis on the bone marrow examination immediately prior to UCBT
  • Patients requiring more than one platelet transfusion per day
  • History of an allergy to romiplostim

Information from the National Library of Medicine

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


Contacts
Contact: Angela Smith, MD 612-626-2778 smith719@umn.edu

Locations
United States, Minnesota
University of Minnesota Masonic Cancer Center Recruiting
Minneapolis, Minnesota, United States, 55455
Contact: Angela Smith, MD    612-626-2778    smith719@umn.edu   
Principal Investigator: Angela Smith, MD         
Sponsors and Collaborators
Masonic Cancer Center, University of Minnesota
Investigators
Principal Investigator: Angela Smith, MD University of Minnesota - Clinical and Translational Science Institute

Responsible Party: Masonic Cancer Center, University of Minnesota
ClinicalTrials.gov Identifier: NCT02046291     History of Changes
Other Study ID Numbers: 2012LS089
MT2012-17R ( Other Identifier: University of Minnesota Blood and Marrow Transplant Program )
First Posted: January 27, 2014    Key Record Dates
Last Update Posted: September 26, 2018
Last Verified: September 2018

Keywords provided by Masonic Cancer Center, University of Minnesota:
umbilical cord transplant
acute leukemia
UCBT
Hodgkin's Lymphoma
Lymphoid Leukemia
Multiple Myeloma
Myeloid and Monocytic Leukemia
Non-Hodgkin's Lymphoma
Hematopoietic malignancies

Additional relevant MeSH terms:
Neoplasms