Efficacy of Mirasol-treated Apheresis Platelets in Patients With Hypoproliferative Thrombocytopenia

Purpose

This is a prospective, multi-center, controlled, randomized, non-inferiority study to evaluate the clinical effectiveness of Conventional versus Mirasol-treated apheresis platelets in subjects with hypoproliferative thrombocytopenia who are expected to have platelet count(s) == 2 platelet transfusions.

Study details

  • Patients will be randomized 1:1 to Mirasol-treated platelets (test platelets) or to conventional, untreated platelets (control platelets).
  • The blood centers will collect the apheresis donor platelets and supply the test platelets to the hospital sites for transfusion into patients.
  • Hospital sites will order control platelets as per their normal process, from their standard vendor.
  • The target population for the MIPLATE study are patients with hematologic malignancies with hypoproliferative thrombocytopenia who are expected to have platelet (PLT) count(s) of == 2 PLT transfusions.
  • The primary objective of MIPLATE is to determine if the hemostatic efficacy of Mirasol-treated plasma stored Trima Accel® Aph PLTs are non-inferior to Conventional plasma stored Aph PLTs in subjects with hypoproliferative thrombocytopenia requiring PLT transfusions.
  • The secondary objectives include comparing other efficacy and safety endpoints between the treatment groups.
  • Subjects with hematologic malignancies with hypoproliferative thrombocytopenia are anticipated to experience a "transfusion episode" where they will require PLT transfusion support until bone marrow recovery.
  • During this period all PLT transfusions required for a study subject will be given according to the subject's treatment allocation for 28 days after the initial PLT transfusion OR until transfusion independence (10 days without PLT transfusion) prior to Day 28.
  • Additionally, serum samples for HLA antibody testing will be collected weekly for 28 days and on Days 42 and 56.
  • At a minimum, the initial post-randomization prophylactic PLT transfusion will be initiated for a PLT count =< 10,000/µL.
  • Thereafter, indications for PLT transfusions may be PLT count-related prophylaxis, intervention-related prophylaxis, or therapeutic (treatment of active bleeding) as determined by the treating physician(s).
  • The indication(s) for the transfusion(s) will be captured.

Eligibility

  • Weight > 10 kg (22 lbs)
  • Subject has a hematologic malignancy with hypoproliferative thrombocytopenia and is expected to have PLT count(s) == 2 PLT transfusions
  • Laboratory results within 5 days prior to anticipated initiation of the first post randomization PLT transfusion: (1) Prothrombin time (PT) and/or international normalized ratio (INR) =< 1.3 × the upper limit of normal (ULN), (2) Activated partial thromboplastin time (aPTT) =< 1.3 × ULN, (3) Fibrinogen >= 100 mg/dL
  • Women of childbearing potential must have a negative pregnancy test and agree to practice a medically acceptable contraception regimen for the study duration. Women who are postmenopausal for at least 1 year (> 12 months since last menses) or are surgically sterilized do not require this test
  • IC from the subject or assent from the subject and consent from a parent or guardian, if the subject is < 18 years of age

Contact

For additional study details and eligibility criteria, please contact Denise Praither:

  • 352-294-8713
  • dpraithe@ufl.edu

Age

18 and under
18 to 65
65 and over

Gender

Male
Female

Keywords

Hematologic Disorders, Blood Platelet Disorders, Pediatric Cancer, Neoplasm, Thrombocytopenia

Principal Investigator

Randall Brown, M.D.

Department

Oncology

Contact Information

dpraithe@ufl.edu

352-294-8713


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