Protocol Summary

Protocol No.: OCR14508

Sponsor Protocol No.: CTS-5030

Study Title
Clinical Effectiveness of Standard Versus Mirasol-treated Apheresis Platelets in Patients with Hypoproliferative Thrombocytopenia (MIPLATE Trial)

Principal Investigator(s)
Brown, Randall

Objective
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.

Description
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 =

Phase: NA

Age Group: Both

Scope: National

Treatment
Mirasol platelets (MIR PLTs)
Leukoreduced, Trima Accel® apheresis platelets stored in 100% plasma, pathogen reduced with the Mirasol® Pathogen Reduction Technology (PRT) System

Reference platelets (REF PLTs)
Leukoreduced, apheresis platelets stored in 100% plasma

Detailed Eligibility
INCLUSION CRITERIA:
1. Weight > 10 kg (22 lbs)
2. Subject has a hematologic malignancy with hypoproliferative thrombocytopenia and is expected to have PLT count(s) == 2 PLT transfusions
3. Laboratory results within 5 days prior to anticipated initiation of the first post randomization PLT transfusion:
- Prothrombin time (PT) and/or international normalized ratio (INR) = - Activated partial thromboplastin time (aPTT) = - Fibrinogen >= 100 mg/dL
4. 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
5. IC from the subject or assent from the subject and consent from a parent or guardian, if the subject is
EXCLUSION CRITERIA:
1. Previous treatment with pathogen-reduced blood products
2. Subject has previously been enrolled in this study and received at least 1 per protocol PLT transfusion
3. Subject is receiving anticoagulant, pro-coagulant or antithrombotic, antiplatelet agents, and/or PLT specific growth factors within 10 days prior to randomization
4. Subject has >= grade 2 bleeding at the time of randomization
5. Planned administration of bedside LR PLT transfusion(s)
6. Subject is anticipated to need washed or volume reduced PLT during the course of this study
7. Presently with or a history of acute promyelocytic leukemia (APML), idiopathic thrombocytopenic purpura (ITP), thrombotic thrombocytopenic purpura (TTP), or hemolytic uremic syndrome (HUS)
8. Positive lymphocytotoxic antibody (> 20% HLA or panel reactive antibody) during screening and/or if the subject is suspected to be refractory to PLTs
9. Splenomegaly (presence of a palpable spleen whose border could be felt more than 4 cm below the costal margin)
10. History or diagnosis of a disease affecting hemostasis
11. Currently taking, or participating in a clinical study involving PLT substitutes, PLT growth factors, or pharmacologic agents intended to enhance (ie, antifibrinolytic agents) or decrease PLT hemostatic function
12. Acute or chronic medical disorder that, in the opinion of the investigator, would impair the ability of the subject to receive protocol treatment
13. Subject is pregnant or lactating
14. Inability of the subject to comply with study procedures and/or follow-up

Applicable Disease Sites
Supportive Care Trials

Participating Institutions
UF Gainesville : Denise Praither

Contact
Denise Praither
Phone: +1 352-294-8713

Email: dpraithe@ufl.edu

More Information:
View study listing on ClinicialTrials.gov
http://www.clinicaltrials.gov/ct2/show/
NCT02964325