Efficacy of Mirasol-treated Apheresis Platelets in Patients With Hypoproliferative Thrombocytopenia (MIPLATE)
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|ClinicalTrials.gov Identifier: NCT02964325|
Recruitment Status : Terminated (Based interim analysis results, Data Monitoring Committee did not believe the primary efficacy endpoint would be met. No patient safety concerns.)
First Posted : November 16, 2016
Results First Posted : July 16, 2021
Last Update Posted : July 16, 2021
|Condition or disease||Intervention/treatment||Phase|
|Hematologic Malignancies Hypoproliferative Thrombocytopenia||Device: Mirasol platelets (MIR PLTs) Device: Reference platelets (REF PLTs)||Not Applicable|
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 ≤ 10,000/μL requiring ≥ 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 on Days 14, 28 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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||422 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Investigator, Outcomes Assessor)|
|Masking Description:||Though this is not a blinded study, treatment assignment is obtained through electronic system and should not be shared those performing the primary outcome assessment or assessors of adverse events.|
|Primary Purpose:||Supportive Care|
|Official Title:||Clinical Effectiveness of Conventional Versus Mirasol-treated Apheresis Platelets in Patients With Hypoproliferative Thrombocytopenia|
|Actual Study Start Date :||May 5, 2017|
|Actual Primary Completion Date :||June 25, 2020|
|Actual Study Completion Date :||June 25, 2020|
Experimental: Mirasol platelets (MIR PLTs)
Leukoreduced, Trima Accel® apheresis platelets stored in 100% plasma, pathogen reduced with the Mirasol® Pathogen Reduction Technology (PRT) System
Device: Mirasol platelets (MIR PLTs)
The final product to be transfused to the subject will be leukoreduced (LR), apheresis (Aph) single-donor platelets (PLTs) at the standard therapeutic dose of 1 unit of Aph PLTs containing ≥ 3.0 × 1.0E11 PLTs. MIR PLTs will be treated with the Mirasol pathogen reduction technology system.
Active Comparator: Reference platelets (REF PLTs)
Leukoreduced, apheresis platelets stored in 100% plasma
Device: Reference platelets (REF PLTs)
The final product to be transfused to the subject will be LR-Aph single-donor PLTs at the standard therapeutic dose of 1 unit of Aph PLTs containing ≥ 3.0 × 1.0E11 PLTs.
- Days of ≥ Grade 2 Bleeding [ Time Frame: From the first post-randomization platelet transfusion through 28 days following the first transfusion. ]Number of days of Grade 2 or higher bleeding recorded from treatment start date through 28 days following the first transfusion, until transfusion independence (10 days without PLT transfusion) prior to Day 28, or study termination, whichever occurred first. Subjects who obtained transfusion independence prior to Day 28 were assumed to have zero bleeding events between the date of transfusion independence and Day 28. Observed and simulated data for off-protocol transfusion intervals were included.
- Human Leukocyte Antigen (HLA) Alloimmunization [ Time Frame: HLA antibodies were measured at Baseline and Days 14, 28, and 56. ]The outcome was the development of a new HLA Class I antibodies among subjects negative at Baseline within each treatment group. Positivity for Class I HLA antibodies was determined by the 5 SD normalized background ratio cutoffs assay threshold (>59.2, LABScreen Mixed LSM12, One Lambda).
- Proportion of Subjects With ≥ Grade 2 Bleeding [ Time Frame: From the first post-randomization platelet transfusion through 28 days following the first transfusion. ]The proportion of subjects with at least 1 day of ≥ Grade 2 bleeding from Day 0 through Day 27 (or until transfusion independence was achieved) by treatment group
- Time to First ≥ Grade 2 Bleed [ Time Frame: From the first post-randomization platelet transfusion through 28 days following the first transfusion. ]The time to first ≥ Grade 2 bleeding was analyzed using a log-rank test comparing survival curves stratified by treatment group.
- Proportion of Subjects With ≥ Grade 3 Bleeding [ Time Frame: From the first post-randomization platelet transfusion through 28 days following the first transfusion. ]The proportion of subjects with at least 1 day of ≥ Grade 3 bleeding from Day 0 through Day 27 (or until transfusion independence was achieved).
- Proportion of Subjects With PLT Refractoriness [ Time Frame: From the first post-randomization platelet transfusion through 28 days following the first transfusion. ]Proportion of subjects with PLT refractoriness defined as 2 sequential transfusions, each with corrected count increments (CCIs) < 5000 measured 1 hour post-transfusion.
- Proportion of Subjects With Immune Platelet Refractoriness [ Time Frame: Initial post-randomization platelet transfusion through high Class I HLA development. ]The proportion of subjects with PLT refractoriness for each treatment group. Subjects were defined as immune PLT refractoriness based on 2 sequential transfusion episodes, each with CCIs < 5000 measured 1 hour post transfusion, and who also had a positive antibody test within 14 days before or after the onset of PLT refractoriness.
- Unanticipated Adverse Device Effects (UADEs) [ Time Frame: From initial post-randomization PLT transfusion through 72 hours following the last per protocol PLT transfusion. ]UADEs are identified as treatment emergent adverse events reported by the investigator as serious, unanticipated, at least possibly related to study device or at least possibly related to treatment. UADEs were coded using Medical Dictionary for Regulatory Activities (MedDRA) Version 19.1
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): NCT02964325
|United States, District of Columbia|
|Children's National Medical Center|
|Washington, District of Columbia, United States, 20010|
|United States, Florida|
|University of Florida Health Shands Hospital|
|Gainesville, Florida, United States, 32608|
|United States, Georgia|
|Emory University/Children's Hospital of Atlanta|
|Atlanta, Georgia, United States, 30322|
|United States, Iowa|
|University of Iowa|
|Iowa City, Iowa, United States, 52242|
|United States, Maryland|
|John Hopkins University School of Medicine/Johns Hopkins Kimmel Cancer Center|
|Baltimore, Maryland, United States, 21231|
|United States, Massachusetts|
|Boston Children's Hospital|
|Boston, Massachusetts, United States, 02115|
|United States, Missouri|
|Washington University in St. Louis|
|Saint Louis, Missouri, United States, 63110|
|United States, Nebraska|
|University of Nebraska Medical Center|
|Omaha, Nebraska, United States, 68198|
|United States, New Jersey|
|Robert Wood Johnson Medical School/RWJ University Hospital|
|New Brunswick, New Jersey, United States, 08903|
|United States, Washington|
|University of Washington Medical Center|
|Seattle, Washington, United States, 98109|
|Study Director:||Robert Cortes, MD||Terumo BCT|
|Principal Investigator:||Sherrill Slichter, MD||Bloodworks Northwest|