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History of Changes for Study: NCT02964325
Efficacy of Mirasol-treated Apheresis Platelets in Patients With Hypoproliferative Thrombocytopenia (MIPLATE)
Latest version (submitted August 14, 2020) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 November 10, 2016 None (earliest Version on record)
2 May 22, 2017 Recruitment Status, Study Status, Study Design, Oversight and Contacts/Locations
3 August 29, 2017 Study Status and Contacts/Locations
4 January 8, 2018 Contacts/Locations and Study Status
5 June 4, 2018 Contacts/Locations, Study Status and Eligibility
6 December 20, 2018 Contacts/Locations and Study Status
7 November 25, 2019 Contacts/Locations, Study Status, Eligibility, Study Design and Study Description
8 August 14, 2020 Recruitment Status, Study Status, Contacts/Locations and Study Design
Comparison Format:

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Changes (Side-by-Side) for Study: NCT02964325
November 10, 2016 (v1) -- August 14, 2020 (v8)

Changes in: Study Status, Study Design, Contacts/Locations, Oversight, Eligibility and Study Description

Study Identification
Unique Protocol ID: CTS-5030 CTS-5030
Brief Title: Efficacy of Mirasol-treated Apheresis Platelets in Patients With Hypoproliferative Thrombocytopenia (MIPLATE)Efficacy of Mirasol-treated Apheresis Platelets in Patients With Hypoproliferative Thrombocytopenia (MIPLATE)
Official Title: Clinical Effectiveness of Conventional Versus Mirasol-treated Apheresis Platelets in Patients With Hypoproliferative Thrombocytopenia Clinical Effectiveness of Conventional Versus Mirasol-treated Apheresis Platelets in Patients With Hypoproliferative Thrombocytopenia
Secondary IDs:
Study Status
Record Verification: November 2016 August 2020
Overall Status: Not yet recruiting Terminated
Study Start: January 2017 May 5, 2017
Primary Completion: March 2021 [Anticipated ] June 25, 2020 [Actual ]
Study Completion: March 2021 [Anticipated ] June 25, 2020 [Actual ]
First Submitted: November 9, 2016 November 9, 2016
First Submitted that
Met QC Criteria:
November 10, 2016 November 10, 2016
First Posted: November 16, 2016 [Estimate ] November 16, 2016 [Estimate ]
Last Update Submitted that
Met QC Criteria:
November 10, 2016 August 14, 2020
Last Update Posted: November 16, 2016 [Estimate ] August 18, 2020 [Actual ]
Sponsor/Collaborators
Sponsor: Terumo BCTbio Terumo BCTbio
Responsible Party: Sponsor Sponsor
Collaborators: Biomedical Advanced Research and Development Authority Biomedical Advanced Research and Development Authority
Oversight
U.S. FDA-regulated Drug: No
U.S. FDA-regulated Device: Yes
Unapproved/Uncleared Device:
Pediatric Postmarket Surveillance:
Data Monitoring: Yes Yes
Study Description
Brief Summary: 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) ≤ 10,000/μL requiring ≥ 2 platelet transfusions. 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) ≤ 10,000/μL requiring ≥ 2 platelet transfusions.
Detailed 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 ≤ 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 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.

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.

Conditions
Conditions: Hematologic Malignancies
Hypoproliferative Thrombocytopenia
Hematologic Malignancies
Hypoproliferative Thrombocytopenia
Keywords: hypoproliferative thrombocytopenia
hematologic malignancies
thrombocytopenia
platelet therapy
apheresis
pathogen reduction therapy
hypoproliferative thrombocytopenia
hematologic malignancies
thrombocytopenia
platelet therapy
apheresis
pathogen reduction therapy
Study Design
Study Type: InterventionalInterventional
Primary Purpose: Supportive CareSupportive Care
Study Phase: Not ApplicableNot Applicable
Interventional Study Model: Parallel Assignment Parallel Assignment
Number of Arms: 22
Masking: None (Open Label)Double (Investigator, Outcomes Assessor)
Allocation: RandomizedRandomized
Enrollment: 556 [Anticipated ] 330 [Actual ]
Arms and Interventions
Arms Assigned Interventions
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.
Outcome Measures
Primary Outcome Measures:
1. Number of days of grade 2 or higher bleeding
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 occurs first. Subjects who obtain transfusion independence prior to Day 28 will be assumed to have zero bleeding events between the date of transfusion independence and Day 28.

[Time Frame: From the first post-randomization platelet transfusion through 28 days following the first transfusion OR until transfusion independence (10 days without platelet transfusion) prior to day 28 ]
Number of days of grade 2 or higher bleeding
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 occurs first. Subjects who obtain transfusion independence prior to Day 28 will be assumed to have zero bleeding events between the date of transfusion independence and Day 28.

[Time Frame: From the first post-randomization platelet transfusion through 28 days following the first transfusion OR until transfusion independence (10 days without platelet transfusion) prior to day 28 ]
Secondary Outcome Measures:
2. Human leukocyte antigen (HLA) alloimmunization
be based on a comparison of the proportion of subjects with HLA alloimmunization between test versus control populations.

[Time Frame: Prior to the first study transfusion and weekly for 28 days and on Days 42 and 56 ]
Human leukocyte antigen (HLA) alloimmunization
be based on a comparison of the proportion of subjects with HLA alloimmunization between test versus control populations.

[Time Frame: Prior to the first study transfusion and weekly for 28 days and on Days 42 and 56 ]
3. Proportion of subjects with ≥ grade 2 bleeding
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 occurs first.
Proportion of subjects with ≥ grade 2 bleeding
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 occurs first.
4. Time to first ≥ grade 2 bleed
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 occurs first.
Time to first ≥ grade 2 bleed
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 occurs first.
5. Proportion of subjects with ≥ grade 3 bleeding
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 occurs first.
Proportion of subjects with ≥ grade 3 bleeding
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 occurs first.
6. Proportion of subjects with PLT refractoriness
Proportion of subjects with PLT refractoriness defined as 2 sequential transfusions, each with corrected count increments (CCIs) < 5000 measured 1 hour post-transfusion

[Time Frame: 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 occurs first. ]
Proportion of subjects with PLT refractoriness
Proportion of subjects with PLT refractoriness defined as 2 sequential transfusions, each with corrected count increments (CCIs) < 5000 measured 1 hour post-transfusion

[Time Frame: 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 occurs first. ]
7. Immune platelet refractoriness
Immune platelet refractoriness will be subjects with platelet refractoriness as defined above and who also have a positive antibody test within 14 days before or after the onset f platelet refractoriness

[Time Frame: Within 14 days before or after onset of platelet refractoriness ]
Immune platelet refractoriness
Immune platelet refractoriness will be subjects with platelet refractoriness as defined above and who also have a positive antibody test within 14 days before or after the onset f platelet refractoriness

[Time Frame: Within 14 days before or after onset of platelet refractoriness ]
Other Pre-specified Outcome Measures:
8. Treatment-emergent adverse events (TEAEs)
from the initial post-randomization PLT transfusion through 72 hours following the last per protocol PLT transfusion
Treatment-emergent adverse events (TEAEs)
from the initial post-randomization PLT transfusion through 72 hours following the last per protocol PLT transfusion
9. Serious adverse events (SAEs)
from the initial post-randomization PLT transfusion through 72 hours following the last per protocol PLT transfusion
Serious adverse events (SAEs)
from the initial post-randomization PLT transfusion through 72 hours following the last per protocol PLT transfusion
10. Unanticipated adverse device effects (UADEs)
from the initial post-randomization PLT transfusion through 72 hours following the last per protocol PLT transfusion
Unanticipated adverse device effects (UADEs)
from the initial post-randomization PLT transfusion through 72 hours following the last per protocol PLT transfusion
Eligibility
Minimum Age:
Maximum Age:
Sex: All All
Gender Based:
Accepts Healthy Volunteers: NoNo
Criteria:

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) ≤ 10,000/µL requiring ≥ 2 PLT transfusions
  3. 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
  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 < 18 years of age

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

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) ≤ 10,000/µL requiring ≥ 2 PLT transfusions
  3. 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
  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 < 18 years of age

Exclusion Criteria:

  1. Treatment with pathogen-reduced blood products within previous 6 months
  2. Subject has been previously enrolled in this study and received at least 1 per protocol PLT transfusion
  3. a.) Subject is receiving therapeutic doses of antiplatelet agents, antifibrinolytics, and/or PLT specific growth factors within 10 days prior to randomization or b.) Subject is receiving therapeutic doses of anticoagulant, pro-coagulant or antithrombotic agents within 10 days prior to randomization. Subjects can be included if receiving the following: prophylactic dosing of anticoagulants (heparin, any low molecular weight heparin, enoxaparin, or fondaparinux), anticoagulants/thrombolytic agents used to maintain or re-establish the patency of catheters (heparin flushes or tissue-plasminogen activase [TPA], therapeutic doses of anticoagulants with a half-life of < 24 hours if it will be discontinued at least 24 hours prior to the first study transfusion, single periprocedural doses of anticoagulants with a half-life of < 24 hours or low dose aspirin (81 mg per day)
  4. Subject has ≥ grade 2 bleeding at the time of randomization
  5. Planned administration of bedside LR PLT transfusion(s)
  6. Presently with or a history of acute promyelocytic leukemia (APML), idiopathic thrombocytopenic purpura (ITP), thrombotic thrombocytopenic purpura (TTP), or hemolytic uremic syndrome (HUS)
  7. HLA and/or HPA-alloimmunization and/or platelet refractory as determined by the investigator
  8. Hypersplenism as evidenced by splenomegaly based on investigator assessment at baseline
  9. History or diagnosis of a disease affecting hemostasis
  10. Currently taking, or participating in a clinical study involving PLT substitutes, PLT growth factors, or pharmacologic agents intended to enhance (i.e, antifibrinolytic agents) or decrease PLT hemostatic function
  11. Acute or chronic medical disorder that, in the opinion of the investigator, would impair the ability of the subject to receive protocol treatment
  12. Subject is pregnant or lactating
  13. Inability of the subject to comply with study procedures and/or follow-up
Contacts/Locations
Central Contact: Chriss Stanford
Telephone: +1 303-542-5276
Email: Chriss.Stanford@terumobct.com
Central Contact Backup: Shannon Godbold, RN, BSN
Telephone: +1 303 239-2010
Email: Shannon.Godbold@terumobct.com
Study Officials: Heather Pidcoke, MD, PhD
Study Director
Terumo BCT
Robert Cortes, MD
Study Director
Terumo BCT
Sherrill Slichter, MD
Principal Investigator
Bloodworks Northwest
Sherrill Slichter, MD
Principal Investigator
Bloodworks Northwest
Locations: 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
IPDSharing
Plan to Share IPD: No No
References
Citations:
Links:
Available IPD/Information:

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