Hematologic MalignanciesMIPLATENCT02964325
Efficacy of Mirasol-treated Apheresis Platelets in Patients With Hypoproliferative Thrombocytopenia
A study testing Mirasol platelets (MIR PLTs) and Reference platelets (REF PLTs) in people with Hematologic Malignancies and Hypoproliferative Thrombocytopenia, run by Terumo BCTbio at 10 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Hematologic Malignancies, Hypoproliferative Thrombocytopenia
- What is being tested?
- Mirasol platelets (MIR PLTs) and Reference platelets (REF PLTs)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 422 participants
- Where
- 10 sitesUnited States
- Study dates
- 5 May 2017to 25 Jun 2020
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Weight > 10 kg (22 lbs)
- Subject has a hematologic malignancy with hypoproliferative thrombocytopenia and is expected to have PLT count(s) ≤ 10,000/µL requiring ≥ 2 PLT transfusions
- 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) ≤ 1.3 × the upper limit of normal (ULN)
- Activated partial thromboplastin time (aPTT) ≤ 1.3 × ULN
- 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
Who cannot join
- Treatment with pathogen-reduced blood products within previous 6 months
- Subject has been previously enrolled in this study and received at least 1 per protocol PLT transfusion
- 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)
- Subject has ≥ grade 2 bleeding at the time of randomization
- Planned administration of bedside LR PLT transfusion(s)
- Presently with or a history of acute promyelocytic leukemia (APML), idiopathic thrombocytopenic purpura (ITP), thrombotic thrombocytopenic purpura (TTP), or hemolytic uremic syndrome (HUS)
Show all 13Show fewer
- HLA and/or HPA-alloimmunization and/or platelet refractory as determined by the investigator
- Hypersplenism as evidenced by splenomegaly based on investigator assessment at baseline
- History or diagnosis of a disease affecting hemostasis
- 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
- Acute or chronic medical disorder that, in the opinion of the investigator, would impair the ability of the subject to receive protocol treatment
- Subject is pregnant or lactating
- Inability of the subject to comply with study procedures and/or follow-up
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
United States10 sites
Emory University/Children's Hospital of Atlanta
Atlanta, Georgia, 30322
John Hopkins University School of Medicine/Johns Hopkins Kimmel Cancer Center
Baltimore, Maryland, 21231
Boston Children's Hospital
Boston, Massachusetts, 02115
University of Florida Health Shands Hospital
Gainesville, Florida, 32608
University of Iowa
Iowa City, Iowa, 52242
Robert Wood Johnson Medical School/RWJ University Hospital
New Brunswick, New Jersey, 08903
University of Nebraska Medical Center
Omaha, Nebraska, 68198
University of Washington Medical Center
Seattle, Washington, 98109
Washington University in St. Louis
St Louis, Missouri, 63110
Children's National Medical Center
Washington D.C., District of Columbia, 20010
About this study
Official title: Clinical Effectiveness of Conventional Versus Mirasol-treated Apheresis Platelets in Patients With Hypoproliferative Thrombocytopenia
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.
Read the 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 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.
- Being tested
- Mirasol platelets (MIR PLTs), Reference platelets (REF PLTs)
- Keywords
- hypoproliferative thrombocytopenia, hematologic malignancies, thrombocytopenia, platelet therapy, apheresis, pathogen reduction therapy
- Medical subject headings
- Hematologic Neoplasms, Thrombocytopenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mirasol platelets (MIR PLTs)Device
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.
Reference platelets (REF PLTs)Device
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.
| Study group | Role | What they receive |
|---|---|---|
| Mirasol platelets (MIR PLTs) | Experimental | Leukoreduced, Trima Accel® apheresis platelets stored in 100% plasma, pathogen reduced with the Mirasol® Pathogen Reduction Technology (PRT) System Receives: Device: Mirasol platelets (MIR PLTs) |
| Reference platelets (REF PLTs) | Active comparator | Leukoreduced, apheresis platelets stored in 100% plasma Receives: Device: Reference platelets (REF PLTs) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Days of ≥ Grade 2 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 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.
Measured: From the first post-randomization platelet transfusion through 28 days following the first transfusion.
Secondary outcomes (6)
Number and Percentage of Subjects With Human Leukocyte Antigen (HLA) Alloimmunization
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).
Measured: HLA antibodies were measured at Baseline and Days 14, 28, and 56.
Number and Percentage of Subjects With ≥ Grade 2 Bleeding
The number and percentage 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
Measured: From the first post-randomization platelet transfusion through 28 days following the first transfusion.
Number and Percentage of Subjects at the First Timepoint of ≥ Grade 2 Bleeding
The time to first ≥ Grade 2 bleeding was analyzed using a log-rank test comparing survival curves stratified by treatment group.
Measured: From the first post-randomization platelet transfusion through 28 days following the first transfusion.
Number and Percentage of Subjects With ≥ Grade 3 Bleeding
The number and percentage of subjects with at least 1 day of ≥ Grade 3 bleeding from Day 0 through Day 27 (or until transfusion independence was achieved).
Measured: From the first post-randomization platelet transfusion through 28 days following the first transfusion.
Number and Percentage of Subjects With PLT Refractoriness
The number and percentage of subjects with PLT refractoriness defined as 2 sequential transfusions, each with corrected count increments (CCIs) < 5000 measured 1 hour post-transfusion.
Measured: From the first post-randomization platelet transfusion through 28 days following the first transfusion.
Number and Percentage of Subjects With Immune Platelet Refractoriness
The number and percentage 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.
Measured: Initial post-randomization platelet transfusion through high Class I HLA development.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Nov 2016 (estimated)
- Study start5 May 2017
- Primary completion25 Jun 2020
- Study completion25 Jun 2020
Why it stopped: Based interim analysis results, Data Monitoring Committee did not believe the primary efficacy endpoint would be met. No patient safety concerns.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Hematologic MalignanciesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 422 participants (actual)
Sponsor and investigators
- Lead sponsor
- Terumo BCTbio
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Biomedical Advanced Research and Development Authority
- Responsible party
- Sponsor
- Investigators
- Robert Cortes, MD, Study director, Terumo BCTSherrill Slichter, MD, Principal investigator, Bloodworks Northwest
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02964325
- Sponsor's protocol ID
- CTS-5030
- Acronym
- MIPLATE
- Status last verified
- Jul 2021
- First submitted
- 9 Nov 2016
- Last updated
- 19 Aug 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Effectiveness of Conventional Versus Mirasol-treated Apheresis Platelets in Patients With Hypoproliferative Thrombocytopenia
- ClinicalTrials.gov ID
- NCT02964325
- Acronym / sponsor ID
- MIPLATE / CTS-5030
- Keywords
- hypoproliferative thrombocytopenia, hematologic malignancies, thrombocytopenia, platelet therapy, apheresis, pathogen reduction therapy
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Based interim analysis results, Data Monitoring Committee did not believe the primary efficacy endpoint would be met. No patient safety concerns.
- Enrolment
- 422 participants (actual)
- Lead sponsor
- Terumo BCTbioIndustry (pharma, biotech, devices)
- Collaborators
- Biomedical Advanced Research and Development Authority
- Study start
- 5 May 2017 (actual)
- Primary completion
- 25 Jun 2020 (actual)
- Study completion
- 25 Jun 2020 (actual)
- First posted
- 16 Nov 2016 (estimated)
- Results
- Posted 16 Jul 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mirasol platelets (MIR PLTs) | Experimental | Device: 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) | Active comparator | Device: Reference platelets (REF PLTs)Leukoreduced, apheresis platelets stored in 100% plasma |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (8 listed)
- Weight > 10 kg (22 lbs)
- Subject has a hematologic malignancy with hypoproliferative thrombocytopenia and is expected to have PLT count(s) ≤ 10,000/µL requiring ≥ 2 PLT transfusions
- Laboratory results within 5 days prior to anticipated initiation of the first post randomization PLT transfusion:
- 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
Key exclusion criteria (13 listed)
- Treatment with pathogen-reduced blood products within previous 6 months
- Subject has been previously enrolled in this study and received at least 1 per protocol PLT transfusion
- 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)
- Subject has ≥ grade 2 bleeding at the time of randomization
- Planned administration of bedside LR PLT transfusion(s)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Device | Mirasol platelets (MIR PLTs) |
| 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. | Device | Reference platelets (REF PLTs) |
Primary outcome
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.
6 secondary outcomes
Number and Percentage of Subjects With Human Leukocyte Antigen (HLA) Alloimmunization
Time frame: HLA antibodies were measured at Baseline and Days 14, 28, and 56.
Number and Percentage of Subjects With ≥ Grade 2 Bleeding
Time frame: From the first post-randomization platelet transfusion through 28 days following the first transfusion.
Number and Percentage of Subjects at the First Timepoint of ≥ Grade 2 Bleeding
Time frame: From the first post-randomization platelet transfusion through 28 days following the first transfusion.
Number and Percentage of Subjects With ≥ Grade 3 Bleeding
Time frame: From the first post-randomization platelet transfusion through 28 days following the first transfusion.
Number and Percentage of Subjects With PLT Refractoriness
Time frame: From the first post-randomization platelet transfusion through 28 days following the first transfusion.
Number and Percentage of Subjects With Immune Platelet Refractoriness
Time frame: Initial post-randomization platelet transfusion through high Class I HLA development.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Robert Cortes, MD study director
Terumo BCT
Sherrill Slichter, MD principal investigator
Bloodworks Northwest
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mirasol platelets (MIR PLTs) and Reference platelets (REF PLTs) in people with Hematologic Malignancies and Hypoproliferative Thrombocytopenia, run by Terumo BCTbio at 10 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 19 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 16 Jul 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Days of ≥ Grade 2 Bleeding (time frame: From the first post-randomization platelet transfusion through 28 days following the first transfusion.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Aug 2021.