Eligibility, any sex, with Hematologic Malignancies or Hypoproliferative Thrombocytopenia. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Days of ≥ Grade 2 BleedingPrimary· 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.
Group
Value
95% CI
MIRASOL
1.7
± 4.05
CONTROL
0.6
± 1.51
Number and Percentage of Subjects With Human Leukocyte Antigen (HLA) AlloimmunizationSecondary· 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).
Group
Value
95% CI
MIRASOL
4
CONTROL
2
Number and Percentage of Subjects With ≥ Grade 2 BleedingSecondary· From the first post-randomization platelet transfusion through 28 days following the first transfusion.
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
Group
Value
95% CI
MIRASOL
58
CONTROL
46
Number and Percentage of Subjects at the First Timepoint of ≥ Grade 2 BleedingSecondary· 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.
Day 4
Group
Value
95% CI
MIRASOL
115
CONTROL
128
Day 8
Group
Value
95% CI
MIRASOL
92
CONTROL
110
Day 12
Group
Value
95% CI
MIRASOL
72
CONTROL
85
Day 16
Group
Value
95% CI
MIRASOL
33
CONTROL
48
Day 20
Group
Value
95% CI
MIRASOL
11
CONTROL
27
Day 24
Group
Value
95% CI
MIRASOL
5
CONTROL
13
Day 28
Group
Value
95% CI
MIRASOL
4
CONTROL
11
Number and Percentage of Subjects With ≥ Grade 3 BleedingSecondary· From the first post-randomization platelet transfusion through 28 days following the first transfusion.
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).
Group
Value
95% CI
MIRASOL
6
CONTROL
2
Number and Percentage of Subjects With PLT RefractorinessSecondary· From the first post-randomization platelet transfusion through 28 days following the first transfusion.
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.
Group
Value
95% CI
MIRASOL
41
CONTROL
20
Number and Percentage of Subjects With Immune Platelet RefractorinessSecondary· Initial post-randomization platelet transfusion through high Class I HLA development.
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.
Group
Value
95% CI
MIRASOL
1
CONTROL
1
Number and Percentage of Subjects With Unanticipated Adverse Device Effects (UADEs)Secondary· 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
Group
Value
95% CI
MIRASOL
1
CONTROL
0
MIRASOL
140
CONTROL
161
Adverse events — posted to ClinicalTrials.gov
Time frame: Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (SAEs) that occurred from initial post randomization platelet transfusion through seventy-two (72) hours following the transfusion end time of the last on-protocol PLT transfusion were reported. Deaths that occurred (including deaths due to bleeding) thirty days (30) following the transfusion end time of the last on-protocol PLT transfusion were reported..
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
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.
Publications & conference data
2 peer-reviewed publications reference this trial (live from Europe PMC):
Other recruiting trials for Hematologic Malignancies
Currently open trials in the same condition.
NCT04546945 — Aberrant Expression of CD56 in Patients With Hematologic Malignancies.
· recruiting
NCT06926595 — Allogeneic HSCT With Low-Dose Post-Transplant Cyclophosphamide for GVHD Prevention
· Phase 2
· recruiting
NCT07186192 — Digital Health Intervention for Self-Management and Telemonitoring in Chimeric Antigen Receptor (CAR-T) Therapy
· Phase 3
· recruiting
NCT07195916 — A Study to Evaluate INCA036873 in Participants With Advanced Solid Tumors and Hematological Malignancies
· Phase 1
· recruiting
NCT07162038 — Phase I Trial Integrating HLA-Haploidentical Anti-CD19 CAR-T Cells With Post-Transplantation Cyclophosphamide-Based HLA-
· Phase 1
· recruiting
Other Terumo BCTbio trials
Trials by the same sponsor.
NCT03329404 — Efficacy and Safety of RBCs Derived From Mirasol-treated Whole Blood in Patients Requiring Chronic Transfusion (PRAISE)
· NA
· terminated
NCT00742001 — Feasibility Study of Mirasol-Treated Whole Blood Red Cell Recovery and Survival
· Phase 1
· terminated
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Terumo BCTbio
Last refreshed: 19 August 2021
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02964325.