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Thrombosomes® in Bleeding Thrombocytopenic Patients Study | Clinical Trials | Clareo Health

TERMINATEDPHASE2

Thrombosomes® in Bleeding Thrombocytopenic Patients Study

A Prospective, Multicenter, Randomized, Open-Label Phase 2, Parallel, Dose Ranging Multidose Study of Thrombosomes® vs Liquid Stored Platelets (LSP) in Bleeding Thrombocytopenic Patients

NCT04631211•Cellphire Therapeutics, Inc.

View on ClinicalTrials.gov

Summary

This prospective, multicenter, randomized, open-label, Phase 2, parallel, dose ranging, multidose trial will enroll patients into 3 Thrombosomes dose groups and 1 control liquid stored platelets (LSP) group in order to evaluate, in a dose-escalation manner, the safety, and impact on bleeding, and the preliminary effect on coagulation measures of increasing doses of allogeneic Thrombosomes in comparison to standard of care, LSP.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Adults (≥18 years) with TCP as defined by BOTH (a) and (b):
•1. a platlet count of ≤ 70,000 platelets/μL blood
•2. ANY ONE OR MORE of (1-3):
•1. confirmed diagnosis of hematologic malignancy, myeloproliferative disorder, myelodysplastic syndrome, or aplasia
•2. undergoing chemotherapy, immunotherapy, radiation therapy or hematopoietic stem cell transplantation
•3. refractory to platelet transfusion defined as two 1-hour CCI of \<5,000 on consecutive transfusions of LSP or as defined by local site policy (Sacher, 2003)
•2. WHO Bleeding Score of 2 or 3
•3. Able to provide informed consent directly or through legally authorized representative, and comply with treatment and monitoring
•4. Negative pregnancy test for women of childbearing potential

Exclusion Criteria

•1. Any disorder or condition related to any venous thrombosis, embolism, or ischemia within the past 3 months
•2. Any disorder or condition related to arterial thrombosis including: ischemia, stroke, MI, or stent placement, within past 6 months
•3. Any valve replacement and/or repair of left atrial appendance occlusion device
•4. Sinusoidal obstruction syndrom (veno-occlusive disease) or cytopkine release syndrome associated with CAR-T cell therapy
•5. Refusal to accept blood products
•6. Liver enzyme blood levels greater than 3× the upper limit of normal (ULN)
•7. Blood creatinine level greater than 3× ULN
•8. Received platelet inhibitor drugs, cyclooxygenase-2 (COX-2) inhibitors, or nonsteroidal anti-inflammatory drugs within 5 days prior to infusion
•9. Currently (at the time of randomization) receiving anticoagulant therapy or antiplatelet therapy. Low dose prophylaxis for line clots is not excluded.
•10. Receipt of any pro-coagulant agents (e.g., DDAVP, recombinant Factor VIIa or prothrombin complex concentrates (PCC)) other than Tranexamic Acid (TXA) or Epsilon Aminocaproic Acid (EACA, Amicar), within 48 hours of first infusion, or with known hypercoagulable state
+11 more criteria

Locations (6)

City of Hope

Duarte, California, United States

Medstar Georgetown

Washington D.C., District of Columbia, United States

Vanderbilt University Medical Center

Nashville, Tennessee, United States

MD Anderson Cancer Center

Houston, Texas, United States

Rambam Medical Center

Haifa, Israel

Helse Bergen Haukeland University Hospital

Bergen, Norway

Key Dates

Start Date

March 5, 2021

Primary Completion Date

January 7, 2022

Completion Date

January 7, 2022

Last Updated

May 25, 2023

Enrollment

ACTUAL participants

Conditions

ThrombocytopeniaHematologic MalignancyBone Marrow AplasiaMyeloproliferative DisordersMyelodysplastic SyndromesPlatelet Refractoriness

Interventions

Thrombosomes

BIOLOGICAL

Liquid Stored Platelets (LSP)

BIOLOGICAL

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: May 25, 2023Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Thrombosomes® in Bleeding Thrombocytopenic Patients Study

Inclusion Criteria

Exclusion Criteria

Phase II Study of Pirtobrutinib With Venetoclax In Relapsed-Refractory MCL (Mantle Cell Lymphoma) Patients

Study to Assess the Safety and Tolerability of Tafasitamab in Adult Participants With Primary Autoimmune Blood Cell Disorders

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