Thrombosomes® in Bleeding Thrombocytopenic Patients

Completed · Phase 1

Conditions studied: Thrombocytopenia, Hematologic Diseases, Bone Marrow Aplasia

In brief

The study evaluates the safety and potential early signals of efficacy of allogeneic Thrombosomes in bleeding thrombocytopenic patients

Key facts

Study ID

NCT03394755

Run by

Cellphire Therapeutics, Inc.

People needed

24

Starts

2018-03-19

Expected to finish

2019-09-25

Last updated by the study team

2023-04-14

Who can join

Age: 18 and older, up to 74. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Adults up to 74 y/o with any of following: acute leukemia (ALL or AML), myelodysplasia, aplasia, and/or therapy (chemotherapy or radiation) induced bone marrow aplasia or hypoplasia with thrombocytopenia (platelet count ≥ 5,000 and ≤ 70,000/μL) for a minimum of 2 days. May include bone marrow transplant or peripheral or cord blood stem cell recipients, but not subjects with Graft-vs-Host disease.
• Hospitalized patients (or willing to be hospitalized for 24 hours after Rx) with Modified WHO Grade 1 (subset) or Grade 2 Bleeding Score or at risk for same within 4 weeks of screening. The Grade 1 subset includes patients who have either epistaxis, hematuria, oral petechiae, or bleeding at invasive or other wound sites.
• No platelet inhibitor drugs within 5 days prior to infusion and through Day 6 follow-up period.

You may not qualify if…

• History or condition related to thrombosis, embolism or vascular occlusion/ischemia, including but not limited to: transient ischemic attack, stroke, myocardial infarction, stent placement, valve replacement and/or repair
• Currently with an active acute infection, or suspected infection, a single oral temperature of ≥ 101° F or a temperature of ≥ 100.4°F sustained over a 1 h period in past 24 h. Subjects on prophylactic antibiotics are not excluded from study
• Coagulopathy or receiving anticoagulants that result in PT (prothrombin time) or aPTT (activated partial thromboplastin time) values greater than 1.3 X upper limit of normal or elevated D-dimer of decreased fibrinogen
• History of any inherited coagulation or platelet function, disorder or ITP (idiopathic thrombocytopenic purpura), TTP (thrombotic thrombocytopenic purpura), or HUS (hemolytic-uremic syndrome)
• Receipt of tranexamic acid or other antifibrinolytics within 48 hrs prior to infusion
• Treatment with an investigational drug within 1 month of infusion, other than for treatment of their underlying disease

Where it is running

• City of Hope — Duarte, California, United States
• Georgetown University Hospital — Washington D.C., District of Columbia, United States
• University of Michigan — Ann Arbor, Michigan, United States
• Dartmouth Hitchcock Medical Center — Lebanon, New Hampshire, United States
• Hoxworth Blood Center/University of Cincinnati — Cincinnati, Ohio, United States
• MD Anderson Cancer Center — Houston, Texas, United States
• Haukeland University Hospital — Bergen, Norway

Full record on ClinicalTrials.gov

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