Status:
COMPLETED
Thrombosomes® in Bleeding Thrombocytopenic Patients
Lead Sponsor:
Cellphire Therapeutics, Inc.
Collaborating Sponsors:
Department of Health and Human Services
Conditions:
Thrombocytopenia
Hematologic Diseases
Eligibility:
All Genders
18-74 years
Phase:
PHASE1
Brief Summary
The study evaluates the safety and potential early signals of efficacy of allogeneic Thrombosomes in bleeding thrombocytopenic patients
Detailed Description
The primary objective of the present study was to assess the safety of increasing dose levels of Thrombosomes in bleeding patients with thrombocytopenia. The secondary objective was to explore early s...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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
Key Trial Info
Start Date :
March 19 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 25 2019
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT03394755
Start Date
March 19 2018
End Date
September 25 2019
Last Update
April 14 2023
Active Locations (7)
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1
City of Hope
Duarte, California, United States, 91010
2
Georgetown University Hospital
Washington D.C., District of Columbia, United States, 20016
3
University of Michigan
Ann Arbor, Michigan, United States, 48109
4
Dartmouth Hitchcock Medical Center
Lebanon, New Hampshire, United States, 03766