Thrombosomes® in Bleeding Thrombocytopenic Patients

Conditions:Blood Cancer, Hematology, Hematology
Therapuetic Areas:Hematology, Oncology
Age Range:18 - 68
Start Date:March 19, 2018
End Date:June 18, 2019
Contact:Michael Fitzpatrick, PhD

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A Phase I, Multi-Center, Open-Label, Dose Escalation Study of Thrombosomes® in Bleeding Thrombocytopenic Patients in Three Cohorts

This study evaluates in a dose-escalation manner, the safety, and preliminary impact on
bleeding, and the preliminary effect on coagulation measures of increasing doses of
allogeneic Thrombosomes in thrombocytopenic patients.

The objectives of this trial, conducted in thrombocytopenic patients with modified World
Health Organization (WHO) Grade 1* or 2 bleeding, assessing the safety of infusing increasing
doses of allogeneic Thrombosomes in WHO bleeding and measures of coagulation.

Inclusion Criteria:

- Adults up to 68 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 during the immediate
study 6 Day follow-up period.

Exclusion Criteria:

- Hx or condition related to thrombosis, embolism or vascular occlusion/ischemia,
including but not limited to: TIA, stroke, MI, 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 or aPTT 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, TTP, or

- Receipt of tranexamic acid or other antifibrinolytics within 48 hrs prior to infusion

- Rx with an investigational drug w/in 1 month of infusion, other than for treatment of
their underlying disease
We found this trial at
Duarte, California 91010
Duarte, CA
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500 S State St
Ann Arbor, Michigan 48109
(734) 764-1817
University of Michigan The University of Michigan was founded in 1817 as one of the...
Ann Arbor, MI
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Cincinnati, Ohio 45267
Principal Investigator: Jose Cancelas, MD, PhD
Cincinnati, OH
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1 Medical Center Dr
Lebanon, New Hampshire 03756
 (603) 650-5000
Dartmouth Hitchcock Medical Center Dartmouth-Hitchcock is a national leader in patient-centered health care and building...
Lebanon, NH
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