Safety Evaluation of Intramuscular Injections of PLX-R18 in Subjects With Incomplete Hematopoietic Recovery Following Hematopoietic Cell Transplantation



Status:Recruiting
Healthy:No
Age Range:18 - Any
Updated:3/22/2019
Start Date:February 8, 2017
End Date:May 2019

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A Phase I Open-label Dose-escalation Study to Evaluate the Safety of Intramuscular Injections of PLX-R18 in Subjects With Incomplete Hematopoietic Recovery Following Hematopoietic Cell Transplantation

This study aims to evaluate the safety of intramuscular (IM) administration of PLX-R18 in
subjects with incomplete hematopoietic recovery following HCT.


Inclusion Criteria:

1. Age ≥18 years.

2. At least 4 months after HCT, either autologous or allogeneic (of any source, with any
preparatory regimen, for any indication), prior to study treatment.

3. Sustained platelet count ≤50,000/µL, and/or sustained Hgb ≤8 g/dL and/or sustained ANC
≤1000/mm3, which is considered by the Investigator as related to the nature of the
graft (higher transient levels following occasional blood product transfusions are
allowed).

4. Stable donor cell chimerism in at least 3 consecutive tests prior to treatment.

5. If the subject had allogeneic HCT for a malignant disease, the subject should have
complete donor chimerism. (*complete donor chimerism determined by the investigator
per site's standards)

6. General performance status evaluated by ECOG 0-2 scale.

Exclusion Criteria:

1. Evidence of active malignancy at the time of HCT or at any time since the HCT.

2. No other known etiology of the thrombocytopenia (such as infection, medication, etc.)
or anemia (such as blood loss, iron deficiency, etc.).

3. Current active infection requiring systemic treatment.

4. Acute graft versus host disease (GvHD) Grade III or IV, or severe chronic GvHD.

5. History of malignancy (other than the disease that required the HCT) within 5 years
prior to screening.

6. History of severe allergic/hypersensitivity reaction or significant transfusion
reaction.

7. Severe or uncontrolled/unstable cardiac, pulmonary, hepatic or renal disease,
including MI or CVA within 3 months prior to treatment.
We found this trial at
8
sites
3500 Gaston Avenue
Dallas, Texas 75246
1.800.422.9567
Principal Investigator: Carolina Escobar, M.D
Phone: 214-370-1500
Baylor University Medical Center Baylor University Medical Center in Dallas, TX is ranked nationally in...
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Baltimore, Maryland 21201
Principal Investigator: Nancy Hardy, Dr.
Phone: 410-328-0372
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5841 S Maryland Ave
Chicago, Illinois 60637
(773) 702-1000
Principal Investigator: Michael Bishop
Phone: 773-702-9297
University of Chicago Medical Center The University of Chicago Medicine has been at the forefront...
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Cleveland, Ohio 44194
Principal Investigator: Leland Metheny, MD
Phone: 216-983-0771
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30 Prospect Ave
Hackensack, New Jersey 07601
(201) 996-2000
Principal Investigator: Scott Rowley, MD
Phone: 201-996-5897
Hackensack University Medical Center Hackensack University Medical Center, part of the Hackensack University Health Network,...
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Haifa, 31096
Phone: +972 (4) 777-3248
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Rochester, Minnesota 55905
Principal Investigator: Mark Litzow, Dr.
Phone: 507-266-4917
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Westwood, Kansas 66205
Principal Investigator: Joseph McGuirk, Dr.
Phone: 913-588-6029
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Westwood, KS
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