A Phase II Study Evaluating the Safety and Efficacy of Subcutaneous Plerixafor



Status:Completed
Conditions:Cancer, Blood Cancer, Lymphoma, Hematology
Therapuetic Areas:Hematology, Oncology
Healthy:No
Age Range:18 - 65
Updated:6/15/2017
Start Date:May 2013
End Date:August 2016

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A Phase II Study Evaluating the Safety and Efficacy of Subcutaneous Plerixafor for the Mobilization and Transplantation of HLA-Matched Sibling Donor Hematopoietic Stem Cells in Recipients With Hematological Malignancies

This is a Phase II, open-label, two strata, multicenter, prospective study of
plerixafor-mobilized HLA-identical sibling allografts in recipients with hematological
malignancies. This study will establish the safety and efficacy of subcutaneous plerixafor
for this purpose.


Inclusion Criteria:

Donor:

- Donor eligibility will be determined according to applicable federal, state and local
regulations and institutional standards

- 18-65 years of age

- 6/6 HLA-matched sibling

- Fulfill individual Transplant Center criteria to serve as a mobilized blood cell
donor

- Serum creatinine <2.0mg/dl

Recipient:

- 18 to 65 years of age

- 6/6 HLA antigen matched sibling willing to donate PBSC for transplant

- Fulfill individual Transplant Center Criteria for transplant

- One of the following diagnoses:

- Acute myelogenous leukemia (AML) in 1st remission or beyond with <5% marrow
blasts and no circulating blasts. Marrow must be done within 30 days of the
start of transplant conditioning regimen in alignment with other pre-transplant
assessments.

- Acute lymphoblastic leukemia (ALL) in 1st remission or beyond with <5% marrow
blasts and no circulating blasts

- Myelodysplastic syndrome, either intermediate-1,2, or high risk by International
Prognostic Scoring System or transfusion dependent

- Chronic myelogenous leukemia (CML) failing or intolerant to tyrosine kinase
inhibitor based therapy

- Non-Hodgkin's lymphoma (NHL) or Hodgkin's disease (HD) in 2nd or greater
complete remission, partial remission, or in relapse (but with at least stable
disease after most recent therapy)

- Chronic lymphocytic leukemia (CLL), relapsing after at least one prior regimen,
or in remission with 17p deletion

- Serum creatinine must be <2.0mg/dl

- Total bilirubin and AST <3x normal

- Infectious disease marker (IDM) monitoring will be performed per institutional
standards

- Karnofsky performance status of 70% or greater.

- Patients who have undergone a prior autologous transplantation are eligible for a
reduced intensity transplant only

Exclusion Criteria:

Donor:

- Donor unwilling or unable to give informed consent, or unable to comply with the
protocol including required follow-up and testing

- Donor already enrolled on another investigational agent study

- Pregnant or breast feeding females, or females not willing or able to use adequate
contraception if sexually active

Recipient:

- Patient unwilling or unable to give informed consent, or unable to comply with the
protocol including required follow-up and testing

- Patients with active, uncontrolled infection at the time of the transplant
preparative regimen

- Pregnant or breast feeding females, or females not willing or able to use adequate
contraception if sexually active

- Patients with a history of previous CNS tumor involvement showing active symptoms or
signs along with documented disease on lumbar puncture and MRI of the brain within 30
days of start of conditioning

- A condition, which, in the opinion of the clinical investigator, would interfere with
the evaluation of primary and secondary endpoints.
We found this trial at
12
sites
Morgantown, West Virginia 26506
(304) 293-0111
West Virginia University West Virginia University, founded in 1867, has a long and rich history...
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201 Dowman Dr
Atlanta, Georgia 30303
(404) 727-6123
Emory University Emory University, recognized internationally for its outstanding liberal artscolleges, graduate and professional schools,...
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Atlanta, GA
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185 Cambridge Street
Boston, Massachusetts 02114
617-724-5200
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Boston, MA
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5801 South Ellis Avenue
Chicago, Illinois 60637
 773.702.1234
University of Chicago One of the world's premier academic and research institutions, the University of...
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Chicago, IL
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9500 Euclid Avenue
Cleveland, Ohio 44106
216.444.2200
Cleveland Clinic Cleveland Clinic is committed to principles as presented in the United Nations Global...
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Cleveland, OH
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Durham, North Carolina 27710
(919) 684-8111
Duke University Younger than most other prestigious U.S. research universities, Duke University consistently ranks among...
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Durham, NC
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Minneapolis, Minnesota 55455
(612) 625-5000
Univ of Minnesota With a flagship campus in the heart of the Twin Cities, and...
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Minneapolis, MN
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281 W. Lane Ave
Columbus, Ohio 43210
(614) 292-6446
Ohio State University The Ohio State University’s main Columbus campus is one of America’s largest...
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Columbus, OH
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8701 W Watertown Plank Rd
Milwaukee, Wisconsin
(414) 955-8296
Medical College of Wisconsin The Medical College (MCW) of Wisconsin is a major national research...
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Milwaukee, WI
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Rochester, Minnesota 55905
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Rochester, MN
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Saint Louis, Missouri 63110
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Saint Louis, MO
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Tampa, Florida 33612
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Tampa, FL
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