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 |
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.
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
Medical College of Wisconsin The Medical College (MCW) of Wisconsin is a major national research...
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Emory University Emory University, recognized internationally for its outstanding liberal artscolleges, graduate and professional schools,...
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University of Chicago One of the world's premier academic and research institutions, the University of...
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Cleveland Clinic Cleveland Clinic is committed to principles as presented in the United Nations Global...
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Duke University Younger than most other prestigious U.S. research universities, Duke University consistently ranks among...
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Univ of Minnesota With a flagship campus in the heart of the Twin Cities, and...
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Ohio State University The Ohio State University’s main Columbus campus is one of America’s largest...
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West Virginia University West Virginia University, founded in 1867, has a long and rich history...
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