A Phase II Study Evaluating the Safety and Efficacy of Subcutaneous Plerixafor (NCT01696461) | Clinical Trial Compass
CompletedPhase 2
A Phase II Study Evaluating the Safety and Efficacy of Subcutaneous Plerixafor
United States127 participantsStarted 2013-05
Plain-language summary
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.
Who can participate
Age range18 Years – 65 Years
SexALL
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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…
What they're measuring
1
Percentage of Donors Whose Cells Were Successfully Mobilized and Collected With a Sufficient CD34+ Cell Dose Using Plerixafor as the Mobilizing Agent, Using an Intention-to-treat Analysis.
Timeframe: donation
Trial details
NCT IDNCT01696461
SponsorCenter for International Blood and Marrow Transplant Research