A Phase II Study Evaluating the Safety and Efficacy of Subcutaneous Plerixafor
Condition: Related Donors Donating Peripheral Blood Stem Cells (PBSC) to a Family Member; Acute Myelogenous Leukemia; Acute Lymphoblastic Leukemia; Myelodysplastic Syndrome; Chronic Myelogenous Leukemia; Non-Hodgkin's Lymphoma; Hodgkin's Disease; Chronic Lymphocytic Leukemia
MeSH terms: Leukemia; Precursor Cell Lymphoblastic Leukemia-Lymphoma; Leukemia, Lymphocytic, Chronic, B-Cell; Leukemia, Myeloid; Leukemia, Myelogenous, Chronic, BCR-ABL Positive; Leukemia, Myeloid, Acute; Hodgkin Disease; Myelodysplastic Syndromes
Intervention: Plerixafor
Intervention MeSH terms: Plerixafor
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 127.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No

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.
    

Eligibility criteria:

        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 aspartate aminotransferase (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 central nervous system (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.