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

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.