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

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.