Plerixafor and Sargramostim (GM-CSF) for Mobilization of Allogeneic Sibling Donors

Inclusion Criteria

Donor Eligibility

• Donor is 18 to 65 years of age inclusive.
• If female and of child-bearing age, donor must be non-pregnant, not breastfeeding, and agree to use adequate contraception.
• Donor is a 6/6 HLA-matched sibling willing to donate PBSC for transplant.
• Donor has adequate cardiac function with no history of congestive heart failure and no history of atrial fibrillation or ventricular tachyarrhythmia.
• Donor has adequate renal function as defined by a calculated serum creatinine clearance of ≥56 ml/min for females and ≥64 ml/min for males.
• Donor has adequate hepatic function as defined by a total bilirubin <2x normal or absence of hepatic fibrosis/cirrhosis.
• Donor has adequate neurologic function as defined by NO evidence of a severe central or peripheral neurologic abnormality. No history of cerebrovascular accident or seizure disorder requiring anticonvulsant medication.
• Donor must be HIV-1&2 antibody and HTLV-I&II antibody sero-negative, by FDA licensed test.
• Donor must have an ECOG performance status of 0 or 1.
• Donor must demonstrate ability to be compliant with study regimen.
• Donor must not have an active infection at the time of study entry.
• Donor does not have active alcohol or substance abuse within 6 months of study entry.
• Donor is not currently enrolled on another investigational agent study.
• Donor does not have any medical condition, which, in the opinion of the clinical investigator, would interfere with his/her evaluation.
• Ability of the donor to understand and the willingness to sign a written informed consent document.

Recipient Eligibility

• Recipient must have available the successful collection of a GM-CSF + plerixafor mobilized product. When an adequate collection cannot be obtained, G-CSF will be used and some recipients may need to receive a combined product of mobilized cells with plerixafor + GM-CSF and G-CSF mobilized cells. Recipients who receive less than 2.0 X 106 CD34+ cells/kg/actual recipient weight after six days of GM-CSF and two days of IV plerixafor will not be considered "eligible" but followed per protocol for safety purposes only.
• Recipient is 18 to 65 years of age inclusive.
• Recipient is willing and has a 6/6 HLA-matched sibling willing to donate PBSC for transplant.
• Recipient must provide signed informed consent.
• If female and of child-bearing age, recipient must be non-pregnant, not breastfeeding, and using adequate contraception.
• Recipient must have one of the following diagnoses:
• Acute myelogenous leukemia (AML) in 1st or subsequent remission or in relapse,
• Acute lymphoblastic leukemia (ALL) in 1st or subsequent remission or in relapse,
• Myelodysplastic syndrome either intermediate 1 or 2, or high risk by the International Prognostic Scoring System,
• Chronic myelogenous leukemia (CML) in accelerated or second chronic phase,
• Non-Hodgkin's lymphoma (NHL) or Hodgkin's disease (HD) in 2nd or greater complete remission, partial remission, or refractory relapse,
• Chronic lymphocytic leukemia (CLL), Rai Stage 2-4, failing at least 2 prior regimens, OR
• Multiple myeloma (MM), Stage 2-3.
• Myeloproliferative disorder or neoplasm
• Recipient must have adequate cardiac function with a left ventricular ejection fraction ≥ 40%.
• Recipient must have adequate pulmonary function defined as NO severe or symptomatic restrictive or obstructive lung disease, and formal pulmonary function testing showing an FEV1 ≥50% of predicted and a DLCO ≥40% of predicted, corrected for hemoglobin.
• Recipient must have adequate renal function as defined by a serum creatinine clearance (Cockcroft-Gault equation)of ≥56 ml/min for females and ≥64 ml/min for males of normal
• Recipient must have adequate hepatic function as defined by a total bilirubin <2x normal or absence of hepatic fibrosis/cirrhosis.
• Recipient must have adequate neurologic function as defined by NO evidence of a severe central or peripheral neurologic abnormality. Patients