Conditions: 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
Allocation: NON_RANDOMIZED | Intervention model: SINGLE_GROUP
Enrollment: 127
Healthy volunteers: no

Brief 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.

Detailed description:
The primary objective is to determine the proportion of donors whose cells can be successfully mobilized and collected with a sufficient CD34+ cell dose using plerixafor as the mobilizing agent, using an intention-to-treat analysis. Donor mobilization following plerixafor will be considered successful if ≥ 2.0x10e6 CD34+ cells/kg recipient weight are collected in no more than two leukapheresis collections.

All donors receiving plerixafor will be included in the analysis of the primary objective based on the intention-to-treat principle.Recipients will be classified into one of the two strata, myeloablative or reduced intensity, according to his/her conditioning regimen. The target enrollment is 64 donor/recipient pairs, 32 pairs per stratum.

Arms:
arm 1: Collection of sufficient CD34+ cells using plerixafor as the mobilizing agent.

Eligible donors determined according to 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 \<1.5 x institution upper limit of normal (ULN) or estimated creatinine clearance (CLCR) \>50 mL/min

Treatment Description:

* Receive subcutaneous plerixafor at 240 μg/kg and commence leukapheresis approximately 4 hours later.
* Leukapheresis will be performed up to two consecutive days. The target CD34+ cell dose is \> 4.0 x 106/kg with a minimum of \> 2.0 x 106/kg. arm 2: Patients undergoing conditioning under a myeloablative regimen

Myeloablative (one of four general regimens):

Busulfan (\> 9 mg/kg po or iv total) with fludarabine Busulfan (\> 9 mg/kg po or iv total) with cyclophosphamide Total body irradiation (\> 1000 cGy) plus etoposide Total body irradiation (\> 500 cGy) plus cyclophosphamide arm 3: Patients undergoing conditioning using a reduced intensity conditioning regimen.

Reduced Intensity (one of three general regimens):

Busulfan (\< 9 mg/kg po or iv total) plus fludarabine Melphalan (100-140 mg/m2 iv total) plus fludarabine Fludarabine plus cyclophosphamide (\> 2000 mg/m2 total)

Interventions: intervention 1: Plerixafor
Intervention descriptions: intervention 1: None

Protocol document: