Bulk Versus Fractionated Stem Cell Infusions in Patients With Hematologic Malignancies Undergoing Stem Cell Transplantation

This is a complex study that involves various interventions, Intervention #1: Donor Initial
Stem Cell Collection; Intervention #2: Stem Cell Product Initial Processing Orders;
Intervention #3 Patient Admission and Transplantation; Intervention #4: Stem cell infusion;
Intervention #5: Post infusion follow up; Intervention #6: Off Study Patient and Donor
Evaluation.

Patients whose donor fails to collect the appropriate number of cells will receive all their
cells as a bulk infusion. These patients will continue to receive a transplant on protocol
but will be replaced until both arms have reached the target accrual.

Inclusion Criteria:

- Patients who are considered candidates for an allogeneic stem cell transplantation as
treatment for any of the following hematologic disorders:

- Acute Leukemia

- Myelodysplastic syndrome

- Other myeloproliferative disorder (i.e. myelofibrosis, chronic myelomonocytic
leukemia, or chronic myelogenous leukemia)

- Non Hodgkins Lymphoma

- Hodgkins Disease

- Multiple Myeloma

- Age includes from birth to < 75 years old.

- Patients must have a Karnofsky (adult) or Lansky (pediatric) Performance Status > 70%

- Patients must have adequate organ function measured by:

- Cardiac: asymptomatic or if symptomatic then LVEF at rest must be > 40%

- Hepatic: < 5x ULN ALT and < 1.5 total serum bilirubin, unless there is congenital
benign hyperbilirubinemia.

- Renal: serum creatinine <1.5 mg/dl or if serum creatinine is outside the normal range,
then CrCl > 40 ml/min (measured or calculated/estimated)

- Pulmonary: asymptomatic or if symptomatic, DLCO > 40% of predicted (corrected for
hemoglobin).

Exclusion Criteria:

- Female patients who are pregnant or breast-feeding.

- Active viral, bacterial or fungal infection

- Patient seropositive for HIV-I/II; HTLV -I/II

- Presence of leukemia in the CNS

- Candidate for a protocol of higher priority. For the purpose of this study, the
following protocols will be considered of higher priority: 10-051

Donor Inclusion Criteria:

- HLA compatible related or unrelated donor, (i.e. a fully matched unmanipulated grafts
or 1-2 HLA allele disparate donor for CD34 selected grafts).

- Meets criteria outlined in the FACT-approved SOP for "DONOR EVALUATION AND SELECTION
FOR ALLOGENEIC TRANSPLANTATION" in the Blood and Marrow Transplant Program Manual,
document E-1 see http://mskweb5.mskcc.org/intranet/html/80312.cfm

- Donor must have adequate peripheral venous catheter access for leukapheresis or must
agree to placement of a central catheter.

- Wt >25kg

Donor Exclusion Criteria:

- Evidence of active infection (including urinary tract infection, or upper respiratory
tract Infection) or viral hepatitis exposure (on screening), unless only HBS Ab+ and
HBV DNA negative.

- Medical or physical reason which makes the donor unlikely to tolerate or cooperate
with growth factor therapy and leukapheresis.

- Factors which place the donor at increased risk for complications from leukapheresis
or GCSF therapy (e.g., autoimmune disease, sickle cell trait, symptomatic coronary
artery disease requiring therapy).

- Pregnancy (positive serum or urine β-HCG) or breastfeeding. Women of childbearing age
must avoid becoming pregnant while on the study