Bulk Versus Fractionated Stem Cell Infusions in Patients With Hematologic Malignancies Undergoing Stem Cell Transplantation
Bulk Versus Fractionated Stem Cell Infusions in Patients With Hematologic Malignancies Undergoing Stem Cell Transplantation
The purpose of this study is to find out if getting a blood stem cell transplant with donor
 stem cells given over several days is better than getting a blood stem cell transplant with
 donor stem cells given over 1 day. We want to find out which procedure over will result in
 improved recovery of blood and immune function after transplant. When donor stem cells are
 given over various days in mice, the blood and immune system recovery is quicker.
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