Randomized Phase II Trial of Bulk Versus Fractionated Stem Cell Infusions in Patients With Hematologic Malignancies Undergoing Stem Cell Transplantation
- Patients who are considered candidates for an allogeneic stem cell transplantation as
treatment for any of the following hematologic disorders:
- Acute Myeloid Leukemia
- Myelodysplastic syndrome
- Other myeloproliferative disorder (i.e. myelofibrosis, chronic myelomonocytic
leukemia, or chronic myelogenous leukemia)
- Acute Lymphoblastic 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
- 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
- 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, 08-008.
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
- 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