Peripheral Blood Stem Cell Allotransplantation for Hematological Malignancies Using a Positive Stem Cell Selection Technique for T Cell Depletion, Followed by Delayed T Cell Add-Back

Inclusion Criteria

- INCLUSION CRITERIA - RECIPIENT:

Ages 10-75 years inclusive

Chronic myelogenous leukemia (CML):

- Subjects under the age of 21 in chronic phase

- Subjects ages 10-75 in chronic phase who have failed treatment with imatinib, have
intolerance to imatinib, or who did not receive imatinib at therapeutic doses within
the first 12 months from diagnosis.

- Subjects ages 10-75 in accelerated phase or blast transformation.

Acute lymphoblastic leukemia (ALL): any of these categories: ALL in first remission with
high-risk features (presenting leukocyte count greater than 100,000/cu mm, Karyotypes t9;
22, t4, t19, t11, biphenotypic leukemia) All second or subsequent remissions, primary
induction failure, partially responding or untreated relapse.

Acute myelogenous leukemia (AML): AML in first remission - except AML with good risk
karyotypes: AML M3 (t15; 17), AML M4Eo (inv 16), AML t (8; 21). All AML in second or
subsequent remission, primary induction failure and resistant relapse

Myelodysplastic syndromes (MDS): any of these categories - refractory anemia with
transfusion dependence, refractory anemia with excess of blasts, transformation to acute
leukemia, chronic myelomonocytic leukemia, atypical MDS/myeloproliferative syndromes

Myeloproliferative disorders including atypical (Ph negative) chronic myeloid and
neutrophilic leukemias, progressing myelofibrosis, and polycythemia vera, essential
thrombocythemia in transformation to acute leukemia or with progressive transfusion
requirements or pancytopenia.

Chronic lymphocytic leukemia refractory to fludarabine treatment and with bulky
progressive disease or with thrombocytopenia (less than or equal to 100,000 /microl) or
anemia (less than or equal to 10g/dl) not due to recent chemotherapy.

Non-Hodgkin's lymphoma including Mantle cell lymphoma relapsing or refractory to standard
of care treatments

Multiple myeloma, Waldenstroms macroglobulinemia, unresponsive or relapsed following
standard of care treatments.

HLA identical (6/6) related donor

For adults: Ability to comprehend the investigational nature of the study and provide
informed consent. For minors: written informed consent from one parent or guardian.
Informed oral consent from minors: the process will be explained to the minor on a level
of complexity appropriate for their age and ability to comprehend.

EXCLUSION CRITERIA - RECIPIENT: (ANY OF THE FOLLOWING)

Estimated probability of surviving less than three months

Major anticipated illness or organ failure incompatible with survival from transplant

Severe psychiatric illness. Mental deficiency sufficiently severe as to make compliance
with the transplant treatment unlikely and making informed consent impossible.

Positive pregnancy test for women of childbearing age.

HIV positive

DLCO adjusted for ventilation and hemoglobin less than 65 percent predicted

Left ventricular ejection fraction less than 40 percent

AST/SGOT greater than 10 times ULN (CTCAE grade IV v3.0)

Bilirubin greater than 5 times ULN (CTCAE grade IV v3.0)

Creatinine greater than 4.5 times ULN (CTCAE grade IV v 3.0)

Prior allogeneic stem cell transplantation.

INCLUSION CRITERIA - DONOR:

Related donor, HLA identical (6/6) with recipient

Weight greater than or equal to 18 kg

Age greater than or equal to 2 or less than or equal to 80 years old

For adults: Ability to comprehend the investigational nature of the study and provide
informed consent. For minors: Written informed consent from one parent or guardian and
informed assent: The process will be explained to the minor on a level of complexity
appropriate for their age and ability to comprehend.

EXCLUSION CRITERIA - DONOR: (ANY OF THE FOLLOWING)

Pregnant. Lactating donors permitted provide breast milk is discarded during the days that
G-CSF is given

Unfit to receive filgrastim (G-CSF) and undergo apheresis (abnormal blood counts, history
of stroke, uncontrolled hypertension)

Sickling hemoglobinopathies including HbSS, HbAS, HbSC

HIV positive donors who are positive for hepatitis B (HBV), hepatitis C (HCV) or human
T-cell lymphotropic virus (HTLV-I/II) will be used at the discretion of the investigator
following counseling and approval from the recipient

Severe psychiatric illness. Mental deficiency sufficiently severe as to make compliance
with the BMT treatment unlikely, and making informed consent impossible