Haploid Allogeneic Transplant Using the CliniMACS System

RECIPIENT INCLUSION CRITERIA

Histopathologically-confirmed diagnosis of hematological or lymphatic malignancy, defined
as one of the following:

   - Acute myeloid leukemia (AML) as primary refractory disease, or in relapse

   - Acute leukemia in first remission with poor risk factors and molecular prognosis

   - AML with -5,-7, t(6;9), tri8, -11

   - Acute lymphocytic / lymphoblastic leukemia (ALL) with Phil+ t(9;22),(q34;q11.2), and
   t(4:11)(q21;23)

   - Chronic myelogenous leukemia (CML in accelerated, second chronic phase

   - Myelodysplastic syndrome with high intermediate to high risk categories

   - Non-Hodgkin's lymphoma (NHL)

   - Chronic lymphocytic leukemia (CLL), Refractory < 50 years old at time of registration
   Donor is related Donor is genotypically-matched and haploidentical for HLA-A, B,C and
   DRB1, DQ loci Donor differs for 2 or 3 HLA alleles on the unshared haplotype in the
   GvHD direction No HLA-matched sibling or matched unrelated donor is identified ECOG
   performance status not more than 2 LVEF > 45% DLCO > 50% corrected for hemoglobin
   Serum creatinine

   - < 1.5 mg/dL OR

   - creatinine clearance > 50 mL/min for those above serum creatinine of 1.5 mg/dL serum
   bilirubin < 2.0 mg/dL ALT < 2x ULN (unless secondary to disease) Females of
   childbearing potential must have a negative serum or urine beta-HCG test within 3
   weeks of registration No prior cancer within 5 years with the exception of
   surgically-cured, non-melanoma skin cancer or in situ cancer of the cervix No prior
   myeloablative therapy or transplant Duly-executed informed consent

RECIPIENT EXCLUSION CRITERIA Suitable candidate for autologous transplantation
Participation in other investigational drugs or devices trials that might influence the
study endpoints Evidence of active hepatitis Evidence of active cirrhosis HIV-positive
History of invasive aspergillosis Presence of any other uncontrolled, active infection, ie,
bacterial, viral or fungal Uncontrolled CNS involvement Documented allergy to murine
proteins Documented allergy to iron dextran Lactating female Female of child-bearing
potential unwilling to implement adequate birth control Medical problem /
neurologic/psychiatric dysfunction which would impair his/her ability to be compliant with
the medical regimen and/or to tolerate transplantation, in the opinion of the principal
investigator Medical problem / neurologic/psychiatric dysfunction which would prolong
hematologic recovery and place the recipient at unacceptable risk, in the opinion of the
principal investigator would .

DONOR INCLUSION CRITERIA Age < 60 years Weight > 25 kg Medical history and physical
examination confirm good health status as defined by institutional standards Within 30 days
of apheresis collection, seronegative for HIV assessed as HIV Ag; HIV 1+2 Ab; or HTLV I/II
Ab Within 30 days of apheresis collection, seronegative for hepatitis assessed as HBsAg;
HBcAb (IgM and IgG); or HCV Ab Within 30 days of apheresis collection, seronegative for
syphilis assessed as RPR Genotypically haploidentical as determined by HLA typing Female
donors of child-bearing potential must have a negative serum or urine beta-HCG test within
3 weeks of mobilization Capable of undergoing leukapheresis Has adequate venous access
Willing to undergo insertion of a central catheter should leukapheresis via peripheral vein
be inadequate Agreeable to second donation of PBPC (or a bone marrow harvest) should the
recipient fail to demonstrate sustained engraftment following the transplant Duly-executed
informed consent Screened for CMV seroreactivity

   - Must be seronegative donor if recipeint is seronegative.

   - Otherwise the donor will be selected on the ability of NK cell alloreactivity based
   upon HLA typing results and donors who are capable of NK cell alloreactivity will be
   used preferentially.

DONOR EXCLUSION CRITERIA Evidence of active infection (including urinary tract infection,
or upper respiratory tract infection) Evidence of hepatitis (on screening) Medical,
physical or psychological reason which makes the donor unlikely to tolerate or cooperate
with growth factor therapy and leukapheresis Factors placing donor at increased risk for
leukapheresis or G-CSF-related complications Lactating female Female of child-bearing
potential unwilling to implement adequate birth control HIV-positive