Inducible Regulatory T Cells (iTregs) in Non-Myeloablative Sibling Donor Peripheral Blood Stem Cell Transplantation

Co-enrollment in University Of Minnesota protocol MT2001-10 is required and transplantation
will be according to that protocol with iTregs administered the morning of day 0 followed no
sooner than 4 hours later by the PBSC transplantation.

Inclusion Criteria:

- 18 - 75 years of age with an HLA-identical sibling donor

- One of the following disease categories:

- Acute myelogenous leukemia - high risk CR1 (as evidenced by preceding MDS,
intermediate to high risk cytogenetics, ≥ 2 cycles to obtain CR, erythroblastic
or megakaryocytic leukemia; CR2+. All patients must be in CR as defined by
hematological recovery (ANC > 0.5x 109/L), AND <5% blasts by light microscopy
within the bone marrow with a cellularity of ≥15%.

- Acute lymphocytic leukemia - high risk CR1 [t(9;22), t (1:19), t(4;11) or other
MLL rearrangements] or >1cycle to obtain CR; CR2+. All patients must be in CR as
defined by hematological recovery (ANC > 0.5x 109/L), AND <5% blasts by light
microscopy within the bone marrow with a cellularity of ≥15%.

- Chronic myelogenous leukemia all types except blast crisis (note treated blast
crisis in chronic phase is eligible)

- Non-Hodgkin lymphoma or Hodgkin lymphoma demonstrating chemosensitive disease

- Myelodysplastic syndrome with severe pancytopenia, leading to either transfusion
dependency or increased risk for infections

- Performance status: Karnofsky ≥ 60%

- Adequate organ function within 28 days of study enrollment defined as:

- Liver: SGOT and SGPT < 5.0 x ULN; total bilirubin < 3 x ULN

- Renal: serum creatinine < 2.0 mg/dl or glomerular filtration rate (GFR) > 40
mL/min/1.73m2. Patients with a creatinine > 1.2 mg/dl or a history of renal
dysfunction must have glomerular filtration rate (GFR) > 40 mL/min/1.73m2

- Albumin: > 2.5 g/dL

- Cardiac: No decompensated CHF or uncontrolled arrhythmia; ejection fraction > 35%
within 6 weeks prior to study enrollment

- Pulmonary: No O2 requirements; DLCO > 30% predicted within 6 weeks prior to study
enrollment

- If recent mold infection (e.g. aspergillus) must have minimum of 30 days of therapy
and responsive disease and be cleared by Infectious Disease

- Sexually active females of child bearing potential and males must agree to use
effective contraception for the duration of the transplant period

- Voluntary written consent

Exclusion Criteria:

- Pregnancy or breast feeding - women of childbearing potential must have a negative
pregnancy test within 28 days of study enrollment.

- Prior myeloablative transplant within previous 3 months of study enrollment.

- Evidence of HIV infection or known HIV positive serology.

- Active serious infection.