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.