Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Masonic Cancer Center, University of Minnesota
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.
Age
18–75
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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
You may not be if
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.
Clareo Health | Inducible Regulatory T Cells (iTregs) in Non-Myeloablative Sibling Donor Peripheral Blood Stem Cell Transplantation
