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

Completed · Phase 1

Conditions studied: Acute Myelogenous Leukemia, Acute Lymphocytic Leukemia, Chronic Myelogenous Leukemia, Non-Hodgkin Lymphoma, Hodgkin Lymphoma, Chronic Lymphocytic Leukemia, Multiple Myeloma, Myelodysplastic Syndrome

In brief

This is a phase I single center dose escalation study with an extension at the best available dose to determine the tolerability of inducible regulatory T cells (iTregs) when given to adult patients undergoing non-myeloablative HLA-identical sibling donor peripheral blood stem cell (PBSC) transplantation for the treatment of a high risk malignancy. Up to 5 dose cohorts will be tested. Once the tolerable dose is determined for iTregs, enrollment will continue with an additional 10 patients using sirolimus/Mycophenolate mofetil (MMF) graft-versus-host disease (GVHD) prophylaxis to gain further safety information and to provide pilot data in this treatment setting.

Key facts

Study ID

NCT01634217

Run by

Masonic Cancer Center, University of Minnesota

People needed

16

Starts

2013-11-08

Expected to finish

2018-12-01

Last updated by the study team

2019-01-18

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify 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 qualify 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.

Where it is running

• Masonic Cancer Center, University of Minnesota — Minneapolis, Minnesota, United States

Full record on ClinicalTrials.gov

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