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Phase I Dose Escalation Study With Extension of Inducible Regulatory T Cells (iTregs) in Adult Patients Undergoing Non-Myeloablative HLA Identical Sibling Donor Peripheral Blood Stem Cell Transplantation


Phase 1
18 Years
75 Years
Not Enrolling
Both
Acute Myelogenous Leukemia, Acute Lymphocytic Leukemia, Chronic Myelogenous Leukemia, Non-Hodgkin Lymphoma, Hodgkin Lymphoma, Chronic Lymphocytic Leukemia, Multiple Myeloma, Myelodysplastic Syndrome

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Trial Information

Phase I Dose Escalation Study With Extension of Inducible Regulatory T Cells (iTregs) in Adult Patients Undergoing Non-Myeloablative HLA Identical 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 but ≤ 75 years of age

- Enrolled in University Of Minnesota study MT2001-10 "Allogeneic Bone Marrow
Transplantation Using Less Intensive Therapy" and fitting into one of the following
disease categories:

- Acute myelogenous leukemia - high risk complete remission (CR1) or ≥ CR2, and in
remission by morphology as defined in MT2001-10. (Must be in remission by
morphology. Patients in morphologic relapse/ persistent disease defined as > 5%
blasts in normocellular bone marrow OR any % blasts if blasts have unique
morphologic markers (eg auer rods) or associated cytogenetic markers that allows
morphologic relapse to be distinguished are not eligible for arms 2 or 3. Note
cytogenetic evidence of disease alone without morphologic relapse is acceptable.
Also a small percentage of blasts that is equivocal between marrow regeneration
vs early relapse is acceptable provided there are no associated cytogenetic
markers consistent with relapse.)

- Acute lymphocytic leukemia - high risk CR1 or ≥CR2, and in remission by
morphology as defined in MT2001-10. (Patients in morphologic relapse/ persistent
disease defined as > 5% blasts in normocellular bone marrow OR any % blasts if
blasts have unique morphologic markers or associated cytogenetic markers that
allows morphologic relapse to be distinguished are not eligible for arms 2 or 3.
Note cytogenetic relapse or persistent disease without morphologic relapse is
acceptable. Also a small percentage of blasts that is equivocal between marrow
regeneration vs early relapse is acceptable provided there are no associated
cytogenetic markers consistent with relapse.)

- Chronic myelogenous leukemia all types except blast crisis (note treated blast
crisis in chronic phase is eligible), as defined in MT2001-10.

- Non-Hodgkin lymphoma or Hodgkin's lymphoma, as defined in MT 2001-10
(demonstrating chemosensitive disease).

- Myelodysplastic syndrome as defined in MT 2001-10. (All subtypes including
refractory anemia (RA) or all IPSS categories if severe pancytopenia,
transfusion requirements not responsive to therapy, or high risk cytogenetics.
Blasts must be less than 5%. If > 5% requires therapy (induction or
Hypomethylating agents) pre-transplant to decrease disease burden.)

- MT2001-10 identified donor is willing to consent to and undergo an additional
apheresis procedure for iTreg production

- Voluntary written consent

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Incidence of grade 3-5 infusional toxicity

Outcome Description:

Targeted adverse events and unexpected events not explained by the PBSCT or disease will be collected [(1-4 hours after the iTreg infusion and before the PBSCT at day 0) and 24 hours and 48 hours after the iTreg infusion (+/- 2 hours)]

Outcome Time Frame:

Within 48 Hours After iTregs Administration

Safety Issue:

Yes

Principal Investigator

Margaret MacMillan, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Masonic Cancer Center, University of Minnesota

Authority:

United States: Food and Drug Administration

Study ID:

2012LS019

NCT ID:

NCT01634217

Start Date:

April 2013

Completion Date:

July 2016

Related Keywords:

  • Acute Myelogenous Leukemia
  • Acute Lymphocytic Leukemia
  • Chronic Myelogenous Leukemia
  • Non-Hodgkin Lymphoma
  • Hodgkin Lymphoma
  • Chronic Lymphocytic Leukemia
  • Multiple Myeloma
  • Myelodysplastic Syndrome
  • Hodgkin Disease
  • Leukemia
  • Leukemia, Lymphocytic, Chronic, B-Cell
  • Leukemia, Lymphoid
  • Precursor Cell Lymphoblastic Leukemia-Lymphoma
  • Leukemia, Myeloid, Acute
  • Leukemia, Myeloid
  • Leukemia, Myelogenous, Chronic, BCR-ABL Positive
  • Lymphoma
  • Lymphoma, Non-Hodgkin
  • Multiple Myeloma
  • Neoplasms, Plasma Cell
  • Myelodysplastic Syndromes
  • Preleukemia

Name

Location
Masonic Cancer Center, University of Minnesota Minneapolis, Minnesota  55455