Symptoms and General Pathology

All Conditions

Neoplasms

Blood and Lymph Conditions

Immune System Diseases

Heart and Blood Diseases

Infections

Rare Diseases

Syndrome

Leukemia

Leukemia, Myeloid

Leukemia, Myeloid, Acute

Preleukemia

Myelodysplastic Syndromes

Precursor Cell Lymphoblastic Leukemia-Lymphoma

Leukemia, Lymphoid

Lymphoma

Multiple Myeloma

Neoplasms, Plasma Cell

Hematologic Neoplasms

Leukemia, Lymphocytic, Chronic, B-Cell

Leukemia, Myelogenous, Chronic, BCR-ABL Positive

Lymphoma, Mantle-Cell

Lymphoma, Follicular

Lymphoma, B-Cell, Marginal Zone

Graft vs Host Disease

Hodgkin Disease

Leukemia, Prolymphocytic

Lymphoma, B-Cell

Burkitt Lymphoma

Waldenstrom Macroglobulinemia

Neoplasms by Histologic Type

Lymphoproliferative Disorders

Lymphatic Diseases

Immunoproliferative Disorders

Hematologic Diseases

Hemostatic Disorders

Blood Coagulation Disorders

Vascular Diseases

Paraproteinemias

Blood Protein Disorders

Hemorrhagic Disorders

Lymphoma, Non-Hodgkin

Bone Marrow Diseases

Leukemia, B-Cell

Chronic Disease

Disease Attributes

Myeloproliferative Disorders

Communicable Diseases

Epstein-Barr Virus Infections

Virus Diseases

Herpesviridae Infections

DNA Virus Infections

Tumor Virus Infections

Myeloid Leukemia

Acute Myeloid Leukemia

Acute Non Lymphoblastic Leukemia

B-cell Lymphoma

Acute Lymphoblastic Leukemia

Lymphoblastic Lymphoma

Chronic Graft Versus Host Disease

Lymphosarcoma

Chronic Lymphocytic Leukemia

Chronic Myeloid Leukemia

Mantle Cell Lymphoma

Follicular Lymphoma

Marginal Zone Lymphoma

Homologous Wasting Disease

Hodgkin Lymphoma

Acute Graft Versus Host Disease

Chronic Myeloproliferative Disorders

Antineoplastic Agents

Antirheumatic Agents

All Drugs and Chemicals

Anti-Infective Agents

Cyclophosphamide

Fludarabine

Fludarabine phosphate

Mycophenolic Acid

Sirolimus

Allopurinol

The Treg cell infusion is given no sooner than 1 hour, but within 24 hours after the 2nd cord blood infusion

Allopurinol on day -7 to day 0 Cyclophosphamide 50 mg/kg IV over 2 hours on day -6 Fludarabine 30mg/m2 IV over 1 hour on day -6, -5, -4, -3, and -2 Total Body Irradiation 200 cGy as a single dose

Sirolimus 8mg-12mg oral loading dose followed by single dose 4mg/day. Levels are to be monitored 3 times/week in the first week, weekly until day +60, and as clinically indicated until day +100 post-transplantation.

Mycophenolate Mofetil (MMF) 3 gram/day IV/PO divided in 2 or 3 doses. Stop MMF at day +30 or 7 days after neutrophil recovery, whichever day is later, if no acute GVHD.

DUCBT followed Tregs - double umbilical cord blood transplant (FIRST) followed by the Treg cell infusion (SECOND) no sooner than 1 hour, but within 24 hours after the 2nd cord blood infusion.

Infusion of Treg

Claudio Brunstein, MD, PhD

This is a single center pilot study of a non-myeloablative umbilical cord blood transplant for the treatment of a hematological malignancy with a single infusion of T regulatory (Treg) given shortly after UCB transplantation.

Adoptive TReg Cell for Suppression of aGVHD After UCB HSCT for Heme Malignancies

Adoptive Transfer of T Regulatory Cell for Suppression of Acute Graft-vs-Host-Disease After an Umbilical Cord Blood Transplant for Hematologic Malignancies

Count of patients who survived 2 years post intervention

Evaluated with descriptive statistics and plots or cumulative incidence curves if enough evaluable patients are available for time-to-event endpoints.

The proportion of patients with detectable Treg cells at day 14 post infusion

The proportion of patients with immune reconstitution. Continuous endpoints will be described by medians, ranges and interquartile ranges as well as means and standard deviations if normally distributed.

Length of Treg survival after infusion of Treg.

The incidence of chimerism in patients treated

The probability of survival, one year post-treatment

The incidence of neutrophil recovery, that is return of neutrophil counts to ≥ 5 X 10\^8/L in treated patients

The incidence of platelet recovery (return of platelet counts to \> 20,000/μL) in treated patients

The incidence of chronic GVHD in treated patients after one year

Masonic Cancer Center, University of Minnesota

Treg Infusion

Age, Categorical

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

United States

Region of Enrollment

Claudio Brunstein

Number of Participants Survived

Number of Participants With Grade II-IV aGVHD

Number of Participants Experiencing Treatment Related Mortality (TRM)

Number of Participants Who Experienced Relapse

Number of Participants With Incidence of Bacterial, Viral and Fungal Infections

Samples were not analyzed, and so data not available for reporting.

Number of Participant With Detectable Treg Cells at d14

Number of Participants With Immune Reconstitution

Number of Participants Experiencing Treg Cell Infusion Toxicity

Length of Treg Survival

Percentage of Donor Cell Chimerism

Number of Participants Survived One Year Post-transplant

Number of Participants With Neutrophil Recovery

Number of Participants With Platelet Recovery

Number of Participants With Chronic GVHD

Overall Study

Spots Global Cancer Trial Database for Adoptive TReg Cell for Suppression of aGVHD After UCB HSCT for Heme Malignancies

Trial Identification

Conditions

Interventions

Study Description

Keywords

Eligibility

Locations

Contact Details

Useful links and downloads for this trial