NCT02991898 · REGISTRY CONDITION SEARCH

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

Found through the registry condition index, not selected as a treatment recommendation. This discovery collection was restricted to studies with posted results.

Phase: PHASE2
Status at capture: TERMINATED
Registry last update: 2020-09-29

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.

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

flow

Participant flow

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baseline

Baseline characteristics

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outcome · POSTED

Number of Participants Survived

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outcome · POSTED

Number of Participants With Grade II-IV aGVHD

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outcome · POSTED

Number of Participants Experiencing Treatment Related Mortality (TRM)

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outcome · POSTED

Number of Participants Who Experienced Relapse

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outcome · POSTED

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

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outcome · POSTED

Number of Participant With Detectable Treg Cells at d14

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outcome · POSTED

Number of Participants With Immune Reconstitution

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outcome · POSTED

Number of Participants Experiencing Treg Cell Infusion Toxicity

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outcome · POSTED

Length of Treg Survival

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outcome · POSTED

Percentage of Donor Cell Chimerism

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outcome · POSTED

Number of Participants Survived One Year Post-transplant

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outcome · POSTED

Number of Participants With Neutrophil Recovery

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outcome · POSTED

Number of Participants With Platelet Recovery

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outcome · POSTED

Number of Participants With Chronic GVHD

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adverse events

Adverse events

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more info

Limitations, agreements, and source contact

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Who could take part

eligibility Criteria: Inclusion Criteria: * Must be ≥18, but \< 70 years of age with no matched 7/8 or 8/8 sibling donor - patients ≥ 70 and ≤ 75 years of age may be eligible if they have a Co-Morbidity score ≤ 2 (http://www.qxmd.com/calculate-online/hematology/hct-ci) * UCB unit(s) composing the graft will be selected according to the current University of Minnesota umbilical cord blood graft selection algorithm and an additional cord blood unit to be used as the source to manufacture the Treg product. This UCB unit must be matched at 4-6/6 to the patient, considering HLA-A, B at the antigen level and DRB1 at the allele level * Acute Leukemias: Must be in remission by morphology. Also a small percentage of blasts that is equivocal between marrow regeneration versus early relapse are acceptable provided there are no associated cytogenetic markers consistent with relapse. Refer to Section 5.2 for complete definitions. * Burkitt's Lymphoma in CR2 or subsequent CR * Natural Killer Cell Malignancies * Chronic Myelogenous Leukemia: all types except refractory blast crisis. Chronic phase patients must have failed at least two different tyrosine-kinase inhibitors (TKIs), or been intolerant to all available TKIs or have T315I mutation. * Myelodysplastic Syndrome: IPSS INT-2 or High Risk; R-IPSS High or Very High; WHO classification: RAEB-1, RAEB-2; Severe Cytopenias: ANC \< 0.8, Anemia or thrombocytopenia requiring transfusion; Poor or very poor risk cytogenetics based on IPSS or R-IPSS definitions; therapy-related MDS. Blasts must be be \< 5%, preferably \< 20% blasts by morphology by bone marrow aspirate morphology.. If ≥ 5% blasts, chemotherapy for cytoreduction to \<5% blasts prior to transplantation may be considered. * Chronic myeloid neoplasms, including but not limited to CMML with blasts must around 5% blasts, preferably \< 20% blasts by morphology by bone marrow aspirate morphology. If ≥5% blasts, chemotherapy for cytoreduction to \<5% blasts prior to transplantation may be considered. * Large-Cell Lymphoma, Hodgkin Lymphoma and Multiple Myeloma with chemotherapy sensitive disease that has failed or patients who are ineligible for an autologous transplant. * Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL), Marginal Zone B-Cell Lymphoma, Follicular Lymphoma, which have progressed within 12 months of achieving a partial or complete remission. Patients who had remissions lasting \> 12 months are eligible after at least two prior therapies. Patients with bulky disease should be considered for debulking chemotherapy before transplant. Patients with refractory disease are eligible, unless has bulky disease and an estimated tumor doubling time of less than one month. * Lymphoplasmacytic Lymphoma, Mantle-Cell Lymphoma, Prolymphocytic Leukemia are eligible after initial therapy if chemotherapy sensitive. * Patients must have undergone an autologous transplant ≤ 12 months prior to transplant on this study or have received multi-agent or immunosuppressive chemotherapy within 3 months of the preparative regimen. Performance Status, Organ Function, Contraception Use * Karnofsky score ≥ 70% (Appendix II) * Adequate organ function within 14 days (30 days for cardiac and pulmonary) of registration on-study defined as: * Renal: creatinine ≤ 2.0 mg/dL, for patient with a creatinine \> 1.2 mg/dL or a history of renal dysfunction an estimated glomerular filtration rate ≥ 40 mL/min/1.73 m2 is required * ALT, AST and alkaline phosphatase ≤ 5 x upper limit of normal and total bilirubin ≤ 2.5 mg/dL except for patients with Gilbert's syndrome or hemolysis * Pulmonary function: DLCO, FEV1, FVC ≥ 40% predicted, and absence of O2 requirements. * Cardiac: Absence of decompensated congestive heart failure, or uncontrolled arrhythmia and left ventricular ejection fraction ≥ 40%. * Sexually active females of childbearing potential and males with partners of child-bearing potential must agree to use adequate birth control during study treatment. * Voluntary written consent Exclusion Criteria: * Untreated active infection * History of HIV infection * Pregnant or breast feeding. The agents used in this study may be teratogenic to a fetus and there is no information on the excretion of agents into breast milk. Females of childbearing potential must have a blood test or urine study within 14 days prior to registration to rule out pregnancy * Prior allogeneic transplantation * Less than 3 months from myeloablative conditioning for autologous transplantation (if applicable) * Evidence of progressive disease by imaging modalities or biopsy - persistent PET activity, though possibly related to lymphoma, is not an exclusion criterion in the absence of CT changes indicating progression. * CML in blast crisis * Large cell lymphoma, mantle cell lymphoma and Hodgkin disease that is progressing on salvage therapy. * Active central nervous system malignancy
healthy Volunteers: false
maximum Age: 75 Years
minimum Age: 18 Years
sex: ALL
std Ages: ADULT
OLDER_ADULT

Treatment arms and interventions

arm Groups

description
The Treg cell infusion is given no sooner than 1 hour, but within 24 hours after the 2nd cord blood infusion
intervention Names
Biological: Infusion of Treg
label
Treg Infusion
type
EXPERIMENTAL

interventions

arm Group Labels
Treg Infusion
description
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.
name
Infusion of Treg
other Names
T regulatory cells
type
BIOLOGICAL

Study design

allocation

intervention Model

SINGLE_GROUP

masking Info

masking: NONE

primary Purpose

TREATMENT

Enrollment

count: 3
type: ACTUAL

Registered outcome plans (not posted results)

primary Outcomes

description
Count of patients who survived 2 years post intervention
measure
Number of Participants Survived
time Frame
2 years

secondary Outcomes

description
Probability of grade II-IV aGVHD
measure
Number of Participants With Grade II-IV aGVHD
time Frame
Assessed weekly until day 100, then day 180, 360
description
Evaluated with descriptive statistics and plots or cumulative incidence curves if enough evaluable patients are available for time-to-event endpoints.
measure
Number of Participants Experiencing Treatment Related Mortality (TRM)
time Frame
6 months
description
Evaluated with descriptive statistics and plots or cumulative incidence curves if enough evaluable patients are available for time-to-event endpoints.
measure
Number of Participants Who Experienced Relapse
time Frame
1 year
description
Evaluated with descriptive statistics and plots or cumulative incidence curves if enough evaluable patients are available for time-to-event endpoints.
measure
Number of Participants With Incidence of Bacterial, Viral and Fungal Infections
time Frame
1 year
description
The proportion of patients with detectable Treg cells at day 14 post infusion
measure
Number of Participant With Detectable Treg Cells at d14
time Frame
14 days
description
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.
measure
Number of Participants With Immune Reconstitution
time Frame
Assessed at Day 4, weekly for 8 weeks
description
Incidence of Adverse Events
measure
Number of Participants Experiencing Treg Cell Infusion Toxicity
time Frame
48 hours post infusion
description
Length of Treg survival after infusion of Treg.
measure
Length of Treg Survival
time Frame
24 hours post infusion
description
The incidence of chimerism in patients treated
measure
Percentage of Donor Cell Chimerism
time Frame
Day +100
description
The probability of survival, one year post-treatment
measure
Number of Participants Survived One Year Post-transplant
time Frame
1 year
description
The incidence of neutrophil recovery, that is return of neutrophil counts to ≥ 5 X 10\^8/L in treated patients
measure
Number of Participants With Neutrophil Recovery
time Frame
Day 42
description
The incidence of platelet recovery (return of platelet counts to \> 20,000/μL) in treated patients
measure
Number of Participants With Platelet Recovery
time Frame
1 year

Full study description

brief Summary: 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.

Source references

Source notices and limitations

Discovery and provenance

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Preserved source evidence · Not medical advice