NCT05350163 · REGISTRY CONDITION SEARCH

T-cell Receptor α/β Depleted Donor Lymphocyte Infusion

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

Phase: PHASE1
Status at capture: TERMINATED
Registry last update: 2024-12-10

This pilot study is being conducted to treat patients who have a certain type of malignancy (lymphoid or myeloid) with immune effector cells after a T-cell depleted allogeneic hematopoietic cell transplantation (TCD HSCT). This study is designed to see whether an investigational cellular product of immune cells obtained from a donor's cells that have been treated so that the type of cells that can lead to graft vs host disease have been removed can be safely administered. These cell products are administered following the initial stem cell transplant to assess the effect and improvement on minimal residual disease status, infectious complication, progression-free and overall survival.

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

Incidence of Treatment-emergent Serious Adverse Events (TE-SAEs)

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outcome · POSTED

Number of Participants in Remission

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outcome · POSTED

Number of Participants With Transplant-associated Viral Complications

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outcome · POSTED

Disease Free Survival- Measured by Absence of Relapse/Recurrence or Death.

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outcome · POSTED

Overall Survival

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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: * Patients with hematologic malignancies that are candidates CD34+ selected, T-cell depleted allogeneic hematopoietic stem cell transplantation. * Patients must have a Karnofsky (adult) Performance Status of at least 70%. * Patients must have adequate organ function measured by: * Cardiac: asymptomatic or if symptomatic then left ventricular ejection fraction (LVEF) at rest must be 50% and must improve with exercise. * Hepatic: \< 3x upper limit of normal (ULN) AST and \< 1.5 mg/dL total serum bilirubin, unless there is congenital benign hyperbilirubinemia. Patients with higher bilirubin levels due to causes other than active liver disease is also eligible with Pl approval (e.g., patients with PNH, Gilbert's disease or other hemolytic disorders). * Renal: serum creatinine: ≤ 1.2 mg/dL or if serum creatinine is outside the normal range, then creatinine clearance (CrCl) \> 40 mL/min (measured or calculated/estimated). * Pulmonary: asymptomatic or if symptomatic, diffusing capacity of the lungs for carbon monoxide (DLCO) 50% of predicted (corrected for hemoglobin). * Each patient must be willing to participate as a research subject and must sign an informed consent form. Exclusion Criteria: * Patients with active acute GvHD.
healthy Volunteers: false
maximum Age: 74 Years
minimum Age: 18 Years
sex: ALL
std Ages: ADULT
OLDER_ADULT

Treatment arms and interventions

arm Groups

description
5 x 10\^5/kg at 6-7 weeks post-transplant (Group A), 4-5 weeks post-transplant (Group B), or 2-3 weeks post-transplant (Group C)
intervention Names
Biological: T-cell Receptor α/β Depleted Donor Lymphocyte Infusions
label
HLA Matched Cohort I
type
EXPERIMENTAL
description
5 x 10\^5/kg starting time point X (whichever was safest as determined by Matched Cohort I), 1 x 10\^6/kg 3-4 weeks after first dose, and 1 x 10\^6/kg 3-4 weeks after second dose
intervention Names
Biological: T-cell Receptor α/β Depleted Donor Lymphocyte Infusions
label
HLA Matched Cohort II
type
EXPERIMENTAL
description
5 x 10\^5/kg starting time point X (whichever was safest as determined by Matched Cohort I), 1 x 10\^6/kg 3-4 weeks after first dose, and 2 x 10\^6/kg 3-4 weeks after second dose
intervention Names
Biological: T-cell Receptor α/β Depleted Donor Lymphocyte Infusions
label
HLA Matched Cohort III
type
EXPERIMENTAL
description
1 x 10\^5/kg at 6-7 weeks post-transplant (Group A), 4-5 weeks post-transplant (Group B), or 2-3 weeks post-transplant (Group C)
intervention Names
Biological: T-cell Receptor α/β Depleted Donor Lymphocyte Infusions
label
HLA Mismatched Cohort I
type
EXPERIMENTAL
description
1 x 10\^5/kg starting time point Y (whichever was safest as determined by Mismatched Cohort I), 5 x 10\^5/kg 3-4 weeks after first dose, and 5 x 10\^5/kg 3-4 weeks after second dose
intervention Names
Biological: T-cell Receptor α/β Depleted Donor Lymphocyte Infusions
label
HLA Mismatched Cohort II
type
EXPERIMENTAL
description
1 x 10\^5/kg starting time point Y (whichever was safest as determined by Mismatched Cohort I), 5 x 10\^5/kg 3-4 weeks after first dose, and 1 x 10\^6/kg 3-4 weeks after second dose
intervention Names
Biological: T-cell Receptor α/β Depleted Donor Lymphocyte Infusions
label
HLA Mismatched Cohort III
type
EXPERIMENTAL

interventions

arm Group Labels
HLA Matched Cohort I
HLA Matched Cohort II
HLA Matched Cohort III
HLA Mismatched Cohort I
HLA Mismatched Cohort II
HLA Mismatched Cohort III
description
T-cell Receptor α/β Depleted Donor Lymphocyte Infusions following CD34+-selected Allogeneic Stem Cell Transplantation from Related and Unrelated Donors for Patients
name
T-cell Receptor α/β Depleted Donor Lymphocyte Infusions
type
BIOLOGICAL

Study design

allocation

NON_RANDOMIZED

intervention Model

PARALLEL

intervention Model Description

The model is both parallel and sequential, in that Matched and Mismatched strata run in parallel and independently. Within each stratum, Cohorts I-III are filled sequentially. In addition, Cohort I of each stratum has three groups (A-C) that are filled sequentially.

masking Info

masking: NONE

primary Purpose

TREATMENT

Enrollment

count: 11
type: ACTUAL

Registered outcome plans (not posted results)

primary Outcomes

description
TE-SAEs are defined as the composite of death, non-fatal pulmonary embolism, stroke, acute graft versus host disease (GvHD), and clinically significant laboratory test abnormalities.
measure
Incidence of Treatment-emergent Serious Adverse Events (TE-SAEs)
time Frame
30 days post-infusion

secondary Outcomes

description
Remission - measured by absence of signs and symptoms
measure
Number of Participants in Remission
time Frame
2 years
description
Transplant-associated viral complications - measured by viral infections associated with transplant
measure
Number of Participants With Transplant-associated Viral Complications
time Frame
2 years
description
Disease free survival - measured by (absence of ) relapse/recurrence or death. Relapse and recurrence, both will be measured by greater than 5% circulating leukemic blasts in the marrow or peripheral blood and/or the presence of blasts in any extra medullary site and/or disease determined by clinical assessment.
measure
Disease Free Survival- Measured by Absence of Relapse/Recurrence or Death.
time Frame
2 years
description
Overall survival - measured by death
measure
Overall Survival
time Frame
2 years

Full study description

brief Summary: This pilot study is being conducted to treat patients who have a certain type of malignancy (lymphoid or myeloid) with immune effector cells after a T-cell depleted allogeneic hematopoietic cell transplantation (TCD HSCT). This study is designed to see whether an investigational cellular product of immune cells obtained from a donor's cells that have been treated so that the type of cells that can lead to graft vs host disease have been removed can be safely administered. These cell products are administered following the initial stem cell transplant to assess the effect and improvement on minimal residual disease status, infectious complication, progression-free and overall survival.

Source references

references

citation
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