NCT03734601 · REGISTRY CONDITION SEARCH

Total Body Irradiation +/- Total Lymphoid Irradiation & Anti-Thymocyte Globulin in Non-myeloablative Hematopoietic Cell Transplantation

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: COMPLETED
Registry last update: 2023-12-12

The purpose of this study is to evaluate whether addition of a low dose of total body irradiation (TBI) to a standard preparation for transplant \[total lymphoid irradiation (TLI) and anti-thymocyte globulin (ATG)\] conditioning will help to augment donor chimerism without reducing tolerability of this regimen or increasing the risk of graft-vs-host disease (GVHD)

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

Full-dose Donor Chimerism (FDC) at Day 28 Following TLI/ATG/TBI Conditioning.

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outcome · POSTED

Disease Progression

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outcome · POSTED

Overall Survival (OS)

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outcome · POSTED

Event-free Survival (EFS) at 1 Year

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outcome · POSTED

Non-relapse Mortality (NRM)

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outcome · POSTED

Graft vs Host Disease (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 * Has a human leukocyte antigen (HLA)-matched or single allele mismatched adult sibling donor or unrelated donor. * Acute myeloid leukemia (AML); myelodysplastic syndrome (MDS); myeloproliferative disease syndrome (MPD)\]; chronic lymphocytic leukemia (CLL); B- or T-cell non Hodgkin lymphoma (NHL); Hodgkin lymphoma (HL); or chronic myelomonocytic leukemia (CMML), suitable for treatment with allogeneic transplant after TLI and ATG reduced intensity conditioning. * Considered at high-risk for regimen-related toxicity from fully-ablative transplant conditioning (therefore reduced-intensity conditioning is recommended). * Ability to understand and the willingness to sign a written informed consent document. Patients must have signed informed consent to participate in the trial. EXCLUSION CRITERIA * Uncontrolled bacterial, viral or fungal infection defined as currently taking medication and progression of clinical symptoms. * Progressive hemato lymphoid malignancy despite conventional therapy. * Chronic myelogenous leukemia (CML). * Active CNS involvement of the underlying malignancy. * HIV positive * Pregnant or lactating * Prior malignancy (EXCEPTION: diagnosed \> 5 years ago without evidence of disease, OR treated ≤ 5 years ago but have a greater than 50% chance of life expectancy of ≥ 5 years for that malignancy). * Have a psychiatric disorder(s) or psychosocial circumstance(s) which in the opinion of the primary physician would place the patient at an unacceptable risk from transplant. * Left ventricular ejection fraction (LEVF) \< 30%, or uncontrolled cardiac failure * Diffusing capacity of lung for carbon monoxide (DLCO) \< 40% predicted * Total bilirubin \> 3 mg/dL * Serum glutamic oxaloacetic transaminase (SGOT) or serum glutamic-pyruvic transaminase (SGPT) \> 4 x upper limit of normal (ULN) * Creatinine \> 2 mg/dL and an estimated creatinine clearance \< 40 mL/min * Poorly-controlled hypertension despite multiple antihypertensive medications * Karnofsky Performance Status (KPS) \< 60%
healthy Volunteers: false
minimum Age: 18 Years
sex: ALL
std Ages: ADULT
OLDER_ADULT

Treatment arms and interventions

arm Groups

description
TBI, single exposure on Day -1, 80 centigray (cGy) in addition to total lymphoid irradiation (TLI, 120 cGy/day for 9 days, weekends excluded) and anti-thymocyte globulin (ATG) 1.5 mg/kg (conditioning regimen)
intervention Names
Radiation: Total body irradiation (TBI)
Drug: Anti-thymocyte globulin (ATG)
Drug: Tacrolimus
Drug: Mycophenolate mofetil (MMF)
Radiation: Total lymphoid irradiation (TLI)
label
TBI+TLI
type
EXPERIMENTAL

interventions

arm Group Labels
TBI+TLI
description
Administer Total body irradiation (TBI) 80 cGy on Day 1 of standard TLI ATG conditioning
name
Total body irradiation (TBI)
type
RADIATION
arm Group Labels
TBI+TLI
description
Given intravenous (IV), Dose 1.5 mg/kg x 5 days
name
Anti-thymocyte globulin (ATG)
type
DRUG
arm Group Labels
TBI+TLI
description
Oral, Dose 0.05 mg/kg twice daily, can be given intravenous (IV)
name
Tacrolimus
other Names
Fujimycin
type
DRUG
arm Group Labels
TBI+TLI
description
Given Oral, 15 mg/k every 2 hours for peripheral blood stem cells (PBSC) from matched related donors; 15 mg/kg every 8 hours for PBSC from unrelated donors (URDs) or mismatched related donors.
name
Mycophenolate mofetil (MMF)
other Names
Cellcept
MMF
type
DRUG
arm Group Labels
TBI+TLI
description
9 x 120 cGy over 11 days
name
Total lymphoid irradiation (TLI)
type
RADIATION

Study design

allocation

intervention Model

SINGLE_GROUP

masking Info

masking: NONE

primary Purpose

TREATMENT

Enrollment

count: 22
type: ACTUAL

Registered outcome plans (not posted results)

primary Outcomes

description
Subsequent to TLI/ATG/TBI conditioning, the proportion of participants with full dose donor chimerism (FDC) will be determined by Day 28. FDC is defined as achieving ≥ 95% donor type in the CD3+ lineage within 28 days of donor cell infusion, as assessed by short tandem repeat (STR) testing. The outcome will be expressed as the number of participants that achieve FDC by Day 28, a number without dispersion.
measure
Full-dose Donor Chimerism (FDC) at Day 28 Following TLI/ATG/TBI Conditioning.
time Frame
Day 28

secondary Outcomes

description
Transplant recipients will be assessed for disease progression at 1 year after hematopoietic cell transplantation (HCT). The outcome is reported as the number of transplant recipients who experienced disease progression.
measure
Disease Progression
time Frame
1 year
description
Overall survival (OS) is defined as the number of transplant recipients remaining alive at 12 months after transplant. The outcome is expressed as the number of transplant recipients who remained alive at 12 months after treatment, a number without dispersion.
measure
Overall Survival (OS)
time Frame
1 year
description
Event-free survival (EFS) is defined as the number of transplant recipients remaining alive at 12 months after transplant and who did not experience disease relapse defined as blasts \< 5%. The outcome is expressed as the number of transplant recipients remaining alive at 12 months after transplant without disease relapse, a number without dispersion.
measure
Event-free Survival (EFS) at 1 Year
time Frame
1 year
description
Non-relapse mortality (NRM) is defined as death without known disease relapse or recurrence. The outcome is expressed as the number of transplant recipients whose cause of death was not disease relapse or recurrence, a number without dispersion.
measure
Non-relapse Mortality (NRM)
time Frame
1 year
description
Recipients will be monitored for Grade 2 to 4 graft vs host disease (GvHD). The outcome is reported as the number of transplant recipients who experienced acute GvHD grades 2 to 4, the number of transplant recipients who experienced chronic and extensive GvHD. In addition, the number of transplant recipients with chronic and extensive GvHD that was refractory to treatment ("persistent") is reported. Per protocol, the result for chronic extensive and persistent GvHD is based on the subset of participants that had chronic and extensive GvHD.
measure
Graft vs Host Disease (GvHD)
time Frame
1 year

Full study description

brief Summary: The purpose of this study is to evaluate whether addition of a low dose of total body irradiation (TBI) to a standard preparation for transplant \[total lymphoid irradiation (TLI) and anti-thymocyte globulin (ATG)\] conditioning will help to augment donor chimerism without reducing tolerability of this regimen or increasing the risk of graft-vs-host disease (GVHD)
detailed Description: Primary Objective: • Determine the proportion of patients with full donor T-cell chimerism at Day 28 following hematopoietic cell transplantation. Secondary Objectives: * Determine the risk of disease progression, overall and event free survival, and non-relapse mortality, following treatment with TLI; ATG; and TBI. * Determine the incidence of acute and chronic GVHD following treatment with TLI; ATG; and TBI. Exploratory Objectives: • Determine the changes in frequency of hematopoietic stem, progenitor, and mature cell subsets and the changes in cytokine milieu and cellular architecture in the bone marrow of patients receiving TLI compared to TLI+TBI.

Source references

Source notices and limitations

Discovery and provenance

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occurrences
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exact text
NCT03734601
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query cond
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source file
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Preserved source evidence · Not medical advice