Non Hodgkin Lymphoma Clinical Trial

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

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)

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Full 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.

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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%

Study is for people with:

Non Hodgkin Lymphoma

Phase:

Phase 2

Estimated Enrollment:

22

Study ID:

NCT03734601

Recruitment Status:

Completed

Sponsor:

Stanford University

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There is 1 Location for this study

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Stanford University School of Medicine
Stanford California, 94305, United States

How clear is this clinincal trial information?

Study is for people with:

Non Hodgkin Lymphoma

Phase:

Phase 2

Estimated Enrollment:

22

Study ID:

NCT03734601

Recruitment Status:

Completed

Sponsor:


Stanford University

How clear is this clinincal trial information?

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