Total Body Irradiation +/- Total Lymphoid Irradiation & Anti-Thymocyte Globulin in Non-myeloablat… (NCT03734601) | Clinical Trial Compass
CompletedPhase 2
Total Body Irradiation +/- Total Lymphoid Irradiation & Anti-Thymocyte Globulin in Non-myeloablative Hematopoietic Cell Transplantation
United States22 participantsStarted 2018-11-05
Plain-language 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)
Who can participate
Age range18 Years
SexALL
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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 un…
What they're measuring
1
Full-dose Donor Chimerism (FDC) at Day 28 Following TLI/ATG/TBI Conditioning.