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Trial ID: NCT03734601
Very Low-dose Total Body Irradiation in Combination With Total Lymphoid Irradiation and Anti-Thymocyte Globulin to Improve Donor Engraftment in Patients Undergoing Non-Myeloablative Hematopoietic Cell Transplantation
Professor of Medicine (Blood and Marrow Transplantation and Cellular Therapy)
Associate Professor of Medicine (Blood and Marrow Transplantation and Cellular Therapy)
- 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
- 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.
- 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%
radiation: Total body irradiation (TBI)
drug: Anti-thymocyte globulin (ATG)
drug: Mycophenolate mofetil (MMF)
radiation: Total lymphoid irradiation (TLI)
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