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Total Body Irradiation +/- Total Lymphoid Irradiation & Anti-Thymocyte Globulin in Non-myeloablative Hematopoietic Cell Transplantation
Not Recruiting
Trial ID: NCT03734601
Purpose
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)
Official Title
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
Stanford Investigator(s)
Robert Lowsky
Professor of Medicine (Blood and Marrow Transplantation and Cellular Therapy)
Lori Muffly
Associate Professor of Medicine (Blood and Marrow Transplantation and Cellular Therapy)
Eligibility
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%
Intervention(s):
radiation: Total body irradiation (TBI)
drug: Anti-thymocyte globulin (ATG)
drug: Tacrolimus
drug: Mycophenolate mofetil (MMF)
radiation: Total lymphoid irradiation (TLI)
Not Recruiting
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
Sivan Yani