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

Not Recruiting

Trial ID: NCT03734601


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
Robert Lowsky

Professor of Medicine (Blood and Marrow Transplantation and Cellular Therapy)

Lori Muffly
Lori Muffly

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: 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

New Trial Alerts