Education and Training
Total Body Irradiation +/- Total Lymphoid Irradiation & Anti-Thymocyte Globulin in Non-myeloablative Hematopoietic Cell Transplantation
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)
Stanford is currently not accepting patients for this trial.
Stanford Investigator(s):
Intervention(s):
- radiation: Total body irradiation (TBI)
- drug: Anti-thymocyte globulin (ATG)
- drug: Tacrolimus
- drug: Mycophenolate mofetil (MMF)
- radiation: Total lymphoid irradiation (TLI)
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%
Ages Eligible for Study
18 Years - N/A
Genders Eligible for Study
All
Not currently accepting new patients for this trial
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
Sivan Yani
Not Recruiting