Allogeneic Transplantation Using Total Lymphoid Irradiation (TLI) and Anti-Thymocyte Globulin (ATG) for Older Patients With Hematologic Malignancies
Blood Cancer, Leukemia
About this trial
This is an interventional treatment trial for Blood Cancer
Eligibility Criteria
INCLUSION CRITERIA: Any patient with one of the following hematolymphoid malignancies or syndromes in whom allogeneic hematopoietic stem cell transplant (HST) is warranted. Specific disease categories include: Indolent advanced stage non-Hodgkin lymphomas Mantle cell lymphoma Chronic lymphocytic leukemia Hodgkin disease (Hodgkin's lymphoma) Acute leukemias in complete remission Aplastic anemia Paroxysmal nocturnal hemoglobinuria Myelodysplastic or myeloproliferative syndromes. Other selected malignancies/disorders may also be considered but must be approved by the transplant team and the Principal Investigator. Age > 50 years, or if < 50 years of age, considered to be at high risk for regimen-related toxicity associated with conventional myeloablative transplants due to pre-existing medical conditions or prior therapy. A fully human leukocyte antigen (HLA)-identical sibling or matched unrelated donor is available. Potential participants with one antigen mismatched donors can be considered but only after discussion with the transplant team and the Principal Investigator. Participant must be competent to give consent. EXCLUSION CRITERIA: Progressive hematolymphoid malignancies despite conventional therapies, or acute leukemias not in complete remission. Uncontrolled central nervous system (CNS) involvement with disease Fertile men or women unwilling to use contraceptive techniques during and for 12 months following treatment Pregnant Cardiac ejection fraction < 30% Uncontrolled cardiac failure Pulmonary diffusing capacity (DLCO) < 40% predicted Elevation of bilirubin to > 3 mg/dL Transaminases > 4 x the upper limit of normal Creatinine clearance < 50 cc/min (24-hour urine collection) Karnofsky performance score < 60% Poorly controlled hypertension on multiple antihypertensives Documented fungal disease that is progressive despite treatment HIV-positive. Other viral infections, ie, Hepatitis B- and C- positive, evaluated on a case-by-case basis Psychiatric disorders or psychosocial problems which in the opinion of the primary physician or Principal Investigator would place the patient at unacceptable risk from this regimen.
Sites / Locations
- Stanford University School of Medicine
Arms of the Study
Arm 1
Experimental
Non-myeloablative transplantation
Pre-transplant total lymphoid irradiation (TLI) and anti-thymocyte globulin (ATG) infusion with Day 0 allogeneic hematopoietic cell transplant (HCT), followed by post-transplant immunosuppression by cyclosporine and mycophenolate mofetil.