Allogeneic Transplantation Using Total Lymphoid Irradiation (TLI) and Anti-Thymocyte Globulin (ATG) for Older Patients With Hematologic Malignancies

• Status: Completed
• Trial end date: 2016-01-01
• Target enrollment: 0
• Participant gender: All

Summary

To measure how frequently and to what degree a complication of transplant cell acute graft versus host disease (GvHD) occurs.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Stanford University
• Treatments: Antilymphocyte Serum; Cyclosporine; Cyclosporins; Lenograstim; Mycophenolate mofetil; Mycophenolic Acid; Sargramostim; Thymoglobulin

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.