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

Completed · Phase 2

Conditions studied: Blood Cancer, Leukemia

In brief

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

Key facts

Study ID

NCT00185640

Run by

Stanford University

People needed

303

Starts

2003-03-01

Expected to finish

2016-01-01

Last updated by the study team

2021-06-29

Who can join

Age: 50 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Stanford University School of Medicine — Stanford, California, United States

Full record on ClinicalTrials.gov

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