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



Status:Completed
Conditions:Cancer, Blood Cancer, Hematology, Leukemia
Therapuetic Areas:Hematology, Oncology
Healthy:No
Age Range:50 - 70
Updated:10/5/2017
Start Date:March 2003
End Date:January 2016

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Allogeneic Hematopoietic Cell Transplantation Using a Non-Myeloablative Preparative Regimen of Total Lymphoid Irradiation and Anti-Thymocyte Globulin for Older Patients With Hematologic Malignancies

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

This study will evaluate if TLI-ATG conditioning followed by allogeneic hematpoietic cell
transplant (HCT), which has provided excellent overall survival for patients with relapsed
lymphoma after failed autologous HCT, provides a similar benefit in the setting of elderly
patients with hematologic malignancies.

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.
We found this trial at
1
site
291 Campus Dr
Stanford, California 94305
(650) 725-3900
Stanford University School of Medicine Vast in both its physical scale and its impact on...
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Stanford, CA
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