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

Not Recruiting

Trial ID: NCT00185640

Purpose

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

Official Title

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

Stanford Investigator(s)

Robert Lowsky
Robert Lowsky

Professor of Medicine (Blood and Marrow Transplantation and Cellular Therapy)

Wen-Kai Weng, MD, PhD
Wen-Kai Weng, MD, PhD

Associate Professor of Medicine (Blood and Marrow Transplantation and Cellular Therapy) and, by courtesy, of Dermatology

Laura Johnston
Laura Johnston

Professor of Medicine (Blood and Marrow Transplantation and Cellular Therapy)

Robert Negrin
Robert Negrin

Professor of Medicine (Blood and Marrow Transplantation and Cellular Therapy)

Sally Arai
Sally Arai

Associate Professor of Medicine (Blood and Marrow Transplantation and Cellular Therapy)

Richard Hoppe
Richard Hoppe

Henry S. Kaplan-Harry Lebeson Professor of Cancer Biology

Judith Shizuru
Judith Shizuru

Professor of Medicine (Blood and Marrow Transplantation and Cellular Therapy) and of Pediatrics (Stem Cell Transplantation)

Eligibility


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.

Intervention(s):

drug: cyclosporine

drug: Anti-thymocyte globulin (ATG)

drug: Mycophenolate mofetil (MMF)

drug: Filgrastim

radiation: Total Lymphoid Irradiation (TLI)

Not Recruiting

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Physician Referrals
650-723-0822

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