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

Trial ID or NCT#

NCT00185640

Status

not recruiting iconNOT RECRUITING

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

Eligibility Criteria

Ages Eligible for Study: 50 to 70
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No
Inclusion Criteria:
  1. * 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:
  2. * 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.
    1. EXCLUSION CRITERIA:
  3. * 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.
Exclusion Criteria:
  1. * 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.
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Investigator(s)

Robert Lowsky
Robert Lowsky
Blood and marrow transplant specialist, Hematologist, Blood and marrow transplant specialist
Professor of Medicine (Blood and Marrow Transplantation and Cellular Therapy)
Sally Arai
Sally Arai
Blood and marrow transplant specialist, Hematologist, Blood and marrow transplant specialist
Professor of Medicine (Blood and Marrow Transplantation and Cellular Therapy)
Wen-Kai Weng, MD, PhD
Wen-Kai Weng, MD, PhD
Blood and marrow transplant specialist, Blood and marrow transplant specialist, Lymphoma specialist, Medical oncologist, Multiple myeloma specialist
Professor of Medicine (Blood and Marrow Transplantation and Cellular Therapy)

Contact us to find out if this trial is right for you.

Contact

Physician Referrals
650-723-0822

View on ClinicalTrials.gov