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 |
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.
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.
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.
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