Status:
COMPLETED
Allogeneic Transplantation Using Total Lymphoid Irradiation (TLI) and Anti-Thymocyte Globulin (ATG) for Older Patients With Hematologic Malignancies
Lead Sponsor:
Stanford University
Conditions:
Blood Cancer
Leukemia
Eligibility:
All Genders
50-70 years
Phase:
PHASE2
Brief Summary
To measure how frequently and to what degree a complication of transplant cell acute graft versus host disease (GvHD) occurs.
Detailed Description
This study evaluated whether TLI-ATG conditioning followed by allogeneic hematpoietic cell transplant (HCT), which has provided excellent overall survival for patients with relapsed lymphoma after fai...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
March 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2016
Estimated Enrollment :
303 Patients enrolled
Trial Details
Trial ID
NCT00185640
Start Date
March 1 2003
End Date
January 1 2016
Last Update
June 29 2021
Active Locations (1)
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1
Stanford University School of Medicine
Stanford, California, United States, 94305