Expired Study
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Stanford, California 94305


Purpose:

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


Study summary:

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.


Criteria:

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.


NCT ID:

NCT00185640


Primary Contact:

Principal Investigator
Robert Lowsky
Stanford University


Backup Contact:

N/A


Location Contact:

Stanford, California 94305
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: October 09, 2019

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