Expired Study
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New York, New York 10065


Purpose:

This study will see if the researchers can lower that risk by giving the patient Palifermin. This drug helps protect the lining of the mouth, throat, and stomach. These areas typically get sores or ulcers while the blood cell counts are very low. The patient can get infections in or from these sores. Palifermin might also help the immune system recover faster. It is currently approved for patients who receive their own stem cells. That is called an autologous transplant. This study will test the use of Palifermin for T-cell depleted allogeneic stem cell transplants.


Criteria:

Inclusion Criteria: - Patients should be < 65 years. Patients > or equal to 65 years will be accrued on a case by case basis after discussion and approval by the BMT Service. - Patients may be of either gender or any ethnic background. - Patients must have a Karnofsky or Lansky Performance Status > or equal to 70%. - Patients must have adequate organ function measured by: * Cardiac: asymptomatic or if symptomatic then LVEF at rest must be > or equal to 50% and must improve with exercise. - Hepatic: < 3x ULN ALT and < 1.5 total serum bilirubin, unless there is congenital benign hyperbilirubinemia. - Renal: serum creatinine < than or equal to 1.2 mg/dl or if serum creatinine is outside the normal range, then CrCl > 60-ml/min/1.73 m2 - Pulmonary: asymptomatic or if symptomatic, DLCO > 50% of predicted (corrected for hemoglobin) - Each patient must be willing to participate as a research subject and must sign an informed consent form. - Parent or legal guardians of patients who are minors will sign the informed consent form. Exclusion Criteria: - Active CNS or skin leukemic involvement - Female patients who are pregnant or breast-feeding - Active viral, bacterial or fungal infection - Patient seropositive for HIV-I/II; HTLV -I/II - Patients who have undergone a prior allogeneic or autologous stem cell transplant within the previous six months. - Patients who have had a previous malignancy that is not in remission.


NCT ID:

NCT00629798


Primary Contact:

Principal Investigator
Roni Tamari, MD
Memorial Sloan Kettering Cancer Center


Backup Contact:

N/A


Location Contact:

New York, New York 10065
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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