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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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25 March 2013 |
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Main ID: |
NCT00697671 |
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Date of registration:
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14/04/2008 |
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Primary sponsor: |
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Public title:
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Pilot Study of Haploidentical Natural Killer Cell Infusions for Poor Prognosis Non-AML Hematologic Malignancies
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Scientific title:
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Pilot Study of Haploidentical Natural Killer Cell Infusions for Poor Prognosis Non-AML Hematologic Malignancies |
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Date of first enrolment:
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March 2007 |
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Target sample size:
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50 |
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Recruitment status: |
Active, not recruiting |
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URL:
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http://clinicaltrials.gov/show/NCT00697671 |
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Study type:
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Interventional |
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Study design:
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Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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Countries of recruitment
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United States
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Contacts
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Name:
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Wing Leung, MD, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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St. Jude Children's Research Hospital |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- At least two weeks since receipt of last biological therapy, chemotherapy, or
radiation therapy.
- Has a suitable adult family member donor available for NK cell donation.
- No current pleural or pericardial effusion.
- HIV negative
- Adequate clinical standing as evidenced by being within multiple renal, hepatic,
pulmonary, and neurological required testing parameters.
Exclusion Criteria:
- Pregnant or lactating
Age minimum:
N/A
Age maximum:
18 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Acute Lymphoblastic Leukemia
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Chronic Myelogenous Leukemia
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Juvenile Myelomonocytic Leukemia
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Myelodysplastic Syndrome
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Non-Hodgkin's Lymphoma
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Intervention(s)
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Biological: Immunotherapy
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Device: Miltenyi Biotec CliniMACS device
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Drug: Clofarabine
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Drug: Cyclophosphamide
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Drug: Etoposide
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Drug: Interleukin-2 (IL-2)
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Other: NK Cell Infusion
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Primary Outcome(s)
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To assess the safety of chemotherapy and IL-2 administration to facilitate transient NK-cell engraftment in research participants with chemotherapy refractory non-acute myelogenous leukemia (non-AML) hematologic malignancies
[Time Frame: 4 months post infusion]
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Secondary Outcome(s)
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To explore the efficacy of NK cell infusion in research participants with chemotherapy refractory hematologic malignancies
[Time Frame: 4 months infusion]
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To study the persistence, phenotype and function of donor natural killer (NK) cells after infusion in research participants with chemotherapy refractory hematologic malignancies.
[Time Frame: 4 months infusion]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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