Myelodysplastic Syndromes Clinical Trial
Official title:
A PHASE I TRIAL OF ALLOREACTIVE NK CELLS INFUSION FOLLOWING TRANSPLANTATION OF HAPLOTYPE MISMATCHED, KIR MISMATCHED HIGHLY PURIFIED CD34 CELLS IN PATIENTS WITH ADVANCED OR REFRACTORY MYELOID MALIGNANCIES
Verified date | August 2015 |
Source | Indiana University |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Food and Drug Administration |
Study type | Interventional |
The purpose of this study is to determine the maximum tolerated dose of alloreactive NK cells that can be transfused following stem cell transplant.
Status | Terminated |
Enrollment | 1 |
Est. completion date | December 2010 |
Est. primary completion date | April 2010 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 65 Years |
Eligibility |
Inclusion Criteria: - Patients must have histologically documented AML, ALL, MDS, CML, - Identification of haploidentical donor - LVEF > 45% corrected - DLCO > 50% predicted - Serum Creatinine <= 2 mg/dL - Bilirubin < 2 x ULN - AST, ALT < 2 x ULN - Age = 65 years - Performance Status 0-1 Exclusion Criteria: - Patients relapsing <6 months after autologous SCT are not eligible. - Patients with active infections requiring oral or intravenous antibiotics are not eligible for enrollment until resolution of infection - No HIV disease - Non-pregnant and non-nursing |
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Indiana University Cancer Center | Indianapolis | Indiana |
Lead Sponsor | Collaborator |
---|---|
Indiana University School of Medicine |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Investigate the maximum-tolerated dose (MTD) of highly-purified alloreactive NK cells infused following haplotype-mismatched, KIR ligand-mismatched transplants in patients with refractory hematological malignancies. | through Day 128 | Yes | |
Secondary | Assess toxicity associated with the infusion of alloreactive NK cells | through Day 128 | Yes | |
Secondary | Assess the risk of acute and chronic GvHD following infusion of alloreactive NK cells. | through Day 128 | No | |
Secondary | Assess the feasibility of multiple harvesting and purifying NK cells to the relatively high-doses. | through Day 128 | No | |
Secondary | Describe the frequency and type of infections occurring within the first year following transplantation. | through Day 128 | No | |
Secondary | Describe immune reconstitution following transplantation. | through Day 128 | No |
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