Status:
COMPLETED
Alloreactive NK Cells for Allogeneic Stem Cell Transplantation for Acute Myeloid Leukemia (AML) and Myelodysplastic Syndrome (MDS)
Lead Sponsor:
M.D. Anderson Cancer Center
Conditions:
Myelodysplastic Syndrome
Leukemia
Eligibility:
All Genders
Up to 70 years
Phase:
PHASE1
Brief Summary
The goal of this clinical research study is to determine the safety and effects of giving a special kind of immune cells called "alloreactive natural killer (NK) cells" with high dose chemotherapy and...
Detailed Description
NK cells are part of the immune system (the cells in your body that fight disease). Sometimes, NK cells react against and fight leukemia cells that are mismatched with your body for certain HLA tissue...
Eligibility Criteria
Inclusion
- Patients with age \</= 70 years with one of of the following: Acute myeloid leukemia past first remission, in first or subsequent relapse, in second or greater remission or primary induction failure; Myelodysplastic syndromes with intermediate or high risk IPSS score; CML which has progressed to accelerated phase or blast crisis despite imatinib treatment
- Patients must have an HLA matched (HLA A, B, C, DR) related or unrelated donor willing to donate for allogeneic peripheral blood progenitor cell transplantation. (Recent large analyses of the National Marrow Donor Program indicate that a mis-match at the DQ locus has no adverse effect on outcome. The current national standard of care is to consider only these 4 loci in identifying suitably "matched" donors.)
- Patients must have a haploidentical relative who is predicted to be alloreactive based upon the presence of the relevant KIR genes and incompatibility with the recipient for HLA C and Bw antigens.
- Zubrod performance status \</= 2.
- Left ventricular ejection fraction \>/= 45%. No uncontrolled arrhythmias or uncontrolled symptomatic cardiac disease.
- No symptomatic pulmonary disease. forced expiratory volume at one second (FEV1), forced vital capacity (FVC) and diffusing capacity of lung for carbon monoxide (DLCO) \>/= 50% of expected, corrected for hemoglobin.
- Serum creatinine \</= 1.8mg%.
- Serum glutamate pyruvate transaminase (SGPT) \</= 200 IU/ml unless related to patients malignancy.
- Bilirubin \</= 1.5 mg/dl (unless Gilbert's syndrome).No evidence of chronic active hepatitis or cirrhosis. If positive hepatitis serology, discuss with Study Chairman and consider liver biopsy.
- Patient or patient's legal representative, parent(s) or guardian able to sign informed consent.
- No known allergy to mouse proteins or monoclonal antibodies
Exclusion
- Uncontrolled infection, not responding to appropriate antimicrobial agents after seven days of therapy. The Protocol PI is the final arbiter of eligibility.
- Pleural/pericardial effusion or ascites estimated to be \>1L.
- HIV-positive.
- Pregnancy: Positive Beta Human Chorionic Gonadotropin (HCG) test in a woman with child bearing potential defined as not post-menopausal for 12 months or no previous surgical sterilization.
- Known allergy to mouse proteins.
- Patient has received other systemic chemotherapeutic drugs (including Mylotarg) within 14 days prior to trial enrollment or has unresolved grade \>1 toxicity from prior chemotherapy treatment. (Hydroxyurea or low dose ara-c less than or equal to 20 mg/m2/d is permitted if indicated to control induction refractory disease, and IT chemotherapy is allowed if indicated as maintenance treatment for previously diagnosed lumbar microdiscectomy (LMD), that is in remission prior to enrollment on this study).
Key Trial Info
Start Date :
May 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2014
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT00402558
Start Date
May 1 2006
End Date
April 1 2014
Last Update
May 8 2015
Active Locations (1)
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1
UT MD Anderson Cancer Center
Houston, Texas, United States, 77030