Status:
COMPLETED
Natural Killer Cells Before and After Donor Stem Cell Transplant in Treating Patients With Acute Myeloid Leukemia, Myelodysplastic Syndrome, or Chronic Myelogenous Leukemia
Lead Sponsor:
M.D. Anderson Cancer Center
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Accelerated Phase Chronic Myelogenous Leukemia, BCR-ABL1 Positive
Acute Myeloid Leukemia Arising From Previous Myelodysplastic Syndrome
Eligibility:
All Genders
2-65 years
Phase:
PHASE1
PHASE2
Brief Summary
This phase I/II studies the side effects and best dose of natural killer cells before and after donor stem cell transplant and to see how well they work in treating patients with acute myeloid leukemi...
Detailed Description
PRIMARY OBJECTIVE: I. To evaluate safety, tolerability and identify the maximum tolerated dose (MTD) of expanded natural killer (NK) cells to be used in patients with myeloid malignancies undergoing ...
Eligibility Criteria
Inclusion
- Eligibility for pediatric patients will be determined in conjunction with an MD Anderson Cancer Center (MDACC) pediatrician; patients age 2-17 years old may be enrolled after at least 4 adults (ages 18-65 years old) have been treated without toxicity
- Patient with no matched related donor who has a related haploidentical donor identified (=\< 7/8 allele match at the A, B, C, DR loci) who is willing to undergo a bone marrow harvest and an NK cell collection approximately 2 weeks of the recipient's admission for transplant; the donor must be 16 years of age or older and weigh at least 110 pounds
- Patients with one of the following diseases: acute myeloid leukemia (AML): a. first complete remission with high-risk features defined as: (i) greater than 1 cycle of induction therapy required to achieve remission; (ii) preceding myelodysplastic syndrome (MDS); (iii) presence of FLT3 mutations or internal tandem duplication or other mutations associated with poor-risk AML (e.g. DNMT3A, TET2); (iv) French-American-British Classification (FAB) M6 or M7 classification; (v) adverse cytogenetics: -5, deletion (del) 5q, -7, del7q, abnormalities involving 3q, 9q, 11q, 20q, 21q, 17, +8 or complex karyotype (\> 3 abnormalities); (vi) treatment-related AML, or b. second or greater remission; patients beyond second remission have to be in complete remission (CR) at transplant to be eligible, or c. primary induction failure with partial response to therapy who achieve adequate cytoreduction
- Patients with myelodysplastic syndromes (MDS): a. de novo MDS with intermediate or high-risk International Prognostic Scoring System (IPSS) scores; patients with intermediate-1 features should have failed to respond to hypomethylating agent therapy, or b. patients with treatment-related MDS
- Chronic myeloid leukemia (CML): a. failed to achieve cytogenetic remission or have cytogenetic relapse after treatment with at least 2 tyrosine kinase inhibitors, or b. accelerated phase or blast phase at any time
- Performance score of at least 70% by Karnofsky or 0 to 1 by Eastern Cooperative Oncology Group (ECOG) (age \>= 12 years), or Lansky Play-performance scale of at least 70% or greater (age \< 12 years)
- Serum creatinine clearance equal or more than 50 ml/min (calculated with Cockcroft-Gault formula)
- Bilirubin equal or less than 1.5 mg/dl except for Gilbert's disease
- Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) equal or less than 200 IU/ml for adults
- Conjugated (direct) bilirubin less than 2 x upper limit of normal
- Left ventricular ejection fraction equal or greater than 40%
- Diffusing capacity of the lung for carbon monoxide (DLCO) equal or greater than 50% predicted corrected for hemoglobin; for children =\< 7 years of age who are unable to perform pulmonary function tests (PFT), oxygen saturation \>= 92% on room air by pulse oximetry
- Patient or patient's legal representative, parent(s) or guardian should provide written informed consent; assent of a minor if participant's age is at least seven and less than eighteen years
Exclusion
- Human immunodeficiency virus (HIV) positive; active hepatitis B or C
- Uncontrolled infections; principal investigator (PI) is the final arbiter of this criterion
- Liver cirrhosis
- Central nervous system (CNS) involvement within 3 months
- Positive pregnancy test in a woman with child bearing potential defined as not post-menopausal for 12 months or no previous surgical sterilization
- Inability to comply with medical therapy or follow-up
Key Trial Info
Start Date :
April 22 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 28 2022
Estimated Enrollment :
54 Patients enrolled
Trial Details
Trial ID
NCT01904136
Start Date
April 22 2014
End Date
February 28 2022
Last Update
January 24 2024
Active Locations (1)
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1
M D Anderson Cancer Center
Houston, Texas, United States, 77030