Ex Vivo Expanded NK Cells Infusion Decrease Relapse Post Hematopoietic Stem Cell Transplantation

  • STATUS
    Recruiting
  • End date
    Dec 31, 2025
  • participants needed
    56
  • sponsor
    Sichuan University
Updated on 10 March 2022
remission
chronic myeloid leukemia
graft versus host disease
myeloid leukemia
fludarabine
mycophenolate mofetil
cyclophosphamide
lymphoma
myelodysplastic syndromes
busulfan
carbon monoxide
ejection fraction
cell transplantation
leukemia
transplant conditioning
mycophenolate

Summary

This phase I/II studies the side effects and efficacy of natural killer cells after donor stem cell transplant and to see how well they work in treating patients with myeloid malignancies, or lymphoproliferative disorders. We ex vivo expanded NK cells with a non-feeder cell regimen to avoid the risk of infusion of feeder cells with expanded NK cells. We infuse NK cells after myeloablative conditioning therapy. These cells may help in decreasing relapse of malignant disease, severe graft versus host disease, reactivation of certain viruses, and, therefore, prolonging survival of recipients.

Details
Condition Hematologic Malignancy
Treatment allogeneic hematopoietic stem cell transplantation
Clinical Study IdentifierNCT05250362
SponsorSichuan University
Last Modified on10 March 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

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 50kg
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
Lymphoma: a. refractory to or released from 1st line therapy, salvaged by 2nd line thrapy, or b. high-risk lymphoma with CR to 1st line therapy
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 Criteria

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
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