A phase II clinical trial of adoptive transfer of haploidentical natural killer cells for consolidation therapy of pediatric acute myeloid leukemia.


Journal

Journal for immunotherapy of cancer
ISSN: 2051-1426
Titre abrégé: J Immunother Cancer
Pays: England
ID NLM: 101620585

Informations de publication

Date de publication:
20 03 2019
Historique:
received: 31 10 2018
accepted: 12 03 2019
entrez: 22 3 2019
pubmed: 22 3 2019
medline: 17 6 2020
Statut: epublish

Résumé

Consolidation therapies for children with intermediate- or high-risk acute myeloid leukemia (AML) are urgently needed to achieve higher cure rates while limiting therapy-related toxicities. We determined if adoptive transfer of natural killer (NK) cells from haploidentical killer immunoglobulin-like receptor (KIR)-human leukocyte antigen (HLA)-mismatched donors may prolong event-free survival in children with intermediate-risk AML who were in first complete remission after chemotherapy. Patients received cyclophosphamide (Day - 7), fludarabine (Days - 6 through - 2), and subcutaneous interleukin-2 (Days - 1, 1, 3, 5, 7, and 9). Purified, unmanipulated NK cells were infused on Day 0, and NK cell chimerism and phenotyping from peripheral blood were performed on Days 7, 14, 21, and 28. As primary endpoint, the event-free survival was compared to a cohort of 55 patients who completed chemotherapy and were in first complete remission but did not receive NK cells. Donor NK cell kinetics were determined as secondary endpoints. Twenty-one patients (median age at diagnosis, 6.0 years [range, 0.1-15.3 years]) received a median of 12.5 × 10

Identifiants

pubmed: 30894213
doi: 10.1186/s40425-019-0564-6
pii: 10.1186/s40425-019-0564-6
pmc: PMC6425674
doi:

Substances chimiques

Interleukin-2 0
Cyclophosphamide 8N3DW7272P
Vidarabine FA2DM6879K
fludarabine P2K93U8740

Banques de données

ClinicalTrials.gov
['NCT00703820']

Types de publication

Clinical Trial, Phase II Comparative Study Journal Article Research Support, N.I.H., Extramural Research Support, Non-U.S. Gov't

Langues

eng

Sous-ensembles de citation

IM

Pagination

81

Subventions

Organisme : NCI NIH HHS
ID : P30 CA021765
Pays : United States

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Auteurs

Rosa Nguyen (R)

Department of Oncology, St. Jude Children's Hospital, 262 Danny Thomas Place, Memphis, TN, 38105, USA.

Huiyun Wu (H)

Department of Biostatistics, St. Jude Children's Hospital, Memphis, TN, USA.

Stanley Pounds (S)

Department of Biostatistics, St. Jude Children's Hospital, Memphis, TN, USA.

Hiroto Inaba (H)

Department of Oncology, St. Jude Children's Hospital, 262 Danny Thomas Place, Memphis, TN, 38105, USA.

Raul C Ribeiro (RC)

Department of Oncology, St. Jude Children's Hospital, 262 Danny Thomas Place, Memphis, TN, 38105, USA.

David Cullins (D)

Department of Bone Marrow Transplantation and Cellular Therapy, St. Jude Children's Hospital, Memphis, TN, USA.

Barbara Rooney (B)

Department of Bone Marrow Transplantation and Cellular Therapy, St. Jude Children's Hospital, Memphis, TN, USA.

Teresa Bell (T)

Department of Oncology, St. Jude Children's Hospital, 262 Danny Thomas Place, Memphis, TN, 38105, USA.

Norman J Lacayo (NJ)

Lucile Packard Children's Hospital and Stanford Cancer Center, Palo Alto, CA, USA.

Kenneth Heym (K)

Cook Children's Medical Center, Fort Worth, TX, USA.

Barbara Degar (B)

Dana-Farber Cancer Institute, Boston, MA, USA.

Deborah Schiff (D)

Rady Children's Hospital, San Diego, CA, USA.

William E Janssen (WE)

Department of Bone Marrow Transplantation and Cellular Therapy, St. Jude Children's Hospital, Memphis, TN, USA.
Human Applications Laboratory, St. Jude Children's Research Hospital, Memphis, TN, USA.

Brandon Triplett (B)

Department of Bone Marrow Transplantation and Cellular Therapy, St. Jude Children's Hospital, Memphis, TN, USA.

Ching-Hon Pui (CH)

Department of Oncology, St. Jude Children's Hospital, 262 Danny Thomas Place, Memphis, TN, 38105, USA.

Wing Leung (W)

Department of Bone Marrow Transplantation and Cellular Therapy, St. Jude Children's Hospital, Memphis, TN, USA.

Jeffrey E Rubnitz (JE)

Department of Oncology, St. Jude Children's Hospital, 262 Danny Thomas Place, Memphis, TN, 38105, USA. Jeffrey.Rubnitz@STJUDE.ORG.

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Classifications MeSH