A phase I study of lenalidomide plus chemotherapy with idarubicin and cytarabine in patients with relapsed or refractory acute myeloid leukemia and high-risk myelodysplastic syndrome.
Adolescent
Adult
Aged
Antineoplastic Combined Chemotherapy Protocols
/ administration & dosage
Cytarabine
/ administration & dosage
Disease-Free Survival
Female
Humans
Idarubicin
/ administration & dosage
Lenalidomide
/ administration & dosage
Leukemia, Myeloid, Acute
/ drug therapy
Male
Middle Aged
Myelodysplastic Syndromes
/ drug therapy
Survival Rate
Journal
American journal of hematology
ISSN: 1096-8652
Titre abrégé: Am J Hematol
Pays: United States
ID NLM: 7610369
Informations de publication
Date de publication:
12 2020
12 2020
Historique:
received:
01
06
2020
revised:
26
07
2020
accepted:
06
08
2020
pubmed:
11
8
2020
medline:
1
12
2020
entrez:
11
8
2020
Statut:
ppublish
Résumé
Patients with relapsed/refractory (R/R) acute myeloid leukemia (AML) have poor outcomes and hematopoietic cell transplantation (HCT) is the only curative treatment. New targeted therapies improved survival in select patients with specific mutations, however management of patients without these molecular alterations is an unmet need. We conducted a phase one study of lenalidomide in combination with cytarabine/idarubicin salvage chemotherapy in patients with R/R AML and high-risk myelodysplastic syndromes. A total of 33 patients were enrolled in the study (30 AML, 3 MDS), and treated at three dose levels with 3 + 3 design. Dose-limiting toxicity (DLT) was seen in eight patients, including four hematologic DLTs. The most commonly observed non-hematologic serious adverse events were febrile neutropenia, rash, sepsis and renal injury. Dose level -1, consisting of 25 mg/d lenalidomide D1-21, 1 g/m
Identifiants
pubmed: 32777116
doi: 10.1002/ajh.25958
pmc: PMC7821016
doi:
Substances chimiques
Cytarabine
04079A1RDZ
Lenalidomide
F0P408N6V4
Idarubicin
ZRP63D75JW
Banques de données
ClinicalTrials.gov
['NCT01132586']
Types de publication
Clinical Trial, Phase I
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Pagination
1457-1465Subventions
Organisme : NCI NIH HHS
ID : P30 CA016058
Pays : United States
Organisme : NCI NIH HHS
ID : U24 CA247648
Pays : United States
Informations de copyright
© 2020 The Authors. American Journal of Hematology published by Wiley Periodicals LLC.
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