title: A phase 1/2 trial of lenalidomide and dexamethasone in adult patients with refractory/relapsed acute lymphoblastic leukemia.
abstract: OBJECTIVE
  Adult patients with refractory/relapsed ALL have poor survival outcomes with current chemotherapies. We aimed to determine safety and efficacy of lenalidomide, an oral immunomodulator, in these patients.
  
  
  METHODS
  This phase 1/2 trial (EUDRACT # 2009-009372-13) included 10 patients who received 28-day cycles of oral lenalidomide 25 mg/day, days 1 through 21, in combination with oral dexamethasone 40 mg/day on days 1, 8, 15, 22. Primary endpoints were tolerance and the overall response rate (ORR). Secondary endpoints included overall survival (OS) and quality of life.
  
  
  RESULTS
  The most common grade 3 or 4 adverse events were myelosuppression. The ORR among the participants who could be evaluated was 28.6% (95% confidence interval [CI], 0-62.2%). The median OS was 92 days (range, 43-133 days). All patients have died because of progressive disease. Quality of life remains stable during treatment cycles.
  
  
  CONCLUSIONS
  The safety of combination therapy consisting of lenalidomide plus dexamethasone is consistent with ambulatory administration. Efficacy should be reevaluated in a larger series including patients less intensively previously treated.
authors.affiliation: a Hematology Unit , Institut de Cancérologie de la Loire , Saint Priest en Jarez , France.
authors.forename: E
authors.initials: E
authors.lastname: Tavernier-Tardy
authors.affiliation: a Hematology Unit , Institut de Cancérologie de la Loire , Saint Priest en Jarez , France.
authors.forename: J
authors.initials: J
authors.lastname: Cornillon
authors.affiliation: b Hematology Unit , CHU Estaing , Clermont-Ferrand , France.
authors.forename: C
authors.initials: C
authors.lastname: Molucon-Chabrot
authors.affiliation: c Hematology Unit , CHU , Grenoble , France.
authors.forename: J Y
authors.initials: JY
authors.lastname: Cahn
authors.affiliation: d Public Health department , Institut de Cancérologie de la Loire , Saint Priest en Jarez , France.
authors.forename: F
authors.initials: F
authors.lastname: Tinquaut
authors.affiliation: d Public Health department , Institut de Cancérologie de la Loire , Saint Priest en Jarez , France.
authors.forename: A
authors.initials: A
authors.lastname: Bourmaud
authors.affiliation: a Hematology Unit , Institut de Cancérologie de la Loire , Saint Priest en Jarez , France.
authors.forename: D
authors.initials: D
authors.lastname: Guyotat
authors.affiliation: e Hematology Unit , CHU Hospices Civils de Lyon , Lyon , France.
authors.forename: X
authors.initials: X
authors.lastname: Thomas
mesh_terms: D000368:Aged; D020533:Angiogenesis Inhibitors / Q000008:administration & dosage; D018931:Antineoplastic Agents, Hormonal / Q000008:administration & dosage; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D003907:Dexamethasone / Q000008:administration & dosage / Q000009:adverse effects; D005260:Female; D006801:Humans; D000077269:Lenalidomide; D008297:Male; D008875:Middle Aged; D054198:Precursor Cell Lymphoblastic Leukemia-Lymphoma / Q000188:drug therapy* / Q000401:mortality; D011788:Quality of Life; D016019:Survival Analysis; D013792:Thalidomide / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives
chemical_list: D020533:Angiogenesis Inhibitors; D018931:Antineoplastic Agents, Hormonal; D013792:Thalidomide; D003907:Dexamethasone; D000077269:Lenalidomide
keywords: Acute lymphoblastic leukemia; lenalidomide; prognosis; refractory; relapse