title: A phase I/IIa clinical trial of CLAOP21 and CLAOP14 in patients with high grade non-Hodgkins lymphoma.
abstract: This study was performed to investigate hematotoxicity and occurrence of PPE in patients with high-grade non-Hodgkins lymphoma treated with a modified CHOP regimen (CLAOP), where doxorubicin had been substituted by a noncardiotoxic pegliposomal doxorubicin. An open-label phase I/IIa study was performed evaluating CLAOP21/20 with 20 mg/m(2) of pegliposomal doxorubicin every 21 days (12 patients), and a dose-dense filgrastim supported CLAOP14 regimen every 14 days with escalating doses of pegliposomal doxorubicin (24 patients) in elderly high-grade lymphoma patients or patients with comorbidity interfering with cardiac function. CLAOP21/20 was well tolerated. Hematotoxicity was similar to that reported with regular CHOP. In the CLAOP14 cohort, a pegliposomal doxorubicin dose of 25 mg/m(2) was associated with dose-limiting hematotoxicity, febrile episodes, and PPE. Both regimens were active with an overall response rate of 60% and 77%, respectively. The recommended dose of pegliposomal doxorubicin in the biweekly regimen for Phase II/III testing is 20 mg/m(2).
authors.affiliation: Department of Medicine III, Charité, Campus Benjamin Franklin, Berlin, Germany.
authors.forename: Antonia
authors.initials: A
authors.lastname: Busse
authors.forename: Gero
authors.initials: G
authors.lastname: Hütter
authors.forename: Jan Michael
authors.initials: JM
authors.lastname: Siehl
authors.forename: Alexander
authors.initials: A
authors.lastname: Schmittel
authors.forename: Eckhard
authors.initials: E
authors.lastname: Thiel
authors.forename: Ulrich
authors.initials: U
authors.lastname: Keilholz
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D003520:Cyclophosphamide / Q000627:therapeutic use; D004317:Doxorubicin / Q000627:therapeutic use; D005260:Female; D000069585:Filgrastim; D016179:Granulocyte Colony-Stimulating Factor / Q000008:administration & dosage; D006321:Heart / Q000187:drug effects; D006801:Humans; D008228:Lymphoma, Non-Hodgkin / Q000188:drug therapy* / Q000401:mortality; D008297:Male; D008875:Middle Aged; D011239:Prednisolone / Q000627:therapeutic use; D011994:Recombinant Proteins; D014750:Vincristine / Q000627:therapeutic use