title: Phase-II study of the new aza-anthracenedione, BBR 2778, in patients with relapsed aggressive non-Hodgkin's lymphomas.
abstract: OBJECTIVE
  BBR 2778 is a new aza-anthracenedione. Its activity against hematologic neoplasias in a mouse model is greater than that of doxorubicin or mitoxantrone. A phase-I study in patients with non-Hodgkin's lymphoma (NHL) showed that the drug has promising anti-tumor activity. Therefore, a phase-II study in patients with relapsed aggressive NHL was initiated.
  
  
  METHODS
  The primary objective was to determine the efficacy of 85 mg/m2 BBR 2278 for a q1w x3 treatment schedule (repeat day 29). Secondary objectives included the evaluation of response duration and safety in this open-label, non-randomized, multicenter trial. Patients with relapsed aggressive NHL according to the REAL-classification were included.
  
  
  RESULTS
  Eight centers enrolled a total of 33 patients. The median age of these patients was 66 years (range 24-81). The majority of patients had diffuse large B-cell lymphoma (n=24) or mantle-cell lymphoma (n=7), pretreated with a median of 2 regimens. Confirmed responses included 5 complete and 4 partial remissions, with the period between the first appearance of response and any signs or symptoms of progression being up to 17+ months. The main toxicity was neutropenia.
  
  
  CONCLUSIONS
  These results indicate that 85 mg/m2 BBR 2778 in a q1w x 3 schedule is active in elderly and pretreated patients with relapsed aggressive NHL and was generally well tolerated. Thus, we recommend further clinical evaluation of this new compound in phase-III studies for the treatment of NHL.
authors.affiliation: Klinik I für Innere Medizin der Universität zu Köln, Germany.
authors.forename: Peter
authors.initials: P
authors.lastname: Borchmann
authors.forename: Franck
authors.initials: F
authors.lastname: Morschhauser
authors.forename: Anne
authors.initials: A
authors.lastname: Parry
authors.forename: Roland
authors.initials: R
authors.lastname: Schnell
authors.forename: Jean Luc
authors.initials: JL
authors.lastname: Harousseau
authors.forename: Christian
authors.initials: C
authors.lastname: Gisselbrecht
authors.forename: Christian
authors.initials: C
authors.lastname: Rudolph
authors.forename: Martin
authors.initials: M
authors.lastname: Wilhelm
authors.forename: Hans
authors.initials: H
authors.lastname: Günther
authors.forename: Derigs Michael
authors.initials: DM
authors.lastname: Pfreundschuh
authors.forename: Gabriella
authors.initials: G
authors.lastname: Camboni
authors.forename: Andreas
authors.initials: A
authors.lastname: Engert
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000740:Anemia / Q000139:chemically induced; D000970:Antineoplastic Agents / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D004334:Drug Administration Schedule; D005260:Female; D006801:Humans; D007546:Isoquinolines / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D008228:Lymphoma, Non-Hodgkin / Q000097:blood / Q000188:drug therapy* / Q000201:enzymology / Q000473:pathology; D008231:Lymphopenia / Q000139:chemically induced; D008297:Male; D008875:Middle Aged; D009364:Neoplasm Recurrence, Local / Q000188:drug therapy* / Q000473:pathology; D009503:Neutropenia / Q000139:chemically induced; D012008:Recurrence; D013921:Thrombocytopenia / Q000139:chemically induced; D059005:Topoisomerase II Inhibitors; D016896:Treatment Outcome
chemical_list: D000970:Antineoplastic Agents; D007546:Isoquinolines; D059005:Topoisomerase II Inhibitors; C086548:pixantrone