title: Phase II trial of zanolimumab (HuMax-CD4) in relapsed or refractory non-cutaneous peripheral T cell lymphoma.
abstract: The efficacy and safety of zanolimumab (HuMax-CD4) in patients with relapsed or refractory peripheral T Cell lymphoma (PTCL) was evaluated. Twenty-one adult patients with relapsed or refractory CD4(+) PTCL of non-cutaneous type (angioimmunoblastic T cell lymphoma (AITL) n = 9, PTCL-not otherwise specified (NOS) n = 7, anaplastic large cell lymphoma (ALCL) n = 4 and enteropathy type T cell lymphoma n = 1) were treated in a single-arm multi-centre study, with weekly intravenous infusions of zanolimumab 980 mg for 12 weeks. Median age was 69 years (range 26-85). Seventeen of the patients had advanced stage disease (Ann Arbor stages III-IV). Objective tumour responses were obtained in 24% of the patients with two complete responses unconfirmed (CRu) and three partial responses (PR). One of the CRus lasted more than 252 d. Responses were obtained in different PTCL entities: AITL (n = 3), ALCL (n = 1) and PTCL-NOS (n = 1). In general, the trial drug was well tolerated with no major toxicity. Zanolimumab at a dose of 980 mg weekly demonstrated clinical activity and an acceptable safety profile in this poor-prognosis patient population, suggesting that the potential benefit combining zanolimumab with standard chemotherapy in the treatment of PTCL should be investigated.
authors.affiliation: Aarhus University Hospital, Aarhus, Denmark. frandamo@rm.dk
authors.forename: Francesco
authors.initials: F
authors.lastname: d'Amore
authors.forename: John
authors.initials: J
authors.lastname: Radford
authors.forename: Thomas
authors.initials: T
authors.lastname: Relander
authors.forename: Mats
authors.initials: M
authors.lastname: Jerkeman
authors.forename: Hervé
authors.initials: H
authors.lastname: Tilly
authors.forename: Anders
authors.initials: A
authors.lastname: Osterborg
authors.forename: Franck
authors.initials: F
authors.lastname: Morschhauser
authors.forename: Martin
authors.initials: M
authors.lastname: Gramatzki
authors.forename: Martin
authors.initials: M
authors.lastname: Dreyling
authors.forename: Bo
authors.initials: B
authors.lastname: Bang
authors.forename: Hans
authors.initials: H
authors.lastname: Hagberg
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000911:Antibodies, Monoclonal / Q000009:adverse effects / Q000097:blood / Q000627:therapeutic use*; D061067:Antibodies, Monoclonal, Humanized; D000970:Antineoplastic Agents / Q000009:adverse effects / Q000097:blood / Q000627:therapeutic use*; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use; D005260:Female; D006801:Humans; D007262:Infusions, Intravenous; D016411:Lymphoma, T-Cell, Peripheral / Q000097:blood / Q000188:drug therapy*; D008297:Male; D008875:Middle Aged; D009894:Opportunistic Infections / Q000139:chemically induced; D011446:Prospective Studies; D012008:Recurrence; D016896:Treatment Outcome
chemical_list: D000911:Antibodies, Monoclonal; D061067:Antibodies, Monoclonal, Humanized; D000970:Antineoplastic Agents; C520522:zanolimumab