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Phase II trial of zanolimumab (HuMax‐CD4) in relapsed or refractory non‐cutaneous peripheral T cell lymphoma
Author(s) -
D’Amore Francesco,
Radford John,
Relander Thomas,
Jerkeman Mats,
Tilly Hervé,
Österborg Anders,
Morschhauser Franck,
Gramatzki Martin,
Dreyling Martin,
Bang Bo,
Hagberg Hans
Publication year - 2010
Publication title -
british journal of haematology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.907
H-Index - 186
eISSN - 1365-2141
pISSN - 0007-1048
DOI - 10.1111/j.1365-2141.2010.08298.x
Subject(s) - medicine , gastroenterology , peripheral t cell lymphoma , refractory (planetary science) , anaplastic large cell lymphoma , lymphoma , population , angioimmunoblastic t cell lymphoma , chemotherapy , phases of clinical research , surgery , t cell , immunology , physics , immune system , environmental health , astrobiology
Summary 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.