Ensayos clínicos

Inclusion Criteria:

• Diagnosis of PTCL according to the most recent edition of the World Health Organization (WHO) Classification of Tumors of Hematopoietic or Lymphoid Tissues, as follows:
  • Anaplastic large cell lymphoma (ALCL), ALK positive;
  • ALCL, ALK negative;
  • Angioimmunoblastic T-cell lymphoma (AITL);
  • Enteropathy-associated T-cell lymphoma;
  • Extranodal natural killer (NK) T-cell lymphoma, nasal type;
  • Hepatosplenic T-cell lymphoma;
  • Peripheral T-cell lymphoma, no otherwise specified (NOS);
  • Subcutaneous panniculitis-like T-cell lymphoma.
• Relapsed or are refractory to at least 1 prior systemic cytotoxic therapy.
• Subjects must have received conventional therapy as a prior therapy.
• ECOG performance status of 0-2.
• Acceptable liver and renal function.
• Acceptable hematologic status.
• Female subjects must be either:
  • Of non-child-bearing potential (surgically sterilized or at least 2 years post-menopausal); or
  • If of child-bearing potential, subject must use an adequate method of contraception consisting of two-barrier method or one barrier method with a spermicide or intrauterine device. Both females and male subjects with female partners of child-bearing potential must agree to use an adequate method of contraception for 2 weeks prior to screening, during, and at least 4 weeks after last dose of trial medication. Female subjects must have a negative serum or urine pregnancy test within 72 hours prior to start of trial medication;
  • Not breast feeding at any time during the study.
• Written and voluntary informed consent.

Exclusion Criteria:

• Diagnosis of any of the following:
  • Precursor T-cell lymphoma or leukemia;
  • Adult T-cell lymphoma/leukemia (ATLL);
  • T-cell prolymphocytic leukemia;
  • T-cell large granular lymphocytic leukemia;
  • Primary cutaneous type anaplastic large cell lymphoma;
  • Mycosis fungoide/Sezary syndrome.
• Ongoing treatment with an anticancer agent not contemplated in this protocol.
• Any history of clinically relevant coronary artery disease or myocardial infarction within the last 3 years.
• Known central nervous system lymphoma.
• Stem cell transplant less than 3 months prior to enrolment.
• Non-tolerable > Grade 2 neuropathy or evidence of unstable neurological symptoms within 4 weeks of Cycle 1 Day 1.
• Major surgery, other than diagnostic surgery, within 2 weeks prior to Cycle 1 Day 1, without complete recovery.
• Other active malignancy requiring therapy such as radiation, chemotherapy, or immunotherapy.
• Active, uncontrolled bacterial, viral, or fungal infections, requiring systemic therapy. Known infection with HIV, or an active infection with hepatitis B or hepatitis C.