Study of Tipifarnib in Subjects With Relapsed or Refractory Peripheral T-Cell Lymphoma


About this study

This Phase II studyis designed to investigate the antitumor activity in terms of objective response rate (ORR) of tipifarnib in 18 subjects with advanced Peripheral T-Cell Lymphoma (PTCL). The total number of patients could be extended to 30 pending on the degree of response observed at an interim analysis. Tipifarnib will be administered until disease progression then followed approximately every 12 weeks for survival until either death or 12 months after accrual of the last study subject, whichever occurs first.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

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.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Thomas Witzig, M.D.

Closed for enrollment

Contact information:

Cancer Center Clinical Trials Referral Office

(855) 776-0015

More information


Publications are currently not available

Mayo Clinic Footer