Clinical trial NCT00431912 (phase 2, status: completed)
Conditions: cutaneous t-cell lymphoma
ICD codes: S33.110S, S33.111S, S33.120S, S33.121S, S33.130S, S33.131S, S33.140S
Drugs: apo866
SMILES: O=C(NCCCCC1CCN(CC1)C(=O)C1=CC=CC=C1)\C=C\C1=CC=CN=C1
Eligibility criteria:

        Inclusion Criteria:

          -  Histologically confirmed diagnosis of CTCL including mycosis fungoides and Sézary
             syndrome

          -  Stage Ib to IVb disease (AJCC TNM staging, see Appendix B)

          -  Relapsed or refractory disease or intolerant to ≥ 2 prior systemic therapy. PUVA,
             topical nitrogen mustard, spot or total skin electron beam therapy or other
             radiotherapy, oral retinoids, immunotherapy (e.g. interferon-α, denileukin difitox,
             alemtuzumab) or mono- or poly-chemotherapy regimen will be considered systemic
             therapy.

          -  ECOG Performance Status < 2 (see Appendix C)

          -  Age > 18 years, of either sex

          -  Female patients with childbearing potential must be using a hormonal contraceptive,
             intra uterine device, diaphragm with spermicide or condom with spermicide for the
             duration of the study. Women of childbearing potential must have a negative serum or
             urinary hCG pregnancy test

          -  Male patients, who are not surgically sterile, must use a condom with spermicide for
             the duration of the study

          -  Have given written informed consent, prior to any study related procedure not part of
             the patient's normal medical care, with the understanding that consent may be
             withdrawn by the patient at any time without prejudice to future medical care.

        Exclusion Criteria:

          -  Have participated in any other investigational study or received an experimental
             therapeutic procedure considered to interfere with the study in the 2 months preceding
             SD1

          -  Have had PUVA, topical nitrogen mustard, spot or total skin electron beam therapy,
             oral retinoids, or any, immunotherapy (e.g. interferon-α, denileukin difitox,
             alemtuzumab) or chemotherapy regimen within 2 weeks of SD1. Patients must have
             recovered from all acute toxicities.

          -  Evidence of CNS lymphoma

          -  Use of prohibited medication due to CYP3A4 metabolism of APO866, as specified in
             Section 6.6.2. concomitant use of these drugs will not be allowed during the study.

          -  Uncontrolled medical conditions, requiring surgical or pharmacological treatment
             (exceptions must be approved by the Study Director).

          -  Serious concomitant disease (e.g. significant cardiac disease) are not eligible

          -  Primary or acquired thrombocytopenia

          -  Inadequate bone marrow reserve: WBC < 3.5x10^9/L, neutrophils < 1.0x10^9/L,
             thrombocytes < 100x10^9/L, Hb < 8.5 g/dL or coagulation abnormalities

          -  Inadequate liver function: total bilirubin > 1.5 x upper limit of normal values (ULN),
             AST, ALT, or alkaline phosphatase > 2.5 x ULN

          -  Have inadequate renal function, defined by serum creatinine > 250 μmol/L

          -  Retinopathy, history of retinal laser surgery, or an ERG < 50% of normal