EpiBrentlen: This phase I trial is evaluating the combination of two drugs (Brentuximab vedotin and lenalidomide) for the treatment of relapsed/refractory T-cell lymphoma or Hodgkin LymphomaBrentuximab Vedotin and Lenalidomide in Patients With Relapsed/ Refractory T-cell Lymphoma or Hodgkin Lymphoma

Inclusion

1. Male or female patients of 18 years or older.

2. Patient must have a diagnosis of a CD30+ Hodgkin Lymphoma or CD30+ peripheral T-cell lymphoma. Patients with either Hodgkin lymphoma or T-cell lymphoma must have expression of CD30 in ≥10% of lymphoma cells. Patients with CTCL will be considered for inclusion even if CD30 immunohistochemical staining with BerH2 antibody is low or negligible (<10%).

   1. Peripheral T-cell lymphoma: patients must be considered relapsed or refractory after at least one prior chemotherapeutic regimen or be considered by the investigator to be not suitable for chemotherapy
   2. Cutaneous T-cell lymphoma: patients must be relapsed or refractory to one prior systemic therapy or be considered by the investigator to be not suitable for chemotherapy
   3. Patients with Hodgkin lymphoma and one of the following:

   i. Relapsed or refractory after at least 2 prior chemotherapy-containing regimens ii.Considered unsuitable for chemotherapy

3. Voluntary written informed consent must be given before performance of any study- related procedure.
4. Female patient is either post-menopausal for at least 1 year before the screening visit or surgically sterile or if of childbearing potential, agree to practice 2 effective methods of contraception, at the same time, from the time of signing the informed consent through 6 months after the last dose of study drug, or agrees to completely abstain from heterosexual intercourse.
5. Male patients, even if surgically sterilized, (i.e., status post vasectomy) agree to practice effective barrier contraception during the entire study period and through 6 months after the last dose of study drug, or agrees to completely abstain from heterosexual intercourse.
6. Performance status of ECOG ≤2.

7. Clinical laboratory values as specified below. Blood tests must be within 10 days of patient registration:

   • Absolute neutrophil count >1.5 x109/L, or >1.0 x109/L in the setting of known marrow involvement by tumour.
   • Platelet count ≥75x109/L.
   • Total bilirubin must be < 1.5 x the upper limit of the normal (ULN) unless the elevation is known to be due to Gilbert syndrome.
   • ALT or AST must be < 2.5 x the upper limit of the normal range. AST or ALT may be elevated up to 5 times the ULN if their elevation can be reasonably ascribed to the presence of haematologic/solid tumor in liver.
   • Serum creatinine must be < 150 µmol/L and/or creatinine clearance or calculated creatinine clearance > 40 mL/minute.
   • Haemoglobin must be ≥ 80g/L.
8. Patients must have fully recovered from the acute toxic effects of all prior chemotherapy, immunotherapy, or radiotherapy (except alopecia) prior to registration.