Brentuximab Vedotin and Lenalidomide in Patients With Relapsed/ Refractory T-cell Lymphoma or Hodgkin Lymphoma

Inclusion Criteria

• •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.