Brentuximab Vedotin Plus Cisplatin, Cytarabine, and Dexamethasone in Patients With Relapsed or Refractory Hodgkin's Lymphoma Who Are Eligible for Transplant
\< STUDY DESIGN \> This study is a multi-center phase II trial in patients with relapsed or refractory Hodgkin's lymphoma after first-line treatment. \< Treatment Schedule \> 1. Induction phase * Patients who sign the informed consent form (ICF) receive BV-DHAP induction therapy within 21 days. * Tumor response is evaluated following 2 cycles of induction therapy. As a result of tumor response evaluation, PD (progressive disease) means a withdrawal from the study; and CR (complete response), PR (partial response), or SD (stable disease) requires peripheral blood stem cell collection (PBSCC) followed by additional one cycle of induction therapy. * Following a total of 3 cycles of induction therapy, tumor response is evaluated again. If the result turns out to be CR or PR, treatment goes on to autologous stem cell transplant (ASCT). SD or PD means a withdrawal from the study. 2. Consolidation phase - ASCT is performed in accordance with a protocol based on the relevant site's policy.
• Histologically confirmed diagnosis of classical Hodgkin's lymphoma. CD30 has to be positive
• Refractory to the first-line treatment or relapse after the first-line treatment (radiologically confirmed)
‣ Deauville score 5 as a result of the restaging PET-CT after 2 to 3 cycles of ABVD treatment
⁃ Deauville score 4 to 5 even after the completion of ABVD treatment or radiotherapy and are not candidates for ISRT (involved site radiation therapy)
⁃ Radiologically confirmed relapsed after achieving CR
• At least one measurable lesion(s)
‣ nodal lesion longest transverse diameter (LDi) ≥ 1.5 cm
⁃ extranodal lesion LDi ≥ 1.0 cm)
• Age 19 to 70 years
• ECOG PS 0 - 2
• Appropriate organ functions to tolerate the protocol treatment and ASCT Absolute Neutrophil Count (ANC) ≥ 1.5 x 10\^9/L Platelets ≥ 75 x 10\^9/L Hemoglobin ≥ 8.0 g/dL Serum Creatinine ≤ 1.5 x upper limit normal (ULN) Serum Bilirubin ≤ 1.5 x ULN AST and ALT ≤ 3 x ULN Corrected diffusing capacity for carbon monoxide (DLCO) ≥50 percent
• 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.
• 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.
• Written informed consent