Relapsed/Refractory Classical Hodgkin Lymphoma Clinical Trial
Official title:
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.
< 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. Study Drug Dosage will be as follows; Brentuximab vedotin: 1.8 mg/kg IV over 30 minutes D1 Cisplatin* 100 mg/m2 + NS 1000 mL CIV over 24 hours D1 Cytarabine* 2.0 g/m2 + 5% DW 250 mL IV over 3 hours twice a day D2 Dexamethasone 40 mg IV or PO D1-4 *If baseline or on treatment creatinine clearance is less than 60 mL/min, 25% dose reduction should strongly be considered (cisplatin 75 mg/m2, cytarabine 1.5 g/m2) - 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. - Each cycle is implemented at an interval of 21 days (± 3 days). 2. Consolidation phase - ASCT is performed in accordance with a protocol based on the relevant site's policy. - Conditioning regimen will be determined by the attending physician. For example, BEAM, BuCyEtopo, BeEAM (Bendamustine+EAM), etc. - Other conservative managements will be carried out according to the policy of participating site < Follow-Up Schedule > - Patients will be recruited up to 3 years from the start date of this study. - Primary analysis and reporting will be carried out at the completion of ASCT of the last patient. - PFS and OS will be followed up for up to 2 years from the completion of ASCT of the last patient. Final analysis will be reported at this point. - After completion of ASCT, a patient will be followed up at an interval of 3 months for 2 years ;