A Randomized Phase IIb Study, Evaluating Efficacy of Salvage Therapy with Brentuximab Vedotin-ESHAP vs ESHAP in Patients with Relapsed / Refractory Classical Hodgkin's Lymphoma, Followed by Brentuximab Vedotin Consolidation (instead of Autologous Hematopoietic Stem Cell Transplantation) in Those who Attained a Metabolic Complete Remission after Salvage Therapy
Male or female patients 18 to 65 years of age
Voluntary written informed consent must be given before performance of any study-related procedure not part of standard medical care, with the understanding that consent may be withdrawn by the patient at any time without prejudice to future medical care
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
Lymphocyte predominant nodular Hodgkin's lymphoma
Prior treatment with brentuximab vedotin
Female patient who are both lactating and breast-feeding or have a positive serum pregnancy test during the screening period or a positive pregnancy test on Day 1 before first dose of study drug
Any serious medical or psychiatric illness that could, in the investigator's opinion, potentially interfere with the completion of treatment according to the protocol.
Parallel
Induction with Brentuximab vedotin (BV)
Drug3 cycles ESHAP plus antibody-drug conjugate brentuximab vedotin (BV) at a dose of 1.8 mg/kg IV
Induction without Brentuximab Vedotin
Drug3 cycles of ESHAP as a standard of care therapy for those patients with primary refractory cHL and those patients relapsing after first-line therapy
Consolidation with Brentuximab Vedotin
DrugUp to 13 or 16 cycles of antibody-drug conjugate brentuximab vedotin (BV) at doses of 1.8 mg/kg iv every 21 days)
PET-CT result
PET-CT negative, Deauville scores 1 and 2
progression-free survival (PFS)
Evaluation of patient without progression of disease
Duration of response
Lenght of time between date of evidence response and progression of disease or death
Overall Survival (OS)
Time from entry onto the clinical trial (random assignment in a phase III study) until death as a result of any cause.
Duration of response (DOR)
Time from first documentation of CR or PR to disease progression
Safety and tolerability
AEs, fertility,infections, and secondary malignancies
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