BREntuximab Vedotin in SEcond LIne Therapy BEfore Transplant

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-65
SponsorGrupo Español de Linfomas y Transplante Autólogo de Médula Ósea

About this trial

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

Eligibility criteria

Qualifiers

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of any study-related procedure not part of standard medical care, with the understanding that consent may be withdrawn by the patient at any time without prejudice to future medical care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

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • Induction with Brentuximab vedotin (BV)
  • Induction without Brentuximab Vedotin
  • Consolidation with Brentuximab Vedotin

Treatment groups

150 Participants
are divided into 2 treatment groups