Phase I-II Study in CD30 Positive Diffuse Large B-cell Lymphoma Patients Refractory to First Line Chemotherapy or in First Relapse

ConditionDLBCL
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorStichting Hemato-Oncologie voor Volwassenen Nederland

About this trial

Patients with CD30 positive DLBCL, primary refractory or in first relapse after R-CHOP or R-CHOP-like therapy will receive brentuximab vedotin in combination with R-DHAP, followed in responsive patients by high dose chemotherapy and ASCT.

Eligibility criteria

Qualifiers

CD30 positive DLBCL, including EBV positive DLBCL

CD30 positive primary mediastinal B-cell lymphoma

Primary refractory to or in first relapse after first line therapy with R-CHOP or R-CHOP-like therapy

Relapse is defined as biopsy confirmed CD30 positive DLBCL after a complete response. The relapse must be histologically confirmed. In case a surgical biopsy is not possible, at least confirmation by FNA biopsy is required

Disqualifiers

Peripheral sensory or motor neuropathy grade ≥ 2

Known cerebral or meningeal disease (NHL or any other etiology), including signs and symptoms of progressive multifocal leukoencephalopathy (PML)

Symptomatic neurological disease compromising normal activities of daily living or requiring medications

Transformed lymphoma

Trial design

Treatments tested in this trial

  • R-DHAP
  • Brentuximab Vedotin

Treatment groups

37 Participants
are divided into 1 treatment group