Study of Pixantrone in CD20+ Relapsed/Refractory Aggressive Non-Hodgkin Lymphoma (NCT03458260) | Clinical Trial Compass
CompletedPhase 2
Study of Pixantrone in CD20+ Relapsed/Refractory Aggressive Non-Hodgkin Lymphoma
Belgium, France74 participantsStarted 2018-12-26
Plain-language summary
This study will evaluate the efficacy of Pixantrone with rituximab, ifosfamide and etoposide as measured by the overall metabolic response rate after 2 cycles of treatment or at permanent treatment discontinuation.
Who can participate
Age range18 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Histologically proven CD20+ aggressive non-Hodgkin lymphoma (diffuse large B-cell lymphoma (DLBCL), de novo or transformed DLBCL from previously untreated low grade non-Hodgkin lymphoma or grade 3b follicular lymphoma) as per the World Health Organization (WHO) 2016 criteria
✓. Relapsed or refractory disease, defined as follows:
✓. Patients eligible for ASCT who failed to achieve a Complete Response (CR) after at least one salvage therapy (eg, Rituximab-Etoposide- Methylprednisolone - Cytarabine - Cisplatin (R-ESHAP) or Rituximab- Dexamethasone- High-dose Cytarabine - Cisplatin (R-DHAP), patients who were previously refractory to Rituximab-Ifosfamide-Cytarabine-Etoposide (R-ICE) (stable disease or progressive disease) are not eligible to the study)
✓. Or patients in first relapse after Autologous Stem Cell Transplant (ASCT)
✓. Or patients not eligible for ASCT who failed to achieve a CR after at least one prior treatment (and no more than 4 previous lines) or in relapse after at least one prior treatment (and no more than 4 previous lines).
✓. Age \> or =18 years
✓. Eastern Cooperative Oncology Group (ECOG) performance status \< or = 2
✓. Subjects must have evaluable disease based on positron emission tomography (PET-CT) scan
Exclusion criteria
✕. Any other histological type of lymphoma (Burkitt lymphoma, mantle-cell lymphoma…)
✕. Any history of previously treated indolent non-Hodgkin lymphoma
What they're measuring
1
Overall Metabolic Response rate (OMR) according to local investigator
Timeframe: After 42 days of treatment (2 cycles) or at permanent treatment discontinuation.
Trial details
NCT IDNCT03458260
SponsorThe Lymphoma Academic Research Organisation