NHL Non-hodgkin lymphoma
Conditions
Interventions
In phase 2 the treatment will depend on if the patient is either classified as
fit or frail.
Fit patients will be treated with the in the phase 1 part of the study
determined MTD of Pixantrone, Etop
Sponsors
Aarhus University Hospital
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: - Patients with a histologically confirmed relapse of an aggressive lymphoma of T- or B-cell phenotype (including follicular lymphoma grade 3b).;- Phase 1 + Phase 2 *fit* patients: --Age 18-70 years at the time of inclusion --ECOG performance score (PS) 0-1 at protocol entry --Deemed *fit* by the treating physician - Phase 2 *frail* patients: --Age 71-85 years at the time of inclusion and/or --ECOG PS 2-3 at protocol entry and/or --Deemed *frail* by the treating physician;- At least 6 months response duration since last given course of treatment - Estimated life expectancy of 3 months or longer - Measurable disease - Hemoglobin >= 8 g/dL (>=5 mmol/l) (can be post transfusion) - Platelets >= 100 x 109/L; >= 75 x 109/L permitted if bone marrow involvement - Absolute neutrophil count >= 1.5 x 109/L; >= 1.0 x 109/L permitted if documented bone marrow involvement - Serum bilirubin
Exclusion criteria
Exclusion criteria: - Patients with primary refractory disease (e.g. progressing under platinum-containing or similar salvage therapy) defined as
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Phase 2: -Objective ORR in both *fit* and *frail* relapsed aNHL pts | — |
Secondary
| Measure | Time frame |
|---|---|
| Phase 2: - Safety and tolerability of the combination of pixantrone, rituximab, etoposide and bendamustine - CRR - DOR - Progression-free survival (PFS) - Overall survival (OS) - Successful bridging to stem cell therapy (e.g. 2nd auto- and/or 1st allo-SCT) or other cell therapy (e.g. chimeric antigen receptor [CAR]-T cell therapy) | — |
Countries
Netherlands
Outcome results
None listed