Malignant Lymphoma
Conditions
Brief summary
This is a phase 1/2 open label study to assess the safety and efficacy of pixantrone in combination with bendamustine, etoposide and , for CD20 positive B-cell lymphomas, rituximab (P\[R\]EBEN), in patients with relapsed aNHL of B- or T-cell phenotype.
Detailed description
This is a phase 1/2 open label study to assess the safety and efficacy of pixantrone in combination with bendamustine, etoposide and , for CD20 positive B-cell lymphomas, rituximab (P\[R\]EBEN), in patients with relapsed aNHL of B- or T-cell phenotype.
Interventions
DRUGPREBEN
Sponsors
University of Aarhus
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
* Patients with a histologically confirmed relapse of an aggressive lymphoma of T- or B-cell phenotype (including follicular lymphoma grade 3b). For excluded histological entities see '
Exclusion criteria
' * Phase 1 + Phase 2 'fit' patients: * Age 18-70 years at the time of inclusion * ECOG 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 six 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) * 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 ≤ 1.5 x upper limit of normal (ULN); patients with proven Gilbert's syndrome (≤ 5 x ULN) may be enrolled. * Serum glutamic-oxaloacetic transaminase (AST) and/or serum glutamic-pyruvic transaminase (ALT) ≤ 2.5 x ULN, or ≤ 5 x ULN if elevation is due to hepatic involvement by lymphoma * Serum creatinine ≤ 2 x ULNb * Women of childbearing potential must use safe anticonception (e.g. contraceptive pills, intrauterine devices etc.) during the study and 12 months after the last administration of study drugs * Male patients must use contraception for the duration of the study and 6 months after the last administration of study drugs if his partner is of childbearing potential * Written informed consent
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| MTD of pixantrone, bendamustine and etoposide in 'fit' relapsed aNHL pts (phase 1) | 1.5 yrs |
| Objective ORR in both 'fit' and 'frail' relapsed aNHL pts (phase 2) | 4 yrs |
Countries
Denmark, Finland, Netherlands, Norway, Sweden
Outcome results
None listed