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Clinical picture: NHL (Non Hodgkin Lymphoma)


1. Overview
Study details
2. Patient eligibility criteria
3. Registration (& randomization) of patients
4. Participating parties
5. Participating sites
6. Instruction videos
7. Download documentation / forms

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1. Overview


This is a Phase 1/2 open label study to assess the safety and efficacy of pixantrone in combination with etoposide, bendamustine (PEBEN) and for CD20 positive B-cell lymphomas, rituximab (P[R]EBEN), in patients with relapsed aNHL of B- or T-cell phenotype.




Nordic Lymphoma Group (sponsor), HOVON, Portugal, Italy, Denmark, Norway, Finland, Sweden

Study details

Type of study

Prospective Phase I/II study

Echelon level

Level D

Type of monitoring for this study

Site evaluation visits

Target number of patients


Study objectives

Phase I

Primary objective

• MTD of pixantrone, bendamustine and etoposide in ‘fit’ relapsed aNHL patients

Secondary objectives

• Complete response rate (CRR)
• Duration of response (DOR)

Phase II

Primary objective

• Objective ORR in both ‘fit’ and ‘frail’ relapsed aNHL patients

Secondary objectives

• Safety and tolerability of the combination of pixantrone, rituximab, etoposide and bendamustine
• 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)

2. Patient eligibility criteria

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
ECOG PS 2-3 at protocol entry
Deemed ‘frail’ by the treating physician
• At least six months response duration since last given
course of treatment (thus: refractory patients are excluded)
• 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 ULN
• 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

Exclusion criteria

• Patients with primary refractory disease (e.g. progressing under platinum-containing or similar salvage therapy) defined as < 6 months response duration from last given course of treatment.
• High-dose therapy with autologous stem cell rescue within the last 6 months prior to study entry.
• Following T-cell lymphoma entities:
o T-cell lymphoblastic lymphoma
o Hepatosplenic T-cell lymphoma
o Extranodal NK/T, nasal type
o Subcutaneous panniculitis-like
o Primary cutaneous T-cell lymphoma
o Primary leukemic T-cell lymphoma
• Following B-cell lymphoma entities:
o Transformed indolent B-cell lymphomas
o Post-transplant B-cell lymphoproliferative disease
o HIV-associated B-cell lymphoma
• Concurrent severe and/or uncontrolled medical disease which is not lymphoma-related
• Left ventricular ejection fraction (LVEF) < 45%
• Suspected or documented central nervous system involvement by NHL
• Patients known to be antigen positive for HIV and/or hepatitis B and/or hepatitis C
• Patients with active, uncontrolled infections
• Vaccination with live, attenuated vaccines within 4 weeks of inclusion
• Pregnant and/or breastfeeding women
• History of active cancer during the past 5 years, except basal carcinoma of the skin or stage 0 cervical carcinoma
• Known hypersensitivity to one or more of the study drugs
• Unwillingness or inability to comply with the protocol

3. Registration (& randomization) of patients

4. Participating parties

5. Participating sites

Included patients *
NL-Amersfoort-Meander MC
NL-Den Bosch-Jeroen Bosch ziekenhuis
NL-Den Haag-Hagaziekenhuis, locatie Leyweg
NL-Doetinchem-Slingeland Hospital
NL-Dordrecht-A. Schweitzer ZH, Dordwijk
NL-Enschede-Medisch Spectrum Twente
NL-Goes-Admiraal de Ruyter ziekenhuis
NL-Rotterdam-Erasmus MC

* Please note that if TOP is not used to register patients for a study, the number of patients shown is zero.

6. Instruction videos

7. Download documentation / forms


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