A phase 1/2 study of the combination of pixantrone, etoposide, bendamustine and rituximab in patients with relapsed lymphomas of B- or T-cell phenotype

Phase 1

• Conditions: Relapse of aggressive non-Hodgkin lymphoma of B and T-cell phenotype; MedDRA version: 20.0 Level: HLGT Classification code 10025320 Term: Lymphomas non-Hodgkin's B-cell System Organ Class: 10005329 - Blood and lymphatic system disorders; MedDRA version: 20.0 Level: HLGT Classification code 10025321 Term: Lymphomas non-Hodgkin's T-cell System Organ Class: 10005329 - Blood and lymphatic system disorders; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2015-000758-39-NL
• Lead Sponsor: Department of Hematology, Aarhus University Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-05-14
• Last Update Posted: 30 April 2019

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Not specified
• Target Recruitment: 84

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 performance score (PS) 0-1 at protocol entry (for ECOG definition see appendix A)
-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 (for ECOG definition see appendix A)
and/or
-Deemed ‘frail’ by the treating physician
•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 = 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
•Written informed consent
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 42
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 42

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:
oT-cell lymphoblastic lymphoma
oHepatosplenic T-cell lymphoma
oExtranodal NK/T, nasal type
oSubcutaneous panniculitis-like
oPrimary cutaneous T-cell lymphoma
oPrimary leukemic T-cell lymphoma
•Following B-cell lymphoma entities:
oTransformed indolent B-cell lymphomas
oPost-transplant B-cell lymphoproliferative disease
oHIV-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
•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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified