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-FI
• 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: 2016-03-31
• 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 follicar lymphoma grade 3b). For excluded hidstological entities seeExclusion Criteria
.Phase 1 + Phase 2fit 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) and/ or
- ECOG PS 2-3 at the 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 = 8g/dL (= 5 mmol/l) (can be post transfusion)
- Platelets = 100 x 109 / L; = 75 x 109/ L permitted if bone marrow involvement
- Absolute netrophil 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 tranaminase (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

- Patient swith primary refratory disease (e.g. prigressing under platinum-containing of similar salvage therapy) defined as < 6 months response duration from last given course of treatment
- High-dose thearpy with autologous stem cell rescue within the last 6 months prior to study entry.
- Following T-cell lymphoma entities:
- T-cell lymphoblastic lymphoma
- Hepatosplenic T-cell lymphoma
- Extranodal NK/ T, nasal type
- Subcutaneous panniculities-like
- Primary cutaneous T-cell lymphoma
- Primary leukemic T-cell lymphoma
- Following B-cell lymphoma entities:
- Transformed indolent B-cell lymphomas
- Post-transplant B-cell lymphoproliferstive disease
- HIV associated B-cell lymphoma
- Concurrent severe and / or uncotrolled medical disease which is not lymphoma-related
- Left ventricular ejection fraction (LVEF) < 45 %
- Suspected or documented central nervous system involment By NHL.
- Patients known to be antigen positie for HIV and / or hepatis 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 carsinoma
- 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