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Phase 1/2 Study of the Combination of Pixantrone, Etoposide, Bendamustine and, in CD20 Positive Tumors, Rituximab in Patients With Relapsed Aggressive Non-Hodgkin Lymphomas of B- or T-cell Phenotype - the P[R]EBEN Study

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ClinicalTrials.gov Identifier: NCT02678299
Recruitment Status : Recruiting
First Posted : February 9, 2016
Last Update Posted : February 9, 2016
Sponsor:
Information provided by (Responsible Party):
University of Aarhus

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

Condition or disease Intervention/treatment Phase
Malignant Lymphoma Drug: PREBEN Phase 1 Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 84 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase 1/2 Study of the Combination of Pixantrone, Etoposide, Bendamustine and, in CD20 Positive Tumors, Rituximab in Patients With Relapsed Aggressive Non-Hodgkin Lymphomas of B- or T-cell Phenotype - the P[R]EBEN Study
Study Start Date : February 2016
Estimated Primary Completion Date : June 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma

Arm Intervention/treatment
Experimental: Treatment Drug: PREBEN



Primary Outcome Measures :
  1. MTD of pixantrone, bendamustine and etoposide in 'fit' relapsed aNHL pts (phase 1) [ Time Frame: 1.5 yrs ]
  2. Objective ORR in both 'fit' and 'frail' relapsed aNHL pts (phase 2) [ Time Frame: 4 yrs ]


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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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 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

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:

    • T-cell lymphoblastic lymphoma
    • Hepatosplenic T-cell lymphoma
    • Extranodal NK/T, nasal type
    • Subcutaneous panniculitis-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 lymphoproliferative disease
    • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02678299


Contacts
Contact: Francesco d'Amore, MD DMSci frandamo@rm.dk
Contact: Helle Toldbod, Ms PhD helletol@rm.dk

Locations
Denmark
Department of Hematology, Aarhus University Hospital Recruiting
Aarhus, Denmark, DK-8000
Contact: Francesco d'Amore, MD DMSci       frandamo@rm.dk   
Sponsors and Collaborators
University of Aarhus
Investigators
Principal Investigator: Francesco d'Amore, MD DMSci Dept. of Hematology, Aarhus University Hospital

Responsible Party: University of Aarhus
ClinicalTrials.gov Identifier: NCT02678299     History of Changes
Other Study ID Numbers: PREBEN
2015-000758-39 ( EudraCT Number )
First Posted: February 9, 2016    Key Record Dates
Last Update Posted: February 9, 2016
Last Verified: February 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Lymphoma
Lymphoma, Non-Hodgkin
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Pixantrone
Rituximab
Etoposide
Bendamustine Hydrochloride
Antineoplastic Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Antineoplastic Agents, Phytogenic
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents, Alkylating
Alkylating Agents