NCT02678299

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.

Trial Health

50
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Feb 2016

Longer than P75 for phase_1

Geographic Reach
5 countries

18 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2016

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

February 5, 2016

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 9, 2016

Completed
6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2022

Completed
3.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2025

Completed
Last Updated

August 4, 2022

Status Verified

August 1, 2022

Enrollment Period

6 years

First QC Date

February 5, 2016

Last Update Submit

August 3, 2022

Conditions

Malignant Lymphoma

Outcome Measures

Primary Outcomes (2)

  • 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

Study Arms (1)

Treatment

EXPERIMENTAL
Drug: PREBEN

Interventions

PREBENDRUG
Treatment

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may not qualify if:

  • Phase 1 + Phase 2 'fit' patients:
  • ECOG PS 0-1 at protocol entry
  • Deemed 'fit' by the treating physician
  • Phase 2 'frail' patients:
  • 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
  • +25 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (18)

Department of Hematology, Aarhus University Hospital

Aarhus, DK-8200, Denmark

Location

Department of Hematology, Copenhagen University Hospital

Copenhagen, 2100, Denmark

Location

Department of Hematology, Odense University Hospital

Odense, 5000, Denmark

Location

Helsinki University Hospital Comprehensive Cancer Center

Helsinki, 00029, Finland

Location

Jeroen Bosch Hospital

's-Hertogenbosch, Netherlands

Location

Meander Medical Center

Amersfoort, Netherlands

Location

Slingeland Hospital

Doetinchem, Netherlands

Location

Albert Schweitzer Hospital

Dordrecht, Netherlands

Location

Medisch Spectrum Twente

Enschede, Netherlands

Location

Admiraal de Ruyter Hospital

Flushing, Netherlands

Location

Universitair Medisch Centrum Groningen

Groningen, Netherlands

Location

Spaarne Ziekenhuis

Hoofddorp, Netherlands

Location

Erasmus Medical Center

Rotterdam, Netherlands

Location

Haga Hospital, loc. Leyweg

The Hague, Netherlands

Location

Department of Oncology, Oslo University Hospital

Oslo, 0310, Norway

Location

Stavanger University Hospital

Stavanger, Norway

Location

Department of Oncology, St. Olavs Hospital

Trondheim, 7006, Norway

Location

Department of Oncology, Skåne University Hospital

Lund, 221 85, Sweden

Location

MeSH Terms

Conditions

Lymphoma

Condition Hierarchy (Ancestors)

Neoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Study Officials

  • Francesco d'Amore, MD DMSci

    Dept. of Hematology, Aarhus University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 5, 2016

First Posted

February 9, 2016

Study Start

February 1, 2016

Primary Completion

February 1, 2022

Study Completion

December 1, 2025

Last Updated

August 4, 2022

Record last verified: 2022-08

Data Sharing

IPD Sharing
Will not share

Locations

NL(10)DK(3)FI(1)NO(3)SE(1)