Malignant LymphomaPhase 1/2NCT02678299
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
A Phase 1/2 study testing PREBEN in people with Malignant Lymphoma, run by University of Aarhus at 18 sites in 5 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Malignant Lymphoma
- What is being tested?
- PREBEN
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 18 sitesin 5 countries
- Study dates
- Feb 2016to Dec 2025
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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:
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- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
18 sites in 5 countries.
18 sites in 5 countries
Netherlands10 sites
Jeroen Bosch Hospital
's-Hertogenbosch
Meander Medical Center
Amersfoort
Slingeland Hospital
Doetinchem
Albert Schweitzer Hospital
Dordrecht
Medisch Spectrum Twente
Enschede
Admiraal de Ruyter Hospital
Flushing
Universitair Medisch Centrum Groningen
Groningen
Spaarne Ziekenhuis
Hoofddorp
Erasmus Medical Center
Rotterdam
Haga Hospital, loc. Leyweg
The Hague
Denmark3 sites
Department of Hematology, Aarhus University Hospital
Aarhus, DK-8200
Department of Hematology, Copenhagen University Hospital
Copenhagen, 2100
Department of Hematology, Odense University Hospital
Odense, 5000
Norway3 sites
Department of Oncology, Oslo University Hospital
Oslo, 0310
Stavanger University Hospital
Stavanger
Department of Oncology, St. Olavs Hospital
Trondheim, 7006
Finland1 site
Helsinki University Hospital Comprehensive Cancer Center
Helsinki, 00029
About this study
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.
Read the detailed description
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.
- Conditions
- Malignant Lymphoma
- Being tested
- PREBEN
- Medical subject headings
- Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PREBENDrug
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | Not described Receives: Drug: PREBEN |
What is being measured
The primary outcome is the main question the study is designed to answer.
MTD of pixantrone, bendamustine and etoposide in 'fit' relapsed aNHL pts (phase 1)
Measured: 1.5 yrs
Objective ORR in both 'fit' and 'frail' relapsed aNHL pts (phase 2)
Measured: 4 yrs
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2016 (estimated)
- Study startFeb 2016
- Primary completionFeb 2022
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Malignant LymphomaStudies of the same condition, open and under way.
- More trials run by University of AarhusThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Francesco d'Amore, MD DMSci, Principal investigator, Dept. of Hematology, Aarhus University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02678299
- Sponsor's protocol ID
- PREBEN
- Other IDs
- 2015-000758-39, 2015
- Status last verified
- Aug 2022
- First submitted
- 5 Feb 2016
- Last updated
- 4 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02678299
- Acronym / sponsor ID
- PREBEN
- Conditions
- Malignant Lymphoma
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (actual)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Study start
- Feb 2016
- Primary completion
- Feb 2022 (actual)
- Study completion
- Dec 2025 (estimated)
- First posted
- 9 Feb 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Drug: PREBEN |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (21 listed)
- 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:
- Phase 2 'frail' patients:
- At least six months response duration since last given course of treatment
- Estimated life expectancy of 3 months or longer
Key exclusion criteria (23 listed)
- 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:
- Following B-cell lymphoma entities:
- Concurrent severe and/or uncontrolled medical disease which is not lymphoma-related
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PREBEN | Drug | Treatment |
Primary outcome
MTD of pixantrone, bendamustine and etoposide in 'fit' relapsed aNHL pts (phase 1)
Time frame: 1.5 yrs
Objective ORR in both 'fit' and 'frail' relapsed aNHL pts (phase 2)
Time frame: 4 yrs
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Aug 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Francesco d'Amore, MD DMSci principal investigator
Dept. of Hematology, Aarhus University Hospital
18 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing PREBEN in people with Malignant Lymphoma, run by University of Aarhus at 18 sites in 5 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 21 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 4 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 18 sites in Netherlands, Denmark, Norway, Finland, Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
MTD of pixantrone, bendamustine and etoposide in 'fit' relapsed aNHL pts (phase 1) (time frame: 1.5 yrs). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Aug 2022.