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Aggressive Non-Hodgkin LymphomaPhase 2NCT03458260

Study of Pixantrone in CD20+ Relapsed/Refractory Aggressive Non-Hodgkin Lymphoma

A Phase 2 study testing Pixantrone, Ifosfamide and Etoposide in people with Aggressive Non-Hodgkin Lymphoma, run by The Lymphoma Academic Research Organisation at 22 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This study will evaluate the efficacy of Pixantrone with rituximab, ifosfamide and etoposide as measured by the overall metabolic response rate after 2 cycles of treatment or at permanent treatment discontinuation. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Aggressive Non-Hodgkin Lymphoma
What is being tested?
Pixantrone, Ifosfamide and Etoposide
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
74 participants
Where
22 sitesin 2 countries
Study dates
26 Dec 2018to 24 Dec 2024
Phase
Phase 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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Histologically proven CD20+ aggressive non-Hodgkin lymphoma (diffuse large B-cell lymphoma (DLBCL), de novo or transformed DLBCL from previously untreated low grade non-Hodgkin lymphoma or grade 3b follicular lymphoma) as per the World Health Organization (WHO) 2016 criteria
  • Relapsed or refractory disease, defined as follows:
  • Patients eligible for ASCT who failed to achieve a Complete Response (CR) after at least one salvage therapy (eg, Rituximab-Etoposide- Methylprednisolone - Cytarabine - Cisplatin (R-ESHAP) or Rituximab- Dexamethasone- High-dose Cytarabine - Cisplatin (R-DHAP), patients who were previously refractory to Rituximab-Ifosfamide-Cytarabine-Etoposide (R-ICE) (stable disease or progressive disease) are not eligible to the study)
  • Or patients in first relapse after Autologous Stem Cell Transplant (ASCT)
  • Or patients not eligible for ASCT who failed to achieve a CR after at least one prior treatment (and no more than 4 previous lines) or in relapse after at least one prior treatment (and no more than 4 previous lines).
  • Age > or =18 years
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  • Eastern Cooperative Oncology Group (ECOG) performance status < or = 2
  • Subjects must have evaluable disease based on positron emission tomography (PET-CT) scan
  • Minimum life expectancy of 6 months
  • Signed written informed consent
  • Patient covered by any social security system
  • Men must agree to use a barrier method of contraception during the treatment period and until 6 months after the last dose of chemotherapy
  • Women of childbearing potential must agree to use an adequate method of contraception, such as oral contraceptives, intrauterine device, or barrier method of contraception during the treatment period and until 12 months after the last dose of chemotherapy

Who cannot join

  • Any other histological type of lymphoma (Burkitt lymphoma, mantle-cell lymphoma…)
  • Any history of previously treated indolent non-Hodgkin lymphoma
  • Symptomatic central nervous system or meningeal involvement by the lymphoma
  • Contraindication to any drug contained in the Pixantrone with rituximab, ifosfamide and etoposide regimen
  • Treatment with any investigational drug within 28 days before the first study drug administration
  • Any of the following lab abnormalities unless related to the lymphoma or bone marrow infiltration:
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  • Absolute neutrophil count (ANC) < 1.0 G/L
  • Platelet count < 100 G/L
  • Creatinine clearance < 40 mL/min for patients < 70 y, or creatinine clearance < 60 mL/min for patients > or = 70 y, by Modification of Diet in Renal Disease (MDRD) method.
  • Total bilirubin level > 1,5 x Upper Limit of Normal (ULN)
  • Serum ASpartate Transaminase (AST) or ALanine Transaminase (ALT)> 2,5x ULN
  • Known Human Immunodeficiency Virus (HIV) positive
  • Active hepatitis C virus (HCV) (Positive HCV serology with positive Polymerase Chain Reaction (PCR) for HCV RNA)
  • Active hepatitis B (HB) :
  • HBsAg positive
  • HBsAg negative, Ac anti-HBs positive and/or Ac anti-HB core (HBc) positive (Patients who are seropositive due to a history of hepatitis B vaccine are eligible. Patients with Ac anti-HBs positive and/or Ac anti-HBc positive and no history of hepatitis B vaccine are eligible only if PCR for HB virus DNA is negative)
  • Cumulative dose of doxorubicine or equivalent > 450mg/m2
  • Left ventricular ejection fraction (LVEF) < 50% measured by echocardiography or isotopic method
  • Congestive heart failure (any stage from New York Heart Association (NYHA) classification)
  • Uncontrolled arterial hypertension
  • Severe rhythmic heart disease
  • Uncontrolled ischemic heart disease, including patients with stable angina
  • Significant valvular heart disease
  • History of a myocardial infarction within 6 months prior to enrolment
  • Pregnant or lactating females
  • Prior history of malignancies with the exception of non-melanoma skin tumors (basal cell or squamous cell carcinoma) or in situ cervical carcinoma
  • Any serious active disease or co-morbid medical condition according to the investigator's decision
  • Adult person unable to provide informed consent because of intellectual impairment, any serious medical condition, laboratory abnormality or psychiatric illness
  • Use of any standard or experimental anti-cancer drug therapy within 28 days before the first study drug administration
  • Use of corticosteroids prior to baseline PET-CT
  • Person deprived of his/her liberty by a judicial or administrative decision
  • Person hospitalized without consent
  • Adult person under legal protection

Trial locations and contacts

22 sites in 2 countries.

22 sites in 2 countries

France19 sites

  • CH d'Avignon

    Avignon

  • Centre Hospitalier de la Côte Basque

    Bayonne

  • CHU Jean Minjoz

    Besançon

  • Hôpital Haut-Lévèque

    Bordeaux

  • Centre Hospitalier William Morey

    Chalon-sur-Saône

  • Clinique Victor Hugo

    Le Mans

  • CHRU de Lille

    Lille

  • CHU Lyon Sud

    Lyon

  • CHU de la Conception

    Marseille

  • Centre Lacassagne

    Nice

  • Hopital La Pitié Salpétriere

    Paris

  • Hôpital St louis

    Paris

  • CHU de Poitiers

    Poitiers

  • Centre Hospitalier Annecy Genevois

    Pringy

  • CH de Cornouaille

    Quimper

  • Hôpital Robert Debré

    Reims

  • CHU de Rouen

    Rouen

  • CHU de Strasbourg

    Strasbourg

  • CHU de Tours

    Tours

Other trials in France

Belgium3 sites

  • AZ Sint Jan

    Bruges

  • Institut Jules Bordet - Centre des tumeurs de l'ULB

    Brussels

  • Centre Hospitalier de Jolimont

    Haine-Saint-Paul

Other trials in Belgium

About this study

Official title: A Multicentre, Phase II, Open Label, Single Arm Study of Pixantrone in Patients With CD20-positive Relapsed or Refractory Aggressive Non-Hodgkin Lymphoma Treated With Rituximab, Ifosfamide and Etoposide.

This study will evaluate the efficacy of Pixantrone with rituximab, ifosfamide and etoposide as measured by the overall metabolic response rate after 2 cycles of treatment or at permanent treatment discontinuation.

Read the detailed description

This study will evaluate the efficacy of Pixantrone with rituximab, ifosfamide and etoposide as measured by the overall metabolic response rate after 2 cycles of treatment or at permanent treatment discontinuation.

Being tested
Pixantrone, Ifosfamide, Etoposide, Rituximab, Transplant
Keywords
Diffuse Large B-Cell Lymphoma (DLBCL), relapsed or refractory
Medical subject headings
Lymphoma, Large B-Cell, Diffuse, Recurrence

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PixantroneDrug

    Also called Pixuvri

    6 cycles - dose = 80mg/m²

  • IfosfamideOther

    Also called Holoxan

    6 cycles - 1500 mg/m2

  • EtoposideOther

    Also called Vepeside

    6 cycles - 150 mg/m2

  • RituximabOther

    Also called Mabthera

    6 cycles - 375 mg/m2

  • TransplantProcedure or surgery

    after 2 or 6 cycles

Study groups in NCT03458260
Study groupRoleWhat they receive
ExperimentalExperimentalPixantrone plus rituximab, ifosfamide and etoposide.
Receives: Drug: Pixantrone; Other: Ifosfamide; Other: Etoposide; Other: Rituximab; Procedure: Transplant

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Overall Metabolic Response rate (OMR) according to local investigator

    by local investigator according to Lugano classification 2014

    Measured: After 42 days of treatment (2 cycles) or at permanent treatment discontinuation.

Secondary outcomes (7)

  1. Complete Metabolic Response rate (CMR) according to local investigator

    according to local investigator

    Measured: After 42 days of treatment (2 cycles of 21 days) or at permanent treatment discontinuation.

  2. Overall Metabolic Response rate (OMR) according to central review

    according to local investigator

    Measured: After 42 days of treatment (2 cycles of 21 days) or at permanent treatment discontinuation.

  3. Complete Metabolic Response rate (CMR) according to central review

    according to local investigator

    Measured: After 42 days of treatment (2 cycles of 21 days) or at permanent treatment discontinuation.

  4. Number of Adverse Events (AEs) and Serious Adverse Events (SAEs)

    Number of Adverse Events (AEs) and Serious Adverse Events (SAEs)

    Measured: After 42 or 126 days of treatment (2 or 6 cycles of 21 days) or at permanent treatment discontinuation.

  5. Number of patients for whom Partial Metabolic Response (PMR) is transformed into CMR

    Number of patients for whom Partial Metabolic Response is transformed into CMR

    Measured: After 42 days of treatment (2 cycles of 21 days) or at permanent treatment discontinuation.

  6. Rate of ASCT

    Number of patients who perform an ASCT out of total number of patients

    Measured: After 42 days of treatment (2 cycles of 21 days) or at permanent treatment discontinuation.

  7. Success of stem cell collection after treatment

    Rate of successful stem cell collection

    Measured: After 42 days of treatment (2 cycles of 21 days) or at permanent treatment discontinuation.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Mar 2018
  2. Study start26 Dec 2018
  3. Primary completion24 Dec 2024
  4. Study completion24 Dec 2024

Resources

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 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
74 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03458260
Sponsor's protocol ID
PIVeR
Status last verified
Mar 2026
First submitted
26 Feb 2018
Last updated
10 Mar 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Pixantrone, Ifosfamide and Etoposide in people with Aggressive Non-Hodgkin Lymphoma, run by The Lymphoma Academic Research Organisation at 22 sites in 2 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 13 inclusion and 33 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: finished, as of the sponsor's last update on 10 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 22 sites in France, Belgium. 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 phase mean?

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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Overall Metabolic Response rate (OMR) according to local investigator (time frame: After 42 days of treatment (2 cycles) or at permanent treatment discontinuation.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03458260.

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 10 Mar 2026.

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