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

March 6, 2026 updated by: The Lymphoma Academic Research Organisation

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
74

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Belgium
      • Bruges, Belgium
        • AZ Sint Jan
      • Brussels, Belgium
        • Institut Jules Bordet - Centre des tumeurs de l'ULB
      • Haine-Saint-Paul, Belgium
        • Centre Hospitalier de Jolimont
  • France
      • Avignon, France
        • CH d'Avignon
      • Bayonne, France
        • Centre Hospitalier de la côte Basque
      • Besançon, France
        • Chu Jean Minjoz
      • Bordeaux, France
        • Hôpital Haut-Lévêque
      • Chalon-sur-Saône, France
        • Centre Hospitalier William Morey
      • Le Mans, France
        • Clinique Victor Hugo
      • Lille, France
        • CHRU de Lille
      • Lyon, France
        • CHU Lyon Sud
      • Marseille, France
        • CHU de la Conception
      • Nice, France
        • Centre Lacassagne
      • Paris, France
        • Hôpital St Louis
      • Paris, France
        • Hôpital La Pitié Salpêtrière
      • Poitiers, France
        • Chu de Poitiers
      • Pringy, France
        • Centre Hospitalier Annecy Genevois
      • Quimper, France
        • CH de Cornouaille
      • Reims, France
        • Hôpital Robert Debré
      • Rouen, France
        • CHU de Rouen
      • Strasbourg, France
        • CHU de Strasbourg
      • Tours, France
        • CHU de Tours

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. 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

  2. Relapsed or refractory disease, defined as follows:

    1. 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)
    2. Or patients in first relapse after Autologous Stem Cell Transplant (ASCT)
    3. 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).
  3. Age > or =18 years
  4. Eastern Cooperative Oncology Group (ECOG) performance status < or = 2
  5. Subjects must have evaluable disease based on positron emission tomography (PET-CT) scan
  6. Minimum life expectancy of 6 months
  7. Signed written informed consent
  8. Patient covered by any social security system
  9. Men must agree to use a barrier method of contraception during the treatment period and until 6 months after the last dose of chemotherapy
  10. 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

Exclusion Criteria:

  1. Any other histological type of lymphoma (Burkitt lymphoma, mantle-cell lymphoma…)
  2. Any history of previously treated indolent non-Hodgkin lymphoma
  3. Symptomatic central nervous system or meningeal involvement by the lymphoma
  4. Contraindication to any drug contained in the Pixantrone with rituximab, ifosfamide and etoposide regimen
  5. Treatment with any investigational drug within 28 days before the first study drug administration

  6. Any of the following lab abnormalities unless related to the lymphoma or bone marrow infiltration:

    1. Absolute neutrophil count (ANC) < 1.0 G/L
    2. Platelet count < 100 G/L
    3. 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.
    4. Total bilirubin level > 1,5 x Upper Limit of Normal (ULN)
    5. Serum ASpartate Transaminase (AST) or ALanine Transaminase (ALT)> 2,5x ULN
  7. Known Human Immunodeficiency Virus (HIV) positive
  8. Active hepatitis C virus (HCV) (Positive HCV serology with positive Polymerase Chain Reaction (PCR) for HCV RNA)

  9. Active hepatitis B (HB) :

    1. HBsAg positive
    2. 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)
  10. Cumulative dose of doxorubicine or equivalent > 450mg/m2
  11. Left ventricular ejection fraction (LVEF) < 50% measured by echocardiography or isotopic method
  12. Congestive heart failure (any stage from New York Heart Association (NYHA) classification)
  13. Uncontrolled arterial hypertension
  14. Severe rhythmic heart disease
  15. Uncontrolled ischemic heart disease, including patients with stable angina
  16. Significant valvular heart disease
  17. History of a myocardial infarction within 6 months prior to enrolment
  18. Pregnant or lactating females
  19. Prior history of malignancies with the exception of non-melanoma skin tumors (basal cell or squamous cell carcinoma) or in situ cervical carcinoma
  20. Any serious active disease or co-morbid medical condition according to the investigator's decision
  21. Adult person unable to provide informed consent because of intellectual impairment, any serious medical condition, laboratory abnormality or psychiatric illness
  22. Use of any standard or experimental anti-cancer drug therapy within 28 days before the first study drug administration
  23. Use of corticosteroids prior to baseline PET-CT
  24. Person deprived of his/her liberty by a judicial or administrative decision
  25. Person hospitalized without consent
  26. Adult person under legal protection

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Experimental
Pixantrone plus rituximab, ifosfamide and etoposide.
Drug: Pixantrone
6 cycles - dose = 80mg/m²
Other Names:
  • Pixuvri
Other: Ifosfamide
6 cycles - 1500 mg/m2
Other Names:
  • Holoxan
Other: Etoposide
6 cycles - 150 mg/m2
Other Names:
  • Vepeside
Other: Rituximab
6 cycles - 375 mg/m2
Other Names:
  • Mabthera
Procedure: Transplant
after 2 or 6 cycles

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Overall Metabolic Response rate (OMR) according to local investigator
Time Frame: After 42 days of treatment (2 cycles) or at permanent treatment discontinuation.
by local investigator according to Lugano classification 2014
After 42 days of treatment (2 cycles) or at permanent treatment discontinuation.

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Complete Metabolic Response rate (CMR) according to local investigator
Time Frame: After 42 days of treatment (2 cycles of 21 days) or at permanent treatment discontinuation.
according to local investigator
After 42 days of treatment (2 cycles of 21 days) or at permanent treatment discontinuation.
Overall Metabolic Response rate (OMR) according to central review
Time Frame: After 42 days of treatment (2 cycles of 21 days) or at permanent treatment discontinuation.
according to local investigator
After 42 days of treatment (2 cycles of 21 days) or at permanent treatment discontinuation.
Complete Metabolic Response rate (CMR) according to central review
Time Frame: After 42 days of treatment (2 cycles of 21 days) or at permanent treatment discontinuation.
according to local investigator
After 42 days of treatment (2 cycles of 21 days) or at permanent treatment discontinuation.
Rate of ASCT
Time Frame: After 42 days of treatment (2 cycles of 21 days) or at permanent treatment discontinuation.
Number of patients who perform an ASCT out of total number of patients
After 42 days of treatment (2 cycles of 21 days) or at permanent treatment discontinuation.
Success of stem cell collection after treatment
Time Frame: After 42 days of treatment (2 cycles of 21 days) or at permanent treatment discontinuation.
Rate of successful stem cell collection
After 42 days of treatment (2 cycles of 21 days) or at permanent treatment discontinuation.
Number of Adverse Events (AEs) and Serious Adverse Events (SAEs)
Time Frame: After 42 or 126 days of treatment (2 or 6 cycles of 21 days) or at permanent treatment discontinuation.
Number of Adverse Events (AEs) and Serious Adverse Events (SAEs)
After 42 or 126 days of treatment (2 or 6 cycles of 21 days) or at permanent treatment discontinuation.
Number of patients for whom Partial Metabolic Response (PMR) is transformed into CMR
Time Frame: After 42 days of treatment (2 cycles of 21 days) or at permanent treatment discontinuation.
Number of patients for whom Partial Metabolic Response is transformed into CMR
After 42 days of treatment (2 cycles of 21 days) or at permanent treatment discontinuation.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
The Lymphoma Academic Research Organisation

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Luc-Matthieu Fornecker, CHU de Strasbourg
  • Principal Investigator: Eric Van den Neste, UCL St Luc Bruxelles
  • Principal Investigator: Sandy Amorin, Hôpital St Louis - Paris

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 26, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 24, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 24, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 26, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 1, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 8, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 10, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 6, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • PIVeR

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Aggressive Non-Hodgkin Lymphoma

Clinical Trials on Pixantrone

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings