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New targeted therapy combo aims to boost remission in Tough-to-Treat lymphoma

NCT ID NCT04833114

Disease control Sponsor: GWT-TUD GmbH Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This Phase 3 trial tested whether adding the targeted drug polatuzumab vedotin to a standard chemotherapy regimen (R-ICE) helps people with relapsed or refractory diffuse large B-cell lymphoma (DLBCL). The study enrolled 306 adults whose lymphoma had come back or did not respond to initial treatment. The main goal was to see if the new combination improves event-free survival compared to R-ICE alone.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Polatuzumab vedotin (a targeted antibody-drug conjugate) combined with rituximab, ifosfamide, carboplatin, and etoposide (chemotherapy)
What this could lead to
If successful, this combination could become a new standard salvage therapy for people with relapsed or refractory DLBCL, potentially improving the chance of remission before a stem cell transplant.
What could go wrong
This is a completed Phase 3 trial, but results are not yet widely published. Adding polatuzumab vedotin may increase side effects like nerve damage or infections, and it may not improve outcomes enough to change current practice.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

306 people

The number who actually took part.

Started

Apr 2021

Finished

Dec 2025

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. The informed consent form must be signed before any study specific tests or procedures are done 2. Adult male and female patients ≥18 years (≥16 years in the UK\*) at the time of inclusion in the study (\* In the UK an "adult" means a person who has attained the age of 16 years, according to The Medicines for Human Use (Clinical Trials) Regulations 2004, Part 1 Point 2.) 3. Ability to understand and follow study-related instructions 4. Risk group: All patients with one of the following histologically defined entities: Histological diagnosis of primary refractory or relapsed aggressive B-cell non-Hodgkin lymphoma (B-NHL), confirmed by a biopsy of involved nodal or extranodal site. Patients with any of the following histologies can be included: * DLBCL not otherwise specified (NOS) * T-cell/histiocyte-rich large B-cell lymphoma * Primary cutaneous DLBCL, leg type * Epstein-Barr virus (EBV)-positive DLBCL, NOS * DLBCL associated with chronic inflammation * Primary mediastinal (thymic) large B-cell lymphoma * High-grade B-cell lymphoma, with MYC and BCL2 and/or BCL6 rearrangements * High-grade B-cell lymphoma, NOS Refractory disease is defined as no complete remission to first line therapy; subjects who are intolerant to first line therapy are excluded. Three groups of patients are eligible: * Progressive disease (PD) as best response to first line therapy (biopsy not mandatory if diagnostic sample available). * Stable disease (SD) as best response after at least 4 cycles of first line therapy (e.g., 4 cycles of R-CHOP) (biopsy not mandatory if diagnostic sample available). * Partial response (PR) as best response after at least 6 cycles, and biopsy-proven residual disease or disease Progression after the partial response. Relapsed disease is defined as complete remission to first line therapy followed by biopsy proven disease relapse. 5. Performance Status ECOG 0-2 at time of randomization or ECOG 3 at screening if this is DLBCL-related and has improved to ECOG 2 or less with a 7-day steroid treatment during the screening Phase (e.g. 1 mg/kg prednisone). 6. Information on all 5 International Prognostic Index (IPI) factors 7. Staging (PET-CT based-staging according to Lugano criteria 2014). Patients must have PET-positive lesions. 8. Subjects must have received adequate first line therapy including at a minimum: i) anti-CD20 monoclonal antibody unless Investigator determines that tumor is CD20 negative, and ii) an anthracycline containing chemotherapy Regimen 9. Intent to proceed to high-dose therapy (HDT) and stem cell transplantation (SCT) if response to second line therapy 10. Adequate hematological function, as defined by: hemoglobin ≥ 8 g/dL, absolute neutrophil count (ANC) ≥ 1.0 x 109/L OR ≥ 0.5 x 109/L if neutropenia is attributable to underlying disease and before the administration of steroids, and platelet count ≥ 75 x 109/L OR ≥ 50 x 109/L if thrombocytopenia is attributable to Underlying disease 11. Women of childbearing potential must have a negative pregnancy test result within 7 days prior to the first study drug Administration 12. For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive measures, and agreement to refrain from donating eggs 13. For men: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive measures, and agreement to refrain from donating sperm Exclusion Criteria: (1) Serious accompanying disorder leading to impaired organ function causing significant clinical problems and reduced life expectancy of less than 3 months. In particular, patients with the following organ dysfunction caused by accompanying disorders are to be excluded: * Heart failure with left ventricular ejection fraction (LVEF) \< 45% * Impaired pulmonary function with vital capacity (VC) or forced expiratory volume (FEV1) \< 50% of normal (only in case of history of significant pulmonary disease) * Impaired renal function with glomerular filtration rate (GFR) \< 50 mL/min (calculated) * Impaired liver function with alanine aminotransferase (ALAT), aspartate aminotransferase (ASAT) or Bilirubin \> 1.5 x upper limit of normal (ULN). If elevation is caused by the disease, threshold of 2.5 x ULN is accepted * Peripheral neuropathy \> Grade II (2) Human immunodeficiency virus (HIV)-positivity with detectable viral load and/or a CD4+ count below 0.3/nL (3) Hepatitis B and C as defined by seropositivity (HBsAG and anti HBe/ anti HBc; anti-Hc); in case of false positive serology (transfused antibodies) negative PCR-results will allow patient inclusion. Patients with occult or prior HBV infection (defined as negative HBsAg and positive hepatitis B core antibody \[HBcAb\]) may be included if HBV DNA is undetectable, provided that they are willing to undergo DNA testing on Day 1 of every cycle and monthly for at least 12 months after the last cycle of study Treatment (4) Known active bacterial, viral, fungal, mycobacterial, parasitic, or other infection (excluding fungal infections of nail beds) at study inclusion or any unresolved major episode of infection (as evaluated by the investigator) within 1 week prior to Cycle 1 Day 1 (5) Patients with suspected or latent tuberculosis. Latent tuberculosis needs to be confirmed by positive interferon-gamma release Assay (6) Primary or secondary central nervous system (CNS) lymphoma at the time of recruitment (7) Richter's transformation or prior chronic lymphocytic leukemia (CLL) (8) Vaccination with a live vaccine within 4 weeks prior to Treatment (9) Recent major surgery (within 6 weeks before the start of Cycle 1 Day 1) other than for diagnosis (10) Treatment with radiotherapy, chemotherapy, immunotherapy, immunosuppressive therapy, or any investigational agent for the purposes of treating cancer within 2 weeks prior to Cycle 1 Day 1 (11) Received more than one line of therapy for DLBCL (12) Received polatuzumab vedotin as part of the first line therapy (13) Any other diseases, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or that may affect the interpretation of the results or render the patient at high risk from treatment complications (14) Ongoing treatment or study procedures within any other Investigational Medicinal Product (IMP) clinical trial with the exception of follow-up. In case of a preceding clinical trial, last application of the respective IMP(s) must have been done more than five elimination half-lives before start of study medication in this trial. (15) History of severe allergic or anaphylactic reactions to human, humanized, chimeric, or murine monoclonal antibodies (16) History of hypersensitivity to any of the study drugs or their ingredients or to drugs with similar structure (17) Contraindications according to the Investigator´s Brochure (IB) of polatuzumab vedotin or the local Summary of Product Characteristics (SmPCs) of the used rituximab, ifosfamide, carboplatin or etoposide products (18) Criteria which in the opinion of the investigator preclude participation for scientific reasons, for reasons of compliance, or for reasons of the subject's Safety (19) Pregnancy or breastfeeding, or intending to become pregnant during the study or within 12 months after the last dose of study drug (20) Close affiliation with the investigator (e.g. a close relative) or persons working at the study site (21) Subject is an employee of the sponsor or involved Contract Research Organization At study inclusion, any organ impairment due to lymphoma infiltration is NOT regarded as an exclusion criterion.

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Conditions

The condition(s) this trial relates to.

diffuse large B-cell lymphoma diffuse large B-cell lymphoma with chronic inflammation Epstein-Barr virus-positive diffuse large B-cell lymphoma of the elderly high grade B-cell lymphoma high grade B-cell lymphoma with MYC and/ or BCL2 and/or BCL6 rearrangement primary cutaneous diffuse large B-cell lymphoma, Leg type primary mediastinal large B-cell lymphoma relapsed/refractory diffuse large B-cell lymphoma T-cell/histiocyte rich large B cell lymphoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Refractory diffuse large B-cell lymphoma Relapsed diffuse large B cell lymphoma

Contacts and locations

Locations

  • AKH Meduni Wien Universitätsklinik für Innere Medizin I:

    Vienna, 1090, Austria

  • Belfast City Hospital

    Belfast, BT9 7AB, United Kingdom

  • Clínica Universidad de Navarra (Madrid location)

    Madrid, 28027, Spain

  • Clínica Universidad de Navarra (Pamplona location)

    Pamplona, 31008, Spain

  • Complejo Asistencial Universitario de Salamanca

    Salamanca, 37007, Spain

  • Complejo Hospitalario Universitario de Gran Canaria Dr. Negrín

    Las Palmas de Gran Canaria, 35012, Spain

  • Complejo Hospitalario Universitario de Vigo

    Vigo, 36212, Spain

  • DIAKO Ev.Diakonie-Krankenhaus gemeinnützige GmbH

    Bremen, Germany

  • Derriford Hospital, Plymouth

    Plymouth, PL6 8DH, United Kingdom

  • Georg-August-Universität Göttingen Universitätsmedizin Göttingen

    Göttingen, Germany

  • HELIOS Klinik Berlin-Buch, Klinik für Hämatologie und Stammzelltransplantation

    Berlin, 13125, Germany

  • Hanusch Krankenhaus

    Vienna, 1140, Austria

  • Helios St. Johannes Klinik

    Duisburg, Germany

  • Helios Universitätsklinikum Wuppertal

    Wuppertal, Germany

  • Hospital Clinic i Provincial de Barcelona

    Barcelona, 08036, Spain

  • Hospital Clínico Universitario de Valencia

    Valencia, 46010, Spain

  • Hospital General Universitario de Alicante

    Alicante, 03010, Spain

  • Hospital Germans Trias I Pujol

    Badalona, 08916, Spain

  • Hospital Universitari Vall d'Hebron

    Barcelona, 8035, Spain

  • Hospital Universitario 12 de Octubre

    Madrid, 28041, Spain

  • Hospital Universitario Fundación Jimenez Díaz

    Madrid, 28040, Spain

  • Hospital Universitario La Paz

    Madrid, 28046, Spain

  • Hospital Universitario Marqués de Valdecilla

    Santander, 39908, Spain

  • Hospital Universitario Ramón y Cajal

    Madrid, Spain

  • Hospital Universitario Son Espases

    Palma, Balearic Islands, 07120, Spain

  • Hospital Universitario Virgen de la Arrixaca

    Murcia, 30003, Spain

  • Hospital Universitario Virgen del Rocío

    Seville, 41013, Spain

  • Hospital Universitario de Cabueñes

    Gijón, 33394, Spain

  • Hospital Universitario de Donostia

    Donostia / San Sebastian, 20014, Spain

  • Institut Català d'oncologia de L'Hospitalet (ICO-L'Hospitalet)

    L'Hospitalet de Llobregat, 08908, Spain

  • Kepler Universitätsklinikum Med Campus III, Univ.-Klinik für Hämatologie und Internistische Onkologie

    Linz, 4021, Austria

  • Klinik für Onkologie, Hämatologie und Palliativmedizin

    Düsseldorf, 40479, Germany

  • Klinikum Chemnitz gGmbH

    Chemnitz, Germany

  • Klinikum Ludwigshafen

    Ludwigshafen, Germany

  • Klinikum Mutterhaus

    Trier, Germany

  • Klinikum Oldenburg

    Oldenburg, Germany

  • Klinikum Stuttgart

    Stuttgart, Germany

  • Klinikum Wels-Grieskirchen Abteilung für Innere Medizin IV

    Wels, 4600, Austria

  • LKH Hochsteiermark Standort Leoben Abteilung für Innere Medizin Department für Hämato-Onkologie

    Leoben, 8700, Austria

  • Landeskrankenhaus Salzburg

    Salzburg, 5020, Austria

  • Nottingham City Hospital

    Nottingham, NG5 1PB, United Kingdom

  • Ordensklinikum Linz GmbH- Elisabethinen: I. Interne Abteilung Hämato-Onkologie

    Linz, 4020, Austria

  • Philipps-Universität Marburg

    Marburg, Germany

  • Queens Hospital, Romford

    Romford, RM7 0AG, United Kingdom

  • Royal Cornwall Hospital

    Cornwell, TR1 3LJ, United Kingdom

  • St James University Hospital

    Leeds, LS9 7TF, United Kingdom

  • St. Johannes Hospital Dortmund

    Dortmund, Germany

  • Städtisches Klinikum Braunschweig

    Braunschweig, Germany

  • Städtisches Krankenhaus Kiel

    Kiel, Germany

  • The Christie NHS Foundation Trust

    Manchester, M20 4BX, United Kingdom

  • UK Graz Universitätsklinik für Innere Medizin Klinische Abteilung für Hämatologie

    Graz, 8036, Austria

  • University Hospital Southampton NHS

    Southampton, S016 6YD, United Kingdom

  • University London College Hospitals

    London, NW1 2PG, United Kingdom

  • Universitätsklinikum Dresden

    Dresden, Germany

  • Universitätsklinikum Frankfurt

    Frankfurt, Germany

  • Universitätsklinikum Hamburg-Eppendorf

    Hamburg, Germany

  • Universitätsklinikum Jena

    Jena, Germany

  • Universitätsklinikum Magdeburg

    Magdeburg, Germany

  • Universitätsklinikum Münster

    Münster, Germany

  • Universitätsklinikum RWTH-Aachen

    Aachen, Germany

  • Universitätsklinikum Ulm

    Ulm, Germany

  • Universitätsmedizin der Johannes Gutenberg-Universität Mainz

    Mainz, Germany

  • Unversitätsmedizin Rostock

    Rostock, Germany

  • Westpfalz-Klinikum GmbH

    Kaiserslautern, Germany

More trials for these conditions

Other studies related to the condition(s) this trial covers.