Den här översättningen är inte klar ännu. Den här sidan är just nu på engelska.

Gå till den engelska sidan

Cure My Disease

Don't miss your cure!

 Log in / Sign up

New hope for Hard-to-Treat lymphoma: targeted drug combo shows promise in phase 3 trial

NCT ID NCT04182204

Disease control Sponsor: Hoffmann-La Roche 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This Phase 3 trial tested whether adding the targeted drug polatuzumab vedotin to standard chemotherapy (R-GEMOX) helps people with relapsed or refractory diffuse large B-cell lymphoma. The study involved 270 participants and compared the combination to chemotherapy alone. The main goals were to check safety and see if the combination improves overall survival.

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, gemcitabine, and oxaliplatin (R-GEMOX chemotherapy)
What this could lead to
If successful, this combination could offer a more effective treatment option for people with relapsed or refractory diffuse large B-cell lymphoma, potentially improving survival.
What could go wrong
This is a completed Phase 3 trial, but results are not yet widely available. The added drug may increase side effects like nerve damage, and it may not work for everyone.

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

270 people

The number who actually took part.

Started

Feb 2020

Finished

Nov 2024

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

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: * Histologically-confirmed diffuse large B-cell lymphoma, not otherwise specified (NOS) or history of transformation of indolent disease to DLBCL * Relapsed disease (disease that has recurred following a response that lasted ≥ 6 months from completion of the last line of therapy) or refractory disease (disease that did not respond to or that progressed during therapy or progressed within 6 months (\< 6 months) of prior therapy) * At least one (≥ 1) line of prior systemic therapy: * Patients may have undergone autologous hematopoietic stem cell transplantation (HSCT) prior to recruitment; In such cases, salvage chemotherapy (e.g., rituximab, dexamethasone, cytarabine, and cisplatin \[R-DHAP\] and rituximab, ifosfamide, carboplatin, and etoposide phosphate \[R-ICE\]) will be counted as one line of therapy and conditioning chemotherapy (e.g., BEAM) followed by consolidative autologous HSCT will be counted as one line of therapy * Patients may have undergone allogeneic HSCT prior to recruitment, so long as they are off all immunosuppressive therapy and have no active GVHD; In such cases, salvage chemotherapy (e.g., R-DHAP and R-ICE) will be counted as one line of therapy and conditioning chemotherapy (e.g., carmustine, etoposide, cytarabine, and melphalan \[BEAM\]) followed by allogeneic HSCT will be counted as a separate line of therapy * Participants may have undergone CAR T-cell therapy prior to recruitment. In such cases, cell collection, conditioning chemotherapy, and infusion will be counted as one line of therapy. * Local therapies (e.g., radiotherapy) will not be considered as lines of treatment * For participants with a history of the transformation of indolent disease to DLBCL, it is preferred that participants have received at least one treatment for the transformed lymphoma. However, if there are cases where the participants have received an anthracycline-containing chemotherapy regimen (such as R-CHOP) for the indolent lymphoma only, then these participants can be considered as eligible. * At least one bi-dimensionally measurable lesion, defined as \> 1.5 cm in its longest dimension as measured by CT or MRI * Eastern Cooperative Oncology Group (ECOG) performance status of 0,1 or 2 * Adequate hematological function * For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraception, and agreement to refrain from donating eggs * For men: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive measures, and agreement to refrain from donating sperm, Exclusion Criteria: * History of severe allergic or anaphylactic reactions to humanized or murine monoclonal antibodies (or recombinant antibody-related fusion proteins) or known sensitivity or allergy to murine products * Contraindication to rituximab, gemcitabine or oxaliplatin * Peripheral neuropathy assessed to be \> Grade 1 according to NCI CTCAE v5.0 * Prior use of polatuzumab vedotin or a gemcitabine plus platinum-based agent combination, recent participation in a clinical trial, and/or treatment with radiotherapy, chemotherapy, immunotherapy, immunosuppressive therapy within 2 weeks * Planned autologous or allogenic stem cell transplantation or CAR T-cell therapy at time of recruitment * Primary or secondary central nervous system (CNS) lymphoma * Richter's transformation or prior CLL * Abnormal laboratory values or health conditions, as assessed by the investigator, any known conditions preventing adherence to protocol or active bacterial, viral, fungal, mycobacterial, parasitic, or other infection * Vaccination with a live vaccine within 4 weeks prior to treatment * Recent major surgery (within 6 weeks before the start of Cycle 1 Day 1) other than for diagnosis * 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 * Pregnant or breastfeeding, or intending to become pregnant during the study or within 12 months after the last dose of study drug * Women of childbearing potential must have a negative serum pregnancy test result within 7 days prior to initiation of study drug

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Diffuse large B-cell lymphoma are added.

Vår säkerhetsrekommendation!

Genom att skicka in godkänner du våra Användarvillkor

Conditions

The condition(s) this trial relates to.

diffuse large B-cell lymphoma lymphoma

As listed by the trial registrant

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

Diffuse large B-cell lymphoma

Contacts and locations

Locations

  • Abdurrahman Yurtarslan Onkoloji Training and Research Hospital

    Ankara, 06200, Turkey (Türkiye)

  • Akdeniz Uni School of Medicine

    Antalya, 07059, Turkey (Türkiye)

  • All India Institute of Medical Sciences ,Institute Rotary Cancer Hospital

    New Delhi, National Capital Territory of Delhi, 110029, India

  • Amerikan HAstanesi Onkoloji Birimi Te?vikiye

    Ni?anta??, 34365, Turkey (Türkiye)

  • Attiko Hospital

    Athens, 124 62, Greece

  • Az. Osp. Uni Ria Policlinico Tor Vergata

    Rome, Lazio, 00133, Italy

  • Azienda Ospedaliero-Universitaria Policlinico di Modena Ematologia

    Modena, Emilia-Romagna, 41123, Italy

  • Cancer Center, Sun Yat-sen University of Medical Sciences

    Guangzhou, 510060, China

  • Cancer Specialists

    Jacksonville, Florida, 32256, United States

  • Centre Henri Becquerel

    Rouen, 76038, France

  • Centre hospitalier regional de Trois-Rivieres

    Trois-Rivières, Quebec, G8Z 3R9, Canada

  • Chungnam National University Hospital

    Daejeon, 35015, South Korea

  • First Affiliated Hospital of Medical College of Xi'an Jiaotong University

    Xi'an, 710061, China

  • Guangxi Cancer Hospital of Guangxi Medical University

    Nanning, 530021, China

  • Gyeongsang National University Hospital

    Gyeongsangnam-do, 52727, South Korea

  • Health Pharma Professional Research

    Mexico City, Mexico CITY (federal District), 03100, Mexico

  • Hopital Bretonneau

    Tours, 37044, France

  • Hopital De Haut Leveque

    Pessac, 33604, France

  • Hopital Henri Mondor

    Créteil, 94010, France

  • Hospital Clinico Universitario de Salamanca

    Salamanca, 37007, Spain

  • Hospital Sao Rafael - HSR

    Salvador, Estado de Bahia, 41253-190, Brazil

  • Hospital Univ. 12 de Octubre

    Madrid, 28041, Spain

  • Hospital Universitari Germans Trias i Pujol

    Badalona, Barcelona, 08915, Spain

  • Hospital Universitario Dr. Peset

    Valencia, 46017, Spain

  • Hospital Universitario de Canarias

    San Cristóbal de La Laguna, Tenerife, 38320, Spain

  • Hospital das Clinicas - FMUSP

    São Paulo, São Paulo, 05403-000, Brazil

  • Hospital das Clinicas - UFRGS

    Porto Alegre, Rio Grande do Sul, DUMMY_VALUE, Brazil

  • Hospital de Especialidades Centro Medico Nacional La Raza

    Mexico City, Mexico CITY (federal District), 02990, Mexico

  • Hu Nan Provincial Cancer Hospital

    Changsha, 410006, China

  • ICANS

    Strasbourg, 67200, France

  • IHA Hematology Oncology Consultants - Ann Arbor

    Ann Arbor, Michigan, 48106, United States

  • Institute of Hematology and Hospital of Blood Disease

    Tianjin, 300020, China

  • Instituto Nacional de Cancerologia

    Distrito Federal, 14080, Mexico

  • Istanbul Uni Istanbul Medical Faculty

    Istanbul, 34093, Turkey (Türkiye)

  • Istanbul University Cerrahpasa Medical Faculty

    Istanbul, 34098, Turkey (Türkiye)

  • Kings College Hospital

    London, SE5 9RS, United Kingdom

  • Kocaeli Universitesi Tip Fakultesi

    Kocaeli, 41380, Turkey (Türkiye)

  • Laiko General Hospital

    Athens, 115 27, Greece

  • Liga Norte Riograndense Contra O Câncer

    Natal, Rio Grande do Norte, 59040150, Brazil

  • London Health Sciences Centre

    London, Ontario, N6A 5W9, Canada

  • MSKCC at Basking Ridge

    Basking Ridge, New Jersey, 07920, United States

  • Memorial Cancer Institute at Memorial West

    Pembroke Pines, Florida, 33028, United States

  • Memorial Sloan Kettering Cancer Center at Bergen

    Montvale, New Jersey, 07645, United States

  • Memorial Sloan Kettering Nassau

    Uniondale, New York, 11553, United States

  • Memorial Sloan-Kettering Cancer Center

    New York, New York, 10065, United States

  • Niagara Health Systems - St. Catherines General Site

    St. Catharines, Ontario, L2R 7C6, Canada

  • Nottingham City Hospital

    Nottingham, NG5 1PB, United Kingdom

  • Oulu University Hospital

    Oulu, 90029, Finland

  • Pusan National University Hospital

    Busan, 49241, South Korea

  • Sakarya Universitesi Egitim ve Arastirma Hastanesi

    Adapazari/Sakarya, 54100, Turkey (Türkiye)

  • Seoul National University Bundang Hospital

    Seongnam-si, 13605, South Korea

  • Severance Hospital, Yonsei University Health System

    Seoul, 03722, South Korea

  • St James' Hospital

    Dublin, DUMMY_VALUE, Ireland

  • Tampere University Hospital

    Tampere, 33520, Finland

  • Tata Medical Center

    Kolkata, West Bengal, 700160, India

  • Tata Memorial Hospital

    Mumbai, Maharashtra, 400013, India

  • The 1st Affiliated Hospital of Nanchang Unversity

    Nanchang, 330006, China

  • USL 4 di Prato - Nuovo Ospeale di Prato

    Prato, Tuscany, 59100, Italy

  • Uni Degli Studi Di Bari, Policlinico

    Bari, Apulia, 70124, Italy

  • Union Hospital Tongji Medical College Huazhong University of Science and Technology

    Wuhan, 430023, China

  • Universitätsklinikum Ulm

    Ulm, 89081, Germany

  • West China Hospital - Sichuan University

    Chengdu, 610047, China

More trials for these conditions

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