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 drug combo aims to stall lymphoma without chemo

NCT ID NCT02367040

Disease control Sponsor: Bayer 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This Phase 3 trial tested whether adding the targeted drug copanlisib to the standard antibody rituximab helps people with relapsed indolent B-cell non-Hodgkin's lymphoma live longer without their cancer getting worse. The study included 458 adults who had already received at least one prior treatment. Participants received either copanlisib plus rituximab or a placebo plus rituximab, with the goal of seeing if the combination delays disease progression.

What this could mean

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

Active substance
Copanlisib (Aliqopa) combined with rituximab
What this could lead to
If successful, this combination could offer a new chemotherapy-free option to delay cancer progression in people with relapsed indolent non-Hodgkin's lymphoma.
What could go wrong
This is a completed Phase 3 trial, but results are not yet widely available. The drug may cause side effects like high blood pressure or infections, and not all patients may benefit.

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

458 people

The number who actually took part.

Started

Aug 2015

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 diagnosis of Indolent non-Hodgkin's lymphoma (iNHL) in CD20 positive patients, with histological subtype limited to: * Follicular lymphoma(FL) grade1-2-3a * Small lymphocytic lymphoma(SLL) with absolute lymphocyte count \<5x10\*9/L at study entry * Lymphoplasmacytoid lymphoma/Waldenström macroglobulinemia (LPL/WM) * Marginal zone lymphoma (MZL) (splenic, nodal, or extra-nodal) * Patients must have relapsed (recurrence after complete response or presented progression after partial response) after the last rituximab-, rituximab biosimilars-, or anti-CD20 monoclonal antibody (e.g. obinutuzumab)-containing therapy (other previous treatment lines after rituximab are allowed). A previous regimen is defined as one of the following: at least 2 months of single-agent therapy (less than 2 months of therapy is allowed for patients who responded to single-agent rituximab, rituximab biosimilars, or anti-CD20 monoclonal antibody); at least 2 consecutive cycles of polychemotherapy; autologous transplant; radioimmunotherapy. Previous exposure to PI3K is acceptable (except to copanlisib) provided there is no resistance. Patients with prior intolerance to PI3K inhibitors other than copanlisib are eligible. * Non-WM must have at least one bi-dimensionally measurable lesion (which has not been previously irradiated) according to the Lugano Classification. For patients with splenic MZL (Marginal-zone lymphoma) this requirement may be restricted to splenomegaly alone since that is usually the only manifestation of measurable disease. * Patients affected by WM who do not have at least one bi-dimensionally measurable lesion in the baseline radiologic assessment must have measurable disease, defined as presence of immunoglobulin M (IgM) paraprotein with a minimum IgM level ≥ 2 x upper limit of normal (ULN) and positive immunofixation test . * Male or female patients ≥ 18 years of age * Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2 * Life expectancy of at least 3 months * Availability of fresh tumor tissue and/or archival tumor tissue for central pathology(obtained within 5 years of the consent date) at Screening * Adequate baseline laboratory values collected no more than 7 days before starting study treatment * Left ventricular ejection fraction ≥ 45% * Patients must either: * have had a progression-free and treatment-free interval of at least 12 months after completion of the rituximab-, rituximab biosimilars-, or anti-CD20 monoclonal antibody-containing treatment OR * be considered unfit to receive chemotherapy on reason of age, concomitant morbidities, and/or residual toxicity from previous treatments, or unwillingness to receive chemotherapy. These patients must also have had a progression-free and treatment-free interval of at least 6 months after completion of the last rituximab-, rituximab biosimilars-, or anti-CD20 monoclonal antibody-containing treatment. Patients in whom chemotherapy is contraindicated are defined by one of the following features: * Age ≥ 80 years * Age \< 80 years and at least 1 of the following conditions: * at least 3 grade 3 CIRS-G comorbidities OR * at least 1 grade 4 CIRS-G comorbidity (if compatible to participation in the study). Exclusion Criteria: * Histologically confirmed diagnosis of follicular lymphoma grade 3b or transformed disease, or chronic lymphocytic leukemia * Progression free interval or treatment free interval of less than 12 months since the last rituximab-, rituximab biosimilars-, or anti-CD20 monoclonal antibody (e.g. obinutuzumab)-containing treatment(including maintenance with these drugs). For patients considered unwilling/unfit to receive chemotherapy : progression free interval or treatment free interval of less than 6 months since the last rituximab-, rituximab biosimilars-, or anti-CD20 monoclonal antibody-containing treatment (including maintenance with these drugs), as assessed by the investigator * History or concurrent condition of interstitial lung disease of any severity and/or severely impaired lung function * Known lymphomatous involvement of the central nervous system * Patients with HbA1c \> 8.5% at Screening * Known history of human immunodeficiency virus (HIV) infection * Hepatitis B (HBV) or hepatitis C (HCV). Patients positive for HBsAg or HBcAb will be eligible if they are negative for HBV-DNA, these patients should receive prophylactic antiviral therapy. Patients positive for anti- HCV antibody will be eligible if they are negative for HCV-RNA * Documented evidence of resistance to prior treatment with idelalisib or other PI3K inhibitors. * Prior treatment with copanlisib * Cytomegalovirus (CMV) infection. Patients who are CMV PCR positive at baseline will not be eligible.

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Follicular lymphoma grade 1-2-3A are added.

Vår säkerhetsrekommendation!

Genom att skicka in godkänner du våra Användarvillkor

Conditions

The condition(s) this trial relates to.

B-cell chronic lymphocytic leukemia follicular lymphoma indolent B-cell non-Hodgkin lymphoma lymphoma, non-Hodgkin, familial lymphoplasmacytic lymphoma marginal zone lymphoma non-Hodgkin lymphoma

As listed by the trial registrant

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

Lymphoma, non-Hodgkin

Contacts and locations

Locations

  • Study site

    West Covina, California, 91790, United States

  • Study site

    Ashland, Kentucky, 41101, United States

  • Study site

    Louisville, Kentucky, 40207, United States

  • Study site

    Bethesda, Maryland, 20817, United States

  • Study site

    Las Vegas, Nevada, 89169, United States

  • Study site

    Montvale, New Jersey, 07645, United States

  • Study site

    New York, New York, 10065, United States

  • Study site

    Canton, Ohio, 44718, United States

  • Study site

    Salt Lake City, Utah, 84106, United States

  • Study site

    Spokane, Washington, 99208, United States

  • Study site

    Buenos Aires, Ciudad Auton. de Buenos Aires, TBC, Argentina

  • Study site

    Rosario, Santa Fe Province, S2000DEJ, Argentina

  • Study site

    San Miguel de Tucumán, Tucumán Province, T4000, Argentina

  • Study site

    Córdoba, X5000AOQ, Argentina

  • Study site

    Ballarat, Victoria, 3350, Australia

  • Study site

    Nedlands, 6009, Australia

  • Study site

    Graz, Styria, 8036, Austria

  • Study site

    Vienna, 1090, Austria

  • Study site

    Vienna, 1130, Austria

  • Study site

    Ottignies, 1340, Belgium

  • Study site

    Passo Fundo, Rio Grande do Sul, 99020-240, Brazil

  • Study site

    Porto Alegre, Rio Grande do Sul, 90850-170, Brazil

  • Study site

    Barretos/SP, São Paulo, 14784-400, Brazil

  • Study site

    Jaú, São Paulo, 17210-120, Brazil

  • Study site

    São Paulo, São Paulo, 01234-030, Brazil

  • Study site

    São Paulo, São Paulo, 08270-070, Brazil

  • Study site

    São Paulo, 05403-000, Brazil

  • Study site

    São Paulo, 05651-901, Brazil

  • Study site

    Plovdiv, 4000, Bulgaria

  • Study site

    Sofia, 1756, Bulgaria

  • Study site

    Varna, 9010, Bulgaria

  • Study site

    Temuco, Araucania, 4800827, Chile

  • Study site

    Fuzhou, Fujian, 350000, China

  • Study site

    Guangzhou, Guangdong, 510000, China

  • Study site

    Guangzhou, Guangdong, TBC, China

  • Study site

    Wuhan, Hubei, 430079, China

  • Study site

    Nanjing, Jiangsu, 210000, China

  • Study site

    Suzhou, Jiangsu, 215000, China

  • Study site

    Nanchang, Jiangxi, 330029, China

  • Study site

    Changchun, Jilin, 130061, China

  • Study site

    Shengyang, Liaoning, 110042, China

  • Study site

    Chengdu, Sichuan, 610041, China

  • Study site

    Ürümqi, Xinjiang, 830011, China

  • Study site

    Hangzhou, Zhejiang, 310000, China

  • Study site

    Hangzhou, Zhejiang, 310022, China

  • Study site

    Beijing, 100000, China

  • Study site

    Beijing, 100050, China

  • Study site

    Beijing, 100083, China

  • Study site

    Beijing, 100730, China

  • Study site

    Chongqing, 400030, China

  • Study site

    Chongqing, 400042, China

  • Study site

    Shanghai, 200000, China

  • Study site

    Shanghai, 200025, China

  • Study site

    Shanghai, 200032, China

  • Study site

    Tianjin, 300000, China

  • Study site

    Tianjin, 300121, China

  • Study site

    Medellín, Antioquia, 050034, Colombia

  • Study site

    Bogota, Cundinamarca, 111511, Colombia

  • Study site

    Montería, Departamento de Córdoba, 230002, Colombia

  • Study site

    Cali, Valle del Cauca Department, 760032, Colombia

  • Study site

    Bayonne, 64100, France

  • Study site

    Brest, 29470, France

  • Study site

    Metz, 57085, France

  • Study site

    Nice, 6189, France

  • Study site

    Pessac, 33600, France

  • Study site

    Poitiers, 86021, France

  • Study site

    Saint-Herblain, 44800, France

  • Study site

    München, Bavaria, 81377, Germany

  • Study site

    Recklinghausen, North Rhine-Westphalia, 45659, Germany

  • Study site

    Dresden, Saxony, 1307, Germany

  • Study site

    Halle, Saxony-Anhalt, 6120, Germany

  • Study site

    Berlin, 10967, Germany

  • Study site

    Athens, 106 76, Greece

  • Study site

    Athens, 11527, Greece

  • Study site

    Chaïdári, 12462, Greece

  • Study site

    Pátrai, 26500, Greece

  • Study site

    Chai Wan, 0, Hong Kong

  • Study site

    Hong Kong, MISSING, Hong Kong

  • Study site

    Budapest, 1083, Hungary

  • Study site

    Győr, 9024, Hungary

  • Study site

    Kaposvár, 7400, Hungary

  • Study site

    Pécs, 7623, Hungary

  • Study site

    Tatabánya, 2800, Hungary

  • Study site

    Dublin, D07R2WY, Ireland

  • Study site

    Dublin, D08NHY1, Ireland

  • Study site

    Galway, H91YR71, Ireland

  • Study site

    Udine, Friuli Venezia Giulia, 33038, Italy

  • Study site

    Genoa, Liguria, 16132, Italy

  • Study site

    Milan, Lombardy, 20133, Italy

  • Study site

    Florence, Tuscany, 50134, Italy

  • Study site

    Nagoya, Aichi-ken, 464-8681, Japan

  • Study site

    Nagoya, Aichi-ken, 466-8650, Japan

  • Study site

    Maebashi, Gunma, 371-8511, Japan

  • Study site

    Kobe, Hyōgo, 650-0047, Japan

  • Study site

    Nankoku, Kochi, 783-8505, Japan

  • Study site

    Sendai, Miyagi, 980-8574, Japan

  • Study site

    Ōmura, Nagasaki, 856-8562, Japan

  • Study site

    Kurashiki, Okayama-ken, 710-8602, Japan

  • Study site

    Hirakata, Osaka, 573-1191, Japan

  • Study site

    Izumo, Shimane, 693-8501, Japan

  • Study site

    Chuo-ku, Tokyo, 104-0045, Japan

  • Study site

    Aomori, 030-8553, Japan

  • Study site

    Fukuoka, 811-1395, Japan

  • Study site

    Kumamoto, 860-8556, Japan

  • Study site

    Niigata, 951-8566, Japan

  • Study site

    Osaka, 545-8586, Japan

  • Study site

    Yamagata, 990-9585, Japan

  • Study site

    Kaunas, LT-50009, Lithuania

  • Study site

    Cheras, 56000, Malaysia

  • Study site

    Kota Kinabalu, 88586, Malaysia

  • Study site

    Kuala Lumpur, 59100, Malaysia

  • Study site

    Kuala Selangor, 68000, Malaysia

  • Study site

    Perak, 30450, Malaysia

  • Study site

    Pulau Pinang, 10450, Malaysia

  • Study site

    Morelia, Michoacán, 58260, Mexico

  • Study site

    Monterrey, Nuevo León, 64460, Mexico

  • Study site

    Tauranga, 3112, New Zealand

  • Study site

    City of Taguig, 1102, Philippines

  • Study site

    Pasig, 1605, Philippines

  • Study site

    Gdansk, 80-214, Poland

  • Study site

    Gdynia, 81-519, Poland

  • Study site

    Krakow, 30-727, Poland

  • Study site

    Lublin, 20-090, Poland

  • Study site

    Porto, 4200-072, Portugal

  • Study site

    Porto, 4434-502, Portugal

  • Study site

    Brasov, 500152, Romania

  • Study site

    Bucharest, 10825, Romania

  • Study site

    Bucharest, 20125, Romania

  • Study site

    Bucharest, 22328, Romania

  • Study site

    Bucharest, 30171, Romania

  • Study site

    Cluj-Napoca, 400015, Romania

  • Study site

    Craiova, 200143, Romania

  • Study site

    Târgu Mureş, 540136, Romania

  • Study site

    Chelyabinsk, 454048, Russia

  • Study site

    Irkutsk, 664035, Russia

  • Study site

    Kazan', 420029, Russia

  • Study site

    Kemerovo, 650066, Russia

  • Study site

    Kirov, 610027, Russia

  • Study site

    Novosibirsk, 630087, Russia

  • Study site

    Omsk, 644013, Russia

  • Study site

    Saint Petersburg, 197022, Russia

  • Study site

    Volgograd, 400138, Russia

  • Study site

    Singapore, 119074, Singapore

  • Study site

    Singapore, 168583, Singapore

  • Study site

    Singapore, 169608, Singapore

  • Study site

    Poprad, 058 01, Slovakia

  • Study site

    George, Eastern Cape, 6530, South Africa

  • Study site

    Johannesburg, Gauteng, 2013, South Africa

  • Study site

    Seoul, Seoul Teugbyeolsi, 03722, South Korea

  • Study site

    Seoul, Seoul Teugbyeolsi, 05505, South Korea

  • Study site

    Seoul, Seoul Teugbyeolsi, 3080, South Korea

  • Study site

    Busan, 49201, South Korea

  • Study site

    Busan, 49241, South Korea

  • Study site

    Hwasun Gun, 58128, South Korea

  • Study site

    Seoul, 06351, South Korea

  • Study site

    Majadahonda, Madrid, 28222, Spain

  • Study site

    Málaga, Málaga, 20910, Spain

  • Study site

    Barcelona, 08003, Spain

  • Study site

    Barcelona, 08035, Spain

  • Study site

    Barcelona, 8041, Spain

  • Study site

    Madrid, 28041, Spain

  • Study site

    Salamanca, 37007, Spain

  • Study site

    Changhua, 50006, Taiwan

  • Study site

    Kaohsiung City, 833, Taiwan

  • Study site

    Tainan, 704, Taiwan

  • Study site

    Taipei, 100, Taiwan

  • Study site

    Taipei, 11217, Taiwan

  • Study site

    Chiang Mai, 50200, Thailand

  • Study site

    Pathum Thani, 10120, Thailand

  • Study site

    Ankara, 6100, Turkey (Türkiye)

  • Study site

    Istanbul, 34093, Turkey (Türkiye)

  • Study site

    Izmir, 35100, Turkey (Türkiye)

  • Study site

    Kayseri, 38039, Turkey (Türkiye)

  • Study site

    Trabzon, 61080, Turkey (Türkiye)

  • Study site

    Cherkasy, 18009, Ukraine

  • Study site

    Dnipro, 49102, Ukraine

  • Study site

    Kyiv, 03022, Ukraine

  • Study site

    Lviv, 79044, Ukraine

  • Study site

    Vinnitsa, 21029, Ukraine

  • Study site

    Hà Nội, 10000, Vietnam

  • Study site

    Ho Chi Minh City, 70000, Vietnam

  • MSK Basking Ridge

    New Jersey, New Jersey, United States

  • MSK Bergen

    New Jersey, New Jersey, United States

  • MSK Commack

    Long Island City, New York, United States

  • MSK Monmoth

    New Jersey, New Jersey, United States

  • MSK Rockville Centre

    Long Island City, New York, United States

  • MSK Westchester

    Harrison, New York, United States

More trials for these conditions

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