Lymphoma,Non-HodgkinPhase 3CHRONOS-3NCT02367040
Copanlisib and Rituximab in Relapsed Indolent B-cell Non-Hodgkin's Lymphoma (iNHL)
A Phase 3 study testing Copanlisib (Aliqopa, BAY80-6946) and Rituximab in people with Lymphoma,Non-Hodgkin, run by Bayer at 187 sites in 37 countries.
Trial summary
The purpose of this study was to evaluate whether copanlisib in combination with rituximab is superior to placebo in combination with rituximab in prolonging progression free survival (PFS) in patients with relapsed iNHL who have received one or more lines of treatment, including rituximab and who either had a… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lymphoma,Non-Hodgkin
- What is being tested?
- Copanlisib (Aliqopa, BAY80-6946) and Rituximab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 458 participants
- Where
- 187 sitesin 37 countries
- Study dates
- 3 Aug 2015to 15 Nov 2024
- Phase
- Phase 3
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 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.
Show all 21Show fewer
- 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).
Who cannot join
- 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
Show all 10Show fewer
- 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.
Trial locations and contacts
187 sites in 37 countries.
187 sites in 37 countries
China24 sites
Study site
Beijing, 100000
Study site
Beijing, 100050
Study site
Beijing, 100083
Study site
Beijing, 100730
Study site
Changchun, Jilin, 130061
Study site
Chengdu, Sichuan, 610041
Study site
Chongqing, 400030
Study site
Chongqing, 400042
Study site
Fuzhou, Fujian, 350000
Study site
Guangzhou, Guangdong, 510000
Study site
Guangzhou, Guangdong, TBC
Study site
Hangzhou, Zhejiang, 310000
Study site
Hangzhou, Zhejiang, 310022
Study site
Nanchang, Jiangxi, 330029
Study site
Nanjing, Jiangsu, 210000
Study site
Shanghai, 200000
Study site
Shanghai, 200025
Study site
Shanghai, 200032
Study site
Shengyang, Liaoning, 110042
Study site
Suzhou, Jiangsu, 215000
Study site
Tianjin, 300000
Study site
Tianjin, 300121
Study site
Ürümqi, Xinjiang, 830011
Study site
Wuhan, Hubei, 430079
Japan17 sites
Study site
Aomori, 030-8553
Study site
Chuo-ku, Tokyo, 104-0045
Study site
Fukuoka, 811-1395
Study site
Hirakata, Osaka, 573-1191
Study site
Izumo, Shimane, 693-8501
Study site
Kobe, Hyōgo, 650-0047
Study site
Kumamoto, 860-8556
Study site
Kurashiki, Okayama-ken, 710-8602
Study site
Maebashi, Gunma, 371-8511
Study site
Nagoya, Aichi-ken, 464-8681
Study site
Nagoya, Aichi-ken, 466-8650
Study site
Nankoku, Kochi, 783-8505
Study site
Niigata, 951-8566
Study site
Ōmura, Nagasaki, 856-8562
Study site
Osaka, 545-8586
Study site
Sendai, Miyagi, 980-8574
Study site
Yamagata, 990-9585
United States16 sites
Study site
Ashland, Kentucky, 41101
Study site
Bethesda, Maryland, 20817
Study site
Canton, Ohio, 44718
MSK Westchester
Harrison, New York
Study site
Las Vegas, Nevada, 89169
MSK Commack
Long Island City, New York
MSK Rockville Centre
Long Island City, New York
Study site
Louisville, Kentucky, 40207
Study site
Montvale, New Jersey, 07645
MSK Basking Ridge
New Jersey, New Jersey
MSK Bergen
New Jersey, New Jersey
MSK Monmoth
New Jersey, New Jersey
Study site
New York, New York, 10065
Study site
Salt Lake City, Utah, 84106
Study site
Spokane, Washington, 99208
Study site
West Covina, California, 91790
Russia9 sites
Study site
Chelyabinsk, 454048
Study site
Irkutsk, 664035
Study site
Kazan', 420029
Study site
Kemerovo, 650066
Study site
Kirov, 610027
Study site
Novosibirsk, 630087
Study site
Omsk, 644013
Study site
Saint Petersburg, 197022
Study site
Volgograd, 400138
Brazil8 sites
Study site
Barretos/SP, São Paulo, 14784-400
Study site
Jaú, São Paulo, 17210-120
Study site
Passo Fundo, Rio Grande do Sul, 99020-240
Study site
Porto Alegre, Rio Grande do Sul, 90850-170
Study site
São Paulo, São Paulo, 01234-030
Study site
São Paulo, São Paulo, 08270-070
Study site
São Paulo, 05403-000
Study site
São Paulo, 05651-901
Romania8 sites
Study site
Brasov, 500152
Study site
Bucharest, 10825
Study site
Bucharest, 20125
Study site
Bucharest, 22328
Study site
Bucharest, 30171
Study site
Cluj-Napoca, 400015
Study site
Craiova, 200143
Study site
Târgu Mureş, 540136
France7 sites
Study site
Bayonne, 64100
Study site
Brest, 29470
Study site
Metz, 57085
Study site
Nice, 6189
Study site
Pessac, 33600
Study site
Poitiers, 86021
Study site
Saint-Herblain, 44800
South Korea7 sites
Study site
Busan, 49201
Study site
Busan, 49241
Study site
Hwasun Gun, 58128
Study site
Seoul, Seoul Teugbyeolsi, 03722
Study site
Seoul, Seoul Teugbyeolsi, 05505
Study site
Seoul, Seoul Teugbyeolsi, 3080
Study site
Seoul, 06351
Spain7 sites
Study site
Barcelona, 08003
Study site
Barcelona, 08035
Study site
Barcelona, 8041
Study site
Madrid, 28041
Study site
Majadahonda, Madrid, 28222
Study site
Málaga, Málaga, 20910
Study site
Salamanca, 37007
Malaysia6 sites
Study site
Cheras, 56000
Study site
Kota Kinabalu, 88586
Study site
Kuala Lumpur, 59100
Study site
Kuala Selangor, 68000
Study site
Perak, 30450
Study site
Pulau Pinang, 10450
Germany5 sites
Study site
Berlin, 10967
Study site
Dresden, Saxony, 1307
Study site
Halle, Saxony-Anhalt, 6120
Study site
München, Bavaria, 81377
Study site
Recklinghausen, North Rhine-Westphalia, 45659
Hungary5 sites
Study site
Budapest, 1083
Study site
Győr, 9024
Study site
Kaposvár, 7400
Study site
Pécs, 7623
Study site
Tatabánya, 2800
Taiwan5 sites
Study site
Changhua, 50006
Study site
Kaohsiung City, 833
Study site
Tainan, 704
Study site
Taipei, 100
Study site
Taipei, 11217
Turkey (Türkiye)5 sites
Study site
Ankara, 6100
Study site
Istanbul, 34093
Study site
Izmir, 35100
Study site
Kayseri, 38039
Study site
Trabzon, 61080
Ukraine5 sites
Study site
Cherkasy, 18009
Study site
Dnipro, 49102
Study site
Kyiv, 03022
Study site
Lviv, 79044
Study site
Vinnitsa, 21029
Argentina4 sites
Study site
Buenos Aires, Ciudad Auton. de Buenos Aires, TBC
Study site
Córdoba, X5000AOQ
Study site
Rosario, Santa Fe Province, S2000DEJ
Study site
San Miguel de Tucumán, Tucumán Province, T4000
Colombia4 sites
Study site
Bogota, Cundinamarca, 111511
Study site
Cali, Valle del Cauca Department, 760032
Study site
Medellín, Antioquia, 050034
Study site
Montería, Departamento de Córdoba, 230002
Greece4 sites
Study site
Athens, 106 76
Study site
Athens, 11527
Study site
Chaïdári, 12462
Study site
Pátrai, 26500
Italy4 sites
Study site
Florence, Tuscany, 50134
Study site
Genoa, Liguria, 16132
Study site
Milan, Lombardy, 20133
Study site
Udine, Friuli Venezia Giulia, 33038
Poland4 sites
Study site
Gdansk, 80-214
Study site
Gdynia, 81-519
Study site
Krakow, 30-727
Study site
Lublin, 20-090
Austria3 sites
Study site
Graz, Styria, 8036
Study site
Vienna, 1090
Study site
Vienna, 1130
Bulgaria3 sites
Study site
Plovdiv, 4000
Study site
Sofia, 1756
Study site
Varna, 9010
Ireland3 sites
Study site
Dublin, D07R2WY
Study site
Dublin, D08NHY1
Study site
Galway, H91YR71
Singapore3 sites
Study site
Singapore, 119074
Study site
Singapore, 168583
Study site
Singapore, 169608
Australia2 sites
Study site
Ballarat, Victoria, 3350
Study site
Nedlands, 6009
Mexico2 sites
Study site
Monterrey, Nuevo León, 64460
Study site
Morelia, Michoacán, 58260
South Africa2 sites
Study site
George, Eastern Cape, 6530
Study site
Johannesburg, Gauteng, 2013
About this study
Official title: A Phase III, Randomized, Double-blind, Placebo-controlled Study Evaluating the Efficacy and Safety of Copanlisib in Combination With Rituximab in Patients With Relapsed Indolent B-cell Non-Hodgkin's Lymphoma (iNHL) - CHRONOS-3
The purpose of this study was to evaluate whether copanlisib in combination with rituximab is superior to placebo in combination with rituximab in prolonging progression free survival (PFS) in patients with relapsed iNHL who have received one or more lines of treatment, including rituximab and who either had a treatment-free interval of ≥ 12 months after completion of the last rituximab-containing treatment, or who are unwilling to receive chemotherapy/for whom chemotherapy is contraindicated on reason of age, comorbidities, and/or residual toxicity.
- Conditions
- Lymphoma,Non-Hodgkin
- Being tested
- Copanlisib (Aliqopa, BAY80-6946), Placebo, Rituximab
- Keywords
- Clinical trial, Phase III, Phosphatidylinositol-3-kinase, Non-Hodgkin's lymphoma, Indolent B-cell non-Hodgkin's lymphoma
- Medical subject headings
- Lymphoma, Non-Hodgkin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Copanlisib (Aliqopa, BAY80-6946)Drug
Copanlisib is supplied as lyophilized preparation in a 6 mL injection vial. The total amount of copanlisib per vial is 60 mg. The solution for IV infusions is obtained after reconstitution with normal saline solution. Dosing will be administered on Days 1, 8 and 15 of each 28-day cycle. Copanlisib will be administered before rituximab.
PlaceboDrug
Placebo is supplied as lyophilized preparation in a 6 mL injection vial. The developed placebo lyophilisate is equivalent to the 60 mg copanlisib formulation, with regard to the composition of excipients and the instructions for reconstitution and dose preparation. Placebo dosing will be administered on Days 1, 8 and 15 of each 28-day cycle. Placebo will be administered before rituximab.
RituximabDrug
Rituximab dose 375 mg/m2 body surface weekly during Cycle 1 on Days 1, 8, 15 and 22, and then on Day 1 of Cycles 3, 5, 7 and 9.The solution for IV infusions is obtained after reconstitution of a calculated concentration of 1 to 4 mg/ml rituximab into an infusion bag containing sterile, pyrogen-free sodium chloride 9 mg/ml (0.9%) solution for injection or 5% D-Glucose in water.
| Study group | Role | What they receive |
|---|---|---|
| Copanlisib + Rituximab | Experimental | Combination of the Copanlisib and rituximab Receives: Drug: Copanlisib (Aliqopa, BAY80-6946); Drug: Rituximab |
| Placebo + Rituximab | Placebo comparator | Combination of Copanlisib placebo and rituximab Receives: Drug: Placebo; Drug: Rituximab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression Free Survival (PFS) Based on Independent Central Review.
Progression-free survival (PFS) was defined as the time from randomization to progressive disease (PD) or death due to any cause, whichever was earlier according to the Lugano Classification and Response criteria in patients affected by Waldenström macroglobulinemia (kindly refer to the links in the Protocol section).
Measured: From first participant randomization (20-Aug-2015) up to data cut-off at primary completion (31-Aug-2020), approximately 5 years and 2-year follow-up after primary completion at 31-Aug-2022, up to 7 years and final analysis at 15-Nov-2024 up to 9 years
Secondary outcomes (11)
Objective Response Rate (ORR)
Objective response rate (ORR) was defined as the percentage of participants who have a best response rating over the whole duration of the study (i.e. until time of analysis of PFS) of complete response (CR) or partial response (PR) according to the Lugano Classification and for patients with Waldenström macroglobulinemia (WM) a response rating of CR, very good partial response (VGPR), PR, or minor response (MR) according to the Owen Criteria (kindly refer to the links in the Protocol section).
Measured: From first participant randomization (20-Aug-2015) up to data cut-off date at primary completion (31-Aug-2020), approximately 5 years and 2-year follow-up after primary completion at 31-Aug-2022, up to 7 years
Complete Response Rate (CRR)
Complete response rate (CRR) was defined as the percentage of participants who had a best response rating over the whole duration of the study (i.e., until the time of analysis of PFS) according to the Lugano Classification and for patients with Waldenström macroglobulinemia (WM) a response rating of Complete Response according to the Owen Criteria (kindly refer to the links in the Protocol section).
Measured: From first participant randomization (20-Aug-2015) up to data cut-off date at primary completion (31-Aug-2020), approximately 5 years and 2-year follow-up after primary completion at 31-Aug-2022, up to 7 years
Duration of Response (DOR)
Duration of response (DOR) was defined as the time (in days) from first observed tumor response Complete Response (CR), Very good partial response (VGPR), Partial Response (PR) or Minor Response (MR) until progression or death from any cause, whichever occurred earlier according to the Owen Criteria (kindly refer to the links in the Protocol section). Only patients with response in FAS were included in the analysis.
Measured: From first participant randomization (20-Aug-2015) up to data cut-off date at primary completion (31-Aug-2020), approximately 5 years and 2-year follow-up after primary completion at 31-Aug-2022, up to 7 years
Disease Control Rate (DCR)
Disease control rate was defined as the percentage of participants who had a best response rating as Complete Response (CR), Partial Response (PR) or stable disease (SD) according to the Lugano Classification and for patients with Waldenström macroglobulinemia (WM) as a response rating of CR, very good partial response (VGPR), PR, minor response (MR) or stable disease (SD) according to the Owen Criteria (kindly refer to the links in the Protocol section).
Measured: From first participant randomization (20-Aug-2015) up to data cut-off date at primary completion (31-Aug-2020), approximately 5 years and 2-year follow-up after primary completion at 31-Aug-2022, up to 7 years
Time to Progression (TTP)
Time to progression (TTP) was defined as the time (days) from date of randomization to date of first observed disease progression according to the Lugano Classification and Response criteria in patients affected by Waldenström macroglobulinemia (kindly refer to the links in the Protocol section).
Measured: From first participant randomization (20-Aug-2015) up to data cut-off date at primary completion (31-Aug-2020), approximately 5 years and 2-year follow-up after primary completion at 31-Aug-2022, up to 7 years
Overall Survival (OS)
Overall survival was defined as the time (in days) from randomization until death from any cause.
Measured: From randomization up to the final analysis at 15-Nov-2024 up to 9 years
Time to Deterioration in DRS-P (Disease-Related Symptoms - Physical) of at Least Three Points, as Measured by the Functional Assessment of Cancer Therapy Lymphoma Symptom Index-18 (FLymSI-18) Questionnaire.
Time to deterioration in DRS-P (Disease-Related Symptoms - Physical) of at least three points was defined as the time (in days) from randomization to DRS-P decline, progression, or death due to any reason, whichever occurred earlier. The Lymphoma Symptom Index-18 (FLymSI-18) questionnaire contains 18 items, each of which utilizes a Likert scale with 5 possible responses ranging from 0 'Not at all' to 4 'Very much' and was divided into a total score.
Measured: From first participant randomization (20-Aug-2015) up to data cut-off date at primary completion (31-Aug-2020), approximately 5 years and 2-year follow-up after primary completion at 31-Aug-2022, up to 7 years
Time to Improvement in DRS-P (Disease-Related Symptoms - Physical) of at Least 3 Points, as Measured by the Functional Assessment of Cancer Therapy Lymphoma Symptom Index-18 (FLymSI-18) Questionnaire.
Time to improvement in DRS-P (Disease-Related Symptoms - Physical) was defined as the time (in days) from randomization to DRS-P improvement of at least three points. The Lymphoma Symptom Index-18 (FLymSI-18) questionnaire contains 18 items, each of which utilizes a Likert scale with 5 possible responses ranging from 0 'Not at all' to 4 'Very much' and was divided into a total score.
Measured: From first participant randomization (20-Aug-2015) up to data cut-off date at primary completion (31-Aug-2020), approximately 5 years and 2-year follow-up after primary completion at 31-Aug-2022, up to 7 years
Number of Participants With Treatment-emergent Adverse Events (TEAEs) at Primary Completion Date.
Adverse events were considered to be treatment-emergent if they have started or worsened after first application of study medication up to 30 days after end of treatment with study medication.
Measured: Up to 30 days after end of treatment with study drug, data reporting cut-off at 5 years from the first participant randomization date
Number of Participants With Treatment-emergent Adverse Events (TEAEs) at 2-year Follow-up Cut-off Date.
Adverse events were considered to be treatment-emergent if they have started or worsened after first application of study medication up to 30 days after end of treatment with study medication.
Measured: Up to 30 days after end of treatment with study drug, data reporting cut-off at 7 years from the first participant randomization date
Number of Participants With Treatment-emergent Adverse Events (TEAEs) at Final Analysis
Adverse events were considered to be treatment-emergent if they have started or worsened after first application of study medication up to 30 days after end of treatment with study medication.
Measured: Up to 30 days after end of treatment with study drug, data reporting cut-off at final analysis, up to 9 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2015 (estimated)
- Study start3 Aug 2015
- Primary completion31 Aug 2020
- Study completion15 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Lymphoma,Non-HodgkinStudies of the same condition, open and under way.
- More trials run by BayerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 458 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bayer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bayer Study Director, Study director, Bayer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02367040
- Sponsor's protocol ID
- 17067
- Other IDs
- 2013-003893-29
- Acronym
- CHRONOS-3
- Status last verified
- Sep 2025
- First submitted
- 12 Feb 2015
- Last updated
- 14 Oct 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: Availability of this study's data will later be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014. Interested researchers can use www.vivli.org to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the member section of the portal.
Publications
Matasar MJ, Capra M, Ozcan M, Lv F, Li W, Yanez E, Sapunarova K, Lin T, Jin J, Jurczak W, Hamed A, Wang MC, Baker R, Bondarenko I, Zhang Q, Feng J, Geissler K, Lazaroiu M, Saydam G, Szomor A, Bouabdallah K, Galiulin R, Uchida T, Soler LM, Cao A, Hiemeyer F, Mehra A, Childs BH, Shi Y, Zinzani PL. Copanlisib plus rituximab versus placebo plus rituximab in patients with relapsed indolent non-Hodgkin lymphoma (CHRONOS-3): a double-blind, randomised, placebo-controlled, phase 3 trial. Lancet Oncol. 2021 May;22(5):678-689. doi: 10.1016/S1470-2045(21)00145-5. Epub 2021 Apr 10.
PubMed 33848462Morcos PN, Moss J, Veasy J, Hiemeyer F, Childs BH, Garmann D. Model-Based Benefit/Risk Analysis for the Copanlisib Intermittent Dosing Regimen. Clin Pharmacol Ther. 2024 May;115(5):1092-1104. doi: 10.1002/cpt.3173. Epub 2024 Jan 16.
PubMed 38226495