A Study of Pirtobrutinib (LOXO-305) Versus Bendamustine Plus Rituximab (BR) in Untreated Patients With Chronic Lymphocytic Leukemia (CLL)/Small Lymphocytic Lymphoma (SLL) (BRUIN CLL-313)

January 21, 2026 updated by: Loxo Oncology, Inc.

A Phase 3 Open-Label, Randomized Study of Pirtobrutinib (LOXO-305) Versus Bendamustine Plus Rituximab in Untreated Patients With Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma

The purpose of this study is to compare the efficacy and safety of pirtobrutinib (LOXO-305; Arm A) compared to BR (Arm B) in patients with CLL/SLL who have not been treated. Participation could last up to five years.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

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.

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.
309

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 3

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

  • Australia
    • New South Wales
      • Liverpool, New South Wales, Australia, 2170
        • Liverpool Hospital
      • Wentworthville, New South Wales, Australia, 2145
        • Westmead Hospital
    • Victoria
      • Frankston, Victoria, Australia, 3199
        • Peninsula Private Hospital
  • Austria
      • Salzburg, Austria, 5020
        • Uniklinikum Salzburg
      • Vienna, Austria, 1160
        • Klinik Ottakring
  • Brazil
    • Rio Grande do Sul
      • Porto Alegre, Rio Grande do Sul, Brazil, 90035-903
        • Hospital de Clínicas de Porto Alegre
      • Porto Alegre, Rio Grande do Sul, Brazil, 90050-170
        • Irmandade da Santa Casa de Misericordia de Porto Alegre
      • Porto Alegre, Rio Grande do Sul, Brazil, 90110270
        • Centro Gaucho Integrado - Mae de Deus Center
    • São Paulo
      • Campinas, São Paulo, Brazil, 13083-878
        • Hemocentro UNICAMP
      • Jaú, São Paulo, Brazil, 17210120
        • Fundacao Doutor Amaral Carvalho
  • Bulgaria
      • Plovdiv, Bulgaria, 4000
        • UMHAT "Sveti Georgi" EAD
      • Sofia, Bulgaria, 1431
        • UMHAT 'Sv. Ivan Rilski', EAD
      • Sofia, Bulgaria, 1797
        • "SHATHD" EAD, Sofia
      • Stara Zagora, Bulgaria, 6003
        • UMHAT - Prof. Dr. Stoyan Kirkovich" AD
  • China
      • Beijing, China, 100730
        • Beijing Hospital
      • Chongqing, China, 400030
        • Chongqing Cancer Hospital
      • Zhengzhou, China, 450008
        • Henan Cancer Hospital
    • Anhui
      • Hefei, Anhui, China, 233004
        • Anhui Provincial Cancer Hospital
    • Beijing Municipality
      • Beijing, Beijing Municipality, China, 100191
        • Peking University Third Hospital
      • Beijing, Beijing Municipality, China, 100034
        • Peking University First Hospital
    • Guangdong
      • Guangzhou, Guangdong, China, 510120
        • The First Affiliated Hospital of Guangzhou Medical University
    • Hubei
      • Wuhan, Hubei, China, 430022
        • Union Hospital Tongji Medical College Huazhong University of Science and Technology
    • Hunan
      • Changsha, Hunan, China, 410013
        • Hunan Cancer Hospital
      • Changsha, Hunan, China, 410008
        • Xiangya Hospital Central South University
    • Inner Mongolia
      • Hohhot, Inner Mongolia, China, 010050
        • The Affiliated Hospital of Inner Mongolia Medical University
    • Jiangxi
      • Nanchang, Jiangxi, China, 330006
        • The First Affiliated Hospital of NanChang University
    • Liaoning
      • Shenyany, Liaoning, China, 110022
        • Shengjing Hospital Of China Medical University
    • Nanjing
      • Nanjing, Nanjing, China, 210029
        • Jiangsu Province Hospital
    • Shanghai Municipality
      • Changning District, Shanghai Municipality, China, 200050
        • Shanghai Tongren Hospital
    • Sichuan
      • Chengdu, Sichuan, China, 610041
        • West China Hospital of Sichuan University
    • Tianjin Municipality
      • Tianjin, Tianjin Municipality, China, 300060
        • Tianjin Medical University Cancer Institute and Hospital
      • Tianjin, Tianjin Municipality, China, 300020
        • Institute of hematology&blood disease hospital
    • Zhejiang
      • Hangzhou, Zhejiang, China, 311100
        • The First People's Hospital of Hangzhou Linping District
  • Czechia
      • Brno, Czechia, 62500
        • Fakultni nemocnice Brno
      • Hradec Králové, Czechia, 500 05
        • Fakultni nemocnice Hradec Kralove
  • France
      • Le Mans, France, 72000
        • Hospitalier Le Mans
  • Hungary
      • Debrecen, Hungary, 4032
        • Debreceni Egyetem Orvos-es Egészsegtudomanyi Centrum
      • Nyíregyháza, Hungary, 4400
        • SzSzB Megyei Korhazak es Egyetemi Oktatokorhaz
      • Székesfehérvár, Hungary, 8000
        • Fejer Megyei Szent Gyorgy Egyetemi Oktato Korhaz
  • Italy
      • Bergamo, Italy, 24127
        • Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII
      • Brescia, Italy, 25123
        • Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia
      • Meldola, Italy, 47014
        • Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori
      • Milan, Italy, 20122
        • Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico
      • Milan, Italy, 20162
        • ASST Grande Ospedale Metropolitano Niguarda Comitato Etico Milano Area C
      • Monza, Italy, 20900
        • Azienda Socio Sanitaria Territoriale Di Monza (Presidio San Gerardo)
      • Novara, Italy, 28100
        • Azienda Ospedale Maggiore Della Carita
      • Perugia, Italy, 06132
        • Istituto di Ematologia-C.R.E.O. (Centro di Ricerche Emato-Oncologich)
      • Ravenna, Italy, 48020
        • Ospedale Santa Maria delle Croci
      • Terni, Italy, 05100
        • Azienda Ospedaliera Santa Maria Terni
      • Trieste, Italy, 34125
        • Azienda sanitaria integrata università di Trieste
    • Potenza
      • Rionero in Vulture, Potenza, Italy, 85028
        • Irccs Crob
  • Japan
      • Aomori, Japan, 030-8553
        • Aomori Prefectural Centeral Hospital
      • Fukoka-ken, Japan, 806 8501
        • JCHO Kyushu Hospital
    • Aichi-ken
      • Nagoya, Aichi-ken, Japan, 467-8602
        • Nagoya City University Hospital
    • Chiba
      • Chiba, Chiba, Japan, 260-8717
        • Chiba Cancer Center
    • Fukui
      • Yoshida-Gun, Fukui, Japan, 910-1193
        • Fukui Medical University Hospital
    • Hokkaido
      • Sapporo, Hokkaido, Japan, 0030006
        • Hokuyukai Sapporo Hokuyu Hospital
    • Kochi
      • Nankoku, Kochi, Japan, 783-8505
        • Kochi Medical School Hospital
    • Miyagi
      • Sendai, Miyagi, Japan, 980-8574
        • Tohoku University Hospital
      • Sendai, Miyagi, Japan, 9838520
        • NHO Sendai Medical Center
    • Saitama
      • Koshigaya, Saitama, Japan, 343 8555
        • Dokkyo Medical University - Koshigaya Hospital
    • Yamanshi
      • Chūō, Yamanshi, Japan, 409-3821
        • University of Yamanashi Hospital
  • New Zealand
      • Christchurch, New Zealand, 8011
        • Christchurch Hospital
      • Papatoetoe, New Zealand, 2025
        • Middlemore Clinical Trials
    • Auckland
      • Takapuna, Auckland, New Zealand, 0622
        • North Shore Hospital, Haematology Research
    • Bay of Plenty
      • Tauranga, Bay of Plenty, New Zealand, 3112
        • Tauranga Hospital
  • Poland
      • Biała Podlaska, Poland, 21500
        • KO-MED Centra Kliniczne
      • Bydgoszcz, Poland, 85-168
        • Szpital Uniwersytecki nr 1 im. Antoniego Jurasza
      • Katowice, Poland, 40519
        • Pratia Onkologia Katowice
      • Krakow, Poland, 30727
        • Pratia MCM Krakow
      • Lublin, Poland, 20-090
        • Centrum Onkologii Ziemi Lubelskiej
      • Torun, Poland, 87-100
        • Nasz Lekarz Osrodek Badan Klinicznych
      • Warsaw, Poland, 02781
        • Narodowy Instytut Onkologii im. Marii Skłodowskiej-Cuire - Państwowy Instytut Badawczy
      • Wroclaw, Poland, 50-367
        • Uniwersytecki Szpital Kliniczny Klinika
    • Legnica
      • Iwaszkiewicza 5, Legnica, Poland, 59-220
        • Wojewodzki Szpital Specjalistyczny
    • Lubelskie V
      • Lublin, Lubelskie V, Poland, 20081
        • Klinika Hematoonkologii i Transplantacji Szpiku SPSK1 Lublin
    • Pomeranian Voivodeship
      • Gdansk, Pomeranian Voivodeship, Poland, 80214
        • Uniwersyteckie Centrum Kliniczne
    • Poznan
      • Skorzewo, Poznan, Poland, 60 185
        • Centrum Medyczne Pratia Poznan
  • Portugal
      • Braga, Portugal, 4710-243
        • Centro Clínico Académico - Braga (2CA-Braga) (Hospital de Braga)
      • Lisbon, Portugal, 1649035
        • Centro Hospitalar de Lisboa Norte, E.P.E. - Hospital de Santa Maria
      • Porto, Portugal, 4200-072
        • Instituto Português de Oncologia do Porto Francisco Gentil, EPE
  • Romania
      • Bucharest, Romania, 022328
        • Institutul Clinic Fundeni - Centrul de Hematologie si Transplant Medular
      • Cluj-Napoca, Romania, 400015
        • Institutul Oncologic "Prof. Dr. Ion Chiricuta" Cluj-Napoca
      • Iași, Romania, 700483
        • Institutului Regional de Oncologie IASI
    • Dolj
      • Craiova, Dolj, Romania, 200143
        • Spitalul Clinic Municipal Filantropia Craiova
  • Russia
      • Saint Petersburg, Russia, 197022
        • Academician I.P. Pavlov First St-Petersburg State Medical University
  • South Korea
      • Busan, South Korea, 47392
        • Inje Univ Busan Paik Hospital
    • Incheon-gwangyeoksi [Incheon]
      • Namdong-gu, Incheon-gwangyeoksi [Incheon], South Korea, 21565
        • Gachon University Gil Medical Center
    • Seoul
      • Seocho-Gu, Seoul, South Korea, 06591
        • The Catholic University of Korea-Seoul St. Mary's Hospital
    • Seoul, Korea
      • Seoul, Seoul, Korea, South Korea, 03080
        • Seoul National University Hospital
    • Seoul-teukbyeolsi [Seoul]
      • Seoul, Seoul-teukbyeolsi [Seoul], South Korea, 03722
        • Severance Hospital, Yonsei University Health System
      • Seoul, Seoul-teukbyeolsi [Seoul], South Korea, 06351
        • Samsung Medical Center
  • Spain
      • Barcelona, Spain, 08041
        • Hospital De La Santa Creu I Sant Pau
      • Madrid, Spain, 28040
        • Hospital Universitario Fundacion Jimenez Díaz
      • Seville, Spain, 41013
        • Hospital Universitario Virgen del Rocio
      • Seville, Spain, 41014
        • Hospital Universitario Virgen de Valme
    • Madrid, Comunidad de
      • Madrid, Madrid, Comunidad de, Spain, 28050
        • Hospital Universitario HM Sanchinarro
    • Principality of Asturias
      • Oviedo, Principality of Asturias, Spain, 33011
        • Hospital Universitario Central de Asturias
  • Taiwan
      • Changhua, Taiwan, 50544
        • Chang Bing Show Chwan Memorial Hospital
      • Taichung, Taiwan, 40447
        • China Medical University Hospital
      • Taipei, Taiwan, 10002
        • National Taiwan University Hospital
      • Taoyuan, Taiwan, 333
        • Chang Gung Memorial Hospital - Linkou
  • United Kingdom
    • England
      • Birmingham, England, United Kingdom, B9 5SS
        • Birmingham Heartlands Hospital
  • United States
    • California
      • Los Angeles, California, United States, 90027
        • California Research Institute
      • Whittier, California, United States, 90603
        • Innovative Clinical Research Institute
    • Florida
      • Coral Springs, Florida, United States, 33065
        • Oncology-Hematology Associates of West Broward
    • New Jersey
      • Brick, New Jersey, United States, 08724
        • New Jersey Center for Cancer Research
    • New York
      • Westbury, New York, United States, 11590
        • Clinical Research Alliance, Inc.

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:

  • Confirmed diagnosis of CLL/SLL requiring therapy, per iwCLL 2018 criteria
  • Eastern Cooperative Oncology Group (ECOG) Performance Status 0-2
  • Adequate organ function
  • Platelets greater than or equal to (≥)75 x 10⁹/liter (L) (≥50 × 10⁹/L for patients with evidence of bone marrow infiltrate), hemoglobin ≥8 grams/deciliter (g/dL), and absolute neutrophil count ≥0.75 x 10⁹/L
  • Kidney function: Estimated creatinine clearance ≥40 milliliters per minute (mL/min)

Exclusion Criteria:

  • Known or suspected Richter's transformation at any time preceding enrollment
  • Prior systemic therapy for CLL/SLL
  • Presence of 17p deletion
  • Central nervous system (CNS) involvement
  • Active uncontrolled auto-immune cytopenia (e.g., autoimmune hemolytic anemia [AIHA], idiopathic thrombocytopenic purpura [ITP])
  • Significant cardiovascular disease
  • Active hepatitis B or hepatitis C
  • Active cytomegalovirus (CMV) infection
  • Active uncontrolled systemic bacterial, viral, fungal, or parasitic infection
  • Known human immunodeficiency virus (HIV) infection, regardless of cluster of differentiation 4 (CD4) count
  • Concurrent use of investigational agent or anticancer therapy except hormonal therapy
  • Patients requiring therapeutic anticoagulation with warfarin or another Vitamin K antagonist
  • Vaccination with a live vaccine within 28 days prior to randomization

  • Patients with the following hypersensitivity:

    • Known hypersensitivity, including anaphylaxis, to any component or excipient of pirtobrutinib or bendamustine
    • Prior significant hypersensitivity to rituximab

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: Randomized
  • Interventional Model: Parallel 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: Arm A (Pirtobrutinib)
Pirtobrutinib administered orally
Drug: Pirtobrutinib
Oral
Other Names:
  • LOXO-305
  • LY3527727
Active Comparator: Arm B (BR)
Bendamustine plus rituximab administered intravenously (IV)
Drug: Rituximab
IV
Other Names:
  • Rituxan
  • MabThera
  • Riabni
  • Ruxience
  • Truxima
Drug: Bendamustine
IV
Other Names:
  • Treanda
  • Levact
  • Ribomustin
  • Treakisym

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
To evaluate progression-free survival (PFS) of pirtobrutinib (Arm A) compared to bendamustine and rituximab (Arm B)
Time Frame: Up to approximately 5 years
Assessed by blinded independent review committee (IRC) per International Workshop on Chronic Lymphocytic Leukemia (iwCLL) 2018 Response Criteria
Up to approximately 5 years

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
To evaluate the effectiveness of Arm A compared to Arm B in patient-reported disease-related symptoms
Time Frame: Up to approximately 5 years
Based on time to worsening of CLL/SLL-related symptoms
Up to approximately 5 years
To evaluate the effectiveness of Arm A compared to Arm B in patient-reported physical functioning
Time Frame: Up to approximately 5 years
Based on time to worsening of physical functioning
Up to approximately 5 years
To evaluate the effectiveness of Arm A compared to Arm B: Progression-free survival (PFS)
Time Frame: Up to approximately 5 years
Assessments of effectiveness include PFS, assessed by investigator
Up to approximately 5 years
To evaluate the effectiveness of Arm A compared to Arm B: Overall survival (OS)
Time Frame: Up to approximately 5 years
Assessments of effectiveness include OS, assessed by investigator
Up to approximately 5 years
To evaluate the effectiveness of Arm A compared to Arm B: Time to next treatment (TTNT)
Time Frame: Up to approximately 5 years
Assessments of effectiveness include TTNT, assessed by investigator
Up to approximately 5 years
To evaluate the effectiveness of Arm A compared to Arm B: Overall response rate (ORR)
Time Frame: Up to approximately 5 years
Assessments of effectiveness include ORR, assessed by investigator and IRC
Up to approximately 5 years
To evaluate the effectiveness of Arm A compared to Arm B: Duration of Response (DOR)
Time Frame: Up to approximately 5 years
Assessments of effectiveness include DOR, assessed by investigator and IRC
Up to approximately 5 years

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.
Loxo Oncology, Inc.

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Eli Lilly and Company

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.
  • Study Director: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST), Eli Lilly and Company

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

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.
September 23, 2021

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.
July 11, 2025

Study Completion (Estimated)

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.
October 1, 2027

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).
August 24, 2021

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.
August 24, 2021

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.
August 27, 2021

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.
January 22, 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.
January 21, 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.
January 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.
  • 18088
  • LOXO-BTK-20023 (Other Identifier: Eli Lilly and Company)
  • J2N-OX-JZNP (Other Identifier: Eli Lilly and Company)

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

Yes

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.

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