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JOURNAL ONKOLOGIE – STUDIE

Study of BGB-11417 Monotherapy in Participants With Relapsed or Refractory Mantle Cell Lymphoma

Rekrutierend

NCT-Nummer:
NCT05471843

Studienbeginn:
September 2022

Letztes Update:
25.04.2024

Wirkstoff:
BGB-11417

Indikation (Clinical Trials):
Lymphoma, Lymphoma, Mantle-Cell

Geschlecht:
Alle

Altersgruppe:
Erwachsene (18+)

Phase:
Phase 2

Sponsor:
BeiGene

Collaborator:
-

Kontakt

Studienlocations
(3 von 105)

Universitatsklinikum Dusseldorf
40225 Dusseldorf
(Nordrhein-Westfalen)
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Universitatsklinikum Essen (Aor)
D-45147 Essen
(Nordrhein-Westfalen)
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Universitatsklinikum Schleswig Holstein, Campus Kiel
24105 Kiel
(Schleswig-Holstein)
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Universitatsklinikum Koln, Innere Medizin I
50937 Koeln
(Nordrhein-Westfalen)
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University of Alabama At Birmingham Hospital
35294 Birmingham
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Medstar Georgetown University Hospital
20007 Washington
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Fort Wayne Medical Oncology and Hematology
46804 Fort Wayne
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Des Moines Oncology Research Association
50309 Des Moines
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Tulane Cancer Center
70112 New Orleans
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Luminis Health Anne Arundel Medical Center
21401 Annapolis
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Maryland Oncology Hematology, Pa
21044 Columbia
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University of Missouri Hospital, Ellis Fischel Cancer Center
65212 Columbia
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Nebraska Cancer Specialists
68803 Grand Island
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Dartmouth Cancer Center
03756 Lebanon
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Hackensack University Medical Center
07601 Hackensack
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Novant Health Hematology Charlotte
28204 Charlotte
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The University of Texas Md Anderson Cancer Center
77030-4009 Houston
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Northwest Medical Specialties
98373 Puyallup
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Hospital Aleman
C1118 Ciudad Autonoma de Buenos Aires
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81520-060 Curitiba
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90110-270 Porto Alegre
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14051-140 Ribeirao Preto
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Oncoclinicas Rio de Janeiro Sa
22250-905 Rio de Janeiro
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Instituto Americas Ensino, Pesquisa E Inovacao
22775-001 Rio de Janeiro
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Hospital Sao Rafael (Rede Dor)
41253-190 Salvador
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Hospital Beneficencia Portuguesa de Sao Paulo
01323-001 Sao Paulo
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Instituto Dor de Pesquisa E Ensino Sao Paulo
01401-002 Sao Paulo
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Accamargo Cancer Center
01508-010 Sao Paulo
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Hcfmusp Servico de Hematologia, Hemoterapia E Terapia Celular
05402-000 Sao Paulo
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Sociedade Beneficente Israelita Brasileira Hospital Albert Einstein
05653-120 Sao Paulo
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Anhui Provincial Cancer Hospital Aka West Branch of Anhui Province Hospital
230088 Hefei
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China Japan Friendship Hospital
100029 Beijing
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Beijing Friendship Hospital, Capital Medical University(Tongzhou)
101100 Beijing
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Sun Yat Sen University Cancer Center
510060 Guangzhou
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Guangdong Provincial Peoples Hospital Huifu Branch
510120 Guangzhou
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The Tumor Hospital Affiliated to Guangxi Medical University
530021 Nanning
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Cancer Hospital of Guizhou Medical University
550000 Guiyang
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The First Affiliated Hospital of Zhengzhou University
450052 Zhengzhou
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Tongji Hospital of Tongji Medical College Huazhong University of Science and Technology
430030 Wuhan
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Affiliated Hospital of Nantong University
201203 Nantong
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The Affiliated Hospital of Xuzhou Medical University
221000 Xuzhou
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The First Affiliated Hospital of Nanchang University Branch Donghu
330006 Nanchang
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Jiangxi Province Cancer Hospital
330029 Nanchang
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Liaoning Cancer Hospital and Institute
110042 Shenyang
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General Hospital of Ningxia Medical University
750004 Yinchuan
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The Affiliated Hospital of Qingdao University Branch West Coast
266555 Qingdao
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Shanxi Provincial Cancer Hospital
030013 Taiyuan
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West China Hospital, Sichuan University
610041 Chengdu
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Institute of Hematology and Hospital of Blood Disease
300020 Tianjin
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Tianjin Medical University Cancer Institute and Hospital
300060 Tianjin
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The First Peoples Hospital of Kashgar
844099 Kashgar
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Affiliated Cancer Hospital of Xinjiang Medical University
830000 Urumqi
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The First Affiliated Hospital, Zhejiang University School of Medicine
310003 Hangzhou
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Centre Hospitalier Universitaire Nantes Hotel Dieu
44093 Nantes Cedex
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Hopital Pitie Salpetriere Service Hematologie
75013 Paris
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Chu Tours Hopital Bretonneau Service Pneumologie
37000 Tours
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Assuta Ashdod Medical Center
7747629 Ashdod
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Shaare Zedek Medical Center
9103102 Jerusalem
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Hadassah En Karem Medical Center
9112001 Jerusalem
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Sourasky Tel Aviv Medical Center
64239 Tel Aviv
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Irccs Istituto Tumori Giovanni Paolo Ii
70124 Bari
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Policlinico Sorsola Malpighi, Aou Di Bologna
40138 Bologna
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Azienda Socio Sanitaria Territoriale Degli Spedali Civili Di Brescia
25123 Brescia
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Istituto Romagnolo Per Lo Studio Dei Tumori Dino Amadori Irst
47014 Meldola
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Uniwersyteckie Centrum Kliniczne
80-952 Gdansk
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Samodzielny Publiczny Szpital Kliniczny Nr W Lublinie
20-954 Lublin
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Narodowy Instytut Onkologii Im Marii Skodowskiej Curie Pastwowy Instytut Badawczy
02-034 Warszawa
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Auxilio Mutuo Cancer Center
00917 San Juan
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Hospital Universitario Vall Dhebron
08035 Barcelona
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Institut Catala Dandoncologia
08908 Barcelona
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Hospital Universitario Fundacion Jimenez Diaz
28040 Madrid
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Hospital Universitario Virgen Del Rocio
41013 Sevilla
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Ankara University Medical Faculty
06620 Ankara
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Dr Abdurrahman Yurtaslan Oncology Teaching and Research Hospital
06620 Ankara
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Ondokuz Mayis University Medicine Faculty Hospital
55200 Atakum Samsun
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Bagcilar Medipol Mega Hospital
34214 Istanbul
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Erciyes University School of Medicine
38039 Kayseri
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Kocaeli Universitesi Tip Fakultesi
41380 Kocaeli
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The Christie Hospital
M20 4BX Greater Manchester
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Churchill Hospital Oxford University Hospital Nhs Trust
OX3 7LE Headington
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University College Hospital
NW1 2PG London
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Clatterbridge Cancer Centre
CH63 4JY Wirral
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Alle anzeigen

Studien-Informationen

Brief Summary:

The study consists of two parts. Part 1 determines the safety and tolerability of BGB-11417

(sonrotoclax) monotherapy, the maximum tolerated dose, and the recommended Phase 2 dose of

BGB-11417 monotherapy for relapsed or refractory mantle cell lymphoma. Part 2 evaluates

efficacy of BGB-11417 monotherapy at the recommended Phase 2 dose with recommended ramp-up

schedule from Part 1.

Ein-/Ausschlusskriterien

Key Inclusion Criteria:

1. Histologically confirmed diagnosis of MCL

2. Prior systemic treatments for MCL (at least one line of anti-cluster of

differentiation 20 (anti-CD20) based immune or chemoimmunotherapy and at least one

kind of covalent or non-covalent adequate Bruton Tyrosine Kinase (BTK) inhibitor).

3. Relapsed/refractory disease

4. Presence of measurable disease

5. Availability of archival tissue confirming diagnosis of MCL, or willing to undergo

fresh tumor biopsy

6. Eastern Cooperative Oncology Group (ECOG) performance status of 0,1 or 2.

7. Adequate organ function

Key Exclusion Criteria:

1. Known central nervous system involvement by lymphoma

2. Prior malignancy other than MCL within the past 3 years, except for curatively treated

basal or squamous cell skin cancer, superficial bladder cancer, carcinoma in situ of

the cervix or breast, or localized Gleason score 6 prostate cancer.

3. Prior exposure to a BCL-2 inhibitor (eg, venetoclax/ABT-199).

4. Prior autologous stem cell transplant within the last 3 months; or prior autologous

chimeric antigen receptor T-cell therapy within the last 3 months; or prior allogeneic

stem cell transplant within the last 6 months or currently has an active graft-vs-host

disease requiring the use of immunosuppressants.

5. Clinically significant cardiovascular disease.

6. Major surgery or significant injury ≤ 4 weeks prior to start of study treatment.

7. Active fungal, bacterial or viral infection requiring systemic treatment.

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Studien-Rationale

Primary outcome:

1. Part 1: Number Of Participants Experiencing Dose-limiting Toxicities (DLTs) (Time Frame - Up to 1 Year)

2. Part 1: Number of Participants Reporting One or More Treatment-emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), and adverse events leading to discontinuation. (Time Frame - Up to 5 Years)

3. Part 1: Number of participants experiencing tumor lysis syndrome (TLS) relevant events (Time Frame - Up to 5 Years)

4. Part 2: Overall Response Rate (ORR) as assessed by the Independent Review Committee (IRC) (Time Frame - Up to 4 Years):
Defined as the proportion of participants who achieved a complete response (CR), or partial response (PR) per the Lugano Classification

Secondary outcome:

1. Part 1: Single Dose Area Under the Plasma Concentration Time Curve (AUC) (Time Frame - Up to 2 Years)

2. Part 1: Single Dose Maximum Observed Plasma Concentration (Cmax) (Time Frame - Up to 2 Years)

3. Part 1: Single Dose Time to reach Cmax (Tmax) (Time Frame - Up to 2 Years)

4. Part 1: Steady State Area Under the Plasma Concentration Time Curve (AUC) (Time Frame - Up to 2 Years)

5. Part 1: Steady State Maximum Observed Plasma Concentration (Cmax) (Time Frame - Up to 2 Years)

6. Part 1: Steady State Trough Plasma Concentration (CTrough) (Time Frame - Up to 2 Years)

7. Part 1: Steady State Time to reach Cmax (Tmax) (Time Frame - Up to 2 Years)

8. Overall Response Rate (ORR) as assessed by investigator (Time Frame - Up to 4 Years):
Defined as the proportion of participants who achieved a complete response (CR), or partial response (PR) per Lugano classification

9. Duration of Response (DOR) as assessed by investigator and IRC (Time Frame - Up to 4 Years):
DOR is defined as the time from the date of the first documented response (PR or better) after treatment initiation until the date of first documented disease progression or death due to any cause; whichever occurs first

10. Progression Free Survival (PFS) as assessed by investigator and IRC (Time Frame - Up to 4 Years):
PFS is defined as the time from the date of the first study dose until the date of first documented disease progression or death due to any cause, whichever occurs first.

11. Time to Response (TTR) as assessed by investigator and IRC (Time Frame - Up to 4 Years):
TTR is defined as the time from start of treatment to first documentation of response of Partial Response (PR) or better

12. Overall Survival (OS) (Time Frame - Up to 4 Years):
Defined as time from the start of treatment to the date of death due to any cause

13. Part 2: Number of Participants Reporting One or More Treatment-emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), and adverse events leading to discontinuation. (Time Frame - Up to 4 Years)

14. Part 2: Number of participants with clinically significant changes from baseline in vital signs (Time Frame - Up to 4 Years):
Vital signs include blood pressure and pulse rate

15. Part 2: Number of participants with clinically significant changes from baseline in clinical laboratory values (Time Frame - Up to 4 Years):
Laboratory values include hematology, and clinical chemistry

16. Part 2: Number of Participants With Clinically Significant Physical Examination Findings (Time Frame - Up to 4 Years):
A Physical examination includes head, ears, eyes, nose, mouth, skin, heart and lung examinations, lymph nodes, gastrointestinal and musculoskeletal systems

17. Part 2: Participant Reported Outcomes as measured by NFLymSI-18 (Time Frame - Up to 4 Years):
The National Comprehensive Cancer Network/Functional Assessment of Cancer Therapy Lymphoma Cancer 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 is divided into a total score.

18. Part 2: Participant Reported Outcomes as measured by EQ-5D-5L questionnaires (Time Frame - Up to 4 Years):
The EQ-5D-5L descriptive system assesses health in five dimensions (MOBILITY, SELF-CARE, USUAL ACTIVITIES, PAIN / DISCOMFORT, ANXIETY / DEPRESSION), each of which has five levels of response (no problems, slight problems, moderate problems, severe problems, extreme problems/unable to). This part of the EQ-5D questionnaire provides a descriptive profile that can be used to generate a health state profile. Health state index scores generally range from less than 0 (where 0 is the value of a health state equivalent to dead; negative values representing values as worse than dead) to 1 (the value of full health), with higher scores indicating higher health utility. The second part of the questionnaire consists of a visual analogue scale (VAS) on which the participant rates his/her perceived health from 0 (the worst imaginable health) to 100 (the best imaginable health).

Geprüfte Regime

  • BGB-11417 (sonrotoclax):
    Administered orally

Quelle: ClinicalTrials.gov


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"Study of BGB-11417 Monotherapy in Participants With Relapsed or Refractory Mantle Cell Lymphoma"

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