Efficacy and Safety of Nemtabrutinib (MK-1026) in Participants With Hematologic Malignancies (MK-1026-003)

NCT04728893 | Recruiting Phase 2 FDA Drug

• 5 other identifiers: 1026-003MK-1026-0032023-504931-42-00U1111-1290-40042020-002324-36
• Study Type: interventional
• Target: 490
• Locations: 22 countries
• Sites: 121

Brief Summary

The purpose of this study is to evaluate the safety and efficacy of nemtabrutinib (formerly ARQ 531) in participants with hematologic malignancies of chronic lymphocytic leukemia (CLL)/ small lymphocytic lymphoma (SLL), Richter's transformation, marginal zone lymphoma (MZL), mantle cell lymphoma (MCL), follicular lymphoma (FL), and Waldenström's macroglobulinemia (WM).

Conditions

Hematologic Malignancies; Non-Hodgkins Lymphoma; Waldenstroms Macroglobulinaemia; Chronic Lymphocytic Leukaemia

Outcome Measures

Primary Outcomes (6)

• Part 1: Number of participants experiencing dose-limiting toxicities (DLTs)

  DLTs will be defined as toxicities observed during the first 2 cycles (8 weeks) of Part 1 and include: Grade ≥3 nonhematologic toxicity (except Grade 3 nausea, vomiting, diarrhea, rash, fatigue, and uncontrolled hypertension which will not be considered a DLT unless lasting ≥72 hours despite optimal supportive care); Grade 4 hematologic toxicity lasting \>7 days (except Grade 3 lymphocytosis, Grade 4 platelet count decreased of any duration, or Grade 3 platelet count decreased if associated with bleeding); any Grade 3 or Grade 4 nonhematologic laboratory abnormality if values result in drug-induced liver injury, or medical intervention is required, or the abnormality leads to hospitalization, or the abnormality persists for \>1 week (with exceptions); missing \>25% of nemtabrutinib doses as a result of drug-related adverse events (AEs) during the first 2 cycles (8 weeks); Grade 5 toxicity.

  Up to ~56 days (Cycles 1-2, cycle = 28 days)

• Part 1: Number of participants experiencing adverse events (AEs)

  An AE is any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The number of participants experiencing AEs will be reported for Part 1.

  Up to ~71 months

• Part 1: Number of participants discontinuing study treatment due to AEs

  An AE is any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The number of participants discontinuing study treatment due to an AE will be reported for Part 1.

  Up to ~42 months

• Part 2: Objective Response Rate (ORR) per International Workshop on Chronic Lymphocytic Leukemia (iwCLL) criteria 2018 as assessed by independent central review (ICR)

  ORR per iwCLL 2018 criteria is defined as the percentage of participants achieving a complete response (CR), complete response with incomplete bone marrow recovery (CRi), nodular partial response (nPR), or partial response (PR). CR is defined as meeting the following criteria: no lymph nodes \>1.5 cm, spleen size \<13 cm, liver normal; no constitutional symptoms, normal lymphocyte count, platelets ≥100 x 10\^9/L; hemoglobin ≥11 g/dL; and normocellular marrow (no CLL cells or B lymphoid nodules). CRi is defined as meeting CR criteria but with hypocellular bone marrow. nPR is defined as having features of CR but with lymphoid nodules in the marrow. PR is defined as ≥50% decrease in ≥2 of the following: lymph nodes, liver and/or spleen size, lymphocytes PLUS ≥1 of the following met: platelets ≥100 x 10\^9/L or ≥50% increase from screening, hemoglobin \>11 g/dL or ≥50% increase from screening, CLL cells or B lymphoid nodules in marrow.

  Up to ~61 months

• Part 2: ORR per Lugano criteria 2014 as assessed by ICR

  ORR per Lugano criteria 2014 is defined as the percentage of participants achieving a CR or PR. CR defined as EITHER CR by imaging (computed tomography \[CT\]): all lymph nodes normal (none ≥15 mm) and normal liver and spleen OR complete metabolic response (CMR): score of 1, 2 or 3 on the 5-point scale assessing fluorodeoxyglucose (FDG) metabolic activity in lymphomatous lesions (ranging from 1=no uptake above background to 5=uptake markedly higher than liver) AND bone marrow (BM) normal by morphology. PR defined as EITHER PR by imaging (CT) with ≥50% decrease in the sum of the product of diameters \[SPD\] of target lesions, no worsening of nontarget lesions, no new lesions and ≥50% spleen abnormal portion OR Partial Metabolic Response (PMR) with score of 4 or 5 on the FDG 5-point scale (with no new lesions) and decreased overall uptake AND residual BM abnormalities; OR CR by imaging with residual BM abnormalities; OR PR by imaging without residual BM abnormalities.

  Up to ~61 months

• Part 2: ORR per International Workshop on Waldenström's Macroglobulinemia (IWWM) criteria 2014 as assessed by ICR

  ORR per IWWM criteria 2014 is defined as the percentage of participants achieving a CR, very good partial response (VGPR), or PR. CR is defined as all lymph nodes are normal in size (none ≥15 mm), liver and spleen normal in size, serum immunoglobulin M (IgM) values in the normal range, disappearance of monoclonal protein by immunofixation (confirmation needed with a second immunofixation at any subsequent timepoint), and no histological evidence of BM involvement. VGPR is defined as ≥50% decrease from baseline in SPD of lymph nodes (if abnormal at baseline), ≥50% decrease from baseline in the abnormal portion of the spleen (if previously abnormal), and ≥90% decrease from baseline in serum IgM, or serum IgM values in normal range. PR is defined as ≥50% decrease from baseline in SPD of lymph nodes (if abnormal at baseline), ≥50% decrease from baseline in serum IgM, and ≥50% decrease from baseline in the abnormal portion of the spleen (if previously abnormal).

  Up to ~71 months

Secondary Outcomes (13)

• Part 1: Area Under the Curve (AUC) of Nemtabrutinib

  At designated time points (up to ~57 days)

• Part 1: Minimum Concentration (Cmin) of Nemtabrutinib

  At designated time points (up to ~57 days)

• Part 1: Maximum Concentration (Cmax) of Nemtabrutinib

  At designated time points (up to ~57 days)

• Part 1: ORR per iwCLL criteria 2018 as assessed by ICR

  Up to ~71 months

• Part 1: Duration of Response (DOR) per iwCLL criteria 2018 as assessed by ICR

  Up to ~71 months

Study Arms (1)

Nemtabrutinib

EXPERIMENTAL

Participants receive nemtabrutinib orally once daily (QD) until progressive disease (PD) or discontinuation.

Drug: Nemtabrutinib

Interventions

Nemtabrutinib DRUG

Nemtabrutinib tablets administered orally QD.

Also known as: ARQ 531, MK-1026

Nemtabrutinib

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2 within 7 days before C1D1 (the first dose of study treatment)
• Has a life expectancy of at least 3 months, based on the investigator assessment
• Has the ability to swallow and retain oral medication
• Participants who are Hepatitis B surface antigen (HBsAg)-positive are eligible if they have received Hepatitis B virus (HBV) antiviral therapy for at least 4 weeks and have undetectable HBV viral load prior to randomization
• Participants with history of Hepatitis C virus (HCV) infection are eligible if HCV viral load is undetectable at screening
• Has adequate organ function
• Male participants agree to refrain from donating sperm and agree to either remain abstinent from penile-vaginal intercourse as their preferred and usual lifestyle OR agree to use contraception, during the intervention period and for at least the time required to eliminate the study intervention after last dose of study intervention
• Female participants assigned female sex at birth who are not pregnant or breastfeeding are eligible to participate if not a participant of childbearing potential (POCBP), or if a POCBP they either use a contraceptive method that is highly effective OR remain abstinent from penile-vaginal intercourse as their preferred and usual lifestyle during the intervention period and for at least to eliminate study intervention after the last dose of study intervention
• Participants with Human immunodeficiency virus (HIV) are eligible if they meet all of the following: the CD4 count is \>350 cells/uL at screening, the HIV viral load is below the detectable level, are on a stable ART regimen for at least 4 weeks prior to study entry, and are compliant with their ART
• Part 1 and Part 2 (Cohorts A to C and J)
• Has a confirmed diagnosis of Chronic lymphocytic leukemia/ Small lymphocytic lymphoma (CLL/SLL) with
• At least 2 lines of prior therapy (Part 1 only)
• Part 2 Cohort A: CLL/SLL participants who are relapsed or refractory to prior therapy with a covalent, irreversible Bruton's tyrosine kinase inhibitor (BTKi), and a B-cell lymphoma 2 inhibitor (BCL2i). CLL participants must have received and failed, been intolerant to, or determined by their treating physician to be a poor phosphoinositide 3-kinase inhibitor (PI3Ki) candidate or ineligible for a PI3Ki per local guidelines
• Part 2 Cohort B: CLL/SLL participants who are relapsed or refractory following at least 1 line of prior therapy and are BTKi treatment naive
• Part 2 Cohort C: CLL/SLL participants with 17p deletion or tumor protein p53 (TP53) mutation who are relapsed or refractory following at least 1 line of prior therapy

You may not qualify if:

• Has active HBV/HCV infection (Part 1 and Part 2)
• Has a history of malignancy ≤3 years before providing documented informed consent. Participants with basal cell carcinoma of skin, squamous cell carcinoma of skin, or carcinoma in situ (e.g., breast carcinoma, cervical cancer in situ) that have undergone potential curative therapy are not excluded. Participants with low-risk, early-stage prostate cancer (T1-T2a, Gleason score ≤6, and prostate-specific antigen \<10 ng/mL) either treated with definitive intent or untreated in active surveillance with SD are not excluded
• Has active central nervous system (CNS) disease
• Has an active infection requiring systemic therapy
• Has received prior systemic anti-cancer therapy within 5 half-lives or 4 weeks (if prior therapy was a monoclonal antibody) before C1D1
• Is currently participating in or has participated in a study of an investigational agent or has used an investigational device within 4 weeks prior to the first dose of study intervention
• Has any clinically significant gastrointestinal abnormalities that might alter absorption
• History of severe bleeding disorders

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

Study Sites (121)

Highlands Oncology Group ( Site 2728)

Springdale, Arkansas, 72762, United States

RECRUITING

University of California San Diego Moores Cancer Center ( Site 2717)

La Jolla, California, 92093-0698, United States

RECRUITING

Lundquist Institute for Biomedical Innovation at Harbor-UCLA-Hematology and Medical Oncology ( Site 2724)

Torrance, California, 90502, United States

COMPLETED

Colorado Blood Cancer Institute ( Site 2726)

Denver, Colorado, 80218, United States

RECRUITING

The University of Louisville, James Graham Brown Cancer Center ( Site 2729)

Louisville, Kentucky, 40202, United States

COMPLETED

Mayo Clinic - Rochester ( Site 2706)

Rochester, Minnesota, 55905, United States

RECRUITING

Astera Cancer Care ( Site 2732)

East Brunswick, New Jersey, 08816, United States

RECRUITING

John Theurer Cancer Center at Hackensack University Medical Center ( Site 2704)

Hackensack, New Jersey, 07601, United States

RECRUITING

Sanford Fargo Medical Center-Roger Maris Cancer Center ( Site 2708)

Fargo, North Dakota, 58102, United States

COMPLETED

UT Southwestern-Harold C. Simmons Cancer Center ( Site 2730)

Dallas, Texas, 75390, United States

RECRUITING

Medical Oncology Associates (Summit Cancer Centers) ( Site 2710)

Spokane, Washington, 99208, United States

RECRUITING

Hospital Aleman ( Site 0102)

Ciudad Autonoma de Buenos Aires, Buenos Aires, C1118AAT, Argentina

RECRUITING

Centro de Educación Médica e Investigaciones Clínicas (CEMIC) ( Site 0103)

Buenos Aires, Buenos Aires F.D., C1431FWO, Argentina

RECRUITING

Fundacion Estudios Clinicos ( Site 0112)

Rosario, Santa Fe Province, S2000DEJ, Argentina

RECRUITING

FUNDALEU ( Site 0104)

Caba, C1114AAN, Argentina

RECRUITING

Hospital Privado Universitario de Córdoba ( Site 0107)

Córdoba, X5016KEH, Argentina

RECRUITING

Fundacion Centro Oncologico de Integración Regional-Medical Oncology ( Site 0110)

Mendoza, M5500AYB, Argentina

COMPLETED

Nepean Hospital-Nepean Cancer Care Centre ( Site 0204)

Sydney, New South Wales, 2747, Australia

COMPLETED

Box Hill Hospital ( Site 0203)

Box Hill, Victoria, 3128, Australia

RECRUITING

Sir Charles Gairdner Hospital ( Site 0200)

Nedlands, Western Australia, 6009, Australia

RECRUITING

Hospital das Clinicas FMUSP-Pesquisa Clínica Hematologia ( Site 0303)

São Paulo, São Paulo, 05403-000, Brazil

RECRUITING

Instituto Nacional do Cancer Jose Alencar Gomes da Silva INCA ( Site 0300)

Rio de Janeiro, 20231-050, Brazil

RECRUITING

BP - A Beneficencia Portuguesa de São Paulo ( Site 0302)

São Paulo, 01321-001, Brazil

COMPLETED

Hospital Paulistano - Amil Clinical Research ( Site 0311)

São Paulo, 01321-001, Brazil

RECRUITING

Arthur J.E. Child Comprehensive Cancer Centre ( Site 0401)

Calgary, Alberta, T2N 5G2, Canada

RECRUITING

The Ottawa Hospital ( Site 0404)

Ottawa, Ontario, K1H 8L6, Canada

RECRUITING

Princess Margaret Cancer Centre-Division of Medical Oncology and Hematology ( Site 0406)

Toronto, Ontario, M5G 2M9, Canada

RECRUITING

CIUSSS de l Est de L Ile de Montreal - Hopital Maisonneuve-Rosemont ( Site 0403)

Montreal, Quebec, H1T 2M4, Canada

RECRUITING

Jewish General Hospital ( Site 0400)

Montreal, Quebec, H3T 1E2, Canada

RECRUITING

Anhui Provincial Hospital ( Site 2808)

Hefei, Anhui, 230071, China

RECRUITING

Peking University Third Hospital-Hematology ( Site 2827)

Beijing, Beijing Municipality, 100191, China

RECRUITING

The Second Affiliated Hospital of Chongqing Medical University ( Site 2825)

Chongqing, Chongqing Municipality, 400072, China

COMPLETED

Sun Yat-sen University Cancer Center-Internal Medicine ( Site 2824)

Guangzhou, Guangdong, 510060, China

RECRUITING

Liuzhou People's Hospital ( Site 2817)

Liuzhou, Guangxi, 545006, China

RECRUITING

Guangxi Medical University Cancer Hospital ( Site 2814)

Nanning, Guangxi, 530028, China

RECRUITING

Henan Cancer Hospital-hematology department ( Site 2802)

Zhengzhou, Henan, 450008, China

RECRUITING

Wuhan Union Hospital ( Site 2816)

Wuhan, Hubei, 430022, China

RECRUITING

The Second Xiangya Hospital of Central South University ( Site 2820)

Changsha, Hunan, 410011, China

RECRUITING

Hunan Cancer Hospital ( Site 2822)

Changsha, Hunan, 410013, China

RECRUITING

Jiangsu Province Hospital ( Site 2823)

Nanjing, Jiangsu, 210029, China

RECRUITING

The Affiliated Hospital of Xuzhou Medical College ( Site 2818)

Xuzhou, Jiangsu, 221000, China

COMPLETED

The First Affiliated Hospital of Nanchang University ( Site 2815)

Nanchang, Jiangxi, 330006, China

RECRUITING

The First Hospital of Jilin University-Hematology ( Site 2803)

Changchun, Jilin, 130021, China

RECRUITING

Fudan University Shanghai Cancer Center ( Site 2801)

Shanghai, Shanghai Municipality, 200032, China

RECRUITING

Huashan Hospital, Fudan University ( Site 2821)

Shanghai, Shanghai Municipality, 200040, China

RECRUITING

West China Hospital Sichuan University ( Site 2810)

Chengdu, Sichuan, 610041, China

RECRUITING

Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences & Peking Unio ( Site 2800)

Tianjin, Tianjin Municipality, 301617, China

RECRUITING

The First Affiliated Hospital, Zhejiang University ( Site 2826)

Hangzhou, Zhejiang, 310002, China

RECRUITING

Fakultní nemocnice Brno Bohunice-Interni hematologicka a onkologicka klinika ( Site 0600)

Brno, Brno-mesto, 625 00, Czechia

RECRUITING

Fakultni nemocnice Hradec Kralove ( Site 0601)

Hradec Králové, 500 05, Czechia

RECRUITING

Aarhus University Hospital ( Site 0702)

Aarhus N, Central Jutland, 8200, Denmark

COMPLETED

Aalborg Universitetshospital ( Site 0703)

Aalborg, North Denmark, 9000, Denmark

RECRUITING

Sjaellands Universitetshospital Roskilde ( Site 0701)

Roskilde, Region Sjælland, 4000, Denmark

RECRUITING

Odense University Hospital ( Site 0705)

Odense C, Region Syddanmark, 5000, Denmark

COMPLETED

Centre Hospitalier Universitaire de Nice - Hôpital l'Archet ( Site 0810)

Nice, Alpes-Maritimes, 06202, France

RECRUITING

Centre Hospitalier Lyon-Sud ( Site 0804)

Pierre-Bénite, Auvergne-Rhône-Alpes, 69495, France

RECRUITING

Institut Paoli-Calmettes ( Site 0803)

Marseille, Bouches-du-Rhone, 13009, France

RECRUITING

Centre Hospitalier de Versailles ( Site 0809)

Le Chesnay, Yvelines, 78150, France

COMPLETED

Hopital Saint Louis ( Site 0805)

Paris, 75010, France

RECRUITING

Universitaetsklinikum Ulm. ( Site 0906)

Ulm, Baden-Wurttemberg, 89081, Germany

RECRUITING

Universitaetsklinikum Koeln ( Site 0901)

Cologne, North Rhine-Westphalia, 50937, Germany

RECRUITING

St. Marien-Krankenhaus Siegen ( Site 0914)

Siegen, North Rhine-Westphalia, 57072, Germany

COMPLETED

Universitaetsklinikum Carl Gustav Carus ( Site 0902)

Dresden, Saxony, 01307, Germany

RECRUITING

Pecsi Tudomanyegyetem Altalanos Orvostudomanyi Kar ( Site 1202)

Pécs, Baranya, 7624, Hungary

RECRUITING

Debreceni Egyetem Klinikai Kozpont ( Site 1201)

Debrecen, Hajdú-Bihar, 4032, Hungary

RECRUITING

Szabolcs Szatmár Bereg Vármegyei Oktatókórház ( Site 1206)

Nyíregyháza, Szabolcs-Szatmár-Bereg, 4400, Hungary

RECRUITING

Orszagos Onkologiai Intezet ( Site 1200)

Budapest, 1122, Hungary

RECRUITING

Beaumont Hospital ( Site 2900)

Dublin, Dublin 9, Ireland

RECRUITING

University Hospital Limerick ( Site 2903)

Limerick, V94 F858, Ireland

RECRUITING

Ha Emek Medical Center ( Site 1305)

Afula, 1834111, Israel

RECRUITING

Soroka Medical Center ( Site 1307)

Beersheba, 8457108, Israel

RECRUITING

Rambam Medical Center ( Site 1301)

Haifa, 3109601, Israel

RECRUITING

Hadassah Ein Karem Jerusalem ( Site 1300)

Jerusalem, 9112001, Israel

RECRUITING

Chaim Sheba Medical Center ( Site 1302)

Ramat Gan, 5262001, Israel

RECRUITING

Kaplan Medical Center ( Site 1304)

Rehovot, 76100, Israel

RECRUITING

Sourasky Medical Center ( Site 1303)

Tel Aviv, 6423906, Israel

RECRUITING

Istituto Tumori Giovanni Paolo II ( Site 1409)

Bari, 70124, Italy

RECRUITING

A.O. Universitaria Policlinico S. Orsola-Malpighi ( Site 1400)

Bologna, 40138, Italy

RECRUITING

ASST Spedali Civili di Brescia ( Site 1408)

Brescia, 25123, Italy

RECRUITING

IRCCS Ospedale San Raffaele ( Site 1402)

Milan, 20132, Italy

RECRUITING

Istituto Nazionale Tumori IRCCS Fondazione Pascale ( Site 1403)

Naples, 80131, Italy

RECRUITING

Fondazione IRCCS Policlinico San Matteo ( Site 1407)

Pavia, 27100, Italy

RECRUITING

IRCCS - Arcispedale Santa Maria Nuova ( Site 1405)

Reggio Emilia, 42123, Italy

RECRUITING

Policlinico Umberto I ( Site 1404)

Roma, 00161, Italy

COMPLETED

Pratia MCM Krakow ( Site 1601)

Krakow, Lesser Poland Voivodeship, 30-727, Poland

RECRUITING

Uniwersytecki Szpital Kliniczny-Klinika Hematologii, Nowotworow Krwi i Transplantacji Szpiku ( Site 1606)

Wroclaw, Lower Silesian Voivodeship, 50-367, Poland

RECRUITING

Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - P-Kilinka Onkologii I Hematologii ( Site 1608)

Warsaw, Masovian Voivodeship, 02-781, Poland

RECRUITING

Szpital Wojewódzki w Opolu-Hematology Department ( Site 1607)

Opole, Opole Voivodeship, 45-061, Poland

COMPLETED

Szpitale Pomorskie Sp. z o.o. ( Site 1600)

Gdynia, Pomeranian Voivodeship, 81-519, Poland

COMPLETED

Spitalul Clinic Colțea ( Site 1805)

Bucharest, Bucharest, 030171, Romania

RECRUITING

Ovidius Clinical Hospital ( Site 1804)

Ovidiu, Constanța County, 905900, Romania

COMPLETED

Centrul de Diagnostic si Tratament Oncologic Brasov ( Site 1802)

Brasov, 500052, Romania

RECRUITING

Institutul Regional de Oncologie Iasi ( Site 1801)

Iași, 700483, Romania

RECRUITING

Severance Hospital Yonsei University Health System ( Site 2201)

Seoul, 03722, South Korea

RECRUITING

Samsung Medical Center ( Site 2200)

Seoul, 06351, South Korea

RECRUITING

Instituto Catalan de Oncologia ICO - Hospital Duran i Reynals ( Site 2000)

L'Hospitalet de Llobregat, Barcelona, 08908, Spain

RECRUITING

Hospital Universitario de Salamanca ( Site 2002)

Salamanca, Castille and León, 37007, Spain

RECRUITING

CHUAC-Complejo Hospitalario Universitario A Coruña ( Site 2005)

A Coruña, La Coruna, 15006, Spain

RECRUITING

Hospital General Universitario de Alicante ( Site 2007)

Alicante, 03010, Spain

RECRUITING

Hospital Universitari Vall d'Hebron ( Site 2001)

Barcelona, 08035, Spain

RECRUITING

Hospital Universitario 12 de Octubre ( Site 2003)

Madrid, 28041, Spain

RECRUITING

Hospital Puerta de Hierro ( Site 2009)

Madrid, 28222, Spain

RECRUITING

Inselspital Bern ( Site 2303)

Bern, Canton of Bern, 3010, Switzerland

RECRUITING

Istituto Oncologica della Svizzera Italiana (IOSI) ( Site 2302)

Bellinzona, Canton Ticino, 6500, Switzerland

RECRUITING

Mega Medipol-Hematology ( Site 2406)

Stanbul, Istanbul, 34214, Turkey (Türkiye)

ACTIVE NOT RECRUITING

Ankara Universitesi Tip Fakultesi Cebeci Hastanesi ( Site 2400)

Ankara, 06590, Turkey (Türkiye)

RECRUITING

VKV Amerikan Hastanesi ( Site 2403)

Istanbul, 34365, Turkey (Türkiye)

COMPLETED

Sisli Florence Nightingale Hastanesi ( Site 2407)

Istanbul, 34381, Turkey (Türkiye)

RECRUITING

Dokuz Eylül Üniversitesi-Hematology ( Site 2402)

Izmir, 35340, Turkey (Türkiye)

ACTIVE NOT RECRUITING

MNPE ClinCenter of Oncology,Hematology,Transplantology and Palliative Care of CherkasyRegCouncil ( Site 2509)

Cherkassy, Cherkasy Oblast, 18009, Ukraine

COMPLETED

Communal non-profit enterprise "Regional clinical hospital o-Hematology Department ( Site 2510)

Ivano-Frankivsk, Ivano-Frankivsk Oblast, 76008, Ukraine

COMPLETED

Instit. of Blood Transfusion Medicine of the National Academy ( Site 2506)

Lviv, Lviv Oblast, 79044, Ukraine

RECRUITING

National Cancer Institute ( Site 2507)

Kyiv, 03022, Ukraine

RECRUITING

Bristol Haematology and Oncology Centre ( Site 2610)

Bristol, Bristol, City of, BS2 8ED, United Kingdom

RECRUITING

Nottingham University Hospitals NHS Trust. City Hospital Campus ( Site 2601)

Nottingham, England, NG5 1PF, United Kingdom

RECRUITING

GenesisCare - Windsor ( Site 2608)

Windsor, England, SL4 3HD, United Kingdom

RECRUITING

Sarah Cannon Research Institute UK ( Site 2612)

London, London, City of, W1G 6AD, United Kingdom

RECRUITING

GenesisCare - Oxford ( Site 2607)

Oxford, Oxfordshire, OX4 6LB, United Kingdom

RECRUITING

GenesisCare - Cambridge ( Site 2611)

Newmarket, Suffolk, CB8 7XN, United Kingdom

RECRUITING

The Royal Marsden NHS Foundation Trust. ( Site 2606)

Sutton, Surrey, SM2 5PT, United Kingdom

RECRUITING

The Christie NHS Foundation Trust ( Site 2602)

Manchester, M20 4BX, United Kingdom

RECRUITING

Related Links

• Merck Clinical Trials Information
• Plain Language Summary

MeSH Terms

Conditions

Hematologic Neoplasms; Waldenstrom Macroglobulinemia; Lymphoma, Non-Hodgkin; Leukemia, B-Cell

Interventions

ARQ531

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hemorrhagic Disorders; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Lymphoma; Leukemia, Lymphoid; Leukemia

Study Officials

• Medical Director

  Merck Sharp & Dohme LLC

  STUDY DIRECTOR

Central Study Contacts

Toll Free Number

CONTACT

1-888-577-8839; Trialsites@msd.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 25, 2021
• First Posted: January 28, 2021
• Study Start: April 5, 2021
• Primary Completion (Estimated): January 4, 2029
• Study Completion (Estimated): January 4, 2029
• Last Updated: May 4, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share

Locations

PL (5); HU (4); BR (4); CA (5); IL (7); GB (8); IT (8); DE (4); US (11); RO (4); AU (3); DK (4); AR (6); ES (7); UA (4); CZ (2); FR (5); IE (2); CH (2); TU (5); CN (19); KR (2)