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| ID | Type | Description | Link |
|---|---|---|---|
| MK-1026-003 | Other Identifier | MSD | |
| 2023-504931-42-00 | Registry Identifier | EU CT | |
| U1111-1290-4004 | Registry Identifier | UTN | |
| 2020-002324-36 | EudraCT Number |
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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).
This study will be performed in 2 parts: Dose Escalation and Confirmation (Part 1) and Cohort Expansion (Part 2). Following determination of the recommended phase 2 dose (RP2D) in Part 1, the study plans to proceed with Part 2 using 8 disease-specific expansion cohorts (Cohorts A to H).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Nemtabrutinib | Experimental | Participants receive nemtabrutinib orally once daily (QD) until progressive disease (PD) or discontinuation. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nemtabrutinib | Drug | Nemtabrutinib tablets administered orally QD. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Part 1: Area Under the Curve (AUC) of Nemtabrutinib | Blood samples will be obtained at designated time points during Part 1 for the assessment of nemtabrutinib AUC (Day 1 of Cycles 1 and 2: Pre-dose, 2, 4, 6, 8, and 24 hours post-dose; Day 1 of Cycle 3: pre-dose and 2, 4, and 6 hours post-dose [up to ~57 days]). Each cycle is 28 days. | At designated time points (up to ~57 days) |
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Inclusion Criteria:
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
Part 2 (Cohorts D to G)
- Has a confirmed diagnosis of and meets the following prior therapy requirements:
Part 2 (Cohort H): confirmed diagnosis of Waldenström's macroglobulinemia (WM); participants who are relapsed or refractory to standard therapies for WM including chemoimmunotherapy and a covalent irreversible BTKi
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Toll Free Number | Contact | 1-888-577-8839 | Trialsites@msd.com |
| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Merck Sharp & Dohme LLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Highlands Oncology Group ( Site 2728) | Recruiting | Springdale | Arkansas | 72762 | United States |
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| Label | URL |
|---|---|
| Merck Clinical Trials Information | View source |
| Plain Language Summary | View source |
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| 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 |
| Part 1: Minimum Concentration (Cmin) of Nemtabrutinib | Blood samples will be obtained at designated time points during Part 1 for the assessment of nemtabrutinib Cmin (Day 1 of Cycles 1 and 2: Pre-dose, 2, 4, 6, 8, and 24 hours post-dose; Day 1 of Cycle 3: pre-dose and 2, 4, and 6 hours post-dose [up to ~57 days]). Each cycle is 28 days. | At designated time points (up to ~57 days) |
| Part 1: Maximum Concentration (Cmax) of Nemtabrutinib | Blood samples will be obtained at designated time points during Part 1 for the assessment of nemtabrutinib Cmax (Day 1 of Cycles 1 and 2: Pre-dose, 2, 4, 6, 8, and 24 hours post-dose; Day 1 of Cycle 3: pre-dose and 2, 4, and 6 hours post-dose [up to ~57 days]). Each cycle is 28 days. | At designated time points (up to ~57 days) |
| Part 1: ORR per iwCLL criteria 2018 as assessed by ICR | ORR per iwCLL 2018 criteria is defined as the percentage of participants achieving a CR, CRi, nPR, or 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 ~71 months |
| Part 1: Duration of Response (DOR) per iwCLL criteria 2018 as assessed by ICR | For participants with CR, CRi, nPR, or PR per iwCLL 2018 criteria, DOR is defined as the time from the first documented evidence of objective response until PD or death due to any cause, whichever occurs first. 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 ~71 months |
| Part 2: Number of participants experiencing 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 2. | Up to ~61 months |
| Part 2: 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 2. | Up to ~42 months |
| Part 2: AUC of Nemtabrutinib | Blood samples will be obtained at designated time points during Part 2 for the assessment of nemtabrutinib AUC (Day 1 of Cycles 1, 2, and 3: Pre-dose, 2, 4, 6, hours post-dose [up to ~57 days]). Each cycle is 28 days. | At designated time points (up to ~57 days) |
| Part 2: Cmin of Nemtabrutinib | Blood samples will be obtained at designated time points during Part 2 for the assessment of nemtabrutinib Cmin (Day 1 of Cycles 1, 2, and 3: Pre-dose, 2, 4, 6, hours post-dose [up to ~57 days]). Each cycle is 28 days. | At designated time points (up to ~57 days) |
| Part 2: Cmax of Nemtabrutinib | Blood samples will be obtained at designated time points during Part 2 for the assessment of nemtabrutinib Cmax (Day 1 of Cycles 1, 2, and 3: Pre-dose, 2, 4, 6, hours post-dose [up to ~57 days]). Each cycle is 28 days. | At designated time points (up to ~57 days) |
| Part 2: DOR per iwCLL criteria 2018 as assessed by ICR | For participants with CR, CRi, nPR, or PR per iwCLL 2018 criteria, DOR is defined as the time from the first documented evidence of objective response until disease progression or death due to any cause, whichever occurs first. 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: DOR per Lugano criteria 2014 as assessed by ICR | For participants with CR or PR per Lugano criteria 2014, DOR is defined as the time from the first documented evidence of objective response until PD or death due to any cause, whichever occurs first. CR defined as EITHER CR by imaging (CT): all lymph nodes normal (none ≥15 mm) and normal liver and spleen OR CMR: score of 1, 2 or 3 on the 5-point scale assessing FDG metabolic activity in lymphomatous lesions (ranging from 1=no uptake above background to 5=uptake markedly higher than liver and/or new lesions) AND BM normal by morphology. PR defined as EITHER PR by imaging (CT) with ≥50% decrease in the SPD of target lesions, no worsening of nontarget lesions, no new lesions and ≥50% spleen abnormal portion OR 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: DOR per IWWM criteria 2014 as assessed by ICR | For participants with CR, VGPR, or PR per IWWM criteria 2014, DOR defined as the time from first documented evidence of objective response until PD or death due to any cause, whichever occurs first. CR defined as all lymph nodes normal in size (none ≥15 mm), liver and spleen normal in size, serum IgM values in normal range, disappearance of monoclonal protein by immunofixation (confirmation needed with second immunofixation at any subsequent timepoint), and no histological evidence of BM involvement. VGPR defined as ≥50% decrease from baseline in SPD of lymph nodes (if abnormal at baseline), ≥50% decrease from baseline in 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 abnormal portion of the spleen (if previously abnormal). | Up to ~61 months |
| University of California San Diego Moores Cancer Center ( Site 2717) | Recruiting | La Jolla | California | 92093-0698 | United States |
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| Lundquist Institute for Biomedical Innovation at Harbor-UCLA-Hematology and Medical Oncology ( Site 2724) | Completed | Torrance | California | 90502 | United States |
| Colorado Blood Cancer Institute ( Site 2726) | Recruiting | Denver | Colorado | 80218 | United States |
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| The University of Louisville, James Graham Brown Cancer Center ( Site 2729) | Completed | Louisville | Kentucky | 40202 | United States |
| Mayo Clinic - Rochester ( Site 2706) | Active, not recruiting | Rochester | Minnesota | 55905 | United States |
| Astera Cancer Care ( Site 2732) | Recruiting | East Brunswick | New Jersey | 08816 | United States |
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| John Theurer Cancer Center at Hackensack University Medical Center ( Site 2704) | Recruiting | Hackensack | New Jersey | 07601 | United States |
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| Sanford Fargo Medical Center-Roger Maris Cancer Center ( Site 2708) | Completed | Fargo | North Dakota | 58102 | United States |
| UT Southwestern-Harold C. Simmons Cancer Center ( Site 2730) | Recruiting | Dallas | Texas | 75390 | United States |
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| Medical Oncology Associates (Summit Cancer Centers) ( Site 2710) | Recruiting | Spokane | Washington | 99208 | United States |
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| Hospital Aleman ( Site 0102) | Recruiting | Ciudad Autonoma de Buenos Aires | Buenos Aires | C1118AAT | Argentina |
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| Centro de Educación Médica e Investigaciones Clínicas (CEMIC) ( Site 0103) | Recruiting | Buenos Aires | Buenos Aires F.D. | C1431FWO | Argentina |
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| Fundacion Estudios Clinicos ( Site 0112) | Recruiting | Rosario | Santa Fe Province | S2000DEJ | Argentina |
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| FUNDALEU ( Site 0104) | Recruiting | Caba | C1114AAN | Argentina |
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| Hospital Privado Universitario de Córdoba ( Site 0107) | Recruiting | Córdoba | X5016KEH | Argentina |
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| Fundacion Centro Oncologico de Integración Regional-Medical Oncology ( Site 0110) | Completed | Mendoza | M5500AYB | Argentina |
| Nepean Hospital-Nepean Cancer Care Centre ( Site 0204) | Completed | Sydney | New South Wales | 2747 | Australia |
| Box Hill Hospital ( Site 0203) | Recruiting | Box Hill | Victoria | 3128 | Australia |
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| Sir Charles Gairdner Hospital ( Site 0200) | Recruiting | Nedlands | Western Australia | 6009 | Australia |
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| Hospital das Clinicas FMUSP-Pesquisa Clínica Hematologia ( Site 0303) | Recruiting | São Paulo | São Paulo | 05403-000 | Brazil |
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| Instituto Nacional do Cancer Jose Alencar Gomes da Silva INCA ( Site 0300) | Recruiting | Rio de Janeiro | 20231-050 | Brazil |
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| BP - A Beneficencia Portuguesa de São Paulo ( Site 0302) | Active, not recruiting | São Paulo | 01321-001 | Brazil |
| Hospital Paulistano - Amil Clinical Research ( Site 0311) | Recruiting | São Paulo | 01321-001 | Brazil |
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| Arthur J.E. Child Comprehensive Cancer Centre ( Site 0401) | Recruiting | Calgary | Alberta | T2N 5G2 | Canada |
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| The Ottawa Hospital ( Site 0404) | Recruiting | Ottawa | Ontario | K1H 8L6 | Canada |
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| Princess Margaret Cancer Centre-Division of Medical Oncology and Hematology ( Site 0406) | Recruiting | Toronto | Ontario | M5G 2M9 | Canada |
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| CIUSSS de l Est de L Ile de Montreal - Hopital Maisonneuve-Rosemont ( Site 0403) | Recruiting | Montreal | Quebec | H1T 2M4 | Canada |
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| Département clinique de médecine de laboratoire du CHUM ( Site 0400) | Recruiting | Montreal | Quebec | H3T 1E2 | Canada |
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| Anhui Provincial Hospital ( Site 2808) | Recruiting | Hefei | Anhui | 230071 | China |
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| Peking University Third Hospital-Hematology ( Site 2827) | Recruiting | Beijing | Beijing Municipality | 100191 | China |
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| The Second Affiliated Hospital of Chongqing Medical University ( Site 2825) | Active, not recruiting | Chongqing | Chongqing Municipality | 400072 | China |
| Sun Yat-sen University Cancer Center-Internal Medicine ( Site 2824) | Recruiting | Guangzhou | Guangdong | 510060 | China |
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| Liuzhou People's Hospital ( Site 2817) | Recruiting | Liuzhou | Guangxi | 545006 | China |
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| Guangxi Medical University Cancer Hospital ( Site 2814) | Recruiting | Nanning | Guangxi | 530028 | China |
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| Henan Cancer Hospital-hematology department ( Site 2802) | Recruiting | Zhengzhou | Henan | 450008 | China |
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| Wuhan Union Hospital ( Site 2816) | Recruiting | Wuhan | Hubei | 430022 | China |
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| The Second Xiangya Hospital of Central South University ( Site 2820) | Recruiting | Changsha | Hunan | 410011 | China |
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| Hunan Cancer Hospital ( Site 2822) | Recruiting | Changsha | Hunan | 410013 | China |
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| Jiangsu Province Hospital ( Site 2823) | Recruiting | Nanjing | Jiangsu | 210029 | China |
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| The Affiliated Hospital of Xuzhou Medical College ( Site 2818) | Active, not recruiting | Xuzhou | Jiangsu | 221000 | China |
| The First Affiliated Hospital of Nanchang University ( Site 2815) | Recruiting | Nanchang | Jiangxi | 330006 | China |
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| The First Hospital of Jilin University-Hematology ( Site 2803) | Recruiting | Changchun | Jilin | 130021 | China |
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| Fudan University Shanghai Cancer Center ( Site 2801) | Recruiting | Shanghai | Shanghai Municipality | 200032 | China |
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| Huashan Hospital, Fudan University ( Site 2821) | Recruiting | Shanghai | Shanghai Municipality | 200040 | China |
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| West China Hospital Sichuan University ( Site 2810) | Recruiting | Chengdu | Sichuan | 610041 | China |
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| Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences & Peking Unio ( Site 2800) | Recruiting | Tianjin | Tianjin Municipality | 301617 | China |
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| The First Affiliated Hospital, Zhejiang University ( Site 2826) | Recruiting | Hangzhou | Zhejiang | 310002 | China |
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| Fakultní nemocnice Brno Bohunice-Interni hematologicka a onkologicka klinika ( Site 0600) | Recruiting | Brno | Brno-mesto | 625 00 | Czechia |
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| Fakultni nemocnice Hradec Kralove ( Site 0601) | Recruiting | Hradec Králové | 500 05 | Czechia |
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| Aarhus University Hospital ( Site 0702) | Completed | Aarhus N | Central Jutland | 8200 | Denmark |
| Aalborg Universitetshospital ( Site 0703) | Recruiting | Aalborg | North Denmark | 9000 | Denmark |
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| Sjaellands Universitetshospital Roskilde ( Site 0701) | Recruiting | Roskilde | Region Sjælland | 4000 | Denmark |
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| Odense University Hospital ( Site 0705) | Completed | Odense C | Region Syddanmark | 5000 | Denmark |
| Centre Hospitalier Universitaire de Nice - Hôpital l'Archet ( Site 0810) | Recruiting | Nice | Alpes-Maritimes | 06202 | France |
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| Centre Hospitalier Lyon-Sud ( Site 0804) | Recruiting | Pierre-Bénite | Auvergne-Rhône-Alpes | 69495 | France |
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| Institut Paoli-Calmettes ( Site 0803) | Recruiting | Marseille | Bouches-du-Rhone | 13009 | France |
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| Centre Hospitalier de Versailles ( Site 0809) | Completed | Le Chesnay | Yvelines | 78150 | France |
| Hopital Saint Louis ( Site 0805) | Recruiting | Paris | 75010 | France |
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| Universitaetsklinikum Ulm. ( Site 0906) | Recruiting | Ulm | Baden-Wurttemberg | 89081 | Germany |
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| Universitaetsklinikum Koeln ( Site 0901) | Recruiting | Cologne | North Rhine-Westphalia | 50937 | Germany |
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| St. Marien-Krankenhaus Siegen ( Site 0914) | Completed | Siegen | North Rhine-Westphalia | 57072 | Germany |
| Universitaetsklinikum Carl Gustav Carus ( Site 0902) | Recruiting | Dresden | Saxony | 01307 | Germany |
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| Pecsi Tudomanyegyetem Altalanos Orvostudomanyi Kar ( Site 1202) | Recruiting | Pécs | Baranya | 7624 | Hungary |
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| Debreceni Egyetem Klinikai Kozpont ( Site 1201) | Recruiting | Debrecen | Hajdú-Bihar | 4032 | Hungary |
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| Szabolcs Szatmár Bereg Vármegyei Oktatókórház ( Site 1206) | Recruiting | Nyíregyháza | Szabolcs-Szatmár-Bereg | 4400 | Hungary |
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| Orszagos Onkologiai Intezet ( Site 1200) | Recruiting | Budapest | 1122 | Hungary |
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| Beaumont Hospital ( Site 2900) | Recruiting | Dublin | Dublin 9 | Ireland |
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| University Hospital Limerick ( Site 2903) | Recruiting | Limerick | V94 F858 | Ireland |
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| Ha Emek Medical Center ( Site 1305) | Recruiting | Afula | 1834111 | Israel |
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| Soroka Medical Center ( Site 1307) | Recruiting | Beersheba | 8457108 | Israel |
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| Rambam Medical Center ( Site 1301) | Recruiting | Haifa | 3109601 | Israel |
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| Hadassah Ein Karem Jerusalem ( Site 1300) | Recruiting | Jerusalem | 9112001 | Israel |
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| Chaim Sheba Medical Center ( Site 1302) | Recruiting | Ramat Gan | 5262001 | Israel |
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| Kaplan Medical Center ( Site 1304) | Recruiting | Rehovot | 76100 | Israel |
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| Sourasky Medical Center ( Site 1303) | Recruiting | Tel Aviv | 6423906 | Israel |
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| Istituto Tumori Giovanni Paolo II ( Site 1409) | Active, not recruiting | Bari | 70124 | Italy |
| A.O. Universitaria Policlinico S. Orsola-Malpighi ( Site 1400) | Recruiting | Bologna | 40138 | Italy |
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| ASST Spedali Civili di Brescia ( Site 1408) | Recruiting | Brescia | 25123 | Italy |
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| IRCCS Ospedale San Raffaele ( Site 1402) | Recruiting | Milan | 20132 | Italy |
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| Istituto Nazionale Tumori IRCCS Fondazione Pascale ( Site 1403) | Recruiting | Naples | 80131 | Italy |
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| Fondazione IRCCS Policlinico San Matteo ( Site 1407) | Recruiting | Pavia | 27100 | Italy |
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| IRCCS - Arcispedale Santa Maria Nuova ( Site 1405) | Recruiting | Reggio Emilia | 42123 | Italy |
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| Policlinico Umberto I ( Site 1404) | Completed | Roma | 00161 | Italy |
| Pratia MCM Krakow ( Site 1601) | Recruiting | Krakow | Lesser Poland Voivodeship | 30-727 | Poland |
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| Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego we Wrocławiu ( Site 1606) | Recruiting | Wroclaw | Lower Silesian Voivodeship | 50-367 | Poland |
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| Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - P-Kilinka Onkologii I Hematologii ( Site 1608) | Recruiting | Warsaw | Masovian Voivodeship | 02-781 | Poland |
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| Szpital Wojewódzki w Opolu-Hematology Department ( Site 1607) | Completed | Opole | Opole Voivodeship | 45-061 | Poland |
| Szpitale Pomorskie Sp. z o.o. ( Site 1600) | Completed | Gdynia | Pomeranian Voivodeship | 81-519 | Poland |
| Spitalul Clinic Colțea ( Site 1805) | Recruiting | Bucharest | Bucharest | 030171 | Romania |
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| Ovidius Clinical Hospital ( Site 1804) | Completed | Ovidiu | Constanța County | 905900 | Romania |
| Centrul de Diagnostic si Tratament Oncologic Brasov ( Site 1802) | Recruiting | Brasov | 500052 | Romania |
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| Institutul Regional de Oncologie Iasi ( Site 1801) | Recruiting | Iași | 700483 | Romania |
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| Severance Hospital Yonsei University Health System ( Site 2201) | Recruiting | Seoul | 03722 | South Korea |
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| Samsung Medical Center ( Site 2200) | Recruiting | Seoul | 06351 | South Korea |
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| Instituto Catalan de Oncologia ICO - Hospital Duran i Reynals ( Site 2000) | Recruiting | L'Hospitalet de Llobregat | Barcelona | 08908 | Spain |
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| Hospital Universitario de Salamanca ( Site 2002) | Recruiting | Salamanca | Castille and León | 37007 | Spain |
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| CHUAC-Complejo Hospitalario Universitario A Coruña ( Site 2005) | Recruiting | A Coruña | La Coruna | 15006 | Spain |
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| Hospital General Universitario de Alicante ( Site 2007) | Recruiting | Alicante | 03010 | Spain |
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| Hospital Universitari Vall d'Hebron ( Site 2001) | Recruiting | Barcelona | 08035 | Spain |
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| Hospital Universitario 12 de Octubre ( Site 2003) | Recruiting | Madrid | 28041 | Spain |
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| Hospital Puerta de Hierro ( Site 2009) | Recruiting | Madrid | 28222 | Spain |
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| Inselspital Bern ( Site 2303) | Recruiting | Bern | Canton of Bern | 3010 | Switzerland |
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| Istituto Oncologica della Svizzera Italiana (IOSI) ( Site 2302) | Recruiting | Bellinzona | Canton Ticino | 6500 | Switzerland |
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| Mega Medipol-Hematology ( Site 2406) | Active, not recruiting | Stanbul | Istanbul | 34214 | Turkey (Türkiye) |
| Ankara Universitesi Tip Fakultesi Cebeci Hastanesi ( Site 2400) | Recruiting | Ankara | 06590 | Turkey (Türkiye) |
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| VKV Amerikan Hastanesi ( Site 2403) | Completed | Istanbul | 34365 | Turkey (Türkiye) |
| Sisli Florence Nightingale Hastanesi ( Site 2407) | Recruiting | Istanbul | 34381 | Turkey (Türkiye) |
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| Dokuz Eylül Üniversitesi-Hematology ( Site 2402) | Active, not recruiting | Izmir | 35340 | Turkey (Türkiye) |
| MNPE ClinCenter of Oncology,Hematology,Transplantology and Palliative Care of CherkasyRegCouncil ( Site 2509) | Active, not recruiting | Cherkassy | Cherkasy Oblast | 18009 | Ukraine |
| Communal non-profit enterprise "Regional clinical hospital o-Hematology Department ( Site 2510) | Completed | Ivano-Frankivsk | Ivano-Frankivsk Oblast | 76008 | Ukraine |
| Instit. of Blood Transfusion Medicine of the National Academy ( Site 2506) | Recruiting | Lviv | Lviv Oblast | 79044 | Ukraine |
|
| National Cancer Institute ( Site 2507) | Recruiting | Kyiv | 03022 | Ukraine |
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| Bristol Haematology and Oncology Centre ( Site 2610) | Recruiting | Bristol | Bristol, City of | BS2 8ED | United Kingdom |
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| Nottingham University Hospitals NHS Trust. City Hospital Campus ( Site 2601) | Recruiting | Nottingham | England | NG5 1PF | United Kingdom |
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| GenesisCare - Windsor ( Site 2608) | Recruiting | Windsor | England | SL4 3HD | United Kingdom |
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| Sarah Cannon Research Institute UK ( Site 2612) | Recruiting | London | London, City of | W1G 6AD | United Kingdom |
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| GenesisCare - Oxford ( Site 2607) | Recruiting | Oxford | Oxfordshire | OX4 6LB | United Kingdom |
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| GenesisCare - Cambridge ( Site 2611) | Recruiting | Newmarket | Suffolk | CB8 7XN | United Kingdom |
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| The Royal Marsden NHS Foundation Trust. ( Site 2606) | Recruiting | Sutton | Surrey | SM2 5PT | United Kingdom |
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| The Christie NHS Foundation Trust ( Site 2602) | Recruiting | Manchester | M20 4BX | United Kingdom |
|
| ID | Term |
|---|---|
| D019337 | Hematologic Neoplasms |
| D008258 | Waldenstrom Macroglobulinemia |
| D008228 | Lymphoma, Non-Hodgkin |
| D015448 | Leukemia, B-Cell |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D054219 | Neoplasms, Plasma Cell |
| D009370 | Neoplasms by Histologic Type |
| D020141 | Hemostatic Disorders |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D010265 | Paraproteinemias |
| D001796 | Blood Protein Disorders |
| D006474 | Hemorrhagic Disorders |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D008223 | Lymphoma |
| D007945 | Leukemia, Lymphoid |
| D007938 | Leukemia |
Not provided
Not provided
| ID | Term |
|---|---|
| C000721068 | ARQ531 |
Not provided
Not provided
Not provided