New pill shows promise against tough blood cancers
NCT ID NCT04728893
First seen Jun 27, 2026 · Last updated Aug 21, 2026 · Updated 8 times
Summary
This phase 2 study tests an oral drug called nemtabrutinib in about 490 people with blood cancers like chronic lymphocytic leukemia, non-Hodgkin lymphoma, and Waldenstrom's macroglobulinemia. The goal is to see if the drug can shrink tumors and control the cancer, while also checking for side effects. Participants take a tablet once a day, and the study is currently recruiting.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Nemtabrutinib (also called MK-1026 or ARQ 531), an oral tablet
- What this could lead to
- If successful, this could provide a new oral treatment option for people with certain blood cancers, helping to shrink tumors and control the disease.
- What could go wrong
- This is an early-phase (Phase 2) study, so the drug may not work as hoped or could cause serious side effects. Results may not apply to all patients.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 490 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Apr 2021
- Expected to finish
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Jan 2029
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * 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 * Part 2 Cohort J: CLL/SLL participants whose disease relapsed or was refractory to prior therapy with a covalent/irreversible BTKi and BCL2i. NOTE: As of Protocol Amendment 09, at least 10 CLL/SLL participants whose disease relapsed or was refractory to prior therapy with a covalent/irreversible BTKi, BCL2i and noncovalent/reversible BTKi (all three classes of therapies are required) will be enrolled into Cohort J * Has active disease for CLL/SLL clearly documented to initiate therapy * For SLL participants in Part 2: Has evaluable core or excisional lymph node biopsy for biomarker analysis from an archival or newly obtained biopsy or bone marrow aspirate at Screening (optional for participants enrolling in Part 1) Part 2 (Cohorts D to G) \- Has a confirmed diagnosis of and meets the following prior therapy requirements: * Participants with Richter's transformation who are relapsed or refractory following at least 1 line of prior therapy (Cohort D) * Participants with pathologically confirmed Mantle-cell lymphoma (MCL), documented by either overexpression of cyclin D1 or t (11;14), who are relapsed or are refractory to chemoimmunotherapy and a covalent irreversible BTKi (Cohort E) * Participants with Marginal zone lymphoma (MZL) (including splenic, nodal, and extra nodal MZL) who are relapsed or refractory to at least one prior line of systemic therapy including an anti-CD20-based regimen * Participants with Follicular lymphoma (FL) who are relapsed or refractory to chemoimmunotherapy and immunomodulatory agents (such as lenalidomide based regimen) (Cohort G) * Have measurable disease defined as at least 1 lesion that can be accurately measured in at least 2 dimensions with spiral Computed tomography (CT) scan * Has a lymph node biopsy for biomarker analysis from an archival or newly obtained biopsy or bone marrow aspirate (Cohort D) at Screening 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 * Has active disease defined as 1 of the following: systemic symptoms, physical findings, laboratory abnormalities, coexisting disease * Has measurable disease, satisfying any of the following: at least 1 lesion that can be accurately measured in at least 2 dimensions with spiral CT scan (minimum measurement must be \>15 mm in the longest diameter or \>10 mm in the short axis); IgM ≥450 mg/dL; or bone marrow infiltration of 10% * Has fresh bone marrow aspirate or a lymph node biopsy for biomarker analysis at Screening or a lymph node biopsy from an archival Exclusion Criteria: * 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
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Get notified about this study
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Genom att skicka in godkänner du våra Användarvillkor
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The study's own enquiry address
This study publishes an address for enquiries. See it below .
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The places running it
95 sites in 22 countries. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Show contact details
Enter your email to view the contact information for this study.
Genom att skicka in godkänner du våra Användarvillkor
Study contacts
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Contact
Email: •••••@•••••
Locations
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A.O. Universitaria Policlinico S. Orsola-Malpighi ( Site 1400)
RECRUITINGBologna, 40138, Italy
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ASST Spedali Civili di Brescia ( Site 1408)
RECRUITINGBrescia, 25123, Italy
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Aalborg Universitetshospital ( Site 0703)
RECRUITINGAalborg, North Denmark, 9000, Denmark
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Aarhus University Hospital ( Site 0702)
COMPLETEDAarhus N, Central Jutland, 8200, Denmark
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Anhui Provincial Hospital ( Site 2808)
ACTIVE_NOT_RECRUITINGHefei, Anhui, 230071, China
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Ankara Universitesi Tip Fakultesi Cebeci Hastanesi ( Site 2400)
RECRUITINGAnkara, 06590, Turkey (Türkiye)
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Arthur J.E. Child Comprehensive Cancer Centre ( Site 0401)
RECRUITINGCalgary, Alberta, T2N 5G2, Canada
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Astera Cancer Care ( Site 2732)
RECRUITINGEast Brunswick, New Jersey, 08816, United States
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BP - A Beneficencia Portuguesa de São Paulo ( Site 0302)
ACTIVE_NOT_RECRUITINGSão Paulo, 01321-001, Brazil
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Beaumont Hospital ( Site 2900)
RECRUITINGDublin, Dublin 9, Ireland
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Box Hill Hospital ( Site 0203)
RECRUITINGBox Hill, Victoria, 3128, Australia
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Bristol Haematology and Oncology Centre ( Site 2610)
RECRUITINGBristol, Bristol, City of, BS2 8ED, United Kingdom
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CHUAC-Complejo Hospitalario Universitario A Coruña ( Site 2005)
RECRUITINGA Coruña, La Coruna, 15006, Spain
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CIUSSS de l Est de L Ile de Montreal - Hopital Maisonneuve-Rosemont ( Site 0403)
RECRUITINGMontreal, Quebec, H1T 2M4, Canada
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Centre Hospitalier Lyon-Sud ( Site 0804)
RECRUITINGPierre-Bénite, Auvergne-Rhône-Alpes, 69495, France
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Centre Hospitalier Universitaire de Nice - Hôpital l'Archet ( Site 0810)
RECRUITINGNice, Alpes-Maritimes, 06202, France
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Centre Hospitalier de Versailles ( Site 0809)
COMPLETEDLe Chesnay, Yvelines, 78150, France
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Centro de Educación Médica e Investigaciones Clínicas (CEMIC) ( Site 0103)
RECRUITINGBuenos Aires, Buenos Aires F.D., C1431FWO, Argentina
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Centrul de Diagnostic si Tratament Oncologic Brasov ( Site 1802)
RECRUITINGBrasov, 500052, Romania
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Chaim Sheba Medical Center ( Site 1302)
RECRUITINGRamat Gan, 5262001, Israel
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Colorado Blood Cancer Institute ( Site 2726)
RECRUITINGDenver, Colorado, 80218, United States
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Communal non-profit enterprise "Regional clinical hospital o-Hematology Department ( Site 2510)
COMPLETEDIvano-Frankivsk, Ivano-Frankivsk Oblast, 76008, Ukraine
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Debreceni Egyetem Klinikai Kozpont ( Site 1201)
RECRUITINGDebrecen, Hajdú-Bihar, 4032, Hungary
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Dokuz Eylül Üniversitesi-Hematology ( Site 2402)
ACTIVE_NOT_RECRUITINGIzmir, 35340, Turkey (Türkiye)
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FUNDALEU ( Site 0104)
RECRUITINGCaba, C1114AAN, Argentina
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Fakultni nemocnice Hradec Kralove ( Site 0601)
RECRUITINGHradec Králové, 500 05, Czechia
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Fakultní nemocnice Brno Bohunice-Interni hematologicka a onkologicka klinika ( Site 0600)
RECRUITINGBrno, Brno-mesto, 625 00, Czechia
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Fondazione IRCCS Policlinico San Matteo ( Site 1407)
RECRUITINGPavia, 27100, Italy
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Fudan University Shanghai Cancer Center ( Site 2801)
RECRUITINGShanghai, Shanghai Municipality, 200032, China
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Fundacion Centro Oncologico de Integración Regional-Medical Oncology ( Site 0110)
COMPLETEDMendoza, M5500AYB, Argentina
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Fundacion Estudios Clinicos ( Site 0112)
RECRUITINGRosario, Santa Fe Province, S2000DEJ, Argentina
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GenesisCare - Cambridge ( Site 2611)
RECRUITINGNewmarket, Suffolk, CB8 7XN, United Kingdom
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GenesisCare - Oxford ( Site 2607)
RECRUITINGOxford, Oxfordshire, OX4 6LB, United Kingdom
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GenesisCare - Windsor ( Site 2608)
RECRUITINGWindsor, England, SL4 3HD, United Kingdom
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Guangxi Medical University Cancer Hospital ( Site 2814)
RECRUITINGNanning, Guangxi, 530028, China
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Ha Emek Medical Center ( Site 1305)
RECRUITINGAfula, 1834111, Israel
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Hadassah Ein Karem Jerusalem ( Site 1300)
RECRUITINGJerusalem, 9112001, Israel
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Henan Cancer Hospital-hematology department ( Site 2802)
RECRUITINGZhengzhou, Henan, 450008, China
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Highlands Oncology Group ( Site 2728)
RECRUITINGSpringdale, Arkansas, 72762, United States
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Hopital Saint Louis ( Site 0805)
RECRUITINGParis, 75010, France
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Hospital Aleman ( Site 0102)
RECRUITINGCiudad Autonoma de Buenos Aires, Buenos Aires, C1118AAT, Argentina
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Hospital General Universitario de Alicante ( Site 2007)
RECRUITINGAlicante, 03010, Spain
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Hospital Paulistano - Amil Clinical Research ( Site 0311)
RECRUITINGSão Paulo, 01321-001, Brazil
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Hospital Privado Universitario de Córdoba ( Site 0107)
RECRUITINGCórdoba, X5016KEH, Argentina
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Hospital Puerta de Hierro ( Site 2009)
RECRUITINGMadrid, 28222, Spain
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Hospital Universitari Vall d'Hebron ( Site 2001)
RECRUITINGBarcelona, 08035, Spain
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Hospital Universitario 12 de Octubre ( Site 2003)
RECRUITINGMadrid, 28041, Spain
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Hospital Universitario de Salamanca ( Site 2002)
RECRUITINGSalamanca, Castille and León, 37007, Spain
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Hospital das Clinicas FMUSP-Pesquisa Clínica Hematologia ( Site 0303)
RECRUITINGSão Paulo, São Paulo, 05403-000, Brazil
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Huashan Hospital, Fudan University ( Site 2821)
RECRUITINGShanghai, Shanghai Municipality, 200040, China
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Hunan Cancer Hospital ( Site 2822)
RECRUITINGChangsha, Hunan, 410013, China
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IRCCS - Arcispedale Santa Maria Nuova ( Site 1405)
RECRUITINGReggio Emilia, 42123, Italy
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IRCCS Ospedale San Raffaele ( Site 1402)
RECRUITINGMilan, 20132, Italy
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Inselspital Bern ( Site 2303)
RECRUITINGBern, Canton of Bern, 3010, Switzerland
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Instit. of Blood Transfusion Medicine of the National Academy ( Site 2506)
RECRUITINGLviv, Lviv Oblast, 79044, Ukraine
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Institut Paoli-Calmettes ( Site 0803)
RECRUITINGMarseille, Bouches-du-Rhone, 13009, France
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Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences & Peking Unio ( Site 2800)
RECRUITINGTianjin, Tianjin Municipality, 301617, China
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Instituto Catalan de Oncologia ICO - Hospital Duran i Reynals ( Site 2000)
RECRUITINGL'Hospitalet de Llobregat, Barcelona, 08908, Spain
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Instituto Nacional do Cancer Jose Alencar Gomes da Silva INCA ( Site 0300)
RECRUITINGRio de Janeiro, 20231-050, Brazil
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Institutul Regional de Oncologie Iasi ( Site 1801)
RECRUITINGIași, 700483, Romania
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Istituto Nazionale Tumori IRCCS Fondazione Pascale ( Site 1403)
RECRUITINGNaples, 80131, Italy
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Istituto Oncologica della Svizzera Italiana (IOSI) ( Site 2302)
RECRUITINGBellinzona, Canton Ticino, 6500, Switzerland
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Istituto Tumori Giovanni Paolo II ( Site 1409)
ACTIVE_NOT_RECRUITINGBari, 70124, Italy
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Jewish General Hospital ( Site 0400)
RECRUITINGMontreal, Quebec, H3T 1E2, Canada
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Jiangsu Province Hospital ( Site 2823)
RECRUITINGNanjing, Jiangsu, 210029, China
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John Theurer Cancer Center at Hackensack University Medical Center ( Site 2704)
RECRUITINGHackensack, New Jersey, 07601, United States
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Kaplan Medical Center ( Site 1304)
RECRUITINGRehovot, 76100, Israel
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Liuzhou People's Hospital ( Site 2817)
RECRUITINGLiuzhou, Guangxi, 545006, China
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Lundquist Institute for Biomedical Innovation at Harbor-UCLA-Hematology and Medical Oncology ( Site 2724)
COMPLETEDTorrance, California, 90502, United States
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MNPE ClinCenter of Oncology,Hematology,Transplantology and Palliative Care of CherkasyRegCouncil ( Site 2509)
ACTIVE_NOT_RECRUITINGCherkassy, Cherkasy Oblast, 18009, Ukraine
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Mayo Clinic - Rochester ( Site 2706)
ACTIVE_NOT_RECRUITINGRochester, Minnesota, 55905, United States
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Medical Oncology Associates (Summit Cancer Centers) ( Site 2710)
RECRUITINGSpokane, Washington, 99208, United States
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Mega Medipol-Hematology ( Site 2406)
ACTIVE_NOT_RECRUITINGStanbul, Istanbul, 34214, Turkey (Türkiye)
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Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - P-Kilinka Onkologii I Hematologii ( Site 1608)
RECRUITINGWarsaw, Masovian Voivodeship, 02-781, Poland
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National Cancer Institute ( Site 2507)
RECRUITINGKyiv, 03022, Ukraine
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Nepean Hospital-Nepean Cancer Care Centre ( Site 0204)
COMPLETEDSydney, New South Wales, 2747, Australia
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Nottingham University Hospitals NHS Trust. City Hospital Campus ( Site 2601)
RECRUITINGNottingham, England, NG5 1PF, United Kingdom
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Odense University Hospital ( Site 0705)
COMPLETEDOdense C, Region Syddanmark, 5000, Denmark
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Orszagos Onkologiai Intezet ( Site 1200)
RECRUITINGBudapest, 1122, Hungary
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Ovidius Clinical Hospital ( Site 1804)
COMPLETEDOvidiu, Constanța County, 905900, Romania
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Pecsi Tudomanyegyetem Altalanos Orvostudomanyi Kar ( Site 1202)
RECRUITINGPécs, Baranya, 7624, Hungary
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Peking University Third Hospital-Hematology ( Site 2827)
RECRUITINGBeijing, Beijing Municipality, 100191, China
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Policlinico Umberto I ( Site 1404)
COMPLETEDRoma, 00161, Italy
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Pratia MCM Krakow ( Site 1601)
RECRUITINGKrakow, Lesser Poland Voivodeship, 30-727, Poland
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Princess Margaret Cancer Centre-Division of Medical Oncology and Hematology ( Site 0406)
RECRUITINGToronto, Ontario, M5G 2M9, Canada
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Rambam Medical Center ( Site 1301)
RECRUITINGHaifa, 3109601, Israel
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Samsung Medical Center ( Site 2200)
RECRUITINGSeoul, 06351, South Korea
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Sanford Fargo Medical Center-Roger Maris Cancer Center ( Site 2708)
COMPLETEDFargo, North Dakota, 58102, United States
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Sarah Cannon Research Institute UK ( Site 2612)
RECRUITINGLondon, London, City of, W1G 6AD, United Kingdom
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Severance Hospital Yonsei University Health System ( Site 2201)
RECRUITINGSeoul, 03722, South Korea
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Sir Charles Gairdner Hospital ( Site 0200)
RECRUITINGNedlands, Western Australia, 6009, Australia
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Sisli Florence Nightingale Hastanesi ( Site 2407)
RECRUITINGIstanbul, 34381, Turkey (Türkiye)
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Sjaellands Universitetshospital Roskilde ( Site 0701)
RECRUITINGRoskilde, Region Sjælland, 4000, Denmark
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Soroka Medical Center ( Site 1307)
RECRUITINGBeersheba, 8410101, Israel
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Sourasky Medical Center ( Site 1303)
RECRUITINGTel Aviv, 6423906, Israel
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Spitalul Clinic Colțea ( Site 1805)
RECRUITINGBucharest, Bucharest, 030171, Romania
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St. Marien-Krankenhaus Siegen ( Site 0914)
COMPLETEDSiegen, North Rhine-Westphalia, 57072, Germany
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Sun Yat-sen University Cancer Center-Internal Medicine ( Site 2824)
ACTIVE_NOT_RECRUITINGGuangzhou, Guangdong, 510060, China
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Szabolcs Szatmár Bereg Vármegyei Oktatókórház ( Site 1206)
RECRUITINGNyíregyháza, Szabolcs-Szatmár-Bereg, 4400, Hungary
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Szpital Wojewódzki w Opolu-Hematology Department ( Site 1607)
COMPLETEDOpole, Opole Voivodeship, 45-061, Poland
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Szpitale Pomorskie Sp. z o.o. ( Site 1600)
COMPLETEDGdynia, Pomeranian Voivodeship, 81-519, Poland
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The Affiliated Hospital of Xuzhou Medical College ( Site 2818)
ACTIVE_NOT_RECRUITINGXuzhou, Jiangsu, 221000, China
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The Christie NHS Foundation Trust ( Site 2602)
RECRUITINGManchester, M20 4BX, United Kingdom
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The First Affiliated Hospital of Nanchang University ( Site 2815)
RECRUITINGNanchang, Jiangxi, 330006, China
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The First Affiliated Hospital, Zhejiang University ( Site 2826)
RECRUITINGHangzhou, Zhejiang, 310002, China
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The First Hospital of Jilin University-Hematology ( Site 2803)
RECRUITINGChangchun, Jilin, 130021, China
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The Ottawa Hospital ( Site 0404)
RECRUITINGOttawa, Ontario, K1H 8L6, Canada
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The Royal Marsden NHS Foundation Trust. ( Site 2606)
RECRUITINGSutton, Surrey, SM2 5PT, United Kingdom
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The Second Affiliated Hospital of Chongqing Medical University ( Site 2825)
ACTIVE_NOT_RECRUITINGChongqing, Chongqing Municipality, 400072, China
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The Second Xiangya Hospital of Central South University ( Site 2820)
RECRUITINGChangsha, Hunan, 410011, China
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The University of Louisville, James Graham Brown Cancer Center ( Site 2729)
COMPLETEDLouisville, Kentucky, 40202, United States
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UT Southwestern-Harold C. Simmons Cancer Center ( Site 2730)
RECRUITINGDallas, Texas, 75390, United States
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Universitaetsklinikum Carl Gustav Carus ( Site 0902)
RECRUITINGDresden, Saxony, 01307, Germany
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Universitaetsklinikum Koeln ( Site 0901)
RECRUITINGCologne, North Rhine-Westphalia, 50937, Germany
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Universitaetsklinikum Ulm. ( Site 0906)
RECRUITINGUlm, Baden-Wurttemberg, 89081, Germany
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University Hospital Limerick ( Site 2903)
RECRUITINGLimerick, V94 F858, Ireland
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University of California San Diego Moores Cancer Center ( Site 2717)
RECRUITINGLa Jolla, California, 92093-0698, United States
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Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego we Wrocławiu ( Site 1606)
ACTIVE_NOT_RECRUITINGWroclaw, Lower Silesian Voivodeship, 50-367, Poland
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VKV Amerikan Hastanesi ( Site 2403)
COMPLETEDIstanbul, 34365, Turkey (Türkiye)
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West China Hospital Sichuan University ( Site 2810)
RECRUITINGChengdu, Sichuan, 610041, China
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Wuhan Union Hospital ( Site 2816)
RECRUITINGWuhan, Hubei, 430022, China
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