Study of Ibrutinib + CD20 Antibody and Venetoclax in Patients With Untreated Mantle Cell Lymphoma
NCT ID: NCT04802590
Last Updated: 2024-10-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
194 participants
INTERVENTIONAL
2022-01-24
2031-09-30
Brief Summary
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Treatment duration of Ibrutinib and Venetoclax will be a maximum of two years. Patients will be treated with CD20 Ab for 3.5 years.
The primary aim is to assess MRD status at 6 months in both arms.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Arm A
Ibrutinib (+ CD20Ab)
Ibrutinib 560 mg
560mg/d continuously from C1D2 to end C24
Arm B
Ibrutinib + Venetoclax (+CD20Ab)
Ibrutinib 560 mg
560mg/d continuously from C1D2 to end C24
Venetoclax 10 MG Oral Tablet [Venclexta]
20mg/d from C2D1 to C2D7
Venetoclax 50 MG Oral Tablet [Venclexta]
50mg/d from C2D8 to C2D14
Venetoclax 100 MG Oral Tablet [Venclexta]
100mg/d from C2D15 to C2D21 200mg/d from C2D22 to C2D28 400mg/d from C3D1 to end C24
Interventions
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Ibrutinib 560 mg
560mg/d continuously from C1D2 to end C24
Venetoclax 10 MG Oral Tablet [Venclexta]
20mg/d from C2D1 to C2D7
Venetoclax 50 MG Oral Tablet [Venclexta]
50mg/d from C2D8 to C2D14
Venetoclax 100 MG Oral Tablet [Venclexta]
100mg/d from C2D15 to C2D21 200mg/d from C2D22 to C2D28 400mg/d from C3D1 to end C24
Eligibility Criteria
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Inclusion Criteria
2. Patient understood and voluntarily signed and dated an ICF prior to any study-specific assessments/procedures being conducted.
3. Patient willing and able to adhere to the study visit schedule and other protocol requirements
4. Women of childbearing potential must have negative results for pregnancy test prior to study treatment start and agree to abstain from breastfeeding during study participation and at least 18 months after the last drug administration
5. Men or women of reproductive potential agree to use acceptable method of birth control during treatment and for eighteen months after the last drug administration.
6. Histologically confirmed (according to the World Health Organization (WHO) classification) mantle cell lymphoma. The diagnosis has to be confirmed by phenotypic expression of CD5, CD20 and cyclin D1 or the t(11;14) translocation (by cytogenetics and/or fluorescence in situ hybridization (FISH) and/or BCL1-IgH PCR)
7. Untreated MCL
8. Adequate renal function as demonstrated by a creatinine clearance \> 50 mL/min; calculated by Cockcroft Gault formula or Modification of Diet in Renal Disease (MDRD)
9. Adequate hepatic function per local laboratory reference range as follow:
* Aspartate transaminase (AST) and alanine transaminase (ALT) \< 3.0 x upper limit of normal (ULN)
* Bilirubin \< 1.5 x ULN (unless bilirubin rise is due to Gilbert's syndrome or of non-hepatic origin)
10. Stage II-IV disease, measurable with at least lymph node \> 1.5 cm and requiring treatment in the opinion of the treating clinician
11. Eastern Cooperative Oncology Group (ECOG) performance status of 0 - 2.
12. Life expectancy of more than 3 months.
13. For France: patient affiliated to any social security system
Exclusion Criteria
2. Impaired organ function (other than liver and renal) which will interfere with the treatment
3. Hemoglobin level \< 10g/dL; Neutrophil count \<1 G/L; Platelets \< 75 G/L (except if related to lymphoma then platelet must be \>50),
4. Major surgery within 28 days before enrollment
5. Known central nervous system lymphoma
6. History of stroke or intracranial hemorrhage within 6 months prior to enrollment.
7. Requires anticoagulation with warfarin or equivalent vitamin K antagonists (e.g., phenprocoumon)
8. Requires treatment with strong CYP3A inhibitors
9. Vaccinated with live, attenuated vaccines within 6 months of enrollment (except COVID vaccine)
10. Known history of human immunodeficiency virus (HIV)
11. Evidence of other clinically significant uncontrolled condition(s) including but not limited to:
* Uncontrolled and/or active systemic infection (viral, bacterial or fungal)
* Chronic hepatitis B virus (HBV) or hepatitis C (HCV) requiring treatment. Note: subjects with serologic evidence of prior vaccination to HBV (i.e. HBs antigen negative, anti-HBs antibody + and antiHBc antibody -) and subjects with anti-HB-core antibody that are HBV DNA negative may participate
12. Psychiatric illness or condition which could interfere with their ability to understand the requirements of the study
13. Any life-threatening illness, medical condition, or organ system dysfunction which, in the investigator' opinion, could compromise the patient safety, interfere with the absorption or metabolism of treatment (Ibrutinib, CD20 Ab, venetoclax) or put the study outcomes at undue risk
14. Pregnant, planning to become pregnant, or lactating woman
15. Known hypersensitivity to study treatment (CD20 Ab, Ibrutinib, Venetoclax) or to any of the excipients
16. Known allergy to xanthine oxidase inhibitors or rasburicase
17. Known glucose-6-phosphate dehydrogenase (G6DP) deficiency
18. Known bleeding disorders
19. Severe prior reactions to monoclonal antibodies or with prior significant toxicity (other than thrombocytopenia) from Bcl-2 inhibitor
20. History of prior other malignancy with the exception of:
* curatively treated basal cell carcinoma
* curatively treated squamous cell carcinoma of the skin or carcinoma in situ of the cervix at any time prior to study
* other curatively treated cancer and patient disease-free for over 5 years
21. Anti-cancer therapies including chemotherapy, radiotherapy or other investigational therapy, including targeted small molecule agents
22. Biological agents (e.g. monoclonal antibodies) for anti-neoplastic intent: excluded 30 days prior to first dose of venetoclax
23. Person deprived of his/her liberty by a judicial or administrative decision
24. Adult person under legal protection
18 Years
79 Years
ALL
No
Sponsors
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Institute of Cancer Research, United Kingdom
OTHER
The Lymphoma Academic Research Organisation
OTHER
Responsible Party
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Principal Investigators
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Steven Le Gouill
Role: PRINCIPAL_INVESTIGATOR
Lymphoma Study Association
Toby Eyre
Role: PRINCIPAL_INVESTIGATOR
NCRI UK
David Lewis
Role: PRINCIPAL_INVESTIGATOR
NCRI UK
Locations
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A.Z. Sint Jan AV
Bruges, , Belgium
Universite Libre de Bruxelles - Hopital ERASME
Brussels, , Belgium
Hopital Jolimont
Haine-Saint-Paul, , Belgium
CHU de Liege
Liège, , Belgium
Universite Catholique de Louvain Mont Godinne
Yvoir, , Belgium
CHU d'Angers
Angers, , France
CH d'Avignon - Hopital Henri Duffaut
Avignon, , France
CH de la Côte Basque
Bayonne, , France
CHU Jean Minioz
Besançon, , France
Chu Morvan
Brest, , France
Institut d'Hématologie de Basse Normandie
Caen, , France
Chu Estaing
Clermont-Ferrand, , France
CH Henri Mondor
Créteil, , France
CHU de DIJON
Dijon, , France
CHD de Vendée
La Roche-sur-Yon, , France
CHU de Grenoble
La Tronche, , France
CHRU de Lille
Lille, , France
Hopital DUPUYTREN
Limoges, , France
Centre Léon Bérard
Lyon, , France
Institut Paoli Calmettes
Marseille, , France
CHU de Montpellier
Montpellier, , France
CHU de Nantes
Nantes, , France
Hopital St-Louis
Paris, , France
Hopital NECKER
Paris, , France
Chu de Bordeaux - Hopital Haut-Leveque - Centre Francois Magendie
Pessac, , France
Centre Hospitalier Lyon Sud
Pierre-Bénite, , France
Hopital de la Milétrie
Poitiers, , France
Ch Annecy Gennevois
Pringy, , France
CH de Cornouaille
Quimper, , France
CHU de REIMS
Reims, , France
CHU Pontchaillou
Rennes, , France
Centre Henri BECQUEREL
Rouen, , France
Hopital René Huguenin
Saint-Cloud, , France
Institut de Cancérologie de la Loire Lucien Neuwirth
Saint-Priest-en-Jarez, , France
Institut de Cancérologie Strasbourg Europe
Strasbourg, , France
IUCT Oncopole
Toulouse, , France
CHU Bretonneau
Tours, , France
CHU Nancy Brabois
Vandœuvre-lès-Nancy, , France
CH de Bretagne Atlantique - Hopital CHUBERT
Vannes, , France
Institut Gustave ROUSSY
Villejuif, , France
The Christie NHS Foundation Trust
Manchester, , United Kingdom
Norfolk and Norwich University Hospitals NHS Foundation Trust
Norwich, , United Kingdom
Oxford University Hospitals NHS Foundation Trust
Oxford, , United Kingdom
University Hospitals Plymouth NHS Trust
Plymouth, , United Kingdom
Royal Cornwall Hospital Trust
Truro, , United Kingdom
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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OASIS-II
Identifier Type: -
Identifier Source: org_study_id
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