- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT02341781
Observational Study of Lenalidomide in Subjects With Mantle Cell Lymphoma Who Failed Ibrutinib Treatment (MCL-004)
A Multicenter, Observational Study to Evaluate the Effectiveness of Lenalidomide (Revlimid®) in Subjects With Mantle Cell Lymphoma Who Have Relapsed or Progressed After Treatment With Ibrutinib or Are Refractory or Intolerant to Ibrutinib.
The objective of this study is to determine the effectiveness of lenalidomide in subjects with relapsed or refractory Mantle Cell Lymphoma (MCL) following ibrutinib treatment. MCL subjects who require treatment after receiving ibrutinib therapy are considered a population with high unmet medical need. It is therefore of benefit to have data on the outcomes of treatment options available in this patient population.
An observational study design was chosen to collect the clinical data already existing or being collected for MCL subjects being treated with lenalidomide.
MCL subjects who received lenalidomide either as monotherapy or as combination treatment after having relapsed or progressed on ibrutinib treatment or were refractory or intolerant to ibrutinib treatment are eligible for the study. Lenalidomide does not need to be the next subsequent treatment after ibrutinib.
Aperçu de l'étude
Statut
Les conditions
Type d'étude
Inscription (Réel)
Contacts et emplacements
Lieux d'étude
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Rhineland-Palatinate
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Mainz, Rhineland-Palatinate, Allemagne, 55131
- Universitatsmedizin der Johannes Gutenberg- Universitat
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Emilia-Romagna
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Bologna, Emilia-Romagna, Italie, 40138
- Azienda Ospedaliero Universitaria Di Bologna - Policlinico S.Orsola Malpighi
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Devon
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Plymouth, Devon, Royaume-Uni, Pl68DH
- Derriford Hospital Plymouth Oncology Center Clinical
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Arizona
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Phoenix, Arizona, États-Unis, 85054
- Mayo Clinic Scottsdale
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California
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Whittier, California, États-Unis, 90603
- Innovative Clinical Research Institute
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Florida
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Miami, Florida, États-Unis, 33136
- University of Miami and Sylvester Comprehensive Cancer
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Michigan
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Ann Arbor, Michigan, États-Unis, 48109
- University of Michigan Comprehensive Cancer Center Division of Hematology Oncology
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Missouri
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Jefferson City, Missouri, États-Unis, 65101
- Columbia Comprehensive Cancer Care Clinic
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New Jersey
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Hackensack, New Jersey, États-Unis, 07601
- Hackensack University Medical Center
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New York
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New York, New York, États-Unis, 10065
- Weill Cornell Medical College
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North Carolina
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Charlotte, North Carolina, États-Unis, 28204
- Levine Cancer Institute
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Pennsylvania
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Philadelphia, Pennsylvania, États-Unis, 19104
- University of Pennsylvania
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Texas
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Houston, Texas, États-Unis, 77030
- University of Texas MD Anderson Cancer Center
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Wisconsin
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Milwaukee, Wisconsin, États-Unis, 53226
- Froedtert and The Medical College of Wisconsin
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
Méthode d'échantillonnage
Population étudiée
Mantle Cell Lymphoma (MCL) subjects who received lenalidomide, either as monotherapy or as combination treatment, after having relapsed or progressed on ibrutinib treatment or were refractory or intolerant to ibrutinib treatment.
Lenalidomide does not need to be the next subsequent treatment after ibrutinib.
La description
Inclusion Criteria:
- Understand and voluntarily sign an informed consent document (ICD), if applicable, prior to any collection of study-related data.
- Males or females ≥ 18 years of age at the time of signing the ICD (if informed consent is applicable)
- Diagnosis of Mantle Cell Lymphoma (MCL) as assessed by the investigator. A copy of a pathology report establishing the diagnosis of MCL must be available
- Must have received at least one dose of ibrutinib and must have met at least one of the following criteria:
A. Relapse: Subjects with relapse following initial response of CR to ibrutinib (or an ibrutinib-containing regimen). Subjects may have discontinued or completed ibrutinib treatment at the time of relapse, and there is no upper limit on the time between the last dose of ibrutinib to time of relapse. B. Progressive disease (PD): Subjects with PD following initial response of PR to ibrutinib (or an ibrutinib-containing regimen). Subjects may have discontinued or completed ibrutinib at the time of progression, and there is no upper limit on the time between the last dose of ibrutinib to time of progression. C. Refractoriness: Subjects with i. Best response of stable disease (SD) during treatment with ibrutinib (or an ibrutinib-containing regimen), and then subsequently had PD, or ii. Best response of PD at anytime while on ibrutinib (or an ibrutinib-containing regimen) D. Intolerance: Subjects requiring premature discontinuation of ibrutinib for reasons other than PD prior to the planned end of treatment. Potential reasons for premature discontinuation may include Adverse Event (AE) attributed to ibrutinib or inability to continue ibrutinib for other reasons. Subjects responding to ibrutinib treatment must have documented PD/relapse following discontinuation of ibrutinib. The reason for the premature discontinuation of ibrutinib will be recorded.
Exclusion Criteria:
- no exclusion criteria.
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
Cohortes et interventions
Groupe / Cohorte |
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Relapsed,Progressed,Refractory or Intolerant to ibrutinib
MCL subjects who received lenalidomide after having relapsed or progressed on ibrutinib treatment or were refractory or intolerant to ibrutinib treatment
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
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Overall Response Rate (ORR)
Délai: Approximately 5.7 years
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Overall Response is defined as best response of Partial Remission (PR) or Complete Remission (CR) at any time during lenalidomide treatment.
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Approximately 5.7 years
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
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Duration of response (DoR)
Délai: Approximately 5.7 years
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DoR is defined as the time from the date of the initial response of at least PR (PR or CR) to the date of progressive disease (PD) or relapse.
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Approximately 5.7 years
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Adverse Events
Délai: Approximately 5.7 years
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Number of participants with adverse events.
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Approximately 5.7 years
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Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Directeur d'études: Oliver Manzke, MD, Celgene Corporation
Publications et liens utiles
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Estimation)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- CC-5013-MCL-004
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .
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